How to Develop a Sampling Plan Which Meets EU and FDA GMP Requirements?

Sampling of materials is one of the most important processes in pharmaceutical companies. Today there are more and more detailed questions during regulatory GMP Inspections about the amount of samples to be taken - both in Europe and in the US (FDA).

Sampling by Attributes is a process of inspecting a representative sample of identical product units of product for presence or absence of non-conforming units or nonconformities before accepting or rejecting the whole lot of product. Regulatory agencies require a sampling plan that utilizes basic elements of statistical analysis or provides a scientific rationale for taking a representative sample according to the lot size. In the light of these regulatory requirements, one may wonder whether the Square Root of N is a statistically valid sampling plan.

According to the revised Chapter 6 of EU GMP Guide, the sampling plan used should be appropriately justified and based on a risk management approach. Representative samples should be taken and recorded in accordance with approved written procedures.

The FDA also requires in the Code of Federal Regulations (21 CFR Part 211.84), that sampling should be done upon statistical criteria. In the past the Military Standard 105 D was commonly used in the pharmaceutical industry, but this standard was withdrawn and is now obsolete. Today, either the ISO Standard 2859:1-1999 or the ANSI Z1.4 are applied. Learn more about how to set up a Sampling Plan which meets EU and FDA requirements - from 12-13 June 2019 in Copenhagen. The aim of this course is to discuss the process of the statistical sampling by attributes of units of finished drug products, of packaging materials (primary and secondary) and of medical devices as well as sampling of starting materials (APIs and excipients) and to define the prerequisites for implementing a system for reduced sampling and reduced testing for these products. This course is also intended to provikde a practical training on the use of the most common sampling standards: ISO 2859-1:1999 and ANSI/ASQ Z1.4.  Please read more here.

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