SOP on Internal Audit and Self Inspection

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23106

1.0 Objective

To lay down a procedure for periodic internal audit and self-inspection to ensure current Good Manufacturing practices compliance.

2.0 Scope

This Standard Operating Procedure is applicable to all departments of the pharmaceutical formulation plant.

3.0 Responsibility

3.1 Audit Team   :           Auditing the facility and to prepare audit report comprising or recommendations and corrective action necessary for respective departments.

3.2 Auditee Head :            Head of the audited department, to ensure access is provided to internal audit team to the department and relevant documents required by internal audit team. He or she shall also ensure that corrective actions are taken within a specified time frame as mentioned in the internal audit report.

3.3 Head-QA :            Audit team constitution, audit schedule approval and distribution of Audit Report and Head-QA shall also ensure the compliance to the procedure.

4.0 Accountability

4.1 Department Heads & QA Head shall be accountable for the implementation of this SOP.

5.0 Abbreviations and Definitions

SOP                             :           Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

Internal Audit             :           An onsite verification of activity used to determine effective implementation of documented quality systems.

Self-Inspection            :           Verification of departmental activity used to determine effective implementation of documented quality systems.

Audit                           :           Word represents both Internal Audit and Self Inspection.

Auditor                        :          A person who has the technical qualification or is trained or the experience to perform audits.

Auditee                        :          A department to be audited.

QA                              :           Quality AssurancecGMP                          :            Current Good Manufacturing Practices

cGMP                          :            Current Good Manufacturing Practices

Ltd.                              :            Limited

6.0 Procedure

6.1 Audit shall be carried out at two levels. Self-inspection and Internal Audit.

6.1.1 Self-Inspection is done at departmental level i.e. representative of department shall perform inspection of all the documents and activities done by the department. Self-Inspection shall be conducted once in every two months. The Self Inspection shall have ±7 day’s acceptable tolerance and inspection shall be done within this period. These representatives shall be nominated as auditors by the Department Head and shall have direct reporting to department head. An audit report shall be prepared and corrective and preventive action shall be determined, filed and implemented. The representatives shall perform the audit of previous month document and activities.

6.1.2 Internal Audit shall be carried out by QA & / or by an audit team constituted by head QA in all operational departments. While selecting a team member for audit team, the head QA shall ensure that the member is not from the same department for which audit is to be carried out.

6.2 Internal Audit shall be carried out as per the schedule prepared by QA department (For frequencies of Internal Audit refer Annexure-IV). The month and department to be audited shall be mentioned in the internal audit planner (Annexure-III), which shall be prepared annually. This Internal audit planner shall be circulated to concerned department by Head-QA, preferably in the month of April of every fiscal year. The actual dates of audit shall be proposed by QA before executing the audit.

6.2.1 Quality Assurance shall mark the upper half box in red colour for planned date and the auditee department shall mark the lower half box in green colour against the planned date as per their suitability.

6.2.2 The internal audit planner shall be distributed in triplicates, one copy each for planned date from QA and the agreed date from the user department and one for QA department for execution reference.

6.2.3 The Internal audit shall have ±15 days acceptable tolerance and Audit shall be done within this period.

6.2.4 If internal audit of any particular department / activity is required towards the investigation/ addressing of the product complaint or product recall the same shall be performed any time.

6.2.5 Internal audit may also be conducted before the inspection of any regulatory body.

6.3 During the audit, auditors shall use the checklists for each department as given in Annexure-I (a) to Annexure-I (i), but the scope of audit may not be restricted to the checklist only. In checklist under the ‘Remarks’ column, the auditor shall mention whether the observation is adequate or inadequate.

6.4 The audit team shall evaluate systems, processes, and functions of the department to ascertain current level of the cGMP. The audit team shall check for the compliance for the various procedures, raw data and record the findings in “Internal Audit/Self Inspection Report” (Annexure-II).

6.4.1 The Auditor shall assign a seven character number as ‘AAXX/YY’ in consultation with QA to Audit report where;AA : Denotes the type of Audit i.e.

AA : Denotes the type of Audit i.e.For Internal Audit ‘AA’ shall be represented as (IA)

For Internal Audit ‘AA’ shall be represented as (IA)For Self Inspection ‘AA’ shall be represented as (SI)

For Self Inspection ‘AA’ shall be represented as (SI)XX :  Denotes

XX :  Denotes respective serial number of Audit.YY :  Denotes respective year of the Audit.

YY :  Denotes respective year of the Audit.e.g.   Second Internal Audit of the year 2015 shall be numbered as IA02/15

e.g.   Second Internal Audit of the year 2015 shall be numbered as IA02/15 and third self inspection audit in the month of March in the year 2015 shall be represented as SI03/15.

A new series of Audit report No. shall commence at the beginning of every fiscal year.

6.5 Observation made during the audit shall be discussed with the concerned in-charge of  the concerned department and / or the head of the department. Depending on the nature of the findings and the risk associated with any non-compliance, the following classifications shall be used:

Critical: – Deficiencies which have a high probability of causing adverse consequences to the patient or consumer or may result in significant deviations in the safety, identity, strength or purity of the product; or are a combination of major deficiencies which indicates a critical system failure.

Major: – Deficiencies which could potentially cause adverse consequences to the patient or consumer if left un-addressed could be considered indicative of poor control or are a combination of minor deficiencies which indicate a major system failure.

Minor: – A deficiencies which cannot be classified as critical or major.

Note: – A deficiency which is not related to GMP or regulatory conformance requirement (e.g. EHS), but warrant attention by the auditee.

Good Practice: – Demonstration of exemplary achievement of compliance or setting a precedent within the current industry standard.

6.6 Upon completion of the audit, audit team shall compile the audit report comprising of    recommendations, which shall be forwarded to respective department head for corrective    action and tentative date for compliance. For Internal audit the report shall be send    through Head-QA.

