1.0 Objective
To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Requalification of existing approved vendors.
2.0 Scope
This Standard Operating Procedure is applicable for vendor qualification, De-qualification and Requalification of raw material & packing material to be followed at Pharmaceutical formulation plant.
3.0 Responsibility
3.1 In-charge of Purchase department or his authorized nominee is responsible for identification and selection of vendor.
3.2 In-charge of QA department or his authorized nominee is responsible for evaluation and audit of vendor.
3.3 In-charge of QC department or his authorized nominee is responsible for analysis of samples.
3.4 Head of QA department or his authorized nominee is responsible for the approval/rejection of vendor.
4.0 Accountability
4.1 Department Head & QA Head shall be accountable for 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.
QA : Quality Assurance
QC : Quality Control
CoA : Certificate of Analysis
6.0 Procedure
6.1 The Head QA shall coordinate the vendor qualification process with Manager Purchase and other relevant departments.
6.2 Manager Purchase shall initiate the vendor qualification process for additional / alternative vendor(s) to the existing material(s).
6.3 Based on the reputation, quality standards and marketing trend analysis, Purchase Department initiate to make a possible new vendor list for each material.
6.4 Manager Purchase shall forward the vendor qualification questionnaire along with the current material specification obtained from QA and sent to the respective vendor(s).
6.5 The vendor qualification questionnaire (Annexure- I) consists of three parts.
6.5.1 Part A-Basic information (Site details, contact numbers, Production capacity, turn over, Organization performance, major customers etc.)
6.5.2 Part B-Technical information of the manufacturing site
6.5.3 Part C-Product specific information
6.6 For qualification questionnaire shall be sent to the vendor as stated below:
6.6.1 Complete (Part A, B & C) qualification questionnaire (Annexure –1) shall be sent to all vendors.
6.6.2 For the qualification of the new material from existing qualified vendor of the same site, Part C of qualification questionnaire along with specification shall be sent.
6.7 Vendor approval procedure for raw and packing material shall be as follows:
6.7.1 Vendor Approval for Raw Material
6.7.1.1 The Manager Purchase shall obtain the filled questionnaire and one pre-shipment sample along with certificate of analysis and minimum three CoAs from different batches.
6.7.1.2 The sample shall be analyzed as per current specifications by QC department. The results along with any other relevant comments shall be communicated to Head QA.
6.7.1.3 The Head QA shall assess the vendor based on the filled vendor qualification questionnaire against statutory and in house requirements along with the analytical results of the pre shipment sample.
6.7.1.4 Based on the compliance of statutory and in house requirements, the vendor shall be considered as qualified.
6.7.1.5 A vendor audit shall carried out jointly by Manager Purchase, Head QA and Manager Production whenever necessary as per Annexure II.
6.7.1.6 Wherever vendor audit shall be carried out, the final technical assessment of the vendor shall be done on the percentage score of the vendor from the Vendor Quality Audit Check list.
6.7.1.7 A vendor shall be considered as qualified if the score is 80% or above.
6.7.1.8 If the score is below 80%, corrective actions shall be suggested for system/facility updating.
6.7.1.9 Only after confirmation of the corrective actions the vendor shall be qualified.
6.7.1.10 All the vendors for the existing material shall be qualified by sending the qualification questionnaire and on the past performance.
6.7.2 Vendor Approval for Packing Material
6.7.2.1 The Manager Purchase shall obtain the filled questionnaire and at least one certificate of analysis from the vendors to check the tests carried out at the vendor end and shall communicate the same to Head QA.
6.7.2.2 The Head QA will assess the vendor based on the filled vendor qualification questionnaire and the certificate of analysis.
6.7.2.3 Based on the compliance of requirements indicated in the questionnaire, the vendor shall be approved.
6.7.2.4 Packing Materials shall be classified into the following categories namely:
- Primary Packing Material
- Secondary Packing Material
- Tertiary Packing Material
6.7.2.5 A vendor Audit shall be carried out for primary printed and unprinted packing material as per vendor quality audit checklist (Annexure –II) by a vendor audit team comprising of representatives from Quality Assurance, Quality Control and Production Department as applicable.
6.7.2.6 Wherever possible / applicable Machine suitability test shall be carried out on pre shipment sample to check the suitability of the component. In absence of pre shipment sample, Machine suitability trial shall be carried out on first supply. Observations of the Machine suitability test shall be documented.
