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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

ii. Operator exposure

iii. Environmental factors, etc.

The cleaning procedure information provided by SU to RU should include the

following details:

i. The solubility of API, excipients and vehicles

ii. Minimum therapeutic dose of API

iii. Therapeutic category of product

iv. Toxicological details

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

by SU to RU.

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

product.