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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 |
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10:00 - 10:30 COFFEE
BREAK
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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
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11:20 - 12:10
STERILIZATION PROCESSES VALIDATION ? Cycle development ? Equipment
qualification ? Load qualification ? Sterilization process
validation
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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.
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13:00 - 14:00 Lunch
break
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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
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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.
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15:10 - 15:40 COFFEE
BREAK
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15:40 - 16:30 USE AND
EVALUATION OF BIOINDICATORS ? Types of biological indicators ?
Application of biological indicators ? Evaluation of results
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16:30 - 17:00 CLASSROOM
EXERCISE ? Evaluate questions related to bioindicators as presented
by the trainer.
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| Second Day |
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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
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10:00 - 10:30 CLASSROOM
EXERCISE ? Interpret results of media fills as shown by the trainer
and develop investigation strategies.
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10:30 - 11:00 Coffee
Break
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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.
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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.
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13:00 - 14:00 Lunch
break
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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
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14:30 - 15:00 COFFEE
BREAK
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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
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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.
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16:30 - 17:00 General
Discussion
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