Validation Master Plan

Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise…

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Complaints And Recalls Handling In API Manufacturing Unit- Pharma

COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to…

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Guideline for Buidlings & Facilities

BUILDINGS AND FACILITIES Design and Construction  Buildings and facilities used in the manufacture of intermediates and APIs should be located,…

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SOP on Cleaning Validation

OBJECTIVE  : The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting…

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Hazard and risk analysis in Pharmaceutical Products

Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. Hazard:-  Any circumstance in the production, control, and…

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List of SOP for Pharmaceutical Quality Assurance

SOP List for Pharmaceutical Quality Assurance. A list of Standard Operating Procedure for Pharmaceutical Quality Assurance Department required During Quality…

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Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals.

Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with…

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Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.   Installation Qualification:- Systems and equipment should be correctly installed in accordance…

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Training of employees

Training of employees PROCEDURE:                   Every employee of the organisation shall first undergo an Induction Training and then to be…

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