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Retain Samples Regulation | Regulatory Compliance

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 products.

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.

The cGMP requirement (Annex19) 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. 

4.Contract manufacturers often retain samples in bulk, as manufactured, but do not retain the actual completed finished product.

5. The amount of retained samples must consist of at least twice the amount necessary to determine if the product meets product specifications.

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.


  • EU GMP Annex 19
  • CFR TITLE 21-PART 211 -Subpart I - Sec. 211.170 

Tags in: retention sample guideline, pharmaceutical retention sample, retention time of pharmaceutical products.


  1. Is it important to retain samples from the toxicology studies?

    1. It may necessary to retain few non clinical toxicology study sample. For clarification see the 21 CFR Part 58.

  2. You mention cGMP then quote from Annex 19 of EU GMP. The "c" doesn't get mentioned in EU GMPs, as there is not felt to be a need to remind people to only apply current standards

  3. What will a company do if unexpired retain sample is inadvertently destructed?

    1. A deviation should raise and a CAPA also to be taken for a well controlled destruction procedure.

  4. Annex 13 and 21 CFR refer to IMP or Drug Product, is there any guidance on drug substance retain samples?

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