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Category: Quality Assurance

SOP for Metal Detector / Deduster

September 12, 2020 Admin Leave a comment

Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the…

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Posted in: Quality Assurance Filed under: Deduster, Metal Detector, Pharmaceutical Production, Production SOP

SOP on Technology Transfer of Drug Product

September 7, 2020 Admin Leave a comment

Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first…

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Posted in: Quality Assurance Filed under: Drug Product, production, Technonlogy Transfer

SOP For Handling of Power Failure in Plant

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Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Control, Microbiology, Utility, Stores, etc…

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Posted in: Quality Assurance Filed under: Handling of Power Failure, Quality Assurance

Batch Manufacturing Record

August 17, 2020 Admin Leave a comment

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Posted in: Quality Assurance Filed under: Quality Assurance

European Guidance On:
HOW TO CARRY OUT A RISK ASSESSMENT

July 23, 2020 Admin Leave a comment

At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation…

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Posted in: Quality Assurance Filed under: Pharmaceutical Quality System, Quality Assurance, Quality Management System

CAPA PROCESS – STEP-BY-STEP INSTRUCTIONS

July 17, 2020 Admin Leave a comment

CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a…

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Posted in: Quality Assurance Filed under: CAPA, QMS, Quality Assurance, Quality Management System, Steps of CAPA

Handling of Pharmaceutical Market Complaint

May 17, 2020 Admin Leave a comment

Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the…

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Posted in: Quality Assurance Filed under: Pharmaceutical Market Complaint, Quality Assurance, Quality Management System

SOP For Job Responsibility

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The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals.…

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Posted in: Quality Assurance Filed under: production, Quality Assurance, Quality Assurance SOP, Quality Control, SOP, SOP For Job Responsibility

Validation Master Plan

December 12, 2019 Admin Leave a comment

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

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Posted in: Quality Assurance Filed under: Quality Assurance, Validation Master Plan

Complaints And Recalls Handling In API Manufacturing Unit- Pharma

December 10, 2019 Admin Leave a comment

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

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Posted in: Quality Assurance Filed under: Complaints And Recalls, Quality Assurance

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