GMP15

[भाग II—खण्‍ड 3(i)] भारत‍का‍राजपत्र‍:‍असाधारण 209
National or World Health Organisation (WHO) Recommendations for the preparation, characterisation
and establishment of biological reference standards shall be followed.
13.5. All stability studies including real time or real condition stability, accelerated stability and stress
testing shall be carried out. Trend analysis of the test results from the stability monitoring programme
shall assure the early detection of any process or assay drift and this information shall be part of the PQR
of biological products.
13.6. For products where on-going stability monitoring would normally require testing using animals and
no appropriate alternative or validated techniques are available, the frequency of testing may take into
account a risk-based approach. The principle of bracketing and matrix designs may be applied if
scientifically justified in the stability protocol.
13.7. All analytical methods used in the quality control and in-process control of biological products shall
be well characterised, validated and documented to a satisfactory standard in order to yield reliable
results. The fundamental parameters of this validation include linearity, accuracy, precision, selectivity,
specificity, sensitivity and reproducibility.
13.8. For test methods described in relevant pharmacopoeial monographs, qualification of the laboratory
test equipment and personnel shall be performed. In addition, repeat precision and comparability
precision shall be shown in the case of animal tests. Repeatability and reproducibility shall also be
demonstrated by reviewing retrospective test data. In addition to the common parameters typically used
for validating assays (accuracy and precision) additional measurements (for example, of the performance
of references, critical reagents or cell lines or both) shall be considered during the validation of bioassays
based on the biological nature of the assay and reagents used.
14. Documentation (batch processing records):-
14.1. In general, the processing records of regular production batches shall provide a complete account of
the manufacturing activities of each batch of biological product showing that it has been produced,
tested and dispensed into containers in accordance with the approved procedures. In the case of
vaccines, a batch processing record and a summary protocol shall be prepared for each batch for the
purpose of lot release by the Licensing Authority. The information included in the summary protocol for
independent lot release of vaccines by regulatory authorities. The summary protocol and all associated
records shall be of a type approved by the Licensing Authority.
14.2. Manufacturing batch records shall be retained for at least one year after the expiry date of the batch
of the biological product and shall be readily retrievable for inspection by the Licensing Authority. It has
been found that documents retained for longer periods may provide useful information related to AEFI
and other investigations.
14.3. Starting materials may require additional documentation on source, origin, supply chain, method of
manufacture and controls applied in order to ensure an appropriate level of control, including the
microbiological quality, if applicable.
14.4. Some product types may require a specific definition of what materials constitute a batch
particularly somatic cells in the context of ATMPs. For autologous and donor matched situations, the
manufactured product shall be viewed as a batch.
15. Use of animals:-
15.1. A wide range of animals is used for the manufacture or quality control of biological products.
Special considerations are required when animal facilities are present at a manufacturing site.
15.2. The presence of live animals in the production area shall be avoided unless otherwise justified.
Embryonated eggs are allowed in the production area, if applicable. If the extraction of tissues or organs
from animals is required then particular care shall be taken to prevent contamination of the production
area (for example, appropriate disinfection procedures shall be undertaken).
15.3. Areas used for performing tests involving animals or microorganisms shall be well separated from
premises used for the manufacturing of products and shall have completely separate ventilation systems
and separate staff. The separation of different animal species before and during testing shall be
considered, as the necessary animal acclimatisation process, as part of the test requirements.
15.4. In addition to monitoring compliance with TSE regulations and other adventitious agents that are of
concern (including those causing zoonotic diseases and diseases in source animals) shall also be
monitored and recorded in line with specialist advice on establishing such programmes. Instances of ill
health occurring in the source or donor animals shall be investigated with respect to their suitability and
the suitability of in-contact animals, for continued use (for example, in manufacture, as sources of

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[भाग II—खण्‍ड 3(i)] भारत‍का‍राजपत्र‍:‍असाधारण 209

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