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GMP Compliance for Veterinary Diagnostics - Proven and Independently Certified

IDEXX Switzerland GmbH had itself audited for its veterinary diagnostics by the independent company Bureau Veritas and thus obtained GMP certification.

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Basic Principles of Effective and Efficient Qualification

Practical Suggestions – Part 3: Here we go – the implementation

- New technical publication from gempex

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Inspection-Readiness for the Production of Pharmaceutical Ointments and Creams – Preparation for Inspection by the Russian Health Authorities (MIT)

Preparation for Inspection by the Russian Health Authorities (MIT)

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Product Quality Review and Annual Product Review

5 points for a meaningful PQR/ APR - Process stability and product quality annually checked, verified and improved

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Qualification in the New Construction of a Logistics Centre - Reduce effort through reasonable risk management and integrated qualification

- New technical publication from gempex

- Qualification in the field of Pharma-GDP

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Not all GMP is the same - On the state of harmonisation of GMP

New expert contribution from gempex

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Qualification 4.0 - risk-based and efficient

Expert lecture by gempex on 15 June 2020 at the 18th Swiss Cleanroom Community Event, Pratteln, Switzerland

 

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Basic Principles of Effective and Efficient Qualification

Practical Suggestions – Part 2: Planning is what counts

- New technical publication from gempex

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Update EU-MDR: transitional period extension agreed

How do manufacturers of medical devices of classes I to III ensure the compliance of their products?

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Preparation for EU MDR - Possible Extension of the Transitional Period

The new EU Medical Device Regulation (EU Regulation 2017/745 - EU Medical Device Regulation) came into force on 25 May 2017. The transition period is scheduled to end on May 26, 2020 - now discussions are underway to extend this transition period by another...

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