6.7 A register shall be maintained for self-inspection and Internal audit by QA regarding issuance of audit report to concerned department Head (refer Annexure-V)

6.8 For Internal audit reports concerned department head shall mention corrective action    plan and tentative date for compliance based upon audit observations and shall send back    the Audit Report within 15 working days of receipt of internal Audit report to QA.

6.9 Upon receiving back the internal audit report, Head-QA or his /her designee shall review internal-audit report and shall verify the corrective action taken. If required, a follow-up audit shall be carried out by any member of audit team. A review status of corrective   action taken shall be mentioned in the respective column of Internal Audit Report. A copy of report compiled by the audit team shall be forwarded to concerned department for final action and compliance.

6.9.1 If required, Head- QA shall discuss the action plans with the respective department head.

6.9.2 If Internal Audit Report is not received by QA within specified time limit of working days, a reminder(s) shall be sent to concerned department head.

A copy of this reminder(s) shall be attached with Internal Audit Report.

6.10 Finally Head-QA shall notify the Director of torque pharmaceuticals Pvt.Ltd about the critical audit findings & corrective action proposed/taken by the Auditee.

6.11 Results of previous internal audits shall be reviewed again during the next Internal Audit where no corrective action was taken.

6.12 Audit Planning and audit execution process are delineated in the “Flow chart for Internal Audit” for guidance (Annexure-VI & Annexure-VII).

Note:-The contents of the audit reports generated following this SOP are confidential and revelations of the observations in the audit reports to external auditors shall be at the discretion of Head Quality Assurance.

7.0 Forms and Records

7.1 Internal Audit Checklist     –                       Annexure-I(a) to Annexure-I(i)

7.2 Internal Audit/Self Inspection Report             –                       Annexure-II

7.3 Internal Audit Planner                                  –                       Annexure-III

7.4 Frequency of Internal Audits                        –                       Annexure-IV

7.5 Internal Audit/Self Inspection Register          –                       Annexure-V

7.6 Flow Chart for Internal Audit                         –                       Annexure-VI

7.7 Flow Chart for Internal Audit                         –                       Annexure-VII

8.0 Distribution

8.1 Master Copy :                Quality Assurance

8.2 Controlled Copies :           Administration, Production, Quality Assurance, Quality Control, Human Resource and Store

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

Annexure-I(a)

Audited Department:                                                                       Auditor:

Audit Date:

Inspection Check List for Raw Material Store
S. NO. CHECKLIST COMMENT
1 Are incoming material and components quarantine until approved for use?
2 Is there any material without label?
3 Are all materials stored off the floor?
4 Are all the raw materials stored on pallets?
5 Are materials spaced to allow for cleaning and labeling?
6 Is there any material without a label showing correct status (i.e. quarantined / approved / rejected)
7 Is there a clear demarcation for the following areas :

a)     Quarantine

b)     Approved

c)    Rejected

8

 

Observe the staging area:
     i.   Is the access to area restricted authorized personnel?
   ii.   Is there proper segregation of material issued for different batches?
 iii.   Is there a document indicating material movement in the staging area?
9 Is there an inventory movement record?
10 Is there a stock rotation program if yes, is it followed. Crosscheck five random readings?
11 Whether FIFO & FEFO system is followed?
S. NO. CHECKLIST COMMENT
12 Is the area segregated for raw and packing material?
13 Is the area adequate for physical separation between different materials to prevent mix-ups?
14 Are the material containers visually inspected, cleaned and weighed at the time of receipt? Check the receipt log.
15 Is material stored as per their status: quarantine, Hold, approved / released or rejected.
16 Are material requiring special storage conditions stored as per requirement?
17 Are the labels with complete information duly signed, written clear and legible text?
18 Is sampling done as per the sampling plan by QC?
19 Are the sampled containers labeled as ‘SAMPLED’?
20 Are the containers re-sealed after sampling under supervision?
21 Is sampling being documented in logbook?
22 Is dispensing being carried out in segregated environment?
23 Does the dispensing area have adequate exhaust and environmental monitoring (RH and temperature).Check records
24 Is Reverse LAF of Dispensing Booth working properly?
25 Is the dispensing area clean and clear of previous dispensing (check the equipment log, if any)
26 Check if the list of employees is available and updated.
27   i.      Is it conducted by authorized person under supervision of production / IPQA?
ii.      All dispensed material properly packed in suitable container / double polybag and labeled?
 iii.   All the calculations / weights checked by production / IPQA?
S. NO. CHECKLIST COMMENT
 iv.   Are the original container re-sealed or closed after use?
v.      Observe the area after completion of dispensing?
 vi.   Is there a documented procedure of cleaning of dispensing area after dispensing (i) between batches of same product (ii) between batches of different products?
28 Is the person dispensing raw material wearing gloves/masks/ goggles?
29 Is the weighing balance serviced / calibrated :
  i.      Platform balance
ii.      Electronic balance
30 Is the movement of man & material logical within stores and from stores to the production area?
31 Is the dispensed material moves under supervision from stores to production?
32 Is there a provision for dispensing of extra or additional material is it followed?
33 Are lighting and ventilation adequate to facilitate comfortable working?
34 Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
35 Check if the emergency exits in the building are maintained and unobstructed.
36 Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
37 Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control?
S. NO. CHECKLIST COMMENT
38 Are the SOPs for the following maintained and updated:

i.      Dispensing of Raw Material and transfer of dispensed material from RM store to Production.

ii.      Handling of Obsolete / Rejected Raw Materials

iii.   Cleaning of Equipments in Raw Material Store

iv.   Cleaning of Raw Material Store Area

39 Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
40 Check if cleaning records are maintained.
41 What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
42 Are the personnel trained in personnel Hygiene? Is the training documented?
43 Is SOP and training of personnel Records available? Is the relevant information like study material, attendance record, evaluation record, re-training record etc available?
44   i.      Is the list for storage condition of products available?

ii.      Are products stored as per the storage conditions?

