Lean Validation Strategies for 503A/503B Facilities

The Compound Pharmacy market sector is in the midst of adapting to recent regulatory changes imposed by the U.S. FDA.  Section 503A of the U.S. FD&C Act provides governance for the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility or by a licensed physician, to be exempt from three key sections of the FD&C Act.   Section 503B is relatively new and creates a new entry point for medications into the drug supply chain through outsourcing facilities.

Outsourcing facilities can be used to fill the gap between traditional pharmacy compounding and industrial manufacturing where compounded products are needed for administration by health care facilities.

One of the most significant changes for outsourcing facilities is that they now must comply with cGMPs applicable to drug manufacturers. Although 503A facilities are exempt from cGMP, they are still subject to USP compliance.  From a validation perspective, any computer systems deployed by 503B companies are subject to FDA computer systems guidelines.

OnShore Technology Group has worked with 503B facilities to help them understand validation requirements and apply lean validation techniques to enterprise computer systems that drive cGMP and quality processes.  Click the link below to learn more about our services for Compound Pharmacies.

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CloudMaster 365™ is compliant with current global regulatory guidelines.  The ValidationMaster™ Enterprise Validation Lifecycle Management system includes compliance with 21 CFR Part 11, change control, regulatory content management, incident management, CAPA, nonconformances, training and other regulatory processes.  The system is designed to work together in a cohesive manner to deliver maximum value for lean validation processes.