GMPSOP

MAY 31, 2024

If you are in the pharmaceutical business, regulatory authorities mandate that you develop, implement, and periodically review a validation master plan for qualifying your systems, processes, cleaning method, testing methodologies, equipment, facilities, etc. What is a validation master plan (VMP)? 12 or 24 months). .

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GMPSOP

OCTOBER 26, 2022

Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.

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GMPSOP

JUNE 9, 2024

This article will focus on some of the common activities performed in quality control facilities daily to maintain the expected level of compliance and ensuring product quality. Additional documents included each month. Laboratory equipment must be qualified according to the validation master plan. Checkout sample preview s.

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GMPSOP

JULY 23, 2023

If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. Installation qualification verifies and documents that all critical aspects of equipment installation adhere to predetermined specifications and manufacturer’s recommendations.

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GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

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GMPSOP

NOVEMBER 19, 2023

The scope of this article applies to all regulated medicinal products manufactured at a GMP site that undergo annual product quality review. The content of this article does not supersede or replace any local or international regulatory requirements. Additional documents included each month. Checkout sample preview s.

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GMPSOP

DECEMBER 24, 2023

This article will focus on G(C)LP due to its significance in everyday laboratory operations. Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month.

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