45 Check if fire extinguishers are installed, properly labeled and preventive maintenance records maintained.
46 Are complete index and complete set of SOPs available?
47 Are the returned goods, recalled goods, expired goods completely demarcated?
48 Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
49 Is environmental condition records being maintained and recorded regularly?
50 Are sewage, trash, etc. disposal system adequate?
51 Are proper log maintained, available of all Rejected material in Rejected area room?
S. NO. CHECKLIST COMMENT
52 Are there any insects (Flies, mosquito’s, etc.) in the Receiving Bay?
53 Do the list of Storage Materials is Displayed on all Storage areas?
54 Do the Dispensing Booths are properly cleaned and Labeled?
55 Do Calibration records are available for Weights?
56 Do all Weights are Shrink Wrapped?
57 Do all vacuum cleaners are properly cleaned and placed at respective places?
58 Are there any dust found in Waste bins?
59 Are controlled substance kept under lock and key and purchase/consumption records maintained?
60 Are empty capsules stored under proper temperature & humidity and record maintained?
61 Are cleaned and uncleaned weighing equipments stored separately?
62 Are hazardous substances stored separately?
63 Do batch staging area have a yellow line?
Audited Department:                                                                       Auditor:

Audit Date:

Inspection Check List for Storage of Packing Materials
S. No. CHECKLIST COMMENT
1 Are incoming material and components quarantine until approved for use?
2 Are all materials stored off the floor?
3 Are materials spaced to allow for cleaning and labeling?
4 Are the packing materials of different products properly segregated?
5 Is the area adequate for physical separation between different materials to prevent mix-ups?
6 Is material stored as per their status: quarantine, approved / released or rejected?
7 Are the quarantine, approved / released or rejected area completely demarcated?
8 Whether each pack holding packing material appropriately labelled?
9 Are the printed labels kept under lock and key?
10 Is there a separate arrangement for printing of particulars as per coding record?
11 Are coded materials kept separately?
12 Are Operation and Cleaning records maintained separate for each printing machine?
13 Is there a stock rotation program if yes, is it followed. Crosscheck five random readings.
14 Is the FIFO & FEFO system being followed?
S. No. CHECKLIST COMMENT
15 Are the SOPs for the following maintained & Updated:

a)  Cleaning of packing material stores area

b)  Handling of Obsolete (Rejected Printed/ Unprinted) packing material

c)  Issue of packing Materials and transfer of issued materials from packaging material store to production

16 Are the labels with complete information and duly signed by QC and written clear and legible text?
17 Is sampling done as per the sampling plan by QC?
18 Is dispensing being carried out in segregated environment?
19 Is there a provision for dispensing of extra or additional material is it followed?
20 Check if the list of employees is available and updated.
21 Observer dispensing operation:

i.   Is it conducted by authorized person under supervision of production / IPQA?

ii.   All the calculations / weights checked by production / IPQA?

iii.   Observe the area after completion of dispensing?

22 Is the movement of man & material movement logical within stores and from stores to the production area?
23 Is the dispensed material moves under supervision from stores to production?
24 Observe the printed packaging material area :

i.      Is the entry restricted to authorized people only?

ii.      Is stacking / storage of material adequate?

iii.      Are the materials of different product and pack size segregated properly?

iv.      Is the labeling adequate?

v.      Is there a stock rotation program? If yes, is it properly implemented?

25 Is there a SOP for return of excess material e.g. online rejects etc. from the production to stores?
S. No. CHECKLIST COMMENT
26 Are lighting and ventilation adequate to facilitate comfortable working?
27 Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
28 Check if the emergency exits in the building are maintained and unobstructed.
29 Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
30 Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control?
31 Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
32 Check if cleaning records are maintained.
33 What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
34 Are the workforce trained in personnel Hygiene is the training documented?
35 Is SOP and training of personnel available?
36 Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
37 Are a complete index and a complete set of SOPs available?
38 Are the returned goods, recalled goods, expired goods completely demarcated?
39 Are material requiring special storage conditions stored as per requirement?
40 Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
41 Is environmental condition records being maintained regularly and recorded?
42 Are the weighing balances calibrated, Check records?
S. No. CHECKLIST COMMENT
43 Are sewage, trash, etc. disposal system adequate?
44 Are Proper log maintained & available of all Rejected material in Rejected area room?
45 Are there any insects (Flies, mosquito’s, etc.)?
46 Are All PVC/PVdC properly labeled and shrink wrapped?
47 Do All foils are properly labeled and Shrink wrapped?
48 Do Calibration records are available for weight?
49 Do all weights are Shrink Wrapped?
50 Do label room is Locked or not?
51 Is there Traceability for every label lock, label quantity in the label room?
52 Is there any dust found in waste bins?

 

Audited Department:                                                                       Auditor:

Audit Date:

Inspection Check List for Storage of Finished Products
S. No. CHECKLIST COMMENT
1 Are the products stacked properly, product wise and Batch-wise?
2 Are materials spaced to allow for cleaning and labeling?
3 Are all the products placed on raised platforms?
4 Is sufficient space maintained between rows and at the back with the walls for efficient cleaning purpose?
5 Observe the staging area:

i.   Is the access to area restricted authorized personnel?

ii.   Is there proper segregation of material issued for different batches?

iii.   Is there a document indicating material movement in the staging area?

6 Is there a stock rotation program if yes, is it followed. Crosscheck five random readings.
7 Does the finished goods stock adequately maintained i.e. C-boxes closed, taped and status labeled?
8 Is the area adequate for physical separation between different materials to prevent mix-ups?
9 Is separate space for product recall / return allocated?
10 Are the material containers visually inspected, cleaned and weighed at the time of receipt check the receipt log?
11 Is proper sale record maintained?
S. No. CHECKLIST COMMENT
12 Are material requiring special storage conditions stored as per requirement?
13 Is separate arrangement made for thermolabile products?
14 Is the movement of man & material movement logical within stores and from stores to the production area?
15 Is FIFO & FEFO system being followed?
16 Check if the list of employees is available and updated.
17 Are lighting and ventilation adequate to facilitate comfortable working?
18 Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?
19 Check if the emergency exits in the building are maintained and unobstructed.
20 Verify if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures.
21 Does the solution of cleaning and sanitation indicate rotation of Disinfectant?
22 Check if cleaning records are maintained.
23 What is the level hygiene: Good (G) /Excellent (E) / Satisfactory (S) / Bad (B)?
24 Are the workforce trained in personnel Hygiene? Is the training documented?
25 Is SOP and training of personnel available?
26 Are batch distribution records available?

i) Take 2 different batches and trace back their distribution.

