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In continuation to our previous article entitled "Friability testing of tablets", we are hereby providing you the guidelines on Friability testing of granules and spheroids. British Pharmacopoeia and European Pharmacopoeia provides the method in detail. There are basically two…
April 21, 2021 Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India has introduced a new draft General Chapter on ‘Approach to Alternative Rapid Microbiological Method’. The proposed methods would enable faster laboratory testing of the…
The tablets manufactured by a firm needs to be sufficiently hard to bear the shocks experienced during their packing and transit. Measuring tablet hardness does not reliably indicates the tablet strength as too hard tablets also experience capping or lose…
World Health Organization (WHO) in March, 2021 has come up with revised stability conditions for WHO Member States. The list is prepared on the basis of information obtained from following sources: Respective regional harmonization groups (e.g. ASEAN, ICH and GCC).…
Against the backdrop of globalization, especially in case of pharmaceutical industry, data integrity has become one of the basic expectations that a regulator expects from a manufacturer. USFDA, MHRA, WHO or any other regulatory agency when inspecting an offshore manufacturing…