Discuss GMP aspects of sterile products.
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1.1 The production of sterile preparations should be carried out in clean
areas, entry to which should be through airlocks for personnel and/or for
equipment and materials. Clean areas should be maintained to an appropriate
standard of cleanliness and supplied with air that has passed through fi lters
of the required effi ciency.
1.2 The various operations of component preparation (such as those
involving containers and closures), product preparation, fi lling and
sterilization should be carried out in separate areas within the clean area.
These areas are classifi ed into four grades (see section 4).
1.3 Manufacturing operations are divided here into two categories:
— fi rst, those where the product is terminally sterilized; and
— second, those which are conducted aseptically at some or all stages.
2. Quality control
2.1 The sterility test applied to the fi nished product should only be
regarded as the last in a series of control measures by which sterility is
assured. The test should be validated for the product(s) concerned.
2.2 Samples taken for sterility testing should be representative of the whole
of the batch but should, in particular, include samples taken from parts of
the batch considered to be most at risk of contamination, for example:
• for products that have been fi lled aseptically, samples should include
containers fi lled at the beginning and end of the batch and after any
signifi cant interruption of work;
• for products that have been heat sterilized in their fi nal containers,
consideration should be given to taking samples from that part of the
load that is potentially the coolest.
2.3 The sterility of the fi nished product is assured by validation of
the sterilization cycle in the case of terminally sterilized products, and
by “media simulation” or “media fi ll” runs for aseptically processed
products. Batch-processing records and, in the case of aseptic processing,
environmental quality records, should be examined in conjunction with
the results of the sterility tests. The sterility test procedure should be
validated for a given product. Pharmacopoeial methods should be used for
the validation and performance of the sterility test. In those cases where
parametric release has been authorized in place of sterility testing special
attention should be paid to the validation and the monitoring of the entire
areas, entry to which should be through airlocks for personnel and/or for
equipment and materials. Clean areas should be maintained to an appropriate
standard of cleanliness and supplied with air that has passed through fi lters
of the required effi ciency.
1.2 The various operations of component preparation (such as those
involving containers and closures), product preparation, fi lling and
sterilization should be carried out in separate areas within the clean area.
These areas are classifi ed into four grades (see section 4).
1.3 Manufacturing operations are divided here into two categories:
— fi rst, those where the product is terminally sterilized; and
— second, those which are conducted aseptically at some or all stages.
2. Quality control
2.1 The sterility test applied to the fi nished product should only be
regarded as the last in a series of control measures by which sterility is
assured. The test should be validated for the product(s) concerned.
2.2 Samples taken for sterility testing should be representative of the whole
of the batch but should, in particular, include samples taken from parts of
the batch considered to be most at risk of contamination, for example:
• for products that have been fi lled aseptically, samples should include
containers fi lled at the beginning and end of the batch and after any
signifi cant interruption of work;
• for products that have been heat sterilized in their fi nal containers,
consideration should be given to taking samples from that part of the
load that is potentially the coolest.
2.3 The sterility of the fi nished product is assured by validation of
the sterilization cycle in the case of terminally sterilized products, and
by “media simulation” or “media fi ll” runs for aseptically processed
products. Batch-processing records and, in the case of aseptic processing,
environmental quality records, should be examined in conjunction with
the results of the sterility tests. The sterility test procedure should be
validated for a given product. Pharmacopoeial methods should be used for
the validation and performance of the sterility test. In those cases where
parametric release has been authorized in place of sterility testing special
attention should be paid to the validation and the monitoring of the entire
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