A well-developed cleaning method is a primary requirement for the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
1. Select the cleaning procedure if it will be manual or automated.
2. Cleaning data from the past as difficulties to clean any product, difficulties to clean any area of equipment etc.
3. Our strategy for the cleaning as a process, groups of equipment, the detergent used, equipment for cleaning, any risk included in cleaning etc.
4. Worst case should be selected that is hard to clean as residues on the equipment, corners of equipment and water-insoluble products.
5. Selection of cleaning agent and its concentration that can clean the residues properly.
6. Determination of temperature of water and cleaning agent, the volume of water to be used for cleaning, and contact time of the cleaning agent.
7. Recovery factor should be determined for the analysis of product and detergent residues.
8. A proper validated analytical method should be selected according to the nature of the product and the cleaning agents.
9. Sampling locations should be selected considering the hard to clean place in the equipment.
10. Hold time studies for the clean and dirty equipment should be done.
11. The cleaning process should include the sequence of cleaning of the different parts of the equipment.
Nature of the product as solubility and insolubility should be studied in detail because it plays a great role in the cleaning activities.
Also see: Cleaning Validation Sample Protocol
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can we discuss regarding retesting of active materials. how to keep the expiry date of such material, or till when after retest, the material can be used?
ReplyDeleteAny API can not be used after is expiry date. It should be destroyed.
ReplyDeleteHow about, we re-analyze the API materials before it reaches the expiry date, and if it shows good results, perhaps we could consider to reuse it until a certain period, but must have a strong justification and SOP
ReplyDeleteHow about we do the reanalysis before the expired date and if the result shows a good and reflect to the initial characteristic, perhaps we could consider for prolong for limited period.
ReplyDeleteAPI's to be assigned retest period only instead of expiry date.
ReplyDeleteGenerally Chemical tests (Identification, Related substance and assay) are covered under Specification. What about Polymorphism,Genotoxicity, Photostability,Microbiological tests, stress study and Physical characteritics (Hygroscopicity, Solubility) of the API's after its expiry/retest?
ReplyDeleteI seen, Manufacturer doesnt cover these tests under Stability Specification.
If same study reports for stability sample is avaialbe with manufacturer then can be possible to extend Shelh life i.e. retest period. But Formulator also confirm and check dissolution rate and disintegration rate of tablets also.
manufacturing and filling of dry powder and liquid injection under one area is acceptibal
ReplyDeleteI think a lot of focus should be given to any available information on the stability data from the manufacturer. If stability allows for a retest, then why not?
ReplyDeleteManufacturing and filling of dry powder & liquid injection in same area its not recommended.
ReplyDeleteWhat's is the mean of "SHOP FLOOR"?
ReplyDeletePlease right guide.
the part offactory where production as distinct from administrative work is carried out.
Delete