Cross Contamination Case Study

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1) OBJECTIVE Process variation and cross contamination is the major problem in the manufacture of solid dosage forms like tablets, capsules etc. The objective of the study was to solve this problem. Complete elimination of these variations and cross contamination is highly impossible. But its occurrence can be reduced to a large extent by validation. To establish documented evidence and to prove the process has always remained in control. To check the efficiency of cleaning and to provide documented evidence that the result of cleaning procedure is at (or) below the acceptance criteria. To the cGMP regulations that require manufacturing processes to be designed and controlled to assure that in-process materials and the finished product meet…show more content…
Due to the complexity of today's medical products, routine end product testing alone often is not sufficient to assure product quality for several reasons. Some end-products tests have limited sensitivity. e.g. In some cases, where end product testing does not several all variations that may occur in the product, which may have an impact on safety and effectiveness, destructive testing is required to show that the manufacturing process is…show more content…
at least three consecutive batches (full production scale) should be validated, to demonstrate consistency. Worst-case situations should be considered. There should be a clear distinction between in-process controls and validation. In-process tests are performed during the manufacture of each batch according to specifications and methods devised during the development phase. Their objective is to monitor the process continuously. When a new manufacturing formula or method is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, should be shown to result in the consistent yield of a product of the required quality. Manufacturers should identify what validation work is needed to prove that critical aspects of their operations are appropriately controlled. Significant changes to the facilities or the equipment, and processes that may affect the quality of the product should be validated. A risk assessment approach should be used to determine the scope and extent of validation required. 2.5) Types of process

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