“Obtaining this authorization was not easy as GMP guidelines are very demanding and restrictive. On the other hand, these are the lines followed by the Pharma sector for the production and packaging of its products and they must necessarily be precise and complex. But thanks to the commitment of the team and the passion that has distinguished ECSA for over 100 years, we were able to achieve this great result "
What are the "Good Manufacturing Practice"?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product.
ECSA will have to provide documented evidence that the procedures are constantly followed and controlled at every stage of the production process (and, in our case, also for dilutions).
This authorization was requested by an ECSA Chemicals customer active in the trade of veterinary products, therefore it is specific for this product category, but ECSA is open to any type of request for GMP dilution and filling operations from other potential customers.
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