Pharmaguidances

SOP FOR ACCELERATED STABILITY AND SHELF-LIFE CALCULATION PURPOSE: To lay down a method for accelerated stability and to find out the shelf life of the product for Cephalosporin Block. SCOPE: This SOP is applicable for the standard operating procedure pertaining to all departments. RESPONSIBILITY Preparation of SOPs: Officer/ Executive of Concerned Departments Checking and Review of the … Read more

SOP FOR CALIBRATION OF EQUIPMENT/ INSTRUMENTS FROM OUTSIDE AGENCY PURPOSE: To lay down a procedure for calibration of equipment’s /instrument by outside agency SCOPE: This sop applicable to all the equipment’s/ instruments. RESPONSIBILITY: Preparation of SOPs: Officer/ Executive of Concerned Departments Checking and Review of the SOPs: Next Level of the Concerned Department Approval of the SOPs: … Read more

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 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