SOP ON MANAGEMENT REVIEW SYSTEM IN PHARMA PURPOSE OF SOP: To outline the procedure for Management Review of all systems. SCOPE: This procedure applies to the Management Review of all systems. CROSS-REFERENCE DOCUMENTS OF SOP Corrective action & preventive action (CAPA) ATTACHMENTS S.No. Attachments No. Attachment Title 1 Attachment-I Quality Management Review Report 2 Attachment-II Quality…
OPERATION, CLEANING, AND CALIBRATION PROCEDURE OF DISINTEGRATION TEST APPARATUS PURPOSE: To define a procedure for the Operation, cleaning, and calibration of the disintegration test apparatus. SCOPE: This SOP is applicable for procedures for Operation, cleaning, and calibration of disintegration test apparatus. REFERENCE (S): Indian Pharmacopoeia / United States Pharmacopeia / In-House CROSS-REFERENCE DOCUMENTS: Preparation, Review, Approval,…
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SOP ON PRE-DISPATCH INSPECTION PURPOSE OF SOP: To lay down a procedure to inspect the finished products pack before transferring to finished goods store for dispatch. SCOPE : This SOP is applicable for all finished products to be dispatched from the manufacturing facility for following condition , each batch of products manufactured at the site and…
SOP ON PROCEDURE FOR STABILITY STUDY OF FINISH PRODUCT PURPOSE: This SOP aims to describe a procedure for the stability study of Finish products. SCOPE: This SOP is Applicable to the stability study of finished products. RESPONSIBILITY& ACCOUNTABILITY: RESPONSIBILITY QA personnel shall be responsible for preparing the SOP and stability protocol. QA personnel shall be responsible…
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PREPARATION AND CONTROL OF BMR AND BPR IN PHARMA OBJECTIVE: To describe the procedure to be followed for preparation, and control of Batch Manufacturing Records and Batch Packing Records. SCOPE: This procedure is applicable to Preparation of BMR and BPR . RESPONSIBILITY: Production Personnel: – BMR and BPR shall be prepared by Production personnel. QA Personnel: –…
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RESPONSIBILITIES OF THE QUALITY ASSURANCE DEPARTMENT OBJECTIVE: To lay down the responsibilities of the Quality Assurance Department. SCOPE: The scope of this document is to provide the responsibilities of QA . RESPONSIBILITY: QA Personnel: To perform as per procedure. ACCOUNTABILITY: Head – QA. PROCEDURE: Responsibilities and procedure applicable to QA shall be in writing and same shall be followed….
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TRAINING PROCEDURE FOR PLANT PERSONNEL IN PHARMA OBJECTIVE: To lay down a standard operating procedure for organizing and conducting Training and need gap analysis to all the employees at all levels. SCOPE: This SOP is applicable for organizing and conducting Training Calendar, Programmes, Schedules, Tests to do need gap analysis of all the employees at all levels….
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DOCUMENT AND DATA CONTROL IN PHARMA OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to lay down a procedure for issuance, Retrieval and destruction of various documents to ensure that correct versions of document are in use. SCOPE: This SOP is applicable for issuance, distribution, retrieval and destruction of Standard Operating Procedures, Master…
PREPARATION OF SOP OBJECTIVE: To lay down a standard operating procedure for preparation, approval, control, issuance, implementation, review, change and destruction of Standard Operating Procedures and Master Documents. SCOPE: This SOP is applicable for the preparation, approval, control, issuance, implementation, review, change and destruction of Standard Operating procedures in all departments. RESPONSIBILITY: Concerned Executive / Concern…
