Are you ready for CCS forms and the last revision of the EU GMP?

The last revision of Annex 1 of the EU GMP features CCS forms, where CCS stands for Contamination Control Strategy. This change obliges to changes in the Quality System of Pharmaceutical Manufacturers, a process which can be daunting, but you can find out more about what has changed by reading the RC REDOL article below.

In essence, Contamination Control Strategy is a system that considers all the integral elements of pharmaceutical products manufacturing and demands that these elements are equated in the prevention of microorganisms, pyrogens and particle contamination.

In other words, it is a system that reaches far and wide into all aspects of your production, covering Cleaning and Disinfection, Sterility Assurance, Facility Design, Microbial Contamination, Chemical and Particle Contamination and other forms of contamination that can arise from mix-ups, damage to primary or secondary packaging, distribution problems and environmental fluctuations. It should therefore be approached by combining your processes with specialized technicians who can guide you to better achieve your objectives.

As you might be aware, RC REDOL services can allow you to look at how strategy development can be approached, combining your processes with the right personnel with relevant education, experience and technical knowledge, and this can make all the difference. With our input, you will be able to develop, produce or operate medicines safely and in compliance with customer requirements, legal obligations and market and regulatory authority demands.

Contact RC REDOL today and ready your operations to operate efficiently and under the latest legal requirements.

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