Vendor assessment activities are a routine work for a pharmaceutical industry. During the vendor assessment activities a lot of sequential activities are to be performed including material quality, feasibility and regulatory assessment. Here we mentioned a set of query may asked to a vendor prior the new vendor approval.
General Information
- Vendor Name, Address and Contact Information
- Responsible Person (Head of QA, QC, Manufacturing etc.)
- Regulatory Inspection History (Date of Inspection, Inspecting Authority & Outcome of Inspection)
- Company Overview (Date when company was established, Size of site in terms of total area and building square footage, Nature of Business, Total number of employees, ISO certification, Annual turnover etc.)
API Specification Checklist
- Certificate of analysis (COA)
- EDQM certification
- Compendia reference
- DMFs
- Manufacturing process
- API shelf life
- Packaging material
- Storage condition
- Residual solvent statement
- Stability program and data
- BET, Sterility & Toxicity analysis data (if applicable)
- Typical batch size for order
Quality Management Information
- Independent quality unit
- Authorized person for API release
- Proper recording and documented system
- Appropriate review system for quality-related documents
- Availability of deviation initiation and investigation system
- Stability study procedure as per ICH guideline
- Willing to provide analytical procedure of supplied material
- Availability of internal Audit schedule and SOP for Internal Audit
- Documentation of audit findings and corrective actions
- Procedure to perform product quality review and perform annually
- Availability of quality manual / quality policy
- Application of appropriate GMP and quality management standards
Personnel
- Adequate personnel who are qualified by appropriate education, training and / or experience
- Written procedures for identifying training needs and providing the necessary training to personnel
- Are employee training records maintained?
- Are training records readily retrievable?
- Is there procedure for wearing clean clothing and protective measures appropriate to manufacturing activity?
Building & Facilities
- Adequate space of buildings and facilities
- Defined receiving area for incoming materials
- Defined areas for quarantine and released materials
- Sampling area clearly identified and defined
- Defined area for production operations, packaging & labelling operations
- Defined area for laboratory operations
- Adequate lighting facilities
- Are the washing and toilet facilities separate from production area?
Process Equipment
- Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"?
- Is there written procedures for cleaning of equipment?
- Is the responsibility of cleaning the equipment clearly identified?
- Are there logbooks for equipment cleaning & operation?
- Is equipment inspected immediately prior to use?
Documentation and Records
- Written procedure of document prepared by, reviewed by and approved by
- Proper control of document issuance, revision, superseding and withdrawal
- Procedure for retaining all appropriate documents
- Retention periods for specified documents
- Procedure for writing, handling and updating SOPs
- Are all deviation, investigation, and OOS reports reviewed as part of the batch record review before the batch is released?
Production and In-process Control
- Validated production procedures
- Are weighing and measuring devices with suitable accuracy for the intended use?
- Are the deviations in yield associated with critical process steps investigated to determine their impact or potential impact on the resulting quality of affected batches?
- Do written procedures identify steps for reprocessing batches?
- Are quality control review and approval required for any and all reprocessing of material?
- Is there written procedures to describe the sampling methods for in-process materials, API which is based on scientifically sound sampling practices?
Packaging and Labeling of API
- Is there written procedures describing the receipt, identification, quarantine, sampling, examination and/or testing and release, and handling of packaging and labelling materials?
- Are there established specifications for Packaging and labelling materials?
- Does the company have documented procedures to ensure that correct packaging materials and labels are used?
- Do the labels used on containers of API indicate the name or identifying code, the batch number of the product, and storage conditions, when such information is critical to assure the quality of API?
Storage and Distribution
- Available for the storage of all materials under appropriate conditions
- Any special transport or storage conditions for an API is required
- Is there a system in place by which the distribution of each batch of API can be readily determined to permit its recall?
- Are expiration dates stamped or imprinted on labels?
- Does a written procedure manage stocks?
Laboratory Control
- Independent quality unit(s) should have at its disposal adequate laboratory facilities.
- Does the company have documented procedures describing sampling, testing, approval or rejection of materials, and recording and storage of laboratory data?
- Does the specification include a control of the impurities?
- Is any re-sampling and/or retesting after DOS results performed according to a documented procedure?
- Does the company issue authentic Certificates of Analysis for each batch of API?
- Are the test procedures used in stability testing should be validated and be stability indicating?
- Is the expiry or retest date of API based on an evaluation of data derived from stability studies?
- Does the company store reserve /retention sample from each batch /each marketed packaging system?
Validation
- Availability of written procedure for validation activities
- Are critical process steps defined and validated?
- Does the company have a Validation Master program?
- Availability of written validation protocol
- Are any variations from the validation protocol documented with appropriate justification?
Change Control Procedure
- Is there a formal change control system established to evaluate all changes that may affect the production and control of the API?
- Is there a written procedure in place for the identification, documentation, appropriate review, and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware), processing steps, labelling and packaging materials, and computer software?
Complaints and Recall System
- Is there a procedure for handling complaints?
- All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure.
- Is the action taken in response to each complaint documented?
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