Quality Assurance

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

Quality Assurance

ICH Requirements For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System As Per  ICH Q10) ICH Q10 Guideline deals with Pharmaceutical Quality System which guides about Quality Manual, Management Commitment, Quality planning, Quality Policy & Quality risk management. Now let’s see what ICH Q10 say’s about Pharmaceutical Quality System Q10. Achieve product realisation To […]

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Pharmaceutical Quality System (ICH Q10)

Quality Assurance, Uncategorized

Pharmaceutical Quality System Guideline as per ICH Q10.    Introduction This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model. ICH Q10 describes

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SOP on Change Control

Quality Assurance, Uncategorized

Mastering Change Control in the Pharmaceutical Industry: A Guide to Quality and Compliance Navigate the intricacies of change control with this comprehensive guide! Ensuring the safety, efficacy, and quality of pharmaceutical products hinges on meticulous control over changes. This SOP dives into the essential steps and considerations for implementing an effective change control system in

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SOP For Training of employees

Quality Assurance

Training of employees PROCEDURE:                   Every employee of the organisation shall first undergo an Induction Training and then to be trained on his / her area of operation prior to start the work. Induction Training shall also include a visit and understanding of works done in Departments other than their own. An Induction Training Record

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