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Vendor Evaluation Checklist (Raw Material)

This Vendor Evaluation Checklist for API Vendor Assessment is an essential tool designed to streamline the process of evaluating potential API vendors. It provides a comprehensive framework that covers critical aspects such as technical capabilities, security protocols, compliance standards, and support services. By utilizing this checklist, businesses can ensure that they are making informed decisions based on a thorough analysis of each vendor’s offerings.

The Vendor Evaluation checklist not only helps in identifying the strengths and weaknesses of various vendors but also facilitates a standardized comparison, making it easier to select the most suitable partner for your organization’s needs. With this resource, you can mitigate risks, enhance operational efficiency, and ultimately drive better outcomes for your projects.

Vendor Evaluation Checklist (API & Excipient)

INSTRUCTION TO VENDOR: Please read below before completing this Questionnaire.
You are being asked to complete this questionnaire so that we may evaluate your company’s quality and regulatory profile, and assure ourselves of your ability to meet Good Manufacturing Practices (GMPs).
√ This Questionnaire is to be completed by representative of QA department.
√ This Questionnaire is to be completed by representative from the site of manufacturer only. It is not to be completed by a representative from the marketing facility or company headquarters.
√ Please answer all questions.
√ Please note that some question in the questionnaire required other documents to be submitted. Please attach copy of such document along with questionnaire.
√ Please attach all the documents requested in this questionnaire and also documents as per technical package.
√ Where supporting documents (such as Site Master File, Layout etc.) will it make easier to answer the question; please feel free to add such documents even if not specifically requested to do so.
√ Any changes which may after the status of the completed questionnaire shall be informed  immediately.
√ The objective of this questionnaire is to understand the measures taken and procedures followed by the manufacturing unit to establish the GMP compliance as per the WHO-GMP / ICH Q7a. The confidentiality of the contents shall be maintained.
√

Usage of Options in the Questionnaire: Select any one option
√ Yes: Indicates that you practice the requirement as per the guidelines.
√ No: Indicates that you do not practice the requirement as per the guideline; although it is a requirement.
√ NA [Not Applicable]: Indicates the requirement is not applicable to the practices followed by you as per the guideline. It also indicates the requirement is not mandatory and hence not practiced
√ Remark: Please elaborate wherever the option does not entirely support the query in the extra sheet with reference point number

 Please return complete form to

Quality Assurance

<Company name>

<company Address>.

 

Name of the Vendor  :  
Factory Address  : City:                               State/Province:

Country:

Telephone No.:
Whether Supplier is different from Manufacturer? :  YES/NO
Is your company (above) owned by, or is the division of, another company or entity please state
Name of parent organization  :  
Address of Parent organization  : City:                                State/Province:

Country:

Telephone No.:
Product (s)                     (Attach separate sheet if require) :

Contact Details of Person from Quality department
Name :  
Designation :  
Telephone No(s) :  
E. Mail :  
Contact Details of Person from Manufacturing
Name :  
Designation :  
Telephone No(s) :  
E. Mail :  

 

Sr. No. Questions YES NO NA

1.0

ORGANIZATION
1.1 Do you have a Documented Quality Policy?
1.2 Is the policy implemented throughout the company?
1.3 Who is responsible for the implementation of the policy? (Department/Designation)
1.4 Is there an Organization chart/ Organ gram?
1.5 Is the decision to release or reject a product for sale Independent from production?
1.6 Who signs the Certificate of Analysis (COA)? (Department/Designation)
1.7 Who is responsible for contacts with Concerning questions of quality? (Department/Designation).
1.8 Has US-FDA, MHRA, EDQM, TGA, WHO, ISO or any other regulatory agency inspected this site within the past three years? If yes, please provide dates of inspection & outcome of inspection.

Please attach the following (as applicable):

1   Copy of Manufacturing License or equivalent Factory License.

2   Copy of GMP certificates issued by National Regulatory authority.

3   Copy of GMP     certificates issued by any international Regulatory Authority.
1.9 Do you provide Certificate of Analysis for each consignment supplied by you?

