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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…
As a part of regulatory requirements, we prepare numerous documents. Preparing documents shall not be treated as a burden but shall be considered as an activity of creating proofs or evidences that shows one’s true self. There are many types…
Pharmaceuticals in general not only produce drugs but they also produce tons of data. Regulatory agencies across the globe insist on generation of data for each and every activity. We should understand that there is value in data generation. Data…
No manufacturing firm can design a process where they don’t need to hold the various dispensed, in-process, bulk and finished products for few hours to many months. The duration for which the various materials can be hold under specific environmental…