Continuing the discussion regarding the fundamentals of regulatory compliance in the current US supplements universe, we present a rationale and outline of the training responsibilities under cGMP, targeted at industry as a whole, but specifically at the emerging Internet-first brands dominating the online landscape.
It’s probably quite obvious that a certain level of training is required in order to produce compliant dietary supplements. It’s also probably quite obvious that documentation of this training will be the first recourse under an FDA audit. Developing a systematic training program, at all levels of the organization not only makes regulatory sense, it also makes good business sense, especially when it institutionalizes recent learnings, regulatory developments and quality and supply pain points. Developing a learning culture differentiates the best companies and having a well-planned continuous training program translates to knowledge sharing and culture and the discipline and rigor to being much more than merely compliant.
The premise behind the dietary supplement GMPs is that all products are manufactured in an environment that assures safety and purity of product, and follows established processes and procedures that are documented, in order to produce consistent, reliable product. Without trained and competent personnel in key roles, and without a training program that includes new employee onboarding, a retraining process as well as some pathway to incorporate new patterns, observations and issues found in non-compliance internally and externally, a company will quickly fall out of compliance and put itself into other risk categories. Subpart B of the supplement GMPs deals specifically with Personnel and Subpart P deals specifically with Records and Recordkeeping, both important components as we think of training requirements in order to ensure compliance but also to mitigate company risk.
The Dietary Supplement Good Manufacturing Practices are often only implicit when dealing with the subject of training, and so companies are often left to fend for themselves when setting internal provisions. However, several places in the GMPs refer to qualification of personnel, with said qualification either due to education, training or experience:
The DS CGMP rule requires that:
- You have qualified employees who manufacture, package, label, or hold dietary supplements (21 CFR 111.12(a));
- You identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and such responsibilities must be distinct and separate from other responsibilities (21 CFR 111.12(b)); and
- Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, to have the education, training, or experience to perform the person’s assigned functions (21 CFR 111.12(c)).
The DS CGMP rule requires that:
- You assign qualified personnel to supervise the manufacturing, packaging, labeling, or holding of dietary supplements (21 CFR 111.13(a)); and
- Each supervisor whom you use to be qualified by education, training, or experience to supervise (21 CFR 111.13(b)).
When it comes to the record-keeping requirements, the DS CGMP rule begins to be a bit more specific:
- You must make and keep records required under this subpart B in accordance with subpart P
And must keep the following records:
- Written procedures for fulfilling the requirements of this subpart B:
- Documentation of training, including the date of training, the type of training, and the person(s) trained.
As is the case elsewhere in the GMPs, companies are given latitude on the details and process they set up for internal training and qualification of personnel. However, it is instructional to look to best practices of fully compliant and proactive companies to determine that annual training on both pre-identified curriculum items including basic GMPs, as well as responsive training based on industry issues, audit trends (client and FDA), and non-compliances is the best approach.
In developing your training program, the following must be kept in mind:
- The GMPs for dietary supplements 21 CFR 111 regulation is reviewed annually as the FDA will often issue new guidance documents.
- Your company may experience changes to your manufacturing processes if it changes locations, adds equipment or makes new supplement forms.
- Activities in the market, new personnel, new suppliers and other factors may change your regulatory risk and exposure.
What you can do
- Review training procedures and processes at least annually.
- Review all training records appropriately.
- Pay attention to key staff turnover points as these often open gaps in training compliance.
- Review the latest 483s with particular attention to training, training records and other related deficiency patterns.
- Review all new guidance documents to understand potential training implications.