Highlights from the GMP market and Valicare
You want to know what is driving the industry and ourselves? We have compiled the recent news for you here.
12 Results found
05/06/2024
Do your methods comply with the new ICH requirements?
ICH Q2(R2) and ICH Q14 describe mandatory requirements for the development, life cycle and validation of analytical methods.
08/22/2023
Prohibition of PFAS – Evaluate, assess risks, time to act
Valicare experts present solutions to you Per- und Polyfluoroalkyl substances (PFAS) are widely used in the pharmaceutical and biotech industry as ...
08/02/2023
Revision of Annex 1 - New approaches are required soon!
Get an overview about the most important upcoming changes The revision of Annex 1 of the EU GMP Guideline will be effective this year. It faces ...
04/13/2023
SMEPAC Test to Measure the Tightness of Containment Systems
Working with highly active and hazardous drugs and ingredients requires evidence that the used containment systems are leak proof!
08/29/2022
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?
06/25/2022
New ICH Q14 Guideline: Analytical procedure development
Analytical procedure development: harmonization, development process as well as improvement of change management, approval and communication with ...
02/18/2022
Revision of ICH Q9 (R1) Guideline on Quality Risk Management
Innovations in the implementation of risk management in the pharmaceutical industry: product availability, hazard identification, and attention to ...
04/15/2021
Toxicological assessment gain acceptance for cleaning validation
WHO publishes decision on setting acceptance criteria for cleaning validation
01/08/2021
Integrated Qualification and Validation Guide
New ECA guide helps saving time and money by customer-supplier partnership on qualification and validation.
10/26/2020
Nitrosamines in active substances and finished medicinal products
EMA strongly requests the risk-based proof that active substances and finished medicinal products are free of nitrosamines. Are you prepared for this?
06/15/2020
Cleanroom standard series ISO 14644
The globally recognized standard for the classification of cleanrooms is "ISO 14644 – cleanrooms and associated cleanroom areas". In addition to the ...
06/12/2020
Pharmaceutical procurement & supplier qualification
Through Pharmaceutical Procurement and Supplier Qualification the quality of the components and the compliance to GMP is ensured.