The pharmaceutical industry plays an important role in our life which have contributed to enhance our life quality . So for the pharmaceutical company ,it is critical for them to set an effective and comprehensive audit system to manage their vendors ,reduce the potential risk and ensure the medicine safety. Here are the checklists for vendor audit for plastic pharmaceutical packaging materials .Hope they can help to improve your audit system .
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In what year was the site of manufacture established ?
Which industry do you supply your products to ?
Which countries do you export your products to ?
Site Personnel Information
1.If available ,please enclosed a copy of your organization chart that indicated key personnel.
2.Approximate total number of employee at the site of manufacture:
– Quality Assurance
– Quality Control
3.Please details of the qualifications and years of experience of the Q.A. Manager.
4.Please provide the details of the qualifications and years of experience of the Production Manager.
5.Who does the Q.A./Q.C. Manager report to ?
6.Is there written job description that defines each individual responsibility ?
Quality Standard and Certifications
- What cGMP/quality standards do you follow ?
- Has the site of manufacture been accredited/licensed by a third party ?
- Do you inform your customers prior to implementing significant changes that could affect the quality of material/product being supplied ?
- Does your company have a quality policy and/or mission statement?
Quality Management Documentation
Is there a documented procedure for the following activities:
- Quality Manual
- Site Master File
- Documentation Control
- Equipment and Instrument Validation Program (IQ,OP,PQ)
- Internal Audit
- Supplier Evaluation and Qualification Program
– Is there a system for monitoring/ reviewing supplier performance ?
- Supplier-Auditing System – Are all the suppliers audited by your company ?
- Quality Risk Management
- Deviation/Non-conformance Reporting
- Continuous Improvement (E.g. CAPA)
- Change Control
- Recall System/Procedure
- Annual Product Review /Campaign reviews on products
- Training for all staff on GMP and Quality Assurance(Includes routine retraining )
– Are these documented training records for all employees ?
- Electronic Data Management System
- Health and Hygiene
- Customer Complaint
- Manufacturing procedures
- In-process monitoring with limits established
- Availability of Master Production Instruction and Batch Production Records for all finished products
- Equipment Cleaning Procedures and Records
- Validation for Cleaning and Sanitisation Processes
- Process Validation
- Entry and Exit Procedure
Materials Control System
- Receipt and release of raw materials
- Inspection of incoming materials
- Sampling and testing of incoming materials
- Handling of rejected incoming materials
- Segregation between conforming and non-conforming products
- Identification system/traceability for raw materials,in-process and finished products ?(E.g. Batch numbering)
Packaging and Labeling System
- Packaging materials
- Issuance of labels
- Repackaging or re-labeling
Facilities and Equipment System
- Environmental Monitoring program
- Facility Cleaning and Sanitisation
- Pest Control Program
- Preventative Maintenance Program
- Calibration Program
- Waste Disposal Program
- Access Control
Laboratory/Quality Control System
- Sampling handling and labeling
- Re-sampling or re-testing
- Validated analytical method
– Are quality control inspection/testing traceable to individual staff ?
- Validated assay methods for release of finished product
- Testing Reagents and Reference Standards Controls
- Availability of Analytical Raw Data Documentation
- Out of Specification
- Testing of related substance/impurities
- Testing method of residual solvents in finished product
- Microbial testing of finished product
- Sample retention for finished products
- Calibration program for QC instrument/equipment
- Which department reviews production records to ensure that procedures were followed and documented ?
- Have any products undergone a recall in the last 3 years ?
- Are expiry dated provided for the products sold ?
- Are non-production areas segregated from production areas ?
- Is there traceability throughout the manufacturing process?
- Is reprocessing allowed ?
- Please enclose a copy of your production specification
- Quality Standard used for testing the finished product we wish to purchase.
- If available ,please enclose a copy of the Material Safety Data Sheet for the material we wish to purchase.
- What is the recommended storage condition for the reference product ?
- Does your company generate Certificated of Analysis (COA) or Certificates of Compliance (COC )with each material produced/sold ?
Please enclose a sample copy of your COA/COC.
Are COA/COC that are generated in-house checked for accuracy ?
Are retest date/expiry date provided on COA/COC ?
Is the amount of residual solvent reported on COA/COC for each batch ?
Are certificates issued for each batch ?
- Is there adequate space for the orderly storage of incoming raw materials and finished product?
- Are these physical separators between approved and rejected materials stores?