It is very much necessary to have adequate cleaning procedure so as
i. To ensure the good quality of the product and
ii. To protect the product from contamination
iii. To protect the product from cross-contamination from API or other substances.
Cleaning procedures and their applicability are site-specific. SU should provide
information regarding cleaning procedures which are followed at SU to RU. It helps
RU to minimize cross-contamination because of:
i. Previous manufacturing steps
iii. Environmental factors, etc.
The cleaning procedure information provided by SU to RU should include the
i. The solubility of API, excipients and vehicles
ii. Minimum therapeutic dose of API
iii. Therapeutic category of product
v. Existing cleaning procedures
vi. Cleaning validation report (if available) chemical as well as microbiological
vii. Recovery studies for validation of sampling methodology
viii. All details regarding cleaning agents.
Product residue limits along with criteria for limit selection should also be provided
Based on the information received by RU, RU should design its own cleaning
procedure. RU should take all relevant characteristics like potency, toxicity, solubility,
temperature sensitivity, etc. into account.
All critical parameters and finished product specifications should be assessed at
trial batch(es) level. Once product capability is established at RU then process validation
and cleaning validation should be carried out.
5.9 ANALYTICAL METHOD TRANSFER
In pharmaceutical sciences, analytical methods are the techniques which deal with the
process(es) to identify quantitatively or qualitatively a substance or its components
in the pharmaceutical preparation (solution, mixture, etc.). These techniques are also
used for determining the structure of the chemical component of the pharmaceutical
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