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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ICH Requirement For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System ICH Q10)

ICH Requirements For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System As Per  ICH Q10) ICH Q10…

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Pharmaceutical Quality System (ICH Q10)

Pharmaceutical Quality System Guideline as per ICH Q10.    Introduction This document establishes a new ICH tripartite guideline describing a…

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SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.

  SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites. PROCEDURE: Carryout the microbiological testing of the drain…

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Most Important Definitions In Clinical Trials.

Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE – E6(R1)   What is Clinical Trials? What…

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