2.0

PERSONNEL
2.1 Do employees have adequate training, experience, and Qualifications for their responsibilities?
2.2 Is there a training program for Newly hired personnel?
2.3 Is there a training program for personnel when new process/methods are used?
2.4 Do you maintain records of training of Product integrity, Hygiene and Cleanliness?
2.5 Who is responsible for imparting training?
2.6 Do all personnel those involved directly or indirectly for the quality of the product practice Good sanitation and health habits?
2.7 Are the storage and consumption of foods, beverages, and tobacco limited to designated non-production areas?

3.0

BUILDING AND FACILITY (Vendor Evaluation)
3.1 Do you manufacture this product in a dedicated facility or Multi product facility? (Specify)
3.2 Are adequate and clean washing and toilet facilities available for personnel?
3.3 Are materials handled and stored in a manner to prevent degradation, contamination and cross contamination?
3.4 Is permanently installed pipe lines appropriately identified?
3.5 Is there adequate space for the orderly placement of equipment and materials prevent mix-ups and contamination?
3.6 Are there separate areas for:
3.6.1 Receipt, Identification, Sampling and Quarantine of incoming materials?
3.6.2 Pending Release or Rejection?
3.6.3 Quarantine before release or Rejection of                                products?
3.6.4 Sampling of products?
3.6.5 Holding of Rejected materials before disposition?
3.6.6 Storage of released materials?
3.6.7 Production operations?
3.6.8 Packaging and Labeling Operations?
3.6.9 Laboratory Controls?

3.7

Does the present design prevent:
3.7.1 Chemical contamination?
3.7.2 Extraneous Contamination? (Damage, humidity, dust etc.)
3.7.3 Microbial Contamination?
3.8 Do you have written general housekeeping procedure?
3.9 Do sewage, refuse and other waste (Solids, liquids or Gaseous by products from manufacturing) in and from building and the immediate surrounding area are disposed of in a safe, timely, and sanitary Manner? Do containers and/or pipes for waste materials clearly identified?
3.10 How old is your facility?
3.11 If you are using multi product facility, do you have validated cleaning procedure?
3.12 If answer of above point is Yes, could you mention level of contamination allowed in next product.
3.13 Do you supply the material directly or through an agent? If agent, provide the name and address of agent (attaché separate sheet if require).
3.14 Do you have dedicated manufacturing facility for Penicillin/Cephalosporin/  Cytotoxic Pesticides! Biologicals / Other potent substances.

3.15

Do you use water in the process?
3.15.1 If yes, is your water system qualified Intended use?
3.16 Is feed water coming into the plant, periodically monitored for chemical and microbial quality?
3.17 If the final API / excipient is claimed to be pyrogens-free or sterile, has the water system’s ability to control endotoxins been validated? Is the water tested routinely for endotoxins?
3.18 Please describe your site’s environment monitoring program, especially at key points of ingredients and material exposure (e.g. Sampling, Weighing, compounding, blending, etc.) (Attach a separate sheet if required or relevant documents).
3.19 Where air is circulated to production areas, are appropriate measures taken to control risks of contamination and cross contaminations.
3.20 Are adequate measures in place to control entry of pests / insects etc?
3.21 Are all utilities that could affect the product quality qualified and appropriately monitored?
3.22 Are there adequate measures implemented to prevent cross-contamination from personnel and materials moving from one place to another?

