Background

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.

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.

Target Group

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.

Programme

• Regulatory and compendial requirements around sampling
• Acquaintance with basic sampling distributions
• Classification of nonconformities and allocating AQL to classes
• Acceptance Sampling Plans in ISO-2859-1/ANSI Z1.4
• Risks in sampling with ISO-2859-1/ANSI Z1.4
• Sampling for visual inspection of particles in parenteral drugs
• How to effectively reduce the amount of samples to be tested?
• Sampling according to the WHO Guide
• Sampling of Powders (APIs and Excipients)
• Tools for Sampling in a pharmaceutical plant
• Sampling and inspection of packaging materials
• Charting and trending nonconformities and non-conforming items Good quality practice around sampling plans
• √N rule: its uses and misuses
• WORKSHOP I: Step-by-step use of ISO-2859-1/ANSI Z1.4
• WORKSHOP II Implementing Reduced Testing

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