Compounding Pharmacy Services
Reducing Risk to Patient Safety by Enhancing the Quality of Compounded Drugs
Compounding pharmacies have taken a hard hit since the New England Compounding Pharmacy tragedy. Clinicians have been more hesitant to outsource compounding due to the concern of safety, quality, and efficacy of compounded drugs. Rebuilding confidence in compounding will not be an easy task and will require proven safety and quality over time. ProPharma Group has the expertise you need to achieve compliance with USP <795> or <797>, DQSA (503b registered facilities), and cGMP, which ultimately will enhance the safety and quality of compounded drugs.
Developing and maintaining a robust compliance system is perceived as difficult and costly at times, but take a moment to imagine the price of being found non-compliant. ProPharma Group has developed a systematic approach to lead you to regulatory compliance within USP, cGMP, and DQSA standards so you and your customers have confidence in the safety of your medicines.
- 21 CFR 210/211 cGMP compliance
- DQSA requirements for 503b outsourcing facilities
- Quality systems development and optimization
- Audits and gap assessments
- Sterility assurance
- Qualification and validation
- USP <797> or <795> standards