SOP on Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material

4
20714

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                                                       ___     ___

  1. 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                                                       ___     ___

  1. 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

  1. 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

 

 

 

 

 

 

 

PREPARED BY   CHECKED BY    APPROVED BY AUTHORISED BY
 

 

 

 

 

 

 

 

 

 

 

 

ExecutiveQA

 

Manager – Stores

 

Asst. Manager  – QA

 

Head – QA

 

Annexure-V

History Card of Vendors

Name of Vendor :

 

Address of  the Manufacturing Site :

 

 

 

Names of Material Supplied :

 

 

 

Record of History :
Date Event Sign
 

 

 

 

 

 

Annexure-VI

Caution / Warning Letter

CAUTION / WARNING LETTER Date
A. Vendor Details
Vendor Name  

 

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:

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.

Specific information / Instructions if any

 

 

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  

 

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:

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.

Specific information / Instructions if any

 

 

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  

 

 

Material Name
Material Code
Reason for Activation / Deactivation  

 

 

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      :

B.   HEAD – QA COMMENTS
 

 

 

 

 

 

 

 

 

 

 

Requirement of

Activation/Deactivation

 

 

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:––––––––––––

 

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