27 Is the current list of distributors available?
28 Is the list for storage condition of products available?

i) Are products stored as per the storage conditions?

S. No. CHECKLIST COMMENT
29 Check if fire extinguishers are installed, checked, properly labeled and preventive maintenance records maintained.
30 Are a  complete index and a complete set of SOPs available?
31 Are the returned goods, recalled goods, expired goods completely demarcated?
32 Are material requiring special storage conditions stored as per requirement?
33 Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
34 Is environmental condition records being maintained regularly and recorded?
35 Are the weighing balances calibrated, check records?
36 Are sewage, trash, etc. disposal system adequate?
37 Are Proper log maintained& available of all Rejected material in Rejected area room?
38 Are there any insects (Flies, mosquito’s, etc.) in the buffer zone?
39 Do the change rooms are neat & maintained properly?
40 Do Batch Staging Area have a yellow Line?
41 Do Calibration records are Available for Weight Boxes?
42 Do all Weights are Shrink Wrapped?
43 Are there any Dust found in Waste bins?

 

 Anexxure – I(b)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Documentation / Quality Assurance
S. No. CHECKLIST COMMENT
1 Are master copies of all the SOPs kept lock & Key?
2 Are process deviations recorded?

i.      Is the disposition of deviation being done by department head of QA?

ii.      Are corrective actions taken and recorded?

3 Does the current lists of all the SOPs available?

i.      Verify the master copies of SOPs.

ii.      Verify the SOP distribution and retrieval record.

iii.      Are superseded / obsolete SOPs marked accordingly and preserved separately. Choose any 3 current SOPs and / verify the status of their obsolete SOPs

4 Are the changes in the process, documents introduces as per controlled procedure?

i.      Is the record for change control maintained?

ii.      Is the disposition of change control done by department head of QA?

5 Is the current list of approved vendors available?

i.      Is the list of vendor’s segregated material wise?

ii.      Are the vendors approved by QA verified the records?

6 Is the list of RM / PM available & verify the code numbers?
7  Are market complaints processed and recorded by QA?

i.      Verify from the records and check the action taken on any 3 complaints.

8 Does a person of QA Deptt. remain present at the time of dispensing of RM?
9 Have all the trainings been carried out as per schedule and their assessment records maintained properly?
S. No. CHECKLIST COMMENT
10 Are the self-inspections carried out as per schedule and records maintained?
11 Are all the Batch Manufacturing Records reviewed by the QA Manager before release of the product for sale?
12 Are the manufacturing and packing processes checked during production?
13 Are the BMRs of manufactured product kept properly in the record room year-wise?
14 Are the records maintained for the approval of formats?
15 Is a consolidated list of all the documents and records maintained, department-wise?
16 Is the Quality Policy available and displayed?
17 Is the current Quality manual available?
18 Is the current SMF available & verify that all the information provided in SMF is updated?
19 Is the organogram of the company available?

i.      Does the organization chart demarcates the key responsibilities?

ii.      Are all the functional areas headed by key persons with adequate qualification, experience and training?

20 Is the list of current technical persons/key persons available for QC, Production, QA, Stores and Warehouse?
21 Are the copies of current manufacturing licenses available?
22 Is the list of all the products available?

i.      Verify the code numbers.

ii.      List of products for pharma market.

iii.      List of products for export market.

S. No. CHECKLIST COMMENT
23 Does the current lists of specification / STPs for raw materials, finished products available?

i.      Verify the master copies of specification / STPs.

ii.      Verify specification / STP distribution and retrieval record.

iii.      Are superseded / obsolete specifications / STPs marked accordingly and preserved separately? Choose any 3 specification / STPs and verify the status of obsolete specifications / STPs.

24 Are Master formulae record available for all the products?

i.      Check the list of current MFRs.

ii.      Choose any 2 products and verify the Master formula records.

iii.      Are the master formula records authorized?

iv.      Does MFR includes expected final yields and intermediate yields?

25 Are batch manufacturing records (BMRs) issued and controlled as per the SOP?

i.      Choose any 4 products and verify the status of BMRs

ii.      Check the BMRs for any deviation or discrepancy.

Annexure-I(c) 

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Personnel                                                                                                 
S. No. CHECKLIST COMMENT
1 Verify if the list of employees is current.  
2 Is there a SOP for induction program of new recruits, Check records.  
3 Verify if responsibilities of key personnel’s are clearly designated and documented.  
4 Check induction and medical records of new joinee, select any 2 or 3 employees.  
5 Check the availability of a qualified medical practitioner.  
6 Mention the schedule for medical examination.  
7 Choose 2-3 employees from each section/dept. verify the following: Health records, medical leave records  
8 Verify whether a system exists for re-examination of an employee returning after a long medical leave by the company designated medical practitioner.  
9 Is the training imparted for SOPs, GMP etc.

i.      Check staff training records.

ii.      Check external trainers record and verify the attendance through staff training records

iii.       Is the training literature and material preserved

 
10 Have employees’ undergone training on GMP, SOP and on job requirements, Are records available?  
11 Verify training recording of three personnel.  
 

S. No.

CHECKLIST COMMENT
12 SOP and training of personnel available. Is the relevant information like study material, attendance record, evaluation record, re-training record etc available.  
13 Is the list of current technical persons available?  
14 Is a list of personnel and the responsibilities available?  
15 Is the first aid box provided at all the key locations?  

