Responsibility in Manufacturing, Retained Samples Requirements

2018-11-27T20:32:27+00:00

Continuing the Trust Transparency Emerging Brand Checklist to detail the regulatory and fundamental quality responsibilities that all brand manufacturers (especially online-only brands) need to embrace, this piece offers a short discussion about the need and requirement for a retained samples program.

Introduction:

A retained sample program is an often overlooked, but important component of regulatory compliance. A retained sample program is comprised of a written document establishing a process to maintain a set number of units of finished product as sold at retail, of each lot or batch, that is cataloged and stored in a manner compliant with FDA cGMP requirements. Many uninformed brand owners relegate the retained sample program to their contract manufacturer, but that option is incorrect as defined by FDA. The requirement for retained samples is obligated by FDA and is designed to facilitate safety and quality of manufactured dietary supplements.

Issue:

Obstacles to a retained sample program are often cited as cost, space and perceived complexity of implementation. All of these are legitimate concerns but should not be enough of an issue to ignore the necessity of the requirement. cGMP regulations as defined by 21CFR 111 require brand owners to have a written SOP to cover the existence and maintenance of a retained sample program. While almost all contract manufacturers retain samples at their facility, it is not adequate because the brand owner has neither priority or control over the samples. Many brand owners mistakenly believe retained samples are strictly for the reactive purpose of consumer complaints. Another important aspect of a retained sample program is to proactively monitor product quality and stability. Some brand owners mistakenly believe a sample can consist of a smaller quantity or package size than what is sold at retail. Some brand owners mistakenly believe a “skip lot” of retained samples is adequate to meet cGMP requirements.

Relevance:

The reasons behind the requirement for a retained sample program are predicated to ensuring an adequate amount of product is maintained for testing should consumer, or otherwise, complaints regarding safety or quality of a finished product arise. The cGMP requirement is comprised of five basic components:

  1. The brand owner must reserve samples in a manner that protects against contamination and deterioration.
  2. Retained samples must be held in conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions.
  3. Retained samples must be maintained in the same container-closure system in which the product is distributed and labeled. Contract manufacturers often retain samples in bulk, as manufactured, but do not retain the actual completed finished product.
  4. The amount of retained samples must consist of at least twice the amount necessary to determine if the product meets product specifications.
  5. Retained samples must be retained for 1 year past the shelf life date or 2 years from the last date of distribution of the product retained.

FDA Warning Letters:

FDA has made it abundantly clear through numerous mentions within FDA Warning Letters that the brand owner must have a written procedure, and qualified overseer, to maintain retained samples for all manufactured lots.  The brand owner must take responsibility for retained samples even if manufactured by a third party:

Example:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm553425

Specifically:

Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). Specifically, your firm has been distributing dietary supplements since 2012, but you have not collected and held reserve samples of the products distributed. For each lot of packaged and labeled supplement that you distribute, your firm must collect reserve samples and hold the samples in accordance with 21 CFR 111.83(b). Specifically, the reserve samples that you maintain must:

  • Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].
  • Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].
  • Be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample [21 CFR 111.83(b)(3)].
  • Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications [21 CFR 111.83(b)(4)].

What you can do:

  • Assign a qualified person to design, implement and maintain a retained sample program.
  • Develop a retained sample SOP, product storage area and controlled storage environment.
  • Ensure someone in your organization (or a contractor) is trained and is thoroughly versed in 21 CFR 111.

Other articles from this series: