Challenge
A pharmaceutical manufacture needed to prepare for the FDA’s Pre-Approval Inspection (PAI) for an upcoming new product launch, and implement strategies to increase overall manufacturing capabilities to meet customer requirements.

Solution
Created an action plan with key steps that included the inventory and cataloguing of all systems at a Massachusetts facility involved in manufacturing the new product. Validated all GxP systems and reviewed all SOPs in Europe as applicable.

Benefits
Provided the company with a prioritized action plan that helped them:

		Comply with the FDA’s PAI for new product release
		Utilize recommendations for developing new SOPs to continue to ensure FDA compliance

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