6.7.2.7 Vendor Audit shall be carried out as per vendor Audit checklist as per Annexure-II.
6.7.3 Vendor Approval certificate as per Annexure III, shall be issued to Manager Purchase, Manager Quality control and In-charge Warehouse.
6.7.4 Once the vendor qualifies in the technical assessment the Manager Purchase shall in parallel evaluate the commercial aspects.
6.7.5 The list of Approved Vendors as per Annexure IV shall be updated quarterly and further procurement of the material shall be carried out. The performance of the approved vendors shall review annually through assessment of history records of Vendors (Annexure-V).
6.7.6 Whenever there is a revision in the Raw material specifications, revised specifications shall be forwarded to the respective vendors through Purchase Department.
6.7.7 Purchase Department shall ensure the revised specification forwarded to the supplier before procuring the material from the effective date of specification.
6.8 Disqualification of Vendor
6.8.1 The Approved Vendor shall be Dis-qualified, if the vendor is not able to provide consistent quality product as per the specification consecutively for three times.
6.8.2 In the first rejection of a consignment of any material, the supplier shall be cautioned through the ‘caution/warning’ letter as per Annexure –VI, and shall be asked for a detailed investigation report, if the rejected parameter is not serious in nature. The further procurement of the material shall be kept under hold till the receipt of the investigation report.
6.8.3 Intimation shall be forwarded to the purchase department through ‘Vendor Activation/Deactivation Form’ (Annexure -VIII).
6.8.4 If the rejected parameter is serious in nature e.g. E.coli present, Assay failure, vendor site audit shall be conducted to identify the root cause for failure.
6.8.5 The further procurement of the material shall be kept under hold till the receipt of the investigation report highlighting corrective action plan from the vendor.
6.8.6 Vendor compliance shall be evaluated against vendor site audit report. If any targeted dates found in the compliance report, follow up audit / correspondence shall be conducted based upon the criticality.
6.8.7 After satisfactory completion of evaluation as per Annexure –VII (Vendor Assessment form), the vendor shall be re activated by sending a written communication Annexure -VIII (Vendor Activation/Deactivation form) to the purchase department.
Note: Activation of the supplies shall only be given when all the corrective actions have been completed.
6.8.8 In the second instance of rejection of any material of the vendor from the same manufacturing site, a ‘caution/warning’ letter shall be issued as per Annexure–VI, Followed by re audit of the facility to identify the root cause for non-compliance.
6.8.9 The following disqualifications criteria shall be adopted in case if vendor is supplying more than one material from one site:
- If the failure is originated from Quality system the vendor shall be disqualified.
- If the failure is process related the products manufactured from that site of vendor shall be disqualified.
6.8.10 Point no. 6.8.5 to 6.8.7shall be followed.
6.8.11 After satisfactory completion of evaluation as per Annexure-VII, the vendor shall be activated by sending a written communication Annexure VIII (Vendor Activation / Deactivation form) to the purchase department.
6.8.12 If any Material is rejected for the third consecutive time from the vendor at the same manufacturing site, then the vendor shall be ‘Black Listed’, with a notification to Manager Purchase, In-charge Warehouse, Manager Quality Control and a copy to the vendor through purchase department.
6.8.13 The Approved Vendor List shall be updated quarterly and as on when a vendor is qualified or de qualified as per Annexure – IV.
6.8.14 Approved vendor list shall be stamped as ‘Master Copy’ as described in SOP on “Document and Data Control”.
6.8.15 The document controller shall take photocopy of ‘Master Copy’ and stamped as ‘Controlled Copy’ as described in SOP on “Document and Data Control”.
6.5 Procedure for Provisional approval of vendor
6.5.1 In case of any urgent as per the market requirement the vendor will be provisionally approved as per the following (applicable only for excipients):
- Purchase department in consultation with Head QA and Head QC to decide the vendor
- Vendor’s agreement to supply material meeting the ‘Specification’
- Review of vendor CoAs
- Other commercial terms
6.5.2 In such case commercial lot from the provisionally approved vendor will be considered as vendor sample. Based on these considerations the vendor shall be provisionally approved vendor.
