The U.S. Food and Drug Administration (FDA) announced in a press announcement in May that more unannounced inspections of foreign manufacturing facilities will be conducted. 

The basis for this is President Donald J. Trump's executive order "Regulatory Relief to promote domestic production of critical medicines". This order also requires the FDA Commissioner to make improvements to the risk-based FDA inspection system and to publish a list of annual foreign FDA inspections with detailed information about country and manufacturer. Both demands must be fulfilled by the end of July.

Unannounced inspections by the FDA have long been common practice in the USA. Manufacturers of food, drugs, cosmetics and medical products are affected. Investigations of foreign production facilities are now to be stepped up in the area of the manufacture of drugs, active pharmaceutical ingredients, important raw materials and associated raw materials. 

For companies, this means being GMP-compliant at all times! Being ready for inspection at any time!

gempex has broad practical experience in inspections by the US FDA and other regulatory authorities and offers a comprehensive range of services for guaranteeing inspection readiness. Continuous GMP compliance throughout the development, implementation and operation of production processes and the entire life cycle management plays a crucial role. 

For the successful completion of inspections, gempex's expertise ranges from the initial identification of possible weaknesses in GMP compliance to the competent follow-up of inspections. Individual services are:

• Gap analysis to identify any weaknesses combined with a practice-oriented to-do-list, recommendations for action and support during implementation
• Inspection training for key personnel to strengthen confident communication with the inspecting authority and during an investigation
• Mock inspections, which simulates an inspection situation and provides experience for real-life situations
• Professional inspection support during an investigation accompanies the inspection and optimize the process
• Competent inspection follow-up, such as the correct and prompt response to messages from the respective authority, CAPA management and the processing of any findings lists.

More than 20 years of experience and locations in Germany, Switzerland and China make gempex a strong partner who is familiar with local, country-specific characteristics and regulations and can offer expertise directly on site. 

Ralf Gengenbach, Managing Director of gempex GmbH, will be happy to answer any questions you may have about GMP compliance, inspection readiness, FDA inspections or audit preparation via info-cn@gempex.com.