|21 CFR 111.70(e)
||Specifications – identity, purity, strength, composition
|21 CFR 111.103
||Written procedures – quality control operations
|21 CFR 111.553
||Written procedures – product complaint
|21 CFR 111.75(c)
||Specifications met – verify; finished batch
|21 CFR 111.75(a)(2)(ii)(A)
||Component – qualify supplier
|21 CFR 111.205(a)
||Master manufacturing record – each batch
|21 CFR 111.255(b)
||Batch record – complete
|21 CFR 111.453
||Written procedures – holding
|21 CFR 111.75(a)(1)(i)
||Component – verify identity, dietary ingredient
|21 CFR 111.70(b)(2)
||Specifications-component purity, strength, composition
Late last year FDA released inspection observations (483 citations) for FY 2017. The table above shows the top 10 dietary supplement (21 CFR Part 111 cGMP) inspection observations found during inspections in FY17. Significantly, failure to verify the identity of all dietary ingredients has now dropped to 9th place, down from 2nd place in FY 2016. Lack of established specifications for identity, purity, strength, and composition of finished dietary supplements continues to be a problem found at a large number of firms. Failing to establish written procedures for quality control operations moved up to #2. Subpart E observations (for Production and Process Control) together made up nearly 34% of the total observations by FDA inspectors, continuing the trend upward of the past few fiscal years.
Classifications for FDA inspections during the first half of FY 2016 (Oct 2015 thru March 2016) were released by FDA a few weeks back. The above chart shows inspection outcomes under CFSAN (which includes foods and dietary supplements). The number of 483s issued in the area of “Food Composition, Standards, Labeling and Economics” continues to decline slightly — just short of 60% of inspections in that area now result in no 483 being issued. Most DS inspections occur in that project area, along with “Foodborne Biological Hazards” (which also applies to regular food facilities.) See more by clicking on the chart.
I will be speaking along with 3 other presenters at this workshop on
Wednesday, October 05, 1:30 PM – 4:30 PM
Laboratory testing of ingredients and finished goods is top-of-mind in the natural products industry. Beyond the media coverage of testing methods lie a host of concerns from qualifying and selecting an appropriate laboratory partner to method validation, audits and supply chain integrity. Explore the current state of affairs and join the discussion around how appropriate testing and information sharing throughout the product development process is critical to efficacy and safety.
- What should a laboratory audit entail and can a lab meet specific testing needs
- The GMP testing requirements and their impact on manufacturers and marketers
- Supply chain management and the role of testing throughout the chain
FDA released new spreadsheets for FY 2015 (10/1/2014 – 9/30/2015) which have now been incorporated into my charts.
The total number of observations found during cGMP inspections at dietary supplement firms has declined from FY 2014 (the peak was in FY 2013). Production and Process Control (Subpart E) citations continue to dominate, consisting of ~30% of the problems found. In FY 2015, finished product specifications for identity, purity, strength, composition (and for limits on contaminants) remained the most frequent item (as it was in FY 2014) but by a greater margin. Identity testing of components, followed by batch record requirements, continue to top the list of inspectors’ favorite inspection findings.
Friday, October 9
There are myriad considerations around selecting and working with a contract manufacturer/private label provider and understanding them could be the difference between a successful product launch with a long-term partner, and a disappointment in the market. Experts in the field share their insights into auditing and qualifying suppliers for GMP compliance, understanding finished product specifications and your obligations, risk assessment, and best practice tips for selecting the right manufacturing partner.
Key Considerations in Selecting and Working with a Contract Manufacturer: How to Audit and Qualify Suppliers for CGMP Compliance
Recent FDA and other enforcement activities indicate dietary supplement firms are responsible for choosing CGMP-compliant contract manufacturers and suppliers. This session provides simple steps and actions you can take to minimize risk, protect your brand, and prepare you to audit and work in partnership with your suppliers for maximum compliance.
You will learn:
- Best Practices: Simple, efficient and cost-effective ways to pre-select and audit your contract partners.
- Quality Agreements: When and why do you need one? What items must be included?
- Supplier Qualification: Tools for risk assessment and verifying that your label claims are met.
- Quality Control: How much and which QC operations must you perform before product distribution?