3 Keys to Evaluating the Quality of Your Sterile Compounding Pharmacy

1. Manufacturing integrity

– Do they comply with the requirements of USP 797?

– Is their clean room monitored and validated?

  • Has Ribo-typing been performed?
  • Has the equipment been validated to perform within its specifications?
  • Can the clean room conditions be matched to time of drug compounding? 

– Manufacturing procedures:

  • Are there standard operating procedures in place?
    • Can they be produced for verification?
  • Can they electronically validate all weights of powders in each formula?
  • Can photographic evidence be produced for all liquid measurements in each formula?


2. Third-party validation

– Do they serve national accounts (AmSurg, etc.) or are they vendors for GPOs?

– What other companies or agencies have inspected them (pharma, independent cGMP audits, etc.)?

– Can they provide references from other customers?


3. Leadership/customer service

– What are the resumes of top management? Are pharmacists leading the company?

– Who is available for technical questions and how fast are they answered?

– What are the qualifications of the staff and technicians at the facility?

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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