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Tag: Quality Assurance

Sampling on Starting and Packaging Materials

January 19, 2021 Admin Leave a comment

PrincipleSampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the…

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Posted in: Packaging Filed under: Packaging Materials, Quality Assurance, Sampling

FDA WARNING LETTER – Shilpa Medicare Limited

November 7, 2020 Admin Leave a comment

Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing…

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Posted in: FDA Warning Letter Filed under: FDA Warning Letter, QMS, Quality Assurance, Shilpa Medicare Limited Warning Letter 2020

Cleaning Validation Protocol Format

October 5, 2020 Admin Leave a comment

A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information…

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Posted in: Quality Assurance Filed under: Cleaning Validation, Cleaning Validation Protocol Format, Quality Assurance

SOP For Vendor Management

September 13, 2020 Admin Leave a comment

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after…

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Posted in: Quality Assurance Filed under: QMS, Quality Assurance

SOP for BMR & BPR Review

September 12, 2020 Admin Leave a comment

Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing…

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Posted in: Quality Assurance Filed under: BMR & BPR Review, Quality Assurance, Quality Control SOP

SOP For Handling of Power Failure in Plant

September 7, 2020 Admin Leave a comment

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

SOP For Batch Release of Finished Product

Admin Leave a comment

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply…

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Posted in: Quality Control Filed under: Batch Release, 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

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