3 Stages of Validation – Stage 1
In 2013 the FDA instituted the Drug Quality and Security Act which created section 503B of the Federal Food, Drug and Cosmetic (FD&C) Act. Under section 503B compounding facilities can choose to register with the FDA as an outsourcing facility.
If a facility is registered with the FDA as an outsourcing facility to produce sterile drug products it is required to follow the current Good Manufacturing Practice (cGMP) requirements established in 21 CFR Part 211. An outsourcing facility must also be periodically inspected by the FDA to ensure that the requirements of 21 CFR Part 211, and the FD&C Act are being met.
If the FDA observes any conditions that may have constituted violations of 21 CFR Part 211, or the FD&C Act, it will issue a Form 483 to the outsourcing facility detailing the inspectional observations. Of the 60 registered outsourcing facilities, 51 have received 483 observations from the FDA, and the other 9 have yet to be inspected.
There are many aspects of sterile drug product compounding that fall under cGMP and FD&C requirements, and Mesa Labs can assist in meeting the demands of being a registered outsourcing facility by:
- Auditing the facility, equipment qualification, personnel training, and compounding processes to identify any issues that could lead to a 483 observation.
- Assist in 483 remediation.
- Training in:
- cGMP
- Good documentation practices
- Aseptic technique
- Assist in developing any critical documentation
- Standard operating procedures
- Maintenance procedures
- Addressing failing results
- Development and execution of validation/qualification protocols for:
- Laminar flow hoods
- Autoclaves
- Depyrogenation ovens
- Filling/Stoppering lines
- Cleanroom and controlled area environmental monitoring of:
- Non-viable particulates
- Viable particulates
- Airflow visualization studies (smoke studies)
Ensuring that your facility is in compliance is critical in order to prevent criminal charges. One company was not so lucky and was charged for adulteration of drugs in connection with a compounding pharmacy. To read more about the investigation and charges, click here.
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