Pharmaceutical Manufacturing: Prevention of Cross Comtamination
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Prevention of cross contamination: Contamination is the presence of undesired materials on a surface or fluid, here are some examples of sources of contamination; people, raw materials, air, and water. These should be prevented from occurring as it as a high risk safety effect on patients and it should be considered from design stage. This can be prevented from occurring by implementing, monitoring and following rules which are;
- SOP must be followed at all times.
- Any changes to the SOP must be documented and recorded (GDP).
- SOP must be detailed (should have equipment name and number, type, date approved, revision number, change history if any, process and operation steps, name, etc)
- PPE must be worn at all times.
- No eating or drinking in the production area.
- Only trained and competent personnel should operate on equipment.
- Equipment must be labelled and identified correctly.
- Raw materials must be inspected and testing before and after use.
- Tests must be carried out at each process stages, so as to safe guide cross contamination. If this do happen, it will be easily identified at that stage, when, where and what might have gone wrong.
- After production, equipment must be cleaned properly and tested for cross contamination (GMP).
- Air going in and out of production should be controlled by using filters e.g. HEPA.
- Final product must be tested, to ensure that there are no contaminations in the product.
Validation: Is the documented act of demonstrating that an activity will consistently lead to the expected results while meeting regulatory requirements. It requires a minimum of 3 batches to run simultaneously with an error. If an error occurs ...
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Why Validation Matters: A Brief Guide to a Critical Aspect of the Pharmaceutical Manufacturing Lifecycle
June 3, 2013
Barry Peters and Heather D. Ferrence | Telerx (opened at 13/04/2014 @ 14pm) (http://www.pharmacompliancemonitor.com/why-validation-matters-a-brief-guide-to-a-critical-aspect-of-the-pharmaceutical-manufacturing-lifecycle/