Retention Sample

A sample of fully packaged units from a batch of finished products. It is stored for identification purposes. For ex- presentation, packaging, labeling, patient information leaflet, batch number, and expiry date should the need arise during the shelf life of the batch concerned.

Duration of storage

References and retention samples from each batch of finished products should be retained for a minimum of one year after the expiry date or 2 years from the last date of distribution of the product retained.

A reference sample is a sample for the purpose of future analysis (which could refer to starting material, packaging material, or finished product ).

A retention sample represents a batch of finished products as distributed.

Purpose of keeping potential samples

The purpose of keeping retention samples is to support or verify the food, product shelf life period, quality, microbiology, physical decrease chemical attributes. The sample may also be used as a part of complaint investigation.

Requirements

It’s necessary for the manufacturer, importer, or site of batch realse to keep references or retention samples from each batch of finished product and for manufacturing to keep a reference sample from a batch of starting material/ intermediate product.

Each packaging site should keep references samples of each batch of primary printed pacakging material.

Responsibilty

A retained sample program is an overlooked but important component of regulatory compliance. Its comprised of the written document establishing a process to maintain a set number of units of the finished product as sold retail of each lot or batch, that is cataloged down and stored in a compliant with FDA “GMP” requirements. Many uniform brands evener the retained sample to their correct manufacturer but that is incorrect by the FDA.

Issue

The obstacle to a retained sample program is often cited as cost, space, and perceived implementation complexity. All of these are legislated concerns but should be enough of an issue to ignore the necessity of the requirement. Another important aspect of the retained sample program is to monitor product quality and stability proactively.

Relevance

The reason behinds requiremnt for retained sample are predicated to ensuring an adequate amount of product is maintained for testing should consumer, or etherwise, complaints regarding safety or quality of finished product. The CGMP requiremnt is comprised of 5 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. They 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 manufacturers but do not retain actual completed finished products.
4. The amount of retained samples must consist of at least twice the amount necessary to determine if the product meets the product specification.
5. Retained sample must be retained for one year past shelf life date or 2 years from the last date of distribution of product retained.

Product sampling method

Its a critical step in drug analysis decresases detemining of drug quality, as well as for compliances with GMP.

The objective to verify quality of drug and their components before during and after production process.