SOP ON IMPACT ASSESSMENT FOR EQUIPMENT /SYSTEM OBJECTIVE: To assess the impact of process variables on quality of product prior to carrying out process validation. SCOPE: This SOP is applicable for different stages of manufacturing for product to be validated. RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as … Read more
SOP FOR HANDLING OF REPROCESSING AND REWORKING OBJECTIVE: To describe a procedure for reworking and reprocessing of the batch. SCOPE: This SOP is applicable for reworking and reprocessing of the batch. RESPONSIBILITY: Production Operator & Supervisor: Responsible for compliance the reprocessing of the batch with proper documentation. ACCOUNTABILITY: Head QA is accountable for the implementation … Read more
RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL To establish documented evidence that the design of in–use “Vial Filling and rubber stoppering Machine” is in compliance with the GMP, Safety and Operational requirements identified in the Risk Assessment document. In the project content, risk analyses are performed as basic GMP/EHS-Risk Assessment, which shall help to identify important … Read more
Procedure-for-calibration-of-calculator-quality-assurance/Validation of digital Calculator Objective: The purpose of this SOP is to lay down a procedure for validation of digital calculator. Scope: This SOP is applicable to all digital calculator use in Quality Control Department. Responsibility: Chemist or above of QC laboratory. Accountability: Head – Quality Control. Procedure: Identification to Calculator: Calculators existing in department shall be identified by specific … Read more
ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by settle plate method. SCOPE: This SOP is applicable for Environmental monitoring by settle plate method of this organization. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: Quality control – Head PRECAUTIONS : Glass wares employed for sampling should be … Read more
ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by Air sampling method. SCOPE: This SOP is applicable for Environmental monitoring by Air sampling method of this organization. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: Quality control – Head ABBREVIATIONS: SCDA: Soya bean Casein digest agar PRECAUTIONS: Before … Read more
Personal monitoring by contact plate method in sterility testing area. OBJECTIVE: To lay down a standard operating procedure for personal monitoring by contact plate method in sterility testing area. SCOPE: This SOP is applicable for personal monitoring by contact plate method in sterility testing area. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: … Read more
SOP on container closure integrity for Dry powder for injection Objective : To lay down the procedure for container closure integrity for Dry powder for injection. Scope: This SOP is applicable for container closure integrity for Dry powder for injection. Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Chemical … Read more
SOP on Handling of Returned Goods Objective : To lay down the procedure for handling of returned goods from customer. Scope : This SOP is applicable for handling of returned goods in Formulation. Responsibility: Executive / Manager – Warehouse / Excise Executive / Manager – Quality Assurance. Executive / Manager – Quality Control. Executive / … Read more
SOP on Additional testing Objective: To lay down a procedure to carry out additional testing after necessary QA approval so as to avoid unwanted testing and analysis. Scope: This procedure is applicable to any additional testing required for confirmation or investigation. The additional testing may be required for finished products, Intermediate products, Raw Materials and Packing materials. … Read more