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Quality System Updates, Compliance Checks, Implementation
Quality Systems Review
Good Methods & Procedures
The quality unit requirements within the dietary supplement GMPs are among the most detailed and stringent. These requirements may be the primary focus of FDA investigators based on investigator training and the FDA Compliance Program Guide.
Failure to adequately implement 21 CFR 111.103 and 111.105, including the written procedures and requirements for Quality Control responsibilities, are commonly cited as a cGMP deficiency for dietary supplement companies on FDA Form 483s - Inspectional Observations.
In addition to the roles and responsibilities of the quality staff, the relationship and coordinated interactions between quality and manufacturing are essential to demonstrate control and reproducibility of manufactured products. Regulatory consulting can help clarify these interactions.
For food products, including ingredients, our GMP quality review will focus on the Food Safety Modernization Act (FSMA), the Good Manufacturing Practice guidelines, the Hazard Analysis and Risk-based Preventive Controls for Human Foods Rule (21 Code of Federal Regulations Part 117), and the requirements set forth by the Foreign Supplier Verification Programs (FSVP) requirements.
Our reviews are designed to identify gaps, help reduce regulatory challanges, and support practicle quality system implementation.
Need support with quality GMPs, documentation, or understanding regulatory expectations? Please schedule a consultation for our FDA consulting services.