PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM

Posted on By shivpharma2016

PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM PURPOSE OF SOP ON REPORTING: To describe the procedure for rounding off numerical values and reporting system. SCOPE OF SOP ON REPORTING: This Standard Operating Procedure (SOP) shall be applicable for rounding off numerical values and reporting systems in Quality Control, Production, IPQA and Warehouse Departments….

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Quality Assurance

SOP ON MANAGEMENT REVIEW SYSTEM IN PHARMA

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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…

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Quality Assurance

OPERATION, CLEANING AND CALIBRATION PROCEDURE OF DISINTEGRATION TEST APPARATUS

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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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Quality Assurance

SOP ON PRE-DISPATCH INSPECTION

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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…

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Quality Assurance

SOP ON PROCEDURE FOR STABILITY STUDY OF FINISH PRODUCT

Posted on By shivpharma2016

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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Quality Assurance

SOP ON PROCEDURE FOR MEDICAL EXAMINATION

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SOP ON PROCEDURE FOR MEDICAL EXAMINATION OBJECTIVE: To lay down the procedure for Medical Examination of all employees. SCOPE: This procedure is applicable for Medical Examination of all employees working. RESPONSIBILITY: Officer/ Manager – Personnel & Administration. ACCOUNTABILITY: Head QA – To ensure implementation of SOP. PROCEDURE: Definitions: Qualified Physician- A person having medical degree…

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Human resources

SOP ON PROCEDURE FOR CLOTHING & PERSONAL HYGIENE

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SOP ON PROCEDURE FOR CLOTHING & PERSONAL HYGIENE OBJECTIVE: To lay down the procedure for clothing and personal hygiene. SCOPE: This procedure is applicable for clothing and personal hygiene. RESPONSIBILITY: Officer/ Manager – Personnel & Administration. ACCOUNTABILITY: Head QA – To ensure implementation of SOP. PROCEDURE: Personal Hygiene: Clean outer protective clothing must be worn…

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Human resources

SOP ON PEST AND RODENT CONTROL

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SOP ON PEST AND RODENT CONTROL OBJECTIVE: To lay down a procedure for pest & rodent control with a view to maintain hygiene and sanitation in the factory premises. SCOPE: This SOP is applicable for pest & rodent control of following Mosquitoes, Cockroaches, Bugs, Ants, Silverfish, Rat and Lizards. RESPONSIBILITY: Officer – P&A & Administration &  Technical…

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Human resources

SOP ON OPERATION AND CLEANING OF INSECTICUTER IN PHARMA

Posted on By shivpharma2016

SOP ON OPERATION AND CLEANING OF INSECTICUTER IN PHARMA OBJECTIVE: To lay down the procedure for operation and Cleaning of Insecticuter. SCOPE: This SOP is applicable for the operation and Cleaning of Insecticuter mounted for the protection of ancillary area with insects in the plant. RESPONSIBILITY: Officer/ Manager- Personnel & Administration – To ensure proper…

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Human resources

SOP ON ENTRY & EXIT OF PERSONNEL IN THE FACTORY PREMISES

Posted on By shivpharma2016

SOP ON ENTRY & EXIT OF PERSONNEL IN THE FACTORY PREMISES OBJECTIVE: To lay down a procedure for Entry & Exit of personnel in the factory premises. SCOPE: This SOP is applicable for Entry & Exit of personnel in the factory premises. RESPONSIBILITY: Head of the Department – Personnel and Administration PROCEDURE: Permanent Employees Posted…

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Human resources