MedSpace

Importance of Calibration PHARMACEUTICAL  (FDA, U.S. Food and Drug Administration)  Any pharmaceutical company that sells their products in the USA must comply with FDA regulations, regardless of where the products are manufactured. • Calibration records must be maintained. • Calibrations must be done in accordance with written, approved procedures. • There should be a record of the history of each instrument. • All instrumentation should have a unique ID; all product, process and safety instruments should be physically tagged. • A calibration period and error limits should be defined for each instrument. • Calibration standards should be traceable to national and international standards. • Calibration standards must be more accurate than the required accuracy of the equipment being calibrated. • All instruments used must be fit for purpose. • There must be documented evidence that personnel involved in the calibration process have been trained and ...

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 ...

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)   ...