Checklist for Audit of Raw Material
| Section | Audit Point | Compliance (Y/N) | Remarks |
|---|---|---|---|
| Documentation | Are all necessary and relevant documents received? | ||
| Is the Certificate of Analysis (COA) of the raw material (RM) provided by the manufacturer? | |||
| Does the documentation match the material details (e.g., Name, Batch No., Mfg. and Exp. Dates)? | |||
| Is the material received from a vendor listed in the approved vendor list? | |||
| Vehicle Inspection | Is the vehicle free from any oily, greasy substances, dyes, or other foreign materials? | ||
| Is the vehicle clean and well-maintained as per GMP transportation guidelines? | |||
| Are environmental conditions during transportation monitored and recorded (if required)? | |||
| Labeling | Are the manufacturer’s/supplier’s labels visible and approachable on all containers? | ||
| Are all relevant details like Name, Batch No., Manufacturing and Expiry Dates, and Storage Conditions mentioned on labels? | |||
| Container Inspection | Are all containers, packs, or bags in intact condition, free of damage or tampering? | ||
| Is the packaging material suitable for protecting the contents during transport and storage? | |||
| Physical Verification | Is the physical quantity/count of material the same as mentioned in the received documents? | ||
| Are the materials stored appropriately in the designated storage area immediately after receipt? | |||
| Discrepancies | Are there any discrepancies or abnormalities observed during the receipt process? | ||
| Are observed discrepancies documented and reported according to GMP requirements? | |||
| Have deviations or non-conformances (if any) been addressed and resolved before approval? |
This checklist ensures that all incoming materials are verified, documented, and comply with Good Manufacturing Practices (GMP), emphasizing cleanliness, labeling, storage, and documentation integrity.
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