4.0

PROCESS EQUIPMENT (Vendor Evaluation)
4.1 Are major equipment and permanently installed processing lines appropriately identified?
4.2 Is there a preventive maintenance plan for production machines?
4.3 Is there a validated cleaning procedure for production equipments?
4.4 Is equipment constructed so that product-contact surfaces are not reactive, additive, or absorptive and will not adversely affect the product?
4.5 Are acceptance criteria for residues and the choice of cleaning procedures and cleaning agents been defined and justified?
4.6 Does any manufacturing equipment have software control?
4.6.1 Are any modifications of software or its use done by Manufacturing?
4.6.2 Is there a procedure available with change of software and prevention/ copying?
4.7 Are weighing, measuring, monitoring, and production testing equipment critical for ensuring the quality of product calibrated according written procedure and an established schedule?
4.8 Are calibration performed using standard traceable to certified standards?
4.9 Is there a system to ensure that instruments not meeting calibration criteria are not used?
4.10 Are food grade or medicinal grade lubricants and oils used wherever possible?
4.11 Are GMP related computerized systems validated?
4.12 Do computerized system have sufficient controls to prevents unauthorized access or changes to data?
4.13 Is back-up system provided for system breakdown or failure?

5.0

PRODUCTION AND PROCESS CONTROL/BATCH PRODUCTION RECORDS
5.1 What is capacity of applicable product manufactured by you?  (Attach separate sheet if require).
5.2 How do you define your Lot/batch?
5.3 Please explain how do you assign Lot/batch no.?
5.4 Are equipments and utensils maintained and sanitized (where necessary) at appropriate intervals to prevent malfunctions or that would alter the standards and characteristics of the product beyond the established requirements?
5.5 Has a maximum time between completion of processing and equipment cleaning been established?
5.6 Do you manufacture according to a written procedure for each product supplied?
5.7 Is there an equipment cleaning, use, maintenance and calibration log, or some other documentation system to indicate previous usage and cleaning status?
5.8 Does master production instruction specify time limits?
5.9 Are the Intermediates and in-process materials held for further processing stored under appropriate condition to ensure their suitability?
5.10 Are the manufacturing records formally checked by QA before batch release?
5.11 Do you maintain lot separation during Manufacturing, Packaging and Storage?
5.12 Are rejected lots identified and kept separately? Is the destruction of rejected materials documented?

5.13

Do you retain samples of each lot/batch?
5.14 Do you use recovered solvent during last stage of manufacturing?
5.14.1 If the answer to above is yes, what are the controls in recovered solvents? (Attaché separate sheet if required).
5.15 Does this product or any of the constituents used in manufacturing is from animal origin?
5.15.1 If yes indicate the origin of materials used like Bovine, porcine, Ovine, Caprine, Fish, Poultry, insect, Human or any other please specify.
5.15.2 If No, please attached declaration stating that material is not derive from the animal origin and it is free from TSE/BSE risk. The certificate should be specific to product and site of manufacturer.
5.16 Does this product come in contect with animal origin material at any time during processing/ production?
5.16.1 If yes specify details.
5.17 Is material is free from Aflatoxin and Dioxin Contaminations?
5.18 Whether material is sifted through sieve or some other means to eliminate extraneous contamination?
5.18.1 If yes please give details details.
5.19 Where polythene bags used for final product? Are they Virgin?
5.20 Do you reprocess/time expired batches?
5.20.1 If yes provide details or attach the copy of relevant SOP.
5.21 Are Air Handling Systems Qualified? And Temperature, Humidity monitored and controlled during final stage of Manufacturing and Packaging Operations?

6.0

PACKAGING AND LABELLING (Vendor Evaluation)
6.1 Are the instruction available for;
6.1.1 Packaging component?
6.1.2 Packaging Operation?
6.1.3 Labels and Labelling?
6.2 Do you maintain lot/batch separation during packaging?
6.3 Does your label indicate;
6.3.1 Name of the product and quantity?
6.3.2 The site of Manufacture?
6.3.3 Lot/batch No.?
6.3.4 Purchase Order No.?

