Production of Sterile Pharmaceuticals

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

  Content Day 1
09:00 - 10:00 ANNEX NO. 1 TO THE EUROPEAN GMP-GUIDE AND OTHER INTERNATIONAL REGULATIONS
  • Requirements and their relation to other International Guidelines for manufacturing of sterile pharmaceuticals
  • FDA-guideline for submission of documentation on sterilization processes
  • European Pharmacopoeia general text manufacture of sterile products
  • USP chapters on sterile products
10:00 - 10:30 COFFEE BREAK
10:30 - 11:20

PRINCIPLES OF STERILIZATION PROCESSES

  • Principles of sterilization.
  • Theory of inactivation of microorganisms
  • Steam, dry heat, radiation, gassing
  • Practical application of F, D and z values, Fo value
  • Types of sterilization processes,
  • Sterilization equipment
11:20 - 12:10 STERILIZATION PROCESSES VALIDATION
  • Cycle development
  • Equipment qualification
  • Load qualification
  • Sterilization process validation
12:10 - 13:00 CLASSROOM EXERCISES
  • D, z, F-value calculations
  • Do calculations on sterilization processes to answer prepared questions.
  • Create plans for sterilization cycle development for a given list of products or products proposed from the audience.
13:00 - 14:00 Lunch break
14:00 - 14:50 MEMBRANE FILTRATION
  • Principles of membrane filtration
  • Specific questions associated with membrane filtration sterilization
  • Validation of membrane filtration
  • Membrane filter integrity testing
14:50 - 15:10 CLASSROOM EXERCISE
  • Develop plans for membrane filter selection and validation for a given list of products or products proposed from the audience.
15:10 - 15:40 COFFEE BREAK
15:40 - 16:30 USE AND EVALUATION OF BIOINDICATORS
  • Types of biological indicators
  • Application of biological indicators
  • Evaluation of results
16:30 - 17:00 CLASSROOM EXERCISE
  • Evaluate questions related to bioindicators as presented by the trainer.
  Content Day 2
09:00 - 10:00 ASEPTIC PROCESSING VALIDATION
  • International requirements
  • Media fill considerations
  • Media fill procedures
  • Evaluation and interpretation of results
  • Discussion of recent regulatory development
10:00 - 10:30 CLASSROOM EXERCISE
  • Interpret results of media fills as shown by the trainer and develop investigation strategies.
10:30 - 11:00 Coffee Break
11:00 - 12:00 STERILITY TESTING AND PARAMETRIC RELEASE
  • Nutrient media
  • Reference strains
  • Relevance of the test
  • Interpretation of results
  • Parametric release requirements and procedures.
12:00 - 12:30 CLASSROOM EXERCISE
  • Develop an outline of a plan for application for parametric release for a product proposed by the trainer or a participant.
13:00 - 14:00 Lunch break
13:30 - 14:30 Microbiological Laboratory Procedures
  • General and selective nutrient media
  • Preparation, validation and storage of nutrient media
  • Characterization of reference organisms
  • Storage of reference strains
  • Microbiological method suitability and validation
14:30 - 15:00 COFFEE BREAK
15:00 - 16:00 RISK ANALYSIS AND CONTROL CONCEPTS FOR STERILE PRODUCT MANUFACTURE
  • Process flow chart
  • Critical processing steps
  • Critical control points
  • Risk estimation procedures
16:00 - 16:30 CLASSROOM EXERCISE
  • Develop an the outline of process plans for sterile product proposed by the trainer and do a risk estimation exercise.
16:30 - 17:00 General Discussion

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