Traces of the preceding products should be sought in these samples.
(Note that the sensitivity of the assay may be greatly reduced by dilution of the contaminant.)10.5 Suitable methods that are sensitive and specific should be used where possible and may include chromatographic methods (e.g.
An acceptable strategy is to first manufacture the more dilute form (not necessarily the lowest dose) and then the most concentrated form.
There are sometimes “families” of products which differ slightly as to actives or excipients.); and4.1.4 Cleaning procedures for products and processes which are very similar do not need to be individually validated.
In establishing residual limits it may not be adequate to focus only on the principal reactant, because other chemical variations may be more difficult to remove.11.11 Certain allergenic ingredients (e.g.
penicillins and cephalosporins) and highly potent material (e.g.
Identical cleaning procedures should then be used for these products.4.2.1 The relevant cleaning records (signed by the operator, checked by production and reviewed by quality assurance) and source data (original results) should be kept.
The results of the cleaning validation should be presented in cleaning validation reports stating the outcome and conclusion.6.1 Normally only procedures for the cleaning of surfaces of the equipment that come into contact with the product need to be validated.
Unit readiness, movementdates, passengers, and cargo details should be confirmed with theunit before validation occurs.anovulent steroids, potent steroids and cytotoxics) should be undetectable by the best available analytical methods.(In practice this may mean that dedicated manufacturing facilities should be used for the manufacturing and processing of such products.)Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.The rationale for the residue limits established should be logical, and based on the knowledge of the materials involved.11.2 Each situation should be assessed individually.
The manner in which limits are established should be carefully considered.
Consideration should be given to “non-contact” parts of the equipment into which product or any process material may migrate.