Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 5

Equipment/Line/Area Cleaning, Preparation, and Clearance

• Do written procedures detail how equipment is to be checked immediately prior to use for cleanliness, removal of any labels and labeling from prior print operations? Check here YES / NO
• Do written procedures detail any disconnection and reassembly required to verify readiness for use?

Operational Process Validation and Production Change Order Control,

• Have production procedures been validated? (Review selected procedures for validation documentation. Adequate?) Check here YES / NO
• Does the process control address all issues to ensure identity, strength, quality and purity of product? Check here YES / NO
• Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients? Check here YES / NO
• Are all weighing and measuring preformed by one qualified person and observed by a second person? Check here YES / NO
• Have records indicated preceding policy been followed by presence of two signatures? Check here YES / NO
• Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process? Check here YES / NO
• Are calculations performed by one person? Is there independent verification by a second person? Check here YES / NO

In-Process Inspection, Sampling, and Laboratory Control

• Are written procedures established to monitor output and validate the performance of manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products? Check here YES / NO
• Are in-process materials tested at appropriate phases for identity, strength, quality, purity and are they approved or rejected by Quality Control? Check here YES / NO
• Are there laboratory controls including sampling and testing procedures to assure conformance of components, containers, closures, in-process materials, and finished product specifications? Check here YES / NO
• Reprocessing/Disposition of Materials Check here YES / NO
• Do written procedures identify steps for reprocessing batches? Check here YES / NO
• Are quality control review and approval required for any and all reprocessing of material? Check here YES / NO
• Does testing confirm that reprocessed batches conform to established specification? Check here YES / NO
• Does a written procedure outline steps required to reprocess returned drug products (if it can be determined that such products have not been subjected to improper storage conditions?) Check here YES / NO
• Does Quality Control review such reprocessed returned goods and test such material for conformance to specifications before releasing such material for resale?
  Check here YES / NO

Finished Product Control

• Finished Product Verification, Storage, and Handling Check here YES / NO
• Do written procedures indicate how and who verifies that correct containers and packages are used for finished product during the finishing operation? Check here YES / NO
• In addition, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling? Check here YES / NO
• Are expiration dates stamped or imprinted on labels? Check here YES / NO
• Are expiration dates related to any storage conditions stated on the label? Check here YES / NO
• Are all finished products held in quarantine until QC has completed its testing and releases product on a batch to batch basis for sale? Check here YES / NO
• Is finished product stored under appropriate conditions of temperature, humidity, light, etc. Check here YES / NO

Finished Product Inspection, Sampling, Testing, and Release for Distribution

• Has the formulation for each product been tested for stability based on a written protocol? (Containers must duplicate those used in final product packaging.) Check here YES / NO
• Are written sampling and testing procedures and acceptance criteria available for each product to ensure conformance to finished product specifications? Check here YES / NO
• Is a quantity of samples equal to at least twice the quantity needed for finished product release testing maintained as a reserve sample? Check here YES / NO
• Are sterility and pyrogen testing performed as required? Check here YES / NO
• Are specific tests for foreign particles or abrasives included for any ophthalmic ointments? Check here YES / NO
• Do controlled release or sustained release products include tests to determine conformance to release time specification? Check here YES / NO

Distribution Controls

• Does a written procedure manage stocks to ensure that oldest approved product is sold first? Check here YES / NO
• Are deviations to the policy above documented? Check here YES / NO
• Does a written procedure identify the steps required if a product recall is necessary? Check here YES / NO
• Is the recall policy current and adequate? Check here YES / NO
  
  

Marketing Controls

• The current regulation does not address marketing controls per se except that all finished products must meet their specifications. Check here YES / NO

Complaint Handling and Customer Satisfaction Program

• Are complaints, whether received in oral or written form, documented in writing and retained in a designated file? Check here YES / NO
• Are complaints reviewed on a timely basis by the Quality Control Unit? Check here YES / NO
• Is the action taken in response to each complaint documented? Check here YES / NO
• Are decisions not to investigate a complaint also documented and the name of the responsible person documented? Check here YES / NO
• Are complaint investigations documented and do they include investigation steps, findings, and follow-up steps, if required? Are dates included for each entry? Check here YES / NO
   

Reference : WHO guideline for GMP/Internet