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Common GMP inspection finding in recent years. Laboratory controls ü    Lack of or inadequate method validation, ü    Online documentation, ü    Scientific and appropriate specifications/analytical procedures; Failures of adequate investigations on out-of-specification (OOS) and out-of trends (OOT); ü    Failures of adequate stability testing programs to assess the Quality attributes. Quality system ü    Failure of the quality unit to release/reject APIs, ü    Scrutinized review of quality-related documents; ü    failure in investigations, ü    Quality reviews of the APIs and handling of APIs CMC changes. Equipments ü    Maintenance, ü    Cleaning procedures, ü    Validation of cleaning procedures, ü    Cleaning, ü    Store and sanitization for contamination or carryover. Records and reports ü    Failures in batch records preparation; ü    Establishment of written procedures related to production, Quality, ü    Laborato

An Assignment On  Sustained released dosage form Sustained released dosage form: Sustained released dosage form is a kind of dosage firm which is designed to achieve a prolonged therapeutic effect by continuously releasing medication over a prolonged period of time after administration of a single dose. In this type of dosage form it is designed to deliver an initial therapeutic dose of the drug“loading dose” followed by a slower and constant release of drug. The rate of release of the “maintenance dose” is designed so that the amount of drug loss from the body by elimination is constantly replaced. With the sustained –release product a constant plasma drug concentration is maintained with minimal fluctuation. Figure: Sustained release film coating tablet Why we should go for coating formulation: If the followed questioned are answered concomitantly then one should go for film coating. (a)   Is it nec