January 2019

Prevention of Cross Contamination in Pharmaceutical Industry. Normally, the production of non-medicinal products should be avoided in areas and with equipment destined for the production of medicinal products but, where justified, could be allowed where the measures to prevent cross-contamination with medicinal products described in Eudralex Volume 4 (Chapter 3 & 5) can be applied. …

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SPECIFICATIONS: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substance. Specifications: Definition and Justification Definition of Specifications:- A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the …

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SOP For Cleaning of Quality Control Laboratory. OBJECTIVE:  The Objective of this SOP to lay down a procedure for daily cleaning of Quality Control Laboratory.   SCOPE: This SOP is applicable to describe the procedure of for daily cleaning of quality control Laboratory in Quality Control Department at manufacturing Plant. RESPONSIBILITY: QC Officer/Executive  shall be …

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SOP For Pest & Rodent Control Objective :- To lay out the procedure of the Pest & Rodent control in the manufacturing Plant. Scope :- The SOP is applicable for Pest & Rodent control in the manufacturing Plant. Responsibility :- Housekeeping department officer/Executives  shall be Responsible for effective application OF SOP For Pest  & Rodent …

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SOP For Documentation Control Procedure Standard Operating Procedures for Approval  & Control documentation( SOP For Documentation & Data Control)  in Pharmaceutical Industry.  Objective :- The purpose of this SOP to lay out the procedure for the preparation, Review, Approval, Distribution, Revision , Retrieval, Archival & Destruction of the Master/Control Documents existing in manufacturing Unit & …

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Evaluation of RETESTING In Pharmaceutical (Quality Control) Industry. Evaluate the company’s retesting SOP for compliance with scientifically sound and appropriate procedures. A very important ruling in one recent court decision sets forth a procedure to govern the retesting program. This district court ruling provides an excellent guide to use in evaluating some aspects of a pharmaceutical laboratory, …

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