6.5.3 Vendor documentation for provisionally approved vendor shall be completed before second commercial consignment and then the vendor shall be consider as approved vendor.
6.6 Re-qualification of Vendors
6.6.1 Vendor shall be re-qualified once in two years based upon the history of earlier supplies.
6.6.2 If rejections, caution / warning letters found in the vendor history record, vendor shall be re-qualified followed by vendor site audit.
6.6.3 If the vendor is out-side the country, fresh questionnaire shall be issued and based upon the information, the vendor shall be qualified.
7.0 Forms and Records (Annexures)
- Vendor Qualification questionnaire (Part –A, B (RM) & B (PM) and C) – Annexure I
- Vendor Quality audit check list -Annexure II
- Vendor Approval certificate -Annexure III
- List of approved vendors -Annexure IV
- History Cards of Vendors -Annexure V
- Caution / Warning Letter -Annexure VI
- Vendor assessment form -Annexure VII
- Vendor activation / Deactivation form -Annexure VIII
- Check List for Provisionally approved vendor -Annexure IX
8.0 Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control & Warehouse
8.0 History
Date | Revision Number | Reason for Revision |
– | – | New SOP |
Annexure-I
Vendor Qualification Questionnaire
(Part –A)
General Information
1.0 | Name of the Vendor | ||||||||
2.0 | Address of the Vendor | ||||||||
3.0 | Name of partners / directors | ||||||||
4.0 | Address of factory | ||||||||
5.0 | Telephone Nos.
|
Office | Factory | ||||||
6.0 | Name of the contact person (Factory) | Name | Telephone | E- Mail Address | |||||
7.0 | Technical Matter | ||||||||
8.0 | Commercial Matter | ||||||||
9.0 | Name of bankers | ||||||||
10.0 | Nature of business | ||||||||
11.0 | Tenure in business | ||||||||
12.0 | No. of employees | Office | Factory | ||||||
13.0 | Your major customers | ||||||||
14.0 | Your turn over for the last 3 financial years | Financial year | |||||||
Turn over | |||||||||
15.0 | Total production capacity in Unit / Value | ||||||||
16.0 | Your capacity utilization for the last two years | Year | |||||||
Production | |||||||||
- Rank the reason for underutilization if any of the capacity (rank the most important as number on and the next and so on):
Labour : E Power : E
Raw Material : E Finance : E
Machine Break down : E Lack of orders : E
Lock out : E Others : E
18.0 Is manufacturing process simple/ complex ________________________________________________
19.0 Flow chart of the manufacturing facilities enclosed__________________________________________
20.0 Is your process hazardous? Yes / No.
21.0 Are there any accidents in your plant in the last two years Yes / No.
22.0 How do you rate their performance on the following attributes:
Excellent Good Fair
Price : __________ __________ ____________
Quality : __________ __________ ____________
Delivery : __________ __________ ____________
Service : __________ __________ ____________
23.0 What are your strong points?
_______________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Vendor Qualification Questionnaire
(Part –B)
Technical Information (PM)
1.0 GENERAL INFORMATION
Yes No
- Is your company certified according to Quality Standards? ___ ___
- If yes, which standard? ___ ___
Have any regulatory authorities / government agencies inspected this
Site within the last two years? ___ ___
If yes, Please provide dates:
- If yes, please state which of the products on the “Products involved” list are
covered by this standard ?
________________________________________________________________________
- Is your company in the process of being certified? If yes, when is certification expected?
_______________________________________________________________________
- By which standard? _______________________________________________________
1.6 Do you manufacture, handle, store or use any risk material in the same site as:
Antibiotics ___ ___
Cytotoxics ___ ___
Hormones ___ ___
Vaccines / Sera ___ ___
Biological ___ ___
Pesticides ___ ___
Herbicides ___ ___
Organo phosphrous compounds ___ ___
If yes :
Specify the product names
Yes No
- Are the product being produced using the same manufacturing
equipment? ___ ___
1.8 Do you possess a Quality Manual ___ ___
1.9 Is there a program for self-inspection? ___ ___
1.10 Are Material Safety Data Sheets (MSDS) available for all
Commercially distributed products? ___ ___
1.11 An you provide impurities reference standards and degradation
Products for the Active Pharmaceutical Ingredient together with
their certificate of analysis? ___ ___
1.12 Attach a list of all the products manufactured in the site.
Attached: ___ ___
1.13 Attach the local authorities GMP certification.
Attached: ___ ___
- ORGANISATION AND PERSONNEL
- Is there a quality Control/Assurance Dept. which is responsible for
the approval / rejection of all products, raw materials, Intermediate
products, containers and labels? ___ ___
- Is there a training programme for the employees? ___ ___
- Name the functions responsible for batch release and product Specifications.