6.3.5

Date of Mfg., Date of Expiry/retest?
6.3.6 Mfg. Licenance No.?
6.3.7 Storage Condition?
6.4 Do you re-use container& closures?
6.5 Is there a written procedure for clearing the packaging area after one packaging operation, and clearing before next packaging operations?
6.6 Mention packaging details (Size and types of primary packaging material and secondary packaging Material) (Attach separate sheet if require)
6.7 Are there documented procedures designed to ensure correct packaging materials and labels are used?
6.8 Whether distinctly different looking labels are used to label for the final product containers.
6.8.1 If not, what other means are employed to avoid the product mix-up or mix-up of different grade materials?
6.9 Whether container label mentions the storage condition in which the product needs to be stored / transported?
6.10 Are Master of Approved labels maintained for comparison to issued labels?
6.11 Is there a label reconciliation record maintained for each lot of packaged product?
6.12 Is access to the label storage area restricted to authorized personnel?
6.13 Are obsolete and outdated labels destroyed?

7.0

QUALITY SYSTEMS,  DOCUMENTATION AND RECORDS (Vendor Evaluation)
7.1 Who is Responsible for evaluation and approval of
7.1.1 Specifications and testing procedure
7.1.2 Manufacturing procedure
7.2 Which department reviews & approves master production documents?
7.2.1 Are they prepared, dated and signed by one person and independently checked, dated and signed by a person in the quality unit?
7.3 Is there an SOP for writing, handling and updating SOPs?
7.4 Are the issuance, revision, superseding, and withdrawal of all documents controlled by maintaining revision histories?
7.5 Is there a written procedure pertaining to retention of all appropriate documents? Are the retention periods specified?
7.6 Are manufacturing and packing records checked before issuance to ensure it is correct version and a legible, accurate reproduction of master card?
7.7 Do procedures exist for notifying management of serious GMP deficiencies, product defects and recalls in a timely manner?
7.8 Are all documents related to the manufacture of product prepared, reviewed, approved and distributed according to written procedures?
7.9 Who is responsible for the quality of starting materials?

7.9.1

Are reserve samples of raw material retained?
7.9.2 Are any raw materials that are used in products accepted on the basis of the manufacturer’s certificate of analysis only?
7.9.3 If yes, explain your company’s reduced testing program for raw materials,( attach separate sheet/relevant documents)
7.9.4 Does your firm establish the reliability of the supplier’s analysis through appropriate validation of the supplier’s test results at appropriate intervals?
7.10 Before incoming materials are mixed with existing stocks  (i.e: solvents or stocks in silos), are they identified as correct,  tested, if appropriate and released?
7.10.1 Are procedures available to prevent discharging incoming materials wrongly into the existing stock?
7.11 Who is responsible for release and rejection of finished goods?
7.12 Are all deviations, investigations and 00S reports reviewed as part of the Batch record review before a batch is released?
7.13 Are actual yields compared with expected yields at designated steps in the process?
7.14 Are process wastes, co-products  and    residues managed in an appropriate manner away from the process?

7.15

Are documents reviewed on a periodic basis to access compliance     to current practices and requirements?
7.16 Is there an Internal quality audit program that covers all areas of the operation to verify that procedures and policies are being followed, and                              determines the effectiveness of the quality systems?
7.16.1 Are internal audit conducted and documented?
7.16.2 Are corrective and Preventive Actions documented?
7.17 Are Material issue FIFO basis?
7.18 Are blended processes adequately controlled, documented and validated?
7.19 Do blending batch records allow traceability back to the individual batches making up the blend?
7.20 Is the expiry/retest date of the blended batch based on the manufacturing date of the oldest tailings or batch in the blend?
7.21 Are there written procedures for the recovery of solvents, mother liquors and second crop? Are solvent recovery procedures validated?
7.22 What is the sampling plan for sampling of ‘Starting materials and Finished products’? (Attach separate sheet if require or attach related procedure)

7.23

Are written   specifications and test procedures available for;
7.23.1 Starting materials?
7.23.2 Packing materials?
7.23.3 In-process controls?
7.23.4 Finished products?
7.23.5 Microbiological controls?
7.24 Is there an SOP for investigation of OOS results and retesting?
7.25 Is there a procedure for determining the fate of final product that fails to meet specifications?
7.26 Are all release testing methods validated?
7.26.1 Are methods validated according to current regulatory and compendia guidelines?

