The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

Guidance Aims to Increase Oversight on Conditions at Compounding Facilities

Sept. 30, 2016

The FDA is spelling out its expectations for sanitary conditions during compounding to address repeated issues with adulteration concerns.

The draft guidance gives a laundry list of potential contaminants and practices considered unsanitary. Those range from the obvious, such as vermin or mold, to more subtle issues, like loose ceiling tiles in clean rooms or sterilization settings too low to kill potential pathogens.

The list is meant to give compounders fair warning about what inspectors will look for when determining whether a facility is sanitary, a common issue raised in warning letters. If products are developed under unsanitary conditions, the agency deems affected products to be adulterated.

The draft document recommends that compounding facilities routinely use sterile procedures to monitor the quality of products. It also suggests that compounders develop a checklist of aseptic practices, equipment and facility, sterilization and cleaning and disinfecting procedures.

To simplify the review process, the guidance breaks up the issues inspectors look at by category: production of non-sterile drugs, production of sterile drugs, aseptic practices, equipment and facility maintenance, sterilization procedures, along with cleaning and disinfecting procedures.

The document also outlines the best methods for compounders to determine whether their facilities are sanitary as well as corrective actions companies should take if their facilities are deemed unsanitary.

Read the guidance here:

Know what the investigators look for  before they get there. Know the investigators’ expectations and rights. Find and fix problems before they end up on a Form 483 or warning letter with the FDAnews Investigations Operations Manual, 2016 Edition.

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