Annexure-I(D)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Premises including personnel facilities & Sanitation / Housekeeping
S. No. CHECKLIST REMARKS
1. Is the facility maintained in a clean and sanitary condition?  
2. Are the buildings constructed to facilitate adequate cleaning, sanitation and pest/rodent control?  
3. Are written procedures (SOPs) available for cleaning and sanitation, pest and rodent control (check annual contract)?  
4. Verify, if schedule for cleaning and sanitation are available for: walls, floors, ceiling and fixtures?  
5. Does the facility have written procedures for the safe and correct use of cleaning sanitizing agent?  
6. Does the solution of cleaning and sanitation indicate rotation of Disinfectant If yes, check disinfectant inventory/ stock?  
7. Is the area outside the manufacturing area regularly got sprayed and record maintained?  
8. Are all the common Entry change Rooms cleaned as per daily schedule and record maintained?  
9. Are all the primary area change rooms cleaned properly and records maintained?  
10. Are all the secondary areas of all the sections cleaned regularly as per daily schedule and records maintained?  
11. Are all the lifts kept neat and cleaned?  
12. Are all the wash basins of all the change Rooms kept neat & clean?  
13. Is proper record maintained for the supply of factory uniforms to all the Employees?  
14. Check if cleaning records are maintained?  
15. Are the cleaning material kept at their proper places?  
S. No. CHECKLIST REMARKS
16. What is the level hygiene: Good (G)/Excellent (E)/Satisfactory (S)/Bad (B) (especially check nail, hair, etc.)  
17. Is each workers provided with two sets of uniforms/apparel Check records  
18. Are the gowning and degowning SOPs available and properly displayed in the change room?  
19. Is there a fixed schedule for washing of uniform? Check records.  
20. Are the workforce trained in personnel Hygiene is the training documented?  
21. Is the canteen or eating room facility neat and clean?  
22. Check if fire extinguishers are installed, checked, properly labeled and are fire safety drills performed as per schedule?  
23. Is written procedure describing safety measures is available?  
24. Are lighting and ventilation adequate to facilitate comfortable working?  
25. Check if the emergency exits in the building are maintained and unobstructed?  
26. Check if toilet cleaning and maintenance record are maintained, Availability of soap, hot and cold water air dryers, single service towels?  
27. Is waste being segregated as – plastics, organic, metal etc.?

 

Annexure-I(e)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Maintenance of buildings and Equipments / Engineering Services
S. No. CHECKLIST REMARKS
1. Are written procedure established for maintenance of equipment and utilities?  
2. Are utilities maintain and monitored as per schedule?
3. Is the preventive maintenance of major utilities being performed?

a)   Air Handling Units (AHUs)

b)   Compressed Air

c)   Vacuum Pump

d)  Air Conditioners

e)   Chiller Plant

f)    DG sets

g)   Boiler

4. Does the filters in compressed air units are cleaned as per schedule? Check the SOP & records.
5. Does the filters and prefilters in AHU system are cleaned as per schedule? Check the SOP & records.
6. Is the cleaning procedure available for?

a)   Cooling towers

b)   Chiller plant

c)   Air handling units / duct / dampers

d)  Raw / DM Water storage tanks

7. Are the service pipes clearly marked & indicate direction of flow (air, water, vacuum, LPG, Compressed Air)?
8. Is there a schedule for the maintenance of service pipes? If yes, check the records.
9. Is there a SOP on building maintenance? If yes, check the records?
10. Does calibration planner is available and check for the compliance?
11. Is the preventive Maintenance of all the Machine done according to their preventive maintenance schedule and records maintained?
S. No. CHECKLIST REMARKS
12. Is the proper record regarding re-filling and monthly verification of conditions of Fire Extinguishers installed at various places maintained properly?
13. Is the record of breakdown of machines maintained properly?
14. Are the STP & ETP logbooks maintained?
15. Are the Logbooks of all the DM Water tanks maintained?
16. Are the Logbooks of all the Air Compressors maintained?
17. Is the Logbook of the Electricity Meter Reading maintained?
18. Are the Logbooks of Operation & service of Generators maintained?
19. Is the Logbook of Operation & service of Boiler maintained?
20. Is the Logbook of DM Water Plant Charging maintained?
21. Is the list of critical spare parts for all the machines / equipment’s available?

a)      Check the list of critical spares for equipment; one each from production and utility.

b)     Check the stock ledger for the spare parts.

22. Is the validation / calibration of equipment’s / guages performed as per schedule

i) Check the validation / calibration records of  minimum three equipment

a)…………………………………………..

b)…………………………………………..

c)…………………………………………..

23. Is the annual maintenance contract (AMC) / agreement available for the equipment which are not covered under preventive maintenance schedule?
24. Check the record for job orders received and executed?

 

Annexure-I(f)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Equipment
S. No. CHECKLIST REMARKS
1. Does all equipments used for manufacturing / processing are suitable in their size / capacity?
2. Are the location of the equipment / machines in the facility acceptable?
3. Is there adequate space for the following equipments? blender(s) dryer, compression machine(s) capsule fillers, bottle fillers etc.
4. Are the equipment / machines properly design and installed?
5. Are machine surfaces that direct contact the materials or finished goods non-reactive, non-absorptive and non-adaptive so as not to affect the product?
6. Is the ideal equipment stored in a designated area?
7. Is equipment cleaned promptly after used?
8. Are written operating procedures available for each equipment used in manufacturing / processing or holding of components, in process material or finished product?
9. Does the startup procedure ensure that equipment is thoroughly cleaned?
10. Are all equipments have an identification no.?
11. Do the major equipment have usage logs, cleaning logs, preventive maintenance logs?
12. Are the relevant components of the machines calibrated and records maintained?
13. Are monitoring devices like thermometers, hygrometers installed, calibrated and functional?
14. Does the filters in the inlet of FBD are cleaned as per schedule? Check the SOP.

