Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced.
Checklist for Assessment or Evaluation of Vendor
Vendor Assessment / Evaluation Questionnaire ( Manufacturer ) |
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| Name of the Material | |
- Questionnaire to be filled by Vendors representative with complete details and provide with any other supporting materials, you feel is of relevance.
SOP for Vendor Audit and Qualification
| Name of the company | |
| Corporate Office | |
| Manufacturing Site | |
| Name of the contact Person | |
| Telephone | |
| E. Mail |
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Sr. No |
Questions |
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1.0 Organization, Personnel & Training (Vendor Assessment) |
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| 1.1 | How long are you manufacturing this product? | |
| 1.2 | Please state the other materials manufactured at the site | |
| 1.3 | Do you claim that the product of interest is manufactured according to Good Manufacturing Practices (GMP)?
When was the facility last inspected by a regulatory agency (GMP, ISO, WHO)? (Give dates of inspections) What were the results? |
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| 1.4 | Is the entire production cycle, from storage of starting materials to packaging of final product, performed at one site?
If negative, state the operations carried out off the site and name the sites. |
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| 1.5 | Do you the procedure for training system? If yes please specify the procedure number.
Which kind of training do you perform (GMP, ISO, Safety)? Do you maintain training records? Are employees training records up to date? Do you maintain the training schedule? |
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| 1.6 | Do you define the job descriptions for managerial and supervisory staff responsible for manufacturing and quality activities? | |
| 1.7 | Do you maintain complaint files?
Do you have the procedure for complaint? If yes please specify the procedure number. Do you record corrective actions? |
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| 1.8 | What is your manufacturing batch size of this product? | |
| 1.9 | Do you strictly adhere to the customer’s specification and supply schedule? | |
| 1.10 | Do you have a valid manufacturing license to produce this product? | |
| 1.11 | Would you accept inspection of your facility and documentation by Company? | |
2.0 Environment, Safety And Hygiene (Vendor Assessment) |
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| 2.1 | Are procedures in place to prevent air, water and land contamination?
Are the workers adequately protected from hazardous chemicals at the factory? What are your dress requirements for the personnel in manufacturing, testing, ware house and maintenance areas? |
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| 2.2 | Is the health of workers regularly monitored?
How often? |
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| 2.4 | Which restrictions as regards smoking, eating, drinks and the storage of food have been established in the manufacturing and storage area? | |
3.0 Warehousing & Storage (Vendor Assessment) |
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| 3.1 | Do you have segregated areas for Starting material, Packaging Materials, Semi-finished products and Finished products? | |
| 3.2 | Are storage conditions (temperature & humidity) controlled and regulated? | |
| 3.3 | Do you have a Pest Control and sanitation procedure for your Warehouse? | |
| 3.4 | Which of the following principles is applied in storage operations (FEFO / FIFO)? | |
4.0 Facility & Production (Vendor Assessment) |
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| 4.1 | Are any of the followings produced at the same site? (Penicillins/Cytotoxics/Steroids/Pesticides/Herbicides/Biologicals/High potent drugs) | |
| 4.2 | Do you subcontract manufacture of any stage to a third party?
If so, please give details. |
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| 4.3 | How are a production lot / batch defined?
Describe the lot number system and provide an example? |
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| 4.4 | Are the manufacturing procedures formalized? | |
| 4.5 | Is there a formal procedure for handling deviations to normal practice? | |
| 4.6 | Are there formal procedures for the handling of reworking and re-processing?
Who approves reworking and reprocessing? |
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| 4.7 | Do all the product containers bear label on the side showing product name, operation number / mix or consignment number and date? | |
| 4.8 | Are there written specifications and sampling plans to control in-process materials? | |
| 4.9 | Are there written SOPs for:
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| 4.10 | Are there separate dust extraction facilities in areas where dust is generated?
How often are ventilation and dust extraction systems cleaned? |
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| 4.11 | Is the equipment:
If multipurpose, please state the products for which it is used…………………….. |
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| 4.12 | Has critical equipment been validated for IQ/OQ/PQ | |
| 4.13 | Are critical parameters of the process identified? | |
| 4.14 | Have you validated
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| 4.15 | Is your Air Handling system qualified and pressures differentials monitored? | |
| 4.16 | What type of water do you use in production? | |
| 4.17 | Is your water system validated? | |
5.0 Quality Control & Quality Assurance (Vendor Assessment) |
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| 5.1 | Have you been certified according to WHO, ISO, cGMP OR having COPP certificate?
If YES, please provide copy of the current certificates |
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| 5.2 | Please describe your quality system and how you have documented it? | |||
| 5.3 | Is there an independent Quality Assurance Unit? To whom does Head of Quality Assurance report?
