By Sarfaraz K. Niazi
Over the counter items contain a distinct classification of healthcare items. whereas those formulations have a lot in universal with their prescription opposite numbers, they're awarded during this sequence individually as a result of their improvement procedure taken, labeling concerns required, and help to be had from providers of constituents in designing those items. Highlights from over the counter items, Volume Five comprise: solids, beverages, and suspensions functional suggestion on easy methods to deliver production practices into compliance with regulatory standards cGMP issues in nice element loads of formulations of coatings of reliable dosage varieties
Read or Download Handbook of Pharmaceutical Manufacturing Formulations Series, Second Edition, Volume 5: Over-the-Counter Products PDF
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Additional info for Handbook of Pharmaceutical Manufacturing Formulations Series, Second Edition, Volume 5: Over-the-Counter Products
Lf one material delivery is made up of different batches, each batch must be considered as separate for sampling, testing, and release. Starting materials in the storage area should be appropriately labeled (see Chapter 5, item 13). , in quarantine, on test, released, rejected); and - where appropriate, an expiry date or a date beyond which retesting is necessary. When fully computerized storage systems are used, all the above information need not necessarily be in a legible form on the label. There should be appropriate procedures or measures to assure the identity of the contents of each container of starting material.
Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures. Lighting, temperature, humidity, and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment. Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals.
Beginning or end of a process). 13 Sample containers should bear a label indicating the contents, with the batch number, the date of sampling and the containers from which samples have been drawn. 14 Further guidance on reference and retention samples is given in Annex 19. 15 Analytical methods should be validated. All testing operations described in the marketing authorization should be carried out according to the approved methods. 16 The results obtained should be recorded and checked to make sure that they are consistent with each other.
Handbook of Pharmaceutical Manufacturing Formulations Series, Second Edition, Volume 5: Over-the-Counter Products by Sarfaraz K. Niazi