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ICH Q9

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ICH Q9

We guarantee compliance with ICH Q9 regulations applied to the pharmaceutical and biopharmaceutical field.

The challenge

ICH Q9 Quality Risk Management represents the first internationally recognized guide that specifically addresses QRM (Quality Risk Management) for the pharmaceutical and biopharmaceutical industries. Published in June 2005, the guide provides an overview of the general principles of quality risk management, an example of a risk management life cycle, a discussion of the activities that occur in each phase of the life cycle, and a list of risk tools and areas of the quality system to which QRM can be applied.

Do you need more information about the requirements your company must meet regarding the regulations in force in the sector?

Oqotech's team has over 10 years of experience in the pharmaceutical, biotechnology and food industry. We guarantee that the organization complies with legislation. Leave your details and we will contact you to offer you more detailed advice.

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