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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 give a practical training on the use of the most common sampling standards: ISO 2859-1:1999 and ANSI/ASQ Z1.4. These Standards are widely employed in various types of industries which are required by Regulatory Authorities to follow a statistically sound sampling plan. Starting with regulatory and compendial requirements around sampling, this course will also address charting and trending nonconformities and non-conformant items and good quality practice around sampling plans.
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, both in Europe and in the US (FDA) about the amount of samples to be taken.
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 provide 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.
FDA requires as well 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In the past the Military Standard 105 D was commonly used in the pharmaceutical industry, but this standard has been withdrawn and is now obsolete. Today. either the ISO Standard 2859:1-1999 or the ANSI Z1.4 are applied and the course participants will thus learn how to read and to use this standard for selecting a sampling plan with an understanding of the associated producer and consumer risks.
This GMP Education Course is directed at all those employees from quality control units and production units in the pharmaceutical industry who are competent or responsible for sampling, testing and release of starting materials (APIs and excipients), packaging materials (primary and secondary) as well as finished pharmaceutical products. This course is also of interest to personnel from quality assurance and to those employees from API, excipient or packaging material suppliers who want to inform themselves about the requirements of the pharmaceutical industry on the testing of these materials.
The course does not require prior knowledge in sampling and statistics. It teaches the participant how to use the multiple tables and plots of the Standard for designing a sampling plan.
Relevant tables from the ISO Standard ISO 2859-1:1999
Sampling procedures for inspection by attributes
Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection –
will be made available to the course participants for the purpose of practicing.
Regulatory and compendial requirements around sampling