SPECIFICATIONS FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS ( QUALITY CONTROL)

SPECIFICATIONS: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substance. Specifications: Definition and Justification…

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SOP For Cleaning of Quality Control Laboratory.

SOP For Cleaning of Quality Control Laboratory. OBJECTIVE:  The Objective of this SOP to lay down a procedure for daily…

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SOP For Pest & Rodent Control

SOP For Pest & Rodent Control   Objective :- To lay out the procedure of the Pest & Rodent control…

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SOP FOR DOCUMENTATION CONTROL PROCEDURE

SOP FOR DOCUMENTATION & DATA CONTROL PROCEDURE Standard Operating Procedures for Approval  & Control documentation( SOP For Documentation & Data…

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Evaluation of RETESTING In Pharmaceutical (Quality Control) Industry.

Evaluation of RETESTING In Pharmaceutical (Quality Control) Industry. Evaluate the company’s retesting SOP for compliance with scientifically sound and appropriate…

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FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA)

FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA) Evaluate the company’s system to investigate laboratory test failures (OOS). These investigations represent a…

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SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ).

SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ). OBJECTIVE :- The objective of this SOP…

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What are the responsibilities of a quality control?

What are the responsibilities of a Quality Control?( As per EudraLex Vol-4 & USFDA) Control laboratory premises and equipment should…

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What are the Job Responsibilities of Quality Control Head & Quality Unit Joint Responsibilities.

Job responsibilities of The head of Quality Control & Joint Responsibility of The heads of Production, Quality Control,Head of Quality Assurance…

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The Role of the Qualified Person in European Pharmaceutical Regulations.

The Role of the Qualified Person in European Pharmaceutical Regulations.(EudraLex Vol:4) The role of the Qualified Person In European Pharmaceutical…

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