Please provide an organization chart. |
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| 5.4 | For how long do you retain copies of the production batch records and of the analytical batch documentation? | |||
| 5.5 | Do you have a Site Master File & Validation Master Plan in place? | |||
| 5.6 | Is there a list of approved suppliers for:
All materials used in the production and all services that affect product quality. All starting and packaging materials critical materials only |
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| 5.7 | Is sampling performed by QC done for
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| 5.8 | Are starting and packaging materials accepted on the basis of
If on the basis of supplier’s analytical certificate, how is the supplier controlled? |
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| 5.9 | Is sampling performed according to the sampling plan?
If affirmative, what is the applied standard? |
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| 5.10 |
Do you analyze every batch of your product? |
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| 5.11 | Are all analytical tests performed in-house?
If negative, which is the contractual laboratory? |
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| 5.12 | Do you store your control sample?
If yes, then how long it is stored? |
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| 5.13 | Do you carry out stability studies at your end?
If yes, what are the conditions? |
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| 5.14 | Do you characterize all the impurities?
If yes, can you supply us reference standards of known impurities? |
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| 5.15 | Do you have job description of every employee? | |||
| 5.16 | Do you have formal training program for your employees? | |||
| 5.17 | Do you review all the batch documents before release of the products? | |||
| 5.18 | Are SOPs for final product inspection, sampling, testing and release in place? | |||
| 5.19 | Is full analytical testing against specification performed on each lot to defined test methods?
Do you employ specific assay test method? Do you employ specific impurity test method? Please provide product specifications / test method for the product of interest. (Required as per Technical data package list) |
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| 5.20 | Is Class 1, 2 and 3 solvents used in the manufacturing process for the product?
If yes, please list the solvents concerned and their maximum concentration in the material. *Specify if the European Pharmacopoeia method used. Are any other solvents likely to be present? If yes, please list the solvents concerned and their maximum concentration in the material |
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| 5.21 | Have the laboratory standard test methods been validated? | |||
6.0 Packaging & Dispatch (Vendor Assessment) |
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| 6.1 | What are your standard pack sizes? | |
| 6.2 | What is your standard packaging? | |
| 6.3 | Can you adjust your packing size to our requirements? | |
| 6.4 | Do you have your own transport for delivery of the products to the customers? | |
| 6.5 | Are written procedures and specifications available for Packaging materials and operations? | |
| 6.6 | How do you transport the materials requiring special storage conditions? | |
| 6.7 | Do you use the re-usable packaging material?
If affirmative, state its type and how do you ensure cleaning of the packaging material? |
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| 6.8 | How do you ensure cleaning of the re-usable packaging material? | |
| 6.9 | Do you provide Certificate of Analysis with every batch of material? | |
7.0 Regulatory Compliance (Vendor Assessment) |
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| 7.1 | To which market, do you deliver your product? | |
| 7.2 | Are you a WHO-GMP holder?
If yes, provide the certificate. |
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| 7.3 | Are you having COPP of the product?
If yes, provide. |
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| 7.4 | Are you a Drug Master File (DMF) holder?
If yes, provide the DMF numbers and name of the regulatory agency |
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| 7.5 | Are you a European DMF holder?
If yes, then provide the number and list the countries, where your EDMF have been assessed. |
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| 7.6 | Are you a Certificate of Suitability (COS) holder?
If yes, then write the number. |
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| 7.7 | Is your DMF updated yearly? | |
| 7.8 | If there were any changes in your DMF, would we be notified? | |
8.0 TSE QUESTIONNAIRE (Vendor Assessment) |
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| 8.1 | Origin of starting material (s)
(Tick all boxes that apply) |
Vegetable Synthetic Inorganic
Unknown Animal Fermentation Cell culture Other (Specify): |
| 8.2 | If material is of animal origin and / or if the manufacturing process includes a fermentation and / or cell culture step using animal derived material please specify. | Animal Origin :
Bovine Cattle Caprine (goat) Ovien (Sheep) Other (Pl. Specify) |
| 8.3 | If material is gelatin, tallow, or substances produced from them, please specify. | Tallow or tallow derivative Gelatin |
List of documents to be attached along with this Questionnaire:
| Sr. No. | Documents | Attached | Not Attached | Remarks |
| Site Master File | ||||
| Quality Policy | ||||
| Organizational Chart | ||||
| WHO GMP Certificate and COPP | ||||
| A copy of the DMF/COS letter from Regulatory authority | ||||
| GMO (Genetically Modified Organisms) and Melamine free declaration | ||||
| TSE/BSE declaration | ||||
| Valid Manufacturing License | ||||
| Material Safety Data Sheet (MSDS) | ||||
| Specification & Test Method | ||||
| Certificate of Analysis (Three current batches) | ||||
| Stability data of 3 batches with real time and accelerated storage condition | ||||
| Open part of the DMF/COS | ||||
| Technical Package (Route of Synthesis/Manufacturing Process flow diagram / Impurities/Degradation Products/ Isomers/Polymorphism) | ||||
| Residual Solvents declaration | ||||
| Impurity profile of drug substance | ||||
| Elemental impurities declaration as per ICH Q3D | ||||
| List of SOPs |
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