__________________________________________________________________
__________________________________________________________________
3.0 FACILITIES
- Are the individual production areas sufficiently separated from
each other to prevent cross-contamination and mix-ups? ___ ___
3.2 Is enough room available for equipment and material? ___ ___
3.3 Are there written procedures covering pest control? ___ ___
Yes No
4.0 EQUIPMENT
4.1 Are records available on the cleaning, maintenance, repair and
inspection of equipment? ___ ___
- Is the equipment calibrated in accordance with the written
instructions using certificate measuring instruments? ___ ___
- Are multipurpose facilities cleaned in accordance with a
validated cleaning specifications? ___ ___
- Is there documentary evidence of the equipment qualification
and has inspected and approved by QA? ___ ___
5.0 CONTROL OF MATERIALS
- Is there a system documenting incoming materials (amount,
Lot No., Supplier, etc)? ___ ___
- Is each incoming lot given a separate company control/lot
number and how is this organized? ___ ___
- Are all incoming materials placed in quarantine, either
physically or under computer control, until they are
released for use? ___ ___
5.4 Are only products, which have been approved for release
by the Quality Control Dept.? ___ ___
5.5 Is each lot checked and approved for release by the Quality
Control Dept.? ___ ___
- Does sampling take place in a separate area to prevent cross-
contamination? ___ ___
- Are materials which have been queried blocked and labelled
In such a way as to prevent them from being used? ___ ___
6.0 PRODUCTION
- Are there written procedures for the production and the
in-process control? ___ ___
6.2 Are any deviations documented in the manufacturing records? ___ ___
6.3 Are there written specifications for the in-process controls? ___ ___
- Are rework and reprocessing procedures approved prior to
execution? ___ ___
- Do the Master Formula and the Batch Records Contain details
about the equipment used? ___ ___
6.6 Have the manufacturing processes been validated? ___ ___
6.7 Are equipment and machinery, once cleaned, protected from
contamination (dust, etc.) __ ___
Yes No
- SUPERVISION OF PACKING AND LABELING
- Describe labelling and packaging procedures.
___________________________________________________________________
___________________________________________________________________
7.2 Are access to and the administration of labels limited? ___ ___
7.3 Are different labels used for each batch/lot and are these
carefully checked? ___ ___
- Does repacking take place in a separate area to prevent
cross-contamination and mix-up? ___ ___
8.0 LABORATORIES
- Is the equipment used in the laboratory calibrated and documented
In accordance with written specifications? ___ ___
- Is each batch/lot of raw material, intermediates and finished goods
Tested and approved for release in accordance with special written
Procedures and specifications? ___ ___
- Are products which do not fulfil specifications rejected and the reason
for the discrepancy documented? ___ ___
- Is the work done in the laboratory documented and can it be
traced? ___ ___
8.5 Are reserve samples kept for a specific and documented period
of time? ___ ___
8.6 Is there a written stability testing program? ___ ___
briefly outline the program.
(As per ICH Guide lines)
8.7 Does all product bear expiration date? ___ ___
8.8 Are contract laboratories used to perform testing? ___ ___
- Have the laboratory staff been trained in cGMP and job-related
Procedure, and is there documented evidence of this training? ___ ___
9.0 QUALITY ASSURANCE
- Does the checking of production data include the following
Points?
– Identity of the product ___ ___
– Correct packaging ___ ___
– Control of batch records ___ ___
– Notification forms for kind of deviations ___ ___
– Analytical results ___ ___
9.2 Are there any batch recalls in the last two years ___ ___
- OTHERS:
Please do not fill in the section, reserved for Torque Pharmaceutical Private Limited comments.
