January 6, 2023 Government of India vide gazette notification no. GSR 922 (E) dated 28.12.2023 has notified new set of rules and regulations for implementation of Good Manufacturing Practices for manufacturing of pharmaceutical products. The new rules are covered under…
Going by the classical definition, an impurity can be defined as an unwanted chemical substance which differs from the chemical composition of the material in question. In pharmaceutical preparations, impurities identification, assessment and quantification play a vital role in evaluating…
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…
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there…
Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of the Quality Management System. It is popularly said that “Anything which is not documented, is not done”. Documentation is the…
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