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Quality Risk Management In Pharmaceutical Industry. Quality risk management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. Principles of Quality Risk Management Two primary principles of quality risk management are: The evaluation of the risk to quality should be …

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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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FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA) Evaluate the company’s system to investigate laboratory test failures (OOS). These investigations represent a key issue in deciding whether a product may be released or rejected and form the basis for retesting, and resampling. In a recent court decision the judge used the term “out-of-specification” (OOS) laboratory result rather …

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