COMMENTS:
|
CONCLUSION:
|
______________________ _____________ ________________
Research & Development Quality Control Quality Assurance
Vendor Qualification Questionnaire
(Part –B)
Technical Information (RM)
1.0 GENERAL INFORMATION
Yes No
- Is your company certified according to Quality Standards? ___ ___
- If yes, which standard? ___ ___
Have any regulatory authorities / government agencies inspected this
Site within the last two years? ___ ___
If yes, Please provide dates:
- If yes, please state which of the products on the “Products involved” list are
covered by this standard ?
________________________________________________________________________
- Is your company in the process of being certified? If yes, when is certification expected?
_______________________________________________________________________
- By which standard? _______________________________________________________
1.6 Do you manufacture, handle, store or use any risk material in the same site as:
Antibiotics ___ ___
Cytotoxics ___ ___
Hormones ___ ___
Vaccines / Sera ___ ___
Biological ___ ___
Pesticides ___ ___
Herbicides ___ ___
Organo phosphrous compounds ___ ___
If yes :
Specify the product names
Yes No
- Are the product being produced using the same manufacturing
equipment? ___ ___
1.8 Do you possess a Quality Manual ___ ___
1.9 Is there a program for self-inspection? ___ ___
1.10 Are Material Safety Data Sheets (MSDS) available for all
Commercially distributed products? ___ ___
1.11 An you provide impurities reference standards and degradation
Products for the Active Pharmaceutical Ingredient together with
their certificate of analysis? ___ ___
1.12 Attach a list of all the products manufactured in the site.
Attached: ___ ___
1.13 Attach the local authorities GMP certification.
Attached: ___ ___
- ORGANISATION AND PERSONNEL
- Is there a quality Control/Assurance Dept. which is responsible for
the approval / rejection of all products, raw materials, Intermediate
products, containers and labels? ___ ___
- Is there a training programme for the employees? ___ ___
- Name the functions responsible for batch release and product Specifications.
__________________________________________________________________
__________________________________________________________________
3.0 FACILITIES
- Are the individual production areas sufficiently separated from
each other to prevent cross-contamination and mix-ups? ___ ___
3.2 Is enough room available for equipment and material? ___ ___
3.3 Are there written procedures covering pest control? ___ ___
Yes No
4.0 EQUIPMENT
4.1 Are records available on the cleaning, maintenance, repair and
inspection of equipment? ___ ___
- Is the equipment calibrated in accordance with the written
instructions using certificate measuring instruments? ___ ___
- Are multipurpose facilities cleaned in accordance with a
validated cleaning specifications? ___ ___
- Is there documentary evidence of the equipment qualification
and has inspected and approved by QA? ___ ___
5.0 CONTROL OF MATERIALS
- Is there a system documenting incoming materials (amount,
Lot No., Supplier, etc)? ___ ___
- Is each incoming lot given a separate company control/lot
number and how is this organized? ___ ___
- Are all incoming materials placed in quarantine, either
physically or under computer control, until they are
released for use? ___ ___
5.4 Are only products, which have been approved for release
by the Quality Control Dept.? ___ ___
5.5 Is each lot checked and approved for release by the Quality
Control Dept.? ___ ___
- Does sampling take place in a separate area to prevent cross-
contamination? ___ ___
- Are materials which have been queried blocked and labelled
In such a way as to prevent them from being used? ___ ___
6.0 PRODUCTION
- Are there written procedures for the production and the
in-process control? ___ ___
6.2 Are any deviations documented in the manufacturing records? ___ ___
6.3 Are there written specifications for the in-process controls? ___ ___
- Are rework and reprocessing procedures approved prior to
execution? ___ ___
- Do the Master Formula and the Batch Records Contain details
about the equipment used? ___ ___
6.6 Have the manufacturing processes been validated? ___ ___
6.7 Are equipment and machinery, once cleaned, protected from
contamination (dust, etc.) __ ___
Yes No
- SUPERVISION OF PACKING AND LABELING
- Describe labelling and packaging procedures.
____________________________________________________
____________________________________________________
- Are access to and the administration of labels limited? ___ ___
- Are different labels used for each batch/lot and are these
Carefully checked? ___ ___
- Does repacking take place in a separate area to prevent
Cross-contamination and mix-up? ___ ___
8.0 LABORATORIES
- Is the equipment used in the laboratory calibrated and documented
In accordance with written specifications? ___ ___
- Is each batch/lot of raw material, intermediates and finished goods
Tested and approved for release in accordance with special written
Procedures and specifications? ___ ___
- Are products which do not fulfil specifications rejected and the reason
for the discrepancy documented? ___ ___
- Is the work done in the laboratory documented and can it be
traced? ___ ___
8.5 Are reserve samples kept for a specific and documented period
of time? ___ ___
8.6 Is there a written stability testing program? ___ ___
briefly outline the program.