Annexure-I(g)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Production and In-process Control
S. No. CHECKLIST REMARKS
1. Is the entry to the production area restricted?  
2. Are the work force trained in gowning / degowning / personnel hygiene / SOP / GMP etc? Check compliance to SOP  
3. Are production personnel attired as per SOP?  
4. Does complete set of SOPs available. Is it current?
5. Verify the list of equipment and their identification codes.
6. Is the BMR approved by QA prior to submission in doc cell?
7. Check a current batch record from the shop floor.
8. Are raw and packaging material tags attached in the BMR?
9. Are the environmental conditions in different areas being monitored, maintained and recorded?
10. In case of failure is the concerned department informed. Are the corrective actions documented?
11. Is the impact of such environmental failure evaluated for impact on product?
12. Is the procedure for line clearance followed? Question people regarding pack up at the end of shift or otherwise.
13. Are the line clearance records being attached with the respective BMR?
14. Does the machine indicate batch details and stage of processing of the batch?
15. Are the in process checks being verified by IPQA personnel along with production personnel?
16. Are the technical instruction being followed and entries being made in it, simultaneously?
S. No. CHECKLIST REMARKS
17. Is there a procedure for issue, use and destruction of rubber stereos for coding during labeling and packing operations?
18. Before the start of coding, are all specimens approved by IPQA?
19. Are the approved specimen attached in the BMR of the product?
20. How are coded unused material handled. Ask the manufacturing and packing supervisor?
21. Are the labeling and packaging lines appropriate?
22. Are there any physical separation between packaging lines?
23. Is one product being processed in particular area?
24. Is the wash water concept used for equipment?
25. Are the washed and cleaned containers and machinery stored properly when not in use ?
26. Is the procedure for process deviation implemented? Check records.

 

Annexure-I(h)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Quality Control
S. No. CHECKLIST REMARKS
1. Is the lab neat and orderly with enough space for working space?
2. Lab Reagents:

i.      Reagents bottles properly labeled (Name, date of preparation, use before date, prepared by)

ii.      Reagents bottle properly closed

iii.      Placed as per temperature requirements

3. Is there a ledger maintained for stock of chemicals and media?
4. Is there proper storage area with different chemicals differentiation?
5. Instrument Calibration / Maintenance

i.   Check out three instruments, check calibration SOP and records.

ii.   Is there a specific program schedule of calibration?

iii.   Where external standards are used verify their reliability?

iv.   All the instruments been calibrated in the operational range?

6. Testing and Analysis

i.      Are all tests being performed as per Standard Test Procedure?

ii.      Are the testing report signed and dated by analyst?

iii.      Are the testing records counter checked by QC in-charge before release of sample?

iv.      Is there a SOP on out of specification results?

7. Is entry to laboratory restricted?
8. Are the standard bacterial cultures available?
9. Is the areas passing record available?
10. Is the SOP for cleaning validation available?
11. Is gowning and degowning SOP available for Microbiological Lab?
12. Is there a SOP for fumigation for Microbiological Lab?
S. No. CHECKLIST REMARKS
13. Is there a SOP for cleaning and operation of LAF?
14. Are the cleaning and operation checks implemented and recorded?
15. Is there an SOP describing preparation, usage and discarding of used cultured media?
16. Are the Solutions, Reagents, Indicators etc. stored in Orderly manner?
17. Are the glass wares cleaned properly?
18. Are the testing records maintained regularly giving all the required particulars?
19. Is daily pH and conductivity of Purified water record maintained?
20. Is chemical analysis of Purified water done daily and record maintained?
21. Are all the instruments kept on shelves in orderly manner?
22. Is the Humidity and Temperature record of stability chamber maintained regularly?
23. Are all the Instruments in Micro Lab neat & clean?
24. Is the Incubator in proper working order & required temperature maintained?
25. Are Auto-claves having their SOPs near the Instruments?
26. Are both Autoclaves validated and records maintained?
27. Are log books of all Instruments in Micro lab maintained regularly?
28. Are the Controlled Samples of all batches of all the products are preserved?
29. Is Controlled samples register maintained?
30. Is the Room temperature record of Control sample room maintained?

 

Annexure-I (i)

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Ointments & Creams Section  
S. No. CHECKLIST REMARKS
a) MANUFACTURING
1. Is there any material without label?
2. Is every machine / equipment labelled with correct status?
3. Are operators wearing:

a) Factory uniform properly

b) Gloves/Masks

c) Foot wears

4. Is the weighing balance serviced / calibrated and record maintained?
5. Whether the Operation & Cleaning Log books for the following maintained & updated:

a) Water Vessel

b) Melting Tank

c) Mixing Tank

d) Storage Tank

e) Planetary Mixer

6. Is the batch preparation record compiled concurrently?
7. Are there any Raw Material present in the department which belongs to two different products?
8. Are the SOPs for the following maintained and updated:

a) Cleaning of Mixing Tank during product changeover.

b) Cleaning of Storage Tank

b) TUBE FILLING
1. Whether all the machines are labelled with correct status?
2. Are the operators wearing full sleeve garments /gloves?
3. Is there more than one product in the room?
S. No. CHECKLIST REMARKS
4. Is the room clean and free of any evidence of other products?
5. Are the following In-process controls being exercised by both Asstt. Mfg. Chemist & QA personnel:

a) Weight variation

b) Crimping & embossing check

c) Cap tightening check

6. Whether the Operation & Cleaning log-books for the following maintained & updated:

a) Tube filling machine

b) Transfer pump

7. Is the filling record being compiled concurrently?
c) TUBE PACKING
1. Is there any material or container without proper label?
2. Is the room clean and free of any evidence of other product?
3. Whether all the details in packing record are being entered at appropriate timings?
d) MISCELLANEOUS
1. Is the line clearance procedure being followed?
2. Are Cleaning log-books maintained separately for :

a)      Primary Area

b)      Secondary Area

 
 
 
Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Liquid Section  
S. No. CHECKLIST REMARKS
a) MANUFACTURING
 Is there any material without label?
Is every machine / equipment labelled with correct status?
Are operators wearing:

a) Factory uniform properly

b)Gloves/Masks                                                                                                            c) Foot wears

Whether the Operation & Cleaning log books for the following Maintained & Updated:

a) Melting Tank

b) Mixing Tank

c) Storage Tank

Is the batch preparation record compiled concurrently?
Are there any Raw Materials present in the department which belong to two different products?
Are the SOPs for the following maintained and updated:

a)  Cleaning of Mixing Tank during product changeover.

