EU GMP Annex 1 draft clarification and impact-Workshop- Foster City, CA


The Draft GMP Annex 1 represents an upgraded regulatory perspective by the application of QRM and PQS as they apply to the manufacture of sterile medicinal products as well as other products that are not intended to be sterile.

The principles and guidance put forth in the Draft GMP Annex 1 provide substantial expansion on virtually every topic covered in the 2008 version.  Though not officially implemented yet, this draft represents current regulatory thinking on the manufacturing of all medical products.

Familiarize yourself with all aspects of the Draft GMP Annex 1 in preparation for implementing the finalized document at your facility.

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3 Cs for Microrite

Three Cs for Microrite

C1: Creativity - We believe that creativity, not additional capital, generates the most effective solutions. This is the reason why we use a risk based approach and quality by design approach in all our work.

C2:  Communication - We have no secrets and give no surprises. We always will tell you what is happening and teach you everything we know. We communicate!

C3: Cost conscious - We help you succeed by treating your project as our business. Establishing phase specific systems to avoid overkill and overspending is our specialty.

Do it Once...Do it Right!