(As per ICH Guide lines)
8.7 Does all product bear expiration date? ___ ___
8.8 Are contract laboratories used to perform testing? ___ ___
- Have the laboratory staff been trained in cGMP and job-related
Procedure, and is there documented evidence of this training? ___ ___
9.0 QUALITY ASSURANCE
- Does the checking of production data include the following
Points?
– Identity of the product ___ ___
– Correct packaging ___ ___
– Control of batch records ___ ___
– Notification forms for kind of deviations ___ ___
– Analytical results ___ ___
9.2 Are there any batch recalls in the last two years ___ ___
- OTHERS:
Please do not fill in the section, reserved for Torque Pharmaceutical Private Limited comments.
COMMENTS:
|
CONCLUSION:
|
Done By: Checked By:
Vendor Qualification Questionnaire
(Part –C)
Material Specific Information
Name of the material: | Material Code: |
S.NO. | DESCRIPTION | RESULT |
1. | Do you have approved DMF for the above products? | Yes No |
2. | If yes, mention the DMF number | |
3. | How long you are manufacturing this product? | |
4. | Is it a continuous process or a batch process? | |
5. | What is the batch size? | |
6. | Does the individual production areas sufficiently separated from each other to prevent cross contamination and mix-ups? | Yes No |
7. | Can you meet our specifications? | Yes No |
8. | Have you identified synthetic / theoretical related impurities and degradation products? |
Yes No |
9. | Enclose your product specification, analytical method, brief manufacturing process, likely related impurities and degradation products. |
Yes No |
10. | Do you have expiry period for this product? If yes how do you arrive it? Please specify |
Yes No |
11. | Attach the stability details of the product. If no how much time is required to submit the stability details? |
Yes No |
12. | Describe briefly steps involved from receipt of an order for a product to its final dispatch? | |
13. | Does water is used in the manufacturing process? If yes please write the source of water and how it is purified? |
Yes No |
14. | Please provide your packaging details | |
15. | Please provide labeling details on the container including shelf life and storage conditions. | |
16. | Please mention the Packing measures adopted by you during transit. | |
|
17. | Are all deviations are documented in the manufacturing records? | Yes No |
18. | Do you use any animal origin material or materials of animal origin are manufactured at site? If yes, provide Transferable Spongiform Encephalopathies (TSE Risk free) certificate. |
Yes No |
19. | Do you use Organic Volatile Impurities (OVI) in the manufacturing process? If no, please provide a certificate | Yes No |
20 | Do you manufacture other products? If yes, please specify? | Yes No |
21. | Are the above products being produced using the same manufacturing equipment? | Yes No |
22. | Do you have written cleaning procedures during product changeover? | Yes No |
23. | Does the equipment and machinery protected from contamination after cleaning? |
Yes No |
24. | Please enclose list of companies to whom you supply this product. |
Yes No |
25. | Enclose list of companies who has audited you and approved your facility? |
Yes No |
- OTHERS:
Ensure the following documents are attached along with the questionnaire:
YES NO
- Stability Data
- TSE free certificate
- OVI free certificate
- Certificate of analysis
- Product flow sheet
- Impurity profile
Particle size distribution (If applicable):
Annexure-II
Vendor Quality Audit check list
S. No. | PARTICULARS | OBSERVATIONS | ||||
A | IA | M | NA | |||
1. | Is there any space for the orderly storage of materials? |
|
|
|
|
|
Are the physical specifications between Under test, Approved and Rejected materials stores adequate? Is the Rejected material stored under Restricted entry (lock and key) ?Verify handling of rejected materials | ||||||
Are there separate stores for raw materials, packaging materials, labels and finished products? | ||||||
Are all the stores secure and protected from unauthorized entry? | ||||||
Are materials stored on pallets, shelves or racks off the floor and off the walls in all stores? | ||||||
Is there adequate lighting in all stores? | ||||||
Are minimum and maximum temperatures/humidity in the stores recorded? | ||||||
Is the ambient temperature in all stores suitable for the storage of the materials being stored in those areas? | ||||||
Are there written procedures (SOP) for the receipt, storage and handling of materials in the stores? | ||||||
Do records show that the above SOP is followed? | ||||||
Are materials in the quarantine are labeled with appropriate status labels? | ||||||
Are containers, which have been sampled, identified as such by means of “sampled” stickers? | ||||||
Are containers adequately sealed after sampling? | ||||||
Are all stores protected against entry of insects and birds? | ||||||
Do all containers in the released/ approved raw material store(s) bear “Released” or “Passed” stickers? | ||||||
Do the “Released” stickers identify the name and batch number of the material to which they apply? | ||||||
Do the “Released” stickers bear re-test /re-assay dates? | ||||||