b)   b)  Cleaning of Storage Tank

     b) BOTTLE FILLING
Is there any packing / raw material or finished goods belonging to other products present in the department?
Does the filling machine bear appropriate label?
Has the filling machine been cleaned before commencement of filling?
Is the fill volume checked?
     c) BOTTLE PACKING
Is there any material or container without proper label?
S. No. CHECKLIST REMARKS
Is the room clean and free of any evidence of other product?
Whether all the details in packing record are being entered at appropriate timings?
d) MISCELLANEOUS
1. Is the line clearance procedure being followed?
2. Are Cleaning log-books maintained separately for :

a)      Primary Area

b)     Secondary Area

 

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Oral Liquids Preparation Section
S. No. CHECKLIST REMARKS
a) MANUFACTURING
Is there any material without label?
Is every machine / equipment labelled with correct status?
Are operators wearing:

a) Factory uniform properly

b)Gloves/Masks                                                                                                            c) Foot wears

Whether the Operation & Cleaning log books for the following maintained & updated:

a) Sugar Syrup:

i.   Mfg. Tank

ii.   Storage Tank

iii.Transfer Tank                                                                                   b)Batch Room:

i.   Compounding Tank

ii.   Storage tank for Bulk Products

iii.   Filter Press

Is the batch record compiled concurrently?
Are there any Raw Materials present in the department which belong to two different products?
      b) BOTTLE FILLING LINE-I
Is there any packing / raw material or finished goods belonging to other products present in the department?
Does the filling machine bear appropriate label?
Has the filling machine been cleaned before commencement of filling?
Is the fill volume checked?
S. No. CHECKLIST REMARKS
c) BOTTLE FILLING LINE-II
      1. Is there any packing / raw material or finished goods belonging to other products present in the department?
2. Does the filling machine bear appropriate label?
3. Has the filling machine been cleaned before commencement of filling?
4. Is the fill volume checked?
d) BOTTLE PACKING LINE-I
1. Is there any material or container without proper label?
2. Is the room clean and free of any evidence of other product?
3. Whether all the details in packing record are being entered at appropriate timings?
e) BOTTLE PACKING LINE-II
1. Is there any material or container without proper label?
2. Is the room clean and free of any evidence of other product?
3. Whether all the details in packing record are being entered at appropriate timings?
f) MISCELLANEOUS
1. Is the line clearance procedure being followed?
2. Are Cleaning log-books maintained separately for :

a)      Batch Room

b)     Primary Area Line-I

c)      Primary Area Line-II

d)     Secondary Area Line-II

e)      Secondary Area Line-II

 

 

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Aseptic Section
S. No. CHECKLIST REMARKS
    a) COMPONENT PREPARATION AREA
1. Is decartoning of Vials / Ampoules done in separate decartoning rooms?
     2. Are footwears and uniforms dedicated to components preparation area?
3. Is record of compressed air filters cleaning maintained?
4. Is record for DM water filters cleaning maintained and updated?
5. Is SOP for vials / Ampoules washing machine operating instructions written?
6. Are operators using hand gloves?
7. Are operators trained for the job?
   b) COMPOUNDING
1. Is batch preparation record compiled concurrently?
2. Is the materials weighing done in compounding room?
3. Is compounding room part of Sterile Block?
4. Are footwears and uniforms dedicated to compounding room?
5. Check the area and method of collecting distilled water for batch compounding.
6. Are log books for Operation and Cleaning of compounding tanks maintained & updated?
7. Is SOP of tank calibration written?
8. Are masks worn by compounding personnel?
9. What is the method of make-up the final volume?
10. Is the compounding tank itself used as a pressure vessel for sterile filtration?
   c) STERILE FILTRATION
1. Method of sterilizing membrane filter- Autoclaving / Dry heat
2. Is sterilization indicator used?
3. Is date of sterilization written?
4. How are sterile membranes stored?
S. No. CHECKLIST REMARKS
 5. Is bubble point test of the membrane filters done before and after filtration?
 6. Adequacy of storing sterile filtered bulk solution?
 7. Is HEPA filter tested for DOP test?
   d) DRY HEAT STERILIZATION
    1. Check the loading pattern of S.S. boxes.
    2. How sterilized materials are stored?
   e) AUTOCLAVE STERILIZATION
1. Condition of sterilizing equipment?
2. Are log-books for Operation & Cleaning of both the Autoclaves maintained and updated separately?
3. Is proper procedure followed for sterilization of rubber stoppers?
4. How sterilized materials are stored in sterile area?
    5. Are sterilization indicators used?
    f) SEALING OF VIALS
1. How seals are placed on the stoppered vials?
2. Any stoppers found popped up in vials before placing seals?
   g) VISUAL INSPECTION OF VIALS/AMPOULES
1. Is classification of optical reject done?
2. How different products and batches are segregated?
3. Where rejected vials are stored after completion of inspection?
4. Is inspection of Vials / Ampoules done by rotation of workers?
5. Are optically good vials and rejected vials segregated during optical inspection?
6. Have all the operators undergone eye-check up?
    h) LABELLING
1. Is overprinting done in-house? If it is in house, check overprinting area and comment
2. Is labelling & packing done in one room?
3. If No. 2 is yes, how segregation of batches and product done?
4. How balanced packing materials are destroyed?
S. No. CHECKLIST REMARKS
i) PACKING
1. Check packing records at random.
2. Line clearance for batch / product changeover SOP.
3. Is pack profile for all products available?
   j) NON-VIABLE PARTICULATES MONITORING
1. What is the maximum temperature in filling rooms?
2. What is the humidity in filling room?
3. Is humidity meter calibrated using a sling psychrometer?
4. Comments about sterile area facility
5. Are all HEPA filters tested for integrity?
6. Are HEPA filters tested for integrity by DOP Test / Particle counter / both?
7. Check the air flow direction report
8. Have Rooms been monitored for direction of air flow?
  k) VIABLE PARTICLE MONITORING OF STERILE AREAS
1. What is the size of Petri dishes used?
2. Which media is used to prepare Petri dishes?
3. Are plates preincubated?
4. Check locations of plate exposure
5. How many plates are exposed per room?
6. What is the duration of plate exposure?
7. Which rooms are monitored?
8. Are Rodac contact plates used or swabs are used?
9. If swabs are used, what is the sterilization procedure?
S. No. CHECKLIST REMARKS
10. Is alternate testing media used any time for sterile area monitoring?
    l) TRAINING
1.  Are operators training program record maintained?
2. Is supervisors training programme record maintained?

