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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…
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…
India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility…