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GMP Knowledge

GMP Knowledge

The GMP knowledge mainly concludes the experience of gempex experts in the GMP consulting and execution. All articles mainly cover the whole life cycle of different fields such as pharma, biotech, API, medical devices and raw and auxiliary packages, from the concept design of GMP new plant to the inspection pass, providing readers with comprehensive GMP knowledge and practical experience. Welcome to discuss!

Facilities Validation-Strategic planning

Case Study: How the World's Largest Natural Eye Drop Manufacturer Achieved EU GMP Annex 1 Compliance

This article provides reference strategies for ensuring sterility for eye drop manufacturers and makers of sterile products.

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Facilities Validation-C&Q Execution

Basic Principles of Effective and Efficient Qualification Part 1

This is the 1st part:"Basic Principles".

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Facilities Validation-C&Q Execution

Basic Principles of Effective and Efficient Qualification Part 2

This is the 2nd part: "Basic Principles".

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Facilities Validation-C&Q Execution

Basic Principles of Effective and Efficient Qualification Part 3

This is the 3rd part: "Here we go – the implementation".

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Facilities Validation-C&Q Execution

Basic Principles of Effective and Efficient Qualification Part 4

This is the 4th part: "It becomes formal – comparison with the regulations".

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Facilities Validation-C&Q Execution

Qualification 4.0 – Unused Opportunities-Part 1

How an efficient, time-optimized qualification could work – Part 1

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Facilities Validation-C&Q Execution

Qualification 4.0 – Unused Opportunities-Part 2

How an efficient, time-optimized qualification could work – Part 2

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