SOP FOR MANAGEMENT REVIEW MEETING PURPOSE: The purpose of this SOP is to lay down the procedure for regular Quality management review meeting to determine the performance and effectiveness of in product development, regulatory approval, dossier compliance and GMP scenario during routine and associated documentation. SCOPE: This SOP is applicable for product development, regulatory approvals, … Read more
SOP FOR PREPARATION, APPROVAL, ISSUE AND CONTROL OF ART WORKS FOR LABELING OF DRUG PRODUCTS PURPOSE: To lay down the procedure for preparation, approval, issue and control of art works for labeling of drug products intended for commercial use. SCOPE: This SOP is applicable for preparation, approval, issue and control of artworks for labeling of … Read more
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 OPERATION AND CALIBRATION OF pH METER PURPOSE: To lay down a procedure for Operation and Calibration of pH meter. SCOPE: This SOP is applicable for operation and calibration of pH meter. 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 … 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