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29th of August 2022: Computerized System Validation (CSV) – GAMP 5 Second Edition

2nd Edition of the GAMP 5 Guideline will address required changes in computerized system validation (CSV). Have you adopted the changes yet?

25th of July 2022: Valicare becomes 20 years old

An occasion to celebrate and to sum up.

Historical, current and a look into the future!

For more read our newsletter.

24th of July 2022: SMEPAC test

Valicare s.r.o. provides now Smepac tests (Standardized Measurement for Equipment Particulate Airborne Concentrations) according to the specifications in the ISPE Good Practice Guide: Assessing  the Particulate Containment Performance of Pharmaceutical Equipment. You can find out more in our one-pager. 

25th of June 2022: New ICH Q14 Guideline: Analytical procedure development

Our GMP experts are experienced in the development of analytical procedures and will advise and guide you in the preparation and your considerations for implementing all the requirements of the new ICH Q14 Guideline into practice. First, however, we will give you a brief overview of the new guideline.

1th of March 2022: Klenzaids, joint venture partner of Syntegon Group delivers first mobile BSL-3 laboratory in India

Klenzaids, joint venture partner of the Syntegon Group and close cooperation partner of Valicare GmbH, delivers the first mobile BSL-3 laboratory in India for early detection and control of pathogens.

18th of February 2022: Revision of ICH Q9 quality risk management

Innovations in the implementation of risk management in the pharmaceutical industry: product availability, hazard identification and attention to subjectivity in risk assessment.

27th of May 2021: Novelties by EMA on medicinal products with genetically modified cells

Updated EMA guideline for medicinal products containing modified cells provides innovations, recommendations and improvements to be implemented.

15th of April 2021: Toxicological assessment continues to gain acceptance for cleaning validation

WHO publishes decision on setting acceptance criteria for cleaning validation.

10th of February 2021: FDA approves Breyanzi®, a new CAR-T cell therapy drug

Fourth approved CAR-T cell therapy soon to be available in Europe?