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In-house Training Programme

 
 

Production of Sterile Pharmaceuticals

 
     
 
When What
Day 1  
9:00 - 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.
Day 2  
9:00 - 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
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal 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.

 

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