 

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Tablet Section
S. No. CHECKLIST REMARKS
1.        Are the equipments cleaned properly after change of product / Batch?
2. Are log books for operation and cleaning of Equipments/Machines maintained separately and properly and also updated?
3. Do all the equipments bear status labels?
4. Are the following In-process tests performed by the Asstt. Mfg. Chemist and QA Officer and record maintained?

a)   Weight Variation

b)   Disintegration time

c)   Hardness

d)  Friability

5. Is primary area neat and clean and cleaning log book maintained?
6. Is secondary area neat and clean and cleaning log book maintained?
7. Is Batch coding of strip / foil checked the Asstt. Mfg. Chemist and QA Officer and record maintained?
8. Are strips checked for leakage?
9. Are the balances calibrated and record maintained?
10. Do all the containers bear status labels?
11. Are the tablets visually inspected before packing?
12. Is primary area neat and clean and cleaning log book maintained?
13. Are the AHU filters cleaned as per schedule and record maintained?
Audited Department :                                                                       Auditor :

Audit Date:

Inspection Check List for Capsule Section
S. No. CHECKLIST REMARKS
1.        Is primary area neat and clean and cleaning log book maintained?
2. Is secondary area neat and clean and cleaning log book maintained?
3. Are log books for operation and cleaning of all the Machines/Equipments maintained separately and updated?
4. Are the humidity and temperature controlled in the following rooms and record maintained?

a)  Batch Manufacturing Room

b)Filling Room

c)  Polishing Room

d)  Primary packing Room

5. Are the following In-process tests performed?

a)Weight variation

b)  Disintegration time

c)Leak test

6. Are the balances calibrated and records maintained?
7. Do all the equipments bear proper status labels?
8. Is AHU filter cleaning record maintained?

 

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for Syrup Section
S. No. CHECKLIST REMARKS
1.        Are primary areas neat and clean and cleaning log book maintained?
2. Are secondary areas neat and clean and cleaning log book maintained?
3. Are log books for operation and cleaning of all the Machines/Equipments maintained and updated?
4. Are the humidity and temperature controlled in the following rooms and record maintained?

a)Batch Manufacturing Room

b)     Filling Room

5. Are the following In-process tests performed by the Asstt. Mfg. Chemist and QA Officer and record maintained?

a)Weight variation

b)  Disintegration time

c)Leak test

d)  Sealing of bottles

6. Are the balances calibrated and records maintained?
7. Do all the equipments bear proper status labels?
8. Is batch coding checked?
9. Is AHU filter cleaning record maintained?

 

Audited Department :                                                                       Auditor :

Audit Date :

Inspection Check List for External Powders Section
S. No. CHECKLIST REMARKS
   a) MANUFACTURING
1.        Is there any material without label?
2. Is every machine / equipment labelled with correct status label?
3. Are operators wearing :

a) Factory uniform properly

b) Gloves/Masks

c) Foot wears

4. Is the weighing balance serviced / calibrated?
5. Is the batch record compiled concurrently?
6. Are there any Raw Materials present in the department which belong to two different products?
7. Are the SOP for the following maintained and updated:

a) Cleaning of Blender during product changeover.

b) Operation of Powder Filling Machine

  b) a)      B  BOTTLE FILLING
1.        Is there any packing / raw material or finished goods belonging to other products present in the Filling Room?
2.        Does the filling machine bear appropriate label?
3.        Has the filling machine been cleaned before commencement of filling?
4.        Is the fill weight checked by the Asstt. Mfg. Chemist and QA Officer and record maintained?
 

 

   
S. No. CHECKLIST REMARKS
   c) BOTTLE PACKING
1.        Is there any material or container without proper label?
2.        Is the room clean and free of any evidence of other product?
3.        Whether all the details in packing record are being entered at appropriate timings?
4.        Are the cleaning log books for the following maintained and updated:

a) Primary Area

b) Secondary Area

5.        Is the line clearance procedure being followed?

 

Annexure-II

Audit report No. :                              Date :                       Dept. Audited :                     Area Audited :
Auditor        
Designation        
Department        
Signature        
Date        
S. No. Audit Findings Recommendation Corrective Action Plan Tentative date for compliance Review Status

(By Audit team / member)

/Sign with date

     

 

     

Annexure-III

Department Months
Apr. May June July Aug. Sept. Oct. Nov. Dec. Jan. Feb. Mar.
Production                        
Quality Control                        
Engineering                        
Quality Assurance                        
RM Store                        
PM Store                        
FG Store                        
Administration & Housekeeping                        
HRD                        

The actual dates of audit shall be confirmed before the audit schedule.

           

Prepared by:                                                                                        Approved by :                                                                                                                                                    

Annexure-IV

Departments Frequency of Internal Audit
Production Once in 4 Months
Quality Control Once in 4 Months
Quality Assurance Once in 4 Months
Store Once in 4 Months
Finished Goods Warehouse Once in 4 Months
Engineering Once in 4 Months
Human Resource Development Once in 6 Months
Administration and Housekeeping Once in 6 Months

Annexure-V

S. No. Department Audited Audit date Internal Audit No. Audit Report sent for corrective action plan to concerned Deptt. Head Audit report received after corrective action plan & tentative date for compliance.
Sent by Date Received by Date
               
               
               
               

Annexure-VI

Annexure-VI

                                                                                                                                           

 Annexure-VII

Annexure-VII

 

 

 

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