Checklist
W.H.O. — cGMP MINIMUM DOCUMENT CHECK LIST — SITE MASTER FILE AIR QUALITY MANNUALS. WATER QUALITY MANNUALS ALL PROCESS RELATED SOP MARKET COMPLAIN RECORDS CALIBERATION RECORDS. PROCESS VALIDATION ANALYTICAL METHOD VALIDATION CLEANING METHOD VALIDATION EQUIPMENT QUALIFICATIONS –DQ, IQ, OQ & PQ INTERNAL QUALITY AUDITS REPORTS MEDICAL CHECK-UP RECORDS OF EMPLOYES MASTER FORMULA RECORDS BATCH MANUFACTURING … Read more
The use of this checklist: This transition checklist highlights the changes in the standard compared with the 2008-version and is not intended to cover all requirements of the new standard. It is intended to be a support for the auditor during the transition audit and shall also be kept as a formal record from the … Read more
Pharmaceuticals are stringently regulated by the Food and Drug Administration (FDA). The FDA’s regulatory standards for the industry are referred to as Current Good Manufacturing Practice (CGMP) standards. These standards apply to warehouses, processes, and to the products themselves. Warehouse personnel needs to check the few points which are most important to identify before the audit. … Read more
Observations should be descriptive without any ambiguity and answer like “Yes” or “No” should be avoided : S.No. Reference Checkpoints Observations Rating 1 Building and Premises: 1.1 Sch-M Specify whether the whole facility is separated, dedicated and is not a part of any other non-drug facility. 1.2 Sch-M Specify whether the surroundings of … Read more
Check Points for shop Floor Improvement – Online Documentation Daily calibration status and its record Environmental Records / Differential Pressure as per SOP. Physical cleanliness of the area / equipment / instruments. Status labeling of area / equipment / instruments Cleaning and Sanitization records. Area cleaning records. Training records of the employees performing the activity. … Read more
Checkpoints Observations Y N NA 1.0 Environmental policy Has the organization defined and documented its environmental policy? Is the environmental policy based on:Significant environmental aspects? Corporate policy? Is the policy appropriate to the organization’s activities and their potential environmental impacts? Does the policy include commitments … Read more