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What is GMP?

GMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. These regulations, which have the force of law, require manufacturers, processors and distributors of medicines, cosmetics, medical devices and food products to take proactive measures to ensure that their products are safe, pure and effective.

GMP regulations require a quality approach to manufacturing, allowing companies to minimize or eliminate cases of contamination, mixtures and errors. These regulations protect the consumer from buying a product that is not effective or even dangerous. Failure by companies to comply with GMP regulations can result in very serious consequences, including recall, seizure, suspension of activities, fines and imprisonment.

GMP regulations address issues such as maintenance and traceability of information; qualification of personnel; sanitation; cleaning; verification and qualification of equipment; validation of processes and systems; investigation and treatment of quality deviations and complaints.

Most GMP requirements are very general and open, allowing each manufacturer to individually decide how best to implement the necessary controls. This provides a lot of flexibility, but also requires the manufacturer to interpret the requirements in a way that makes sense for each individual business. In addition, manufacturers should employ technologies and systems that are up to date to comply with the regulation.

It is important to emphasize that cGMPs regulations are minimum requirements. Many manufacturers of pharmaceuticals and medical devices are already implementing comprehensive and modern quality systems and risk management approaches that exceed these minimum standards.

Talk to our consultants about your need, we do GMP auditing anywhere in the world.

For more information and explanations about it, send us an e-mail: [email protected]

Passarini Regulatory Affairs

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