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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Good Documentation Practices of BMR & BPR, Processing & Packaging Instructions,Sampling ,Testing Procedures and Records.

Good Documentation Practices of BMR & BPR, Processing & Packaging Instructions,Sampling ,Testing Procedures and records. (EudraLex  Volume-4) Manufacturing Formula and…

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Good Documentation Practice of Specification, Packaging Materials & Retention of Documents.

Generation and Control of Specifications for Intermediate, Bulk &  Finished Products  and Packaging Materials &  Retention of Documents.(EudraLex 4) All…

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Good Documentation Practice in Pharmaceutical Industry (EudraLex Vol- 4)

Good Documentation Practice in Pharmaceutical Industry ( As Per EudraLex Vol- 4) Principle Good documentation constitutes an essential part of…

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Why Stability Testing is So much Important?

Why Stability Testing is So much Important (Climatic Zone & Conditions)?   As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND…

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Pharmaceutical Quality System Elements & Change Management System (ICHQ10)

Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part…

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MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10)

MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10) Leadership is essential to establish and maintain a…

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