MedisourceRx is proud to announce that NO observations were made by the FDA during our 2022 inspection of our facility.
This is a rare achievement in an ever-evolving regulatory environment!
MedisourceRx is registered with the DEA, State Board of Pharmacy licensed, and registered with the FDA as a 503B outsourcing facility. As an outsourcing facility, we focus exclusively on sterile products and follow cGMP, GDP and cGLP guidelines.
This dedication to sterile products has led to the development of systems that enhance quality assurance and patient safety. We have proved our dedication with our current inspection by the FDA and BOP that resulted in no Observations. We are proud of the team we have put together and the work we have done. Organizations we work with know they can rely on us to deliver consistently, in all our markets.
December 14 - 16, 2023
Las Vegas, NV - USA
Ensure inspection readiness at the preeminent event for compounding professionals with timely regulatory updates, innovative technology solutions, industry best practices and protocols to drive quality assurance facility-wide.
PALLAVI BADKAR, RPH, M.S, BCSCP
Vice President of Operations & Pharmacist in Charge at MedisourceRx.
MedisourceRx's own pharmacist Pallavi Badkar is a key note speaker on the first day of the summit!
Aseptic Compounding in the 503B Industry: Challenges and Mitigations Pallavi Devurkar-Badkar, Director of Operations-503b, MedisourceRx The NECC tragedy in the compounding industry prompted Congress to sign the Drug Quality and Security Act (DQSA) with the goal of preventing future tragedies.
The 503B Outsourcing Facility designation originated from the DQSA. This type of facility is a primary and preferred manufacturing source of drugs on shortage. They also may manufacture sterile injectables from non-sterile APIs from the FDA approved bulk list. The challenge for this entity is that 503B’s must follow cGMP but payers request small batch sizes of several types of drugs packaged in various containers. While it is most ideal to employ automatic filling machines to ensure sterility assurance of aseptic processing of drugs, these technologies are cost prohibitive, inefficient in changeover, and often not flexible in container choice. Therefore, manual aseptic processing (MAP) is often employed in this industry as well as in traditional compounding pharmacies. While MAP allows for an increased flexibility of the containers used and drug formulations produced, there is a high risk of contamination from human interventions.
The goal of this presentation is to discuss various approaches to mitigate the challenges of semi-automatic aseptic processing using best practice aseptic techniques to ensure sterility during critical human interventions. Select small batch filling and finishing equipment, closed ready-to-fill systems, and single-use aseptic processing supplies will also be discussed as aids in achieving sterility with MAP. Finally, the importance of sourcing injectable-grade APIs as a manufacturer’s responsibility in preventing adverse drug events will also be discussed.
October 25th & 26th, 2022 ● San Diego, CA
MedisourceRx's own pharmacist Pallavi Badkar is a key note speaker on the first day of the summit!
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