7.26.2

Does method address all anticipated impurities?
7.27 Are the Quality Control equipments periodically calibrated and documented?
7.28 Is there system in place to ensure equipment, glassware and utensils are cleaned and inspected prior to use?
7.29 Are changes evaluated  for impact  on validated cleaning or manufacturing procedures?
7.29.1 Do you notify regarding changes in process Regulatory issues in writing to Customer that can have impact on product quality and/or regulatory status of product prior to implementation?
7.30 Do you provide appropriate duration and adequate man hours as requested by customers for auditing the facility? (minimum 8 man hours, subjected to change based on scope and complexity of audit)
7.31 Do you have procedure in place to handled Market Complaint?
7.32 Do you have procedure in place to handled returned goods?
7.33 Are investigations conducted, and do they extend to other batches of same product?
7.34 Are reworked batches subjected to appropriate evaluation, testing, stability testing, if warranted, and documentation to show that the reworked product is of equivalent quality to that produced  by the original process?
7.35 Are there procedures for comparing the impurity profile of each reworked batch against the batches manufactured by the established process?

7.36

Do you have stability program in place?
7.37 Are analytical methods used for testing of stability samples proven to be stability indicating?
7.38 Are stability data reviewed and trends monitored, adverse trends addressed?
7.39 Is there a procedure defining how long samples are retained after testing?
7.40 Whether all testing is performed in-house?
7.40.1 If not, the details of outside testing laboratory from whom you are getting the product analyzed
7.41 Is the outside testing laboratory approved/audited by regulatory bodies/by your organization periodically?
7.42 Does the material supplied  by you need special transportation conditions?
7.42.1 If yes, how are these conditions achieved?
7.43 Whether microbiological testing is a part of analysis?
7.44 If Microbiological testing is done then, do you have your own facility for testing?
7.45 Can you supply us properly qualified working standards and/or impurity/degradation products?

7.46

Do you have procedure of handling process deviations/other deviations?
7.47 Please describe in brief your program to qualify the vendors of raw materials, components and services that might affect quality and verify that they have the capability to consistently meet agreed upon requirements. (Attach separate Sheet or respective procedure)
7.48 Is there a procedure to prevent acceptance of materials from an unqualified vendor?
7.49 Does vendor qualification program include periodic audits (or other verification techniques) of vendors?
7.50 Do you have the procedure for evaluating service providers?
7.50.1 If yes, Specify/Ref. SOP.
7.51 Is there a SOP for training? Is GMP training conducted on a continuous basis with sufficient frequency to ensure the employees remains familiar with applicable GMP requirements?

8.0

VALIDATION (Vendor Evaluation)
8.1 Validation policy
8.1.1 Is the company’s policy, intentions and approach to validation documented?
8.1.2 Are critical product attributes, i.e. process parameters, affecting critical quality attributes, ranges for critical process parameters defined?
8.2 Validation Documents
8.2.1 Are written validation protocols used that specifies how validation will be accomplished? What are the critical process steps and acceptance criteria? Does the quality unit approve the protocols?
8.2.2 Do validation reports include results obtained? Do these reports discuss any deviations observed and recommend changes to correct deficiencies?
8.3 Qualification
8.3.1 Have Design, Installation, Operational, and Performance Qualifications been performed for critical equipment and ancillary systems? Have these activities been documented?
8.3.2 Are periodic reviews of system and process conducted that they are still operating in a validated state?
8.4 Process Validation
8.4.1 Has the current process been validated (i.e., defined in terms of raw materials, processing steps, operating parameters, process limitations, and key tests needed for process control, and demonstrated to operate consistently to assure that product meets established specifications)?
8.4.2 If No, Give target date of completion of process validation activity.
8.4.3 Is appropriate qualification of critical equipment and ancillary systems completed prior to the initiation of process validation activities?

