The following article is written by Brian Williamson, PharmD, is president & CEO of JCB Laboratories.
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?
Learn more about JCB Laboratories.
Editor's Note: This article originally appeared in Pharm-ASC, a weekly e-mail publication by Sheldon S. Sones, RPh, FASCP, a Newington, Conn.-based consultant, pharmacist and safe medication officer.
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