Is there an effective system to highlight raw materials due for re-testing or re-assay? | ||||||
Are there no expired raw materials in the raw materials store(s)? |
S. No. | PARTICULARS | OBSERVATIONS | |||||
A | IA | M | NA | ||||
20. | Are raw materials and packaging materials stored in quarantine until they have been tested and released by quality control? | ||||||
After release by quality control, are raw materials and packaging materials released on a FIFO basis? | |||||||
Are inventory / stock records kept for each material and packaging material? | |||||||
Is there any written program /SOP for pest control? Are pest control agents used safe, without risk of contamination of the raw materials? | |||||||
Is there adequate capacity (area) for the operations carried out? | |||||||
Are there effective dust extraction systems over measuring points and other points of dust generation? | |||||||
Are the floors, walls and ceilings, smooth, clean and free from cracks, leaks and peeling paint and do not shed particulate matter? | |||||||
Are calibration records available to verify periodic and scheduled calibration of the weighing balances? | |||||||
Are the records to verify compliance with the calibration program available? | |||||||
Are the raw materials issued against an authorized requisition only? | |||||||
30. | Is their verification for presence of Q.C release label before raw materials are weighed? | ||||||
Are materials measured into clean, properly labeled containers? | |||||||
Is the accuracy of all weights, measures or readings verified and signed by a second person? | |||||||
Do the scales have the measuring capacity, accuracy and precision appropriate to the operations performed on them? | |||||||
Is the dispensary area supplied with filtered air? |
|
||||||
35. | Do personnel follow authorized written procedures regarding washing of equipment and facility? (check records) | ||||||
36. | Do personnel follow authorized written procedure regarding decontamination of equipment and work surfaces? | ||||||
37. | Are solutions handled / measured in a manner which minimizes the risk of contamination or microbial growth? | ||||||
38. | Are dipsticks made of suitable material (not wooden) calibrated for specific tanks and are clearly labeled as such? | ||||||
Observation / Remarks
___________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
_______________________________________________________________________________________
Anexxure-III
Vendor Approval Certificate
Name of the Material :
Material Code :
Vendor Name :
Vendor Address :
Telephone / Fax :
Specification : USP/Ph. Eur/BP/In house /Others
Certificate(s) Of Analysis Received : Y / N , Date:
Questionnaire Issued Date :
Questionnaire Returned Date :
Questionnaire Satisfactory : _____________________ Date:
Signature
Not Satisfactory :
Corrective action requested : Y / N Date Requested:
Corrective action completed Date :
Audit conducted Date :
Audit Satisfactory : _____________________ Date:
Signature
Not Satisfactory :
Corrective action requested : Y / N Date Requested:
Corrective action completed Date :
Vendor Acceptable / Not Acceptable : _____________________ Date:
Signature
(In-Charge – QA)
Vendor Added to Master List : Y / N Date:
Annexure-IV
Approved Vendors
Reference No: | Effective Date: | Page No: | 1 of 1 |
S.No | Material Name | Material Code No. | Vendor’s Name and Manufacturing site Address |
Trader name
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PREPARED BY | CHECKED BY | APPROVED BY | AUTHORISED BY |
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Executive–QA
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Manager – Stores
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Asst. Manager – QA
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Head – QA
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Annexure-V
History Card of Vendors
Name of Vendor :
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Address of the Manufacturing Site :
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Names of Material Supplied :
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Record of History : | ||
Date | Event | Sign |
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Annexure-VI
Caution / Warning Letter
CAUTION / WARNING LETTER | Date | ||||||||||||
A. Vendor Details | |||||||||||||
Vendor Name |
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Material Name | Material Code | ||||||||||||
Received on |
Received Quantity |
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Batch No. | MRR No. | ||||||||||||
Mfg. Date | Exp. Date | ||||||||||||
B. Reason for Rejection | |||||||||||||
a. Failed in
Chemical test |
Test parameter & Result | ||||||||||||
b. Failed in
Microbiology test |
Test parameter & Result | ||||||||||||
c. Failed in Physical
test |
Observation | ||||||||||||
Rejection Status | 1st Time | 2nd Time | 3rd Time | ||||||||||
Date | Date | Date | |||||||||||
Caution letter issued | Y | N | Warning latter issued | Y | N | Vendor Black listed | Y | N | |||||
Prepared by: QA |
Sign and date: |
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C. Conclusion: | |||||||||||||
Based on the above-mentioned information the consignment is rejected.