8.5

Cleaning Validation
8.5.1 Does validation of cleaning procedures reflect actual equipment usage patterns?
8.5.2 Is the selection of an intermediate or API for cleaning validation          based                                            on the solubility or difficulty of cleaning?
8.5.3 Is the calculation of residue limits based on potency, toxicity?
8.5.4 Have analytical methods been validated to demonstrate they have the required sensitivity to evaluate cleaning validation samples?
8.5.5 Does the sampling include swabbing, rinsing, or alternative methods        (e.g., direct extraction), as appropriate, to detect insoluble and soluble residues? Are they capable of quantitatively measuring equipment surface residues remaining after cleaning?
8.5.6 Are cleaning procedures monitored at appropriate intervals after validation to ensure that the procedures are effective when used during routine production?
8.5.7 Have recovery studies  been performed during cleaning validation?
8.5.8 Do the cleaning/sanitation studies address microbiological and endotoxins where there is a need to reduce total microbial count or Endotoxins in the product, or process where such contamination could be concern?

8.6

Validation of Analytical Method
8.6.1 Are records of modification to validated analytical methods maintained?
8.6.2 Has equipment used to carry out method validation been calibrated and qualified for use?
8.6.3 Have all non-compendial test methods been verified/validated as applicable?
8.6.4 Is there a system to review compendia! Method changes and their impact to in-house test methods? Are the methods updated as appropriate?
8.6.5 Is the suitability of employed compendia] methods verified under actual conditions of use?

9.0

CHANGE CONTROL
9.1 Does an adequate system exist, described in an SOP, for controlling changes within the production process?
9.2 Does change system include review and approval of changes to process, test method, specifications, documents, and equipment? Does it require evaluation of the need for re-qualification or re-validation?
9.3 Is quality unit involved in the change control Process?
9.4 Is the potential impact of proposed change evaluated?
9.5 After a change has been implemented, is there an evaluation of the first batches produced or tested?
9.6 Is there a system in place to assure that significant process changes and their effect on the product are communicated to the customer?

 

Following attachments are required to be provided by the manufacturer:
1 Site Master File
2 Organogram
3 Valid Manufacturing License
4 Schedule-M certificate
5 WHO certificate
6 Registration certificate (Form – 41)-CDSCO, India, (Overseas Origin)
7 Open part of the DMF/COS [If applicable]
8 Technical Package (Route of Synthesis / Manufacturing Process / Flow diagram / Impurities / Degradation Products / Isomers / Polymorphism / Stability data)
9 Analytical Method Validation or verification
10 A copy of the DMF/COS letter from Regulatory authority [If applicable]
11 Letter of authorisation/Letter of access [If applicable]
12 Non-GMO (Genetically Modified Organisms) Declaration
13 TSE/BSE Declaration
14 Residual Solvent Statement
15 GDEA Statement [for DMF Source]
16 Gluten free Certificate
17 Specification & Test Method
18 Certificate of Analysis
19 Material Safety Data Sheet (MSDS).
20 Declaration/list in case the material is manufactured at location other than that audited (if any).

 

Note: Elaborate stating the reference point number where the query does not support the reply entirely.

Sr. No.

Explanation with reference point number
   
   
   
   
   
   
   
   
   
   

 

I (Head of Quality Assurance or QA representative person who completed the questionnaire) certify that the information provided in the response to the questions poised is true, accurate and complete.
Name : Company Stamp
Designation :
Signature & Date :
Quality Assurance Review
Conclusion and recommendations (Review all items for adequacy and completeness. Where any Questions are not answer or mentioned Not applicable, see for Explanation with reference point number given on page No.: 16 of 17. Where not available evaluate the criticality and comment)
Reviewed By (QA) :
Name :
Designation :
Signature & Date :

 

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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