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With the latest release of the Second Issue of 2020 GMP Annex I, the standard for all sterile manufacturers has been widely extended and revised.
PQE Group has collected all the informations you need to comply in an exhaustive guide.
Don’t wait: request the download now for free and get all the insights on sterility assurance.
According to the Drug Quality and Security Act of 2013, FDCA establishes all pharmacies need to comply with USP and other regulations, while outsourcing facilities are required to mantain full cGMP Compliance.
In its 20+ years of life, PQE Group has worked with thousands of clients and always applied the latest technologies and discoveries to help companies achieving their full potential.
As an innovation-based agency, we are constantly developing new services and updating our areas of expertise.