SOP for Procedure for Analytical Method Validation and Verification 1.0 OBJECTIVE To establish a documented procedure for Analytical Method Validation and Verification in the Quality Control (QC) Department to ensure analytical methods are suitable for their intended purpose and comply with regulatory requirements. 2.0 SCOPE This SOP applies to all analytical method validation and verification … Read more
SOP for Stability Study of Volumetric Solutions 1.0 Objective To establish a standardized procedure for conducting stability studies of volumetric solutions to determine and assign their shelf life. 2.0 Scope This SOP is applicable to all volumetric solutions prepared and used in the Quality Control Laboratory. 3.0 Responsibility Chemist or above in the QC Laboratory … Read more
SOP for Chemical Analysis of Water Used in Manufacturing 1.0 Objective To establish a standardized procedure for the chemical analysis of water used in manufacturing to ensure compliance with approved specifications. 2.0 Scope This SOP is applicable to the Quality Control Laboratory for performing chemical analysis of water samples used in manufacturing processes. 3.0 Responsibility … Read more
SOP FOR LABORATORY INSTRUMENT QUALIFICATION Objective: To lay down the procedure for Qualification of laboratory instrument / equipment. Scope: This procedure is applicable for the qualification of laboratory instrument /equipment in Quality Control Lab. Responsibility: IT person shall be responsible to provide IT support and implement the data backup policy for electronic data generated by … Read more
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