Description:

Cannabis-based products such as oils, creams, tablets, soft-gels and others, should be manufactured and packaged based on GMP standards and regulations to assure a consistent, safe and effective product is released to the market.
Patients that are treated with cannabis products should consume “pharmaceutical grade” products that faithfully represent required standards of safety, efficacy, quality, accuracy, consistency, etc.
As part of the Cannabis Quality Management System procedures and the GMP of the facility, equipment and systems used throughout the development, manufacturing, packaging, storage and testing of the Cannabis products, should be in a validated state.

The majority of the system and equipment such as solvent system, dryers, extraction, tableting, filling and packaging system as well as the manufacturing processes as a whole, are considered ‘critical’ and have an impact on the safety and quality of the final cannabis product.  The lack of these processes can risk human health and even life and therefore must be qualified for IQ, OQ, PQ and process validation.

The validation area is often inspected as part of the regulatory audits and should be planned and implemented properly.

Syllabus:

  • The US and EU GMP principles and requirements
  • Validation regulations and guidelines
  • Why do we need validation?
  • Validation types
  • Validation project stages
  • System impact
  • Critical components and parameters
  • Design Review
  • Design Qualification
  • Validation’s basic principles
  • Validation Master Plan
  • Validation Plan
  • The validation “V-Model”
  • IQ, OQ, PQ, PPQ
  • Cleaning Validation
  • Analytical methods validation
  • Validation deviations
  • Revalidation
  • IQ, OQ protocols examples

Description:

Duration: 2X4 hours each (Zoom)

Date: 08-09- March-2021

Fee: 945 Euro