| 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
|
