Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 4

Material Component Storage and Handling with respect to

• Are incoming material and components quarantined until approved for use? Check here YES / NO
• Are all materials handled in such a way to prevent contamination? Check here YES / NO
• Are all materials stored off the floor? Check here YES / NO
• Are materials spaced to allow for cleaning and inspection? Check here YES / NO
• Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification? Check here YES / NO
• Is label storage area limited to authorized personnel? Check here YES / NO
• Are rejected components, material, and containers quarantined and clearly marked to prevent their use? Check here YES / NO
  
  

Inventory Control Program for GMP

• Are inventory control procedures written? Check here YES / NO
• Does the program identify destruction dates for obsolete or out-dated materials, components, and packaging materials? Check here YES / NO
• Is stock rotated to ensure that the oldest approved product or material is used first? Check here YES / NO
• Is destruction of materials documented in a way that clearly identifies the material destroyed and the date on which destruction took place? Check here YES / NO

Vendor (Supplier) Control Program

• Are vendors periodically inspected according to a written procedure? Check here YES / NO
• Is the procedure for confirming vendor test results written and followed? Check here YES / NO

Operational Control

• Material/Component/Label Verification, Storage, and Handling Check here YES / NO
• Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use? Check here YES / NO
• Is release of retested material clearly identified for use? Check here YES / NO
• Are retesting information supplements originally obtained? Check here YES / NO
• Do written procedures identify steps in the dispensing of material for production? Check here YES / NO
• Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, and (3) Proper identification of containers? Check here YES / NO
• Does a second person observe weighing/measuring/dispensing and verify accuracy with a second signature? Check here YES / NO
• Is the addition of each component documented by the person adding the material during manufacturing? Check here YES / NO
• Does a second person observe each addition of material and document verification with a second signature? Check here YES / NO
• Does a written procedure specify who is authorized to issue labels? Check here YES / NO
• Does a written procedure specify how labels are issued, used, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies? Check here YES / NO
• Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted? Check here YES / NO

Reference : WHO guideline for GMP/Internet