SOP FOR PREPARE MASTER PRODUCT SPECIFICATION PURPOSE: To lay down a procedure for Preparation, Approval, Authorization of Master product specification. SCOPE: This SOP is applicable for Production Block. RESPONSIBILITY: Preparation of SOPs: Officer QA Department Checking and Review of the SOPs: Sr. Officer QA Department Approval of the SOPs: Executive QA Department Authorizing of SOP: … Read more
SOP FOR REVIEW OF BATCH PROCESSING RECORD PURPOSE: To lay down the procedure for reviewing of contents in Batch manufacturing Record. SCOPE: This SOP is applicable to Batch manufacturing Records at various stages of Manufacturing and Packaging. RESPONSIBILITY: Preparation of SOP: Officer/ Sr.Officer Checking and Review of the SOP: Executive /Sr. Executive Approval of SOP: Head … Read more
SOP FOR RESPONSIBILITY OF QA PERSON PURPOSE: To lay down the responsibilities of the Quality Assurance Department. SCOPE: This procedure is applicable to the Quality Assurance Department. RESPONSIBILITY: Preparation of SOP : Officer/ Sr. Officer Checking and Review of the SOP : Executive/Sr. Executive Approval of SOP : Head of Department/ Assistant Manger Authorization of … Read more
SOP FOR PROCEDURE FOR DESTRUCTION OF WASTE MATERIAL PURPOSE: To lay down a procedure to be followed for the Destruction of Waste Material. SCOPE: This SOP is applicable for the procedure involved in Destruction of waste Material Generated in production department. RESPONSIBILITY Preparation of SOPs: Officer QA Department Checking and Review of the SOPs: Officer QA … Read more
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
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
