WHO GMP for Sterile Pharmaceutical Products Clean Areas & Facilities Question 1. Sterile preparation production should be carried out in: A. Open manufacturing spacesB. Controlled warehousesC. Clean areasD. Regular production roomsAnswer: C Question 2. Entry to clean areas should occur through: A. Free-access doorsB. AirlocksC. Emergency exitsD. Storage roomsAnswer: B Question 3. Air supplied to … Read more
Questions and Answers on Quality Control (QC) Questions 1. QC personnel supporting sterile manufacturing activities must have training and experience in: A. Marketing and financeB. Microbiology, sterility assurance, and process knowledgeC. Mechanical engineering onlyD. Warehouse operationsAnswer: B Questions 2. Specifications for raw materials, components, and products should include limits for: A. Moisture onlyB. Microbial, particulate, … Read more
SOP on receipt and handling of stability samples Objective: To lay down a procedure for receipt and handling of stability samples. Scope: This SOP is applicable for receipt and handling of stability samples in Quality Control Laboratory. Responsibility: QC Chemist or above Accountability: Head – Quality Control Procedure: Receipt of stability samples : Samples for stability studies shall be … Read more
SOP on Pharmacopeial updation of documents as per the Pharmacopeial changes Objective: To lay down a procedure for Pharmacopeial updation of documents as per the Pharmacopeial changes. Scope: This procedure is applicable to Pharmacopeial updation of documents as per the Pharmacopeial changes.. Responsibility: QC Chemist or above & QA officer or above Accountability: Head Quality Control & Head Quality Assurance Procedure: … Read more
SOP on retesting of raw material Objective: To lay down the procedure for re-testing of raw material for material lying in warehouse for longer period. Scope: This SOP is applicable for retesting of raw material for material lying in warehouse for longer period. Responsibility: Chemist or above of QC Department & Officer or above of warehouse Department. Accountability: Head – … Read more
SOP on Sampling of Raw Material Objective: To lay down the procedure for sampling of raw material. Scope: This procedure is applicable for sampling of raw material Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from warehouse. Ensure that material is received from … Read more
SOP for Numbering system for analytical document to be used for regulatory submission Objective:- To lay down a procedure for numbering system for analytical document to be used for regulatory submission. Scope: This SOP is applicable for numbering system for analytical document to be used for regulatory submission in quality control laboratory. Responsibility: Chemist or above of QC … Read more
SOP for Maintaining Quality Control equipment / instrument log book Objective : To lay down the procedure for maintaining equipment / instrument log book in Quality Control Department. Scope: This procedure is applicable for maintaining equipment / instrument log book in Quality Control Department. Responsibility: Chemist or above of QC department Accountability: Head Quality Control Procedure: … Read more
SOP on Entry and Exit into Sampling Booth Area Objective: To lay down a procedure for entry and exit into sampling booth area. Scope: This procedure is applicable for entry and exit into sampling booth area. Responsibility: QC Chemist or above Accountability: Head – Quality Control Procedure: Entry Procedure into Sampling Booth Area: Enter into the personnel air lock … Read more
SOP on Intermediate and finished product Analysis, Approval and Rejection Objective: To lay down the procedure for analysis, approval and rejection of Intermediate and finished product. Scope: This procedure is applicable for analysis, approval and rejection of Intermediate sample, validation sample and finished product sample in QC Department. Responsibility: Chemist or above /Executive / nominee Accountability: Head – Quality … Read more