As it is ……… Rejection, we are issuing ——————— letter and material procurement is stopped until investigation report received from your end. Future supplies shall be depends upon satisfaction of investigations report only. |
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Specific information / Instructions if any
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Approved by: | Sign & Date | ||||||||||||
Head QA | |||||||||||||
CC to: | Manager -Purchase department, Manager -Stores,Manager -Quality Control, |
Annexure-VII
Vendor Assessment Form
CAUTION / WARNING LETTER | Date | ||||||||||||
A. Vendor Details | |||||||||||||
Vendor Name |
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Material Name | Material Code | ||||||||||||
Received on | Received Quantity | ||||||||||||
Batch No. | MRR No. | ||||||||||||
Mfg. Date | Exp. Date | ||||||||||||
B. Reason for Rejection | |||||||||||||
a. Failed in
Chemical test |
Test parameter & Result | ||||||||||||
b. Failed in
Microbiology test |
Test parameter & Result | ||||||||||||
c. Failed in Physical
test |
Observation | ||||||||||||
Rejection Status |
1st Time | 2nd Time | 3rd Time | ||||||||||
Date | Date | Date | |||||||||||
Caution letter issued | Y | N | Warning latter issued | Y | N | Vendor Black listed | Y | N | |||||
Prepared by: QA |
Sign and date: |
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C. Conclusion: | |||||||||||||
Based on the above-mentioned information the consignment is rejected.
As it is ……… Rejection, we are issuing ——————— letter and material procurement is stopped until investigation report received from your end. Future supplies shall be depends upon satisfaction of investigations report only. |
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Specific information / Instructions if any
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Approved by: | Sign & Date | ||||||||||||
Head QA | |||||||||||||
CC to: | Manager -Purchase department, Manager -Stores,Manager -Quality Control, |
Annexure-VIII
Vendor Activation / Deactivation Form
VENDOR ACTIVATION / DEACTIVATION FORM | Date: | ||||||||
A. VENDOR DETAILS | |||||||||
Vendor Name and address |
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Material Name | |||||||||
Material Code | |||||||||
Reason for Activation / Deactivation |
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Audit conducted on | |||||||||
Compliance report received on | |||||||||
Corrective action plan implemented on | |||||||||
Whether all observations have been addressed or not? | |||||||||
Re-activated on | |||||||||
Requested by | Name :
Designation : Department : |
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B. HEAD – QA COMMENTS | |||||||||
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Requirement of
Activation/Deactivation
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Temporary, until further instructions issued | Permanent | |||||||
Approved by: | Sign & Date | ||||||||
Head-QA | |||||||||
CC to: | Manager -Purchase department, Manager -Stores, Manager-Quality Control, |
Annexure-IX
Check List For Provisionally Approved Vendor
CHECK LIST FOR PROVISIONALLY APPROVED VENDOR |
1.0 Vendor Name : 2.0 Address : 3.0 Materials Supplied If any 1. 2. 3. 4.0 Provisionally Approval Status: i) Based on the supplied material specification should meet the current pharmacopoeia specifications/In – House Specification. YES NO ii) Based on the well reputation of quality standards and Market trend analysis YES NO iii) Review of Vendor COAs YES NO iv) Based on the Verification of analytical reports of Vendor sample Approval /rejected Compiled By/on: –––––––– Verified By/On:–––––––––––– |