This module discusses the special problems associated with production, whether active or inactive "chemical" materials, printed or unprinted packaging materials, in-process materials,

process water, or finished product. It reviews the theory and application of statistical and practical sampling plans.

^_Outlines

• Military sampling plans
• Defining an attribute
• Tightened Sampling Plans
• AQL
• Try some sampling plans– case studies and real life examples
• cGMP requirements for raw materials, bulk products, and finished product.
• Chemical sampling plans
• Microbial sampling plans
• Printed matter sampling plans requirements
• Content uniformity
• Liquids sampling issues
• Pooling/compositing rules
• Sampling frequency
• Zero Defect Principle in pharmaceutical Industry
• Targeted sampling
• Limitations of targeted sampling plans
• Water samples requirements and conditions
• Sampling points
• Sampling of Packaging Materials
• Choosing sampling tools
• Sampling tools for each dosage form
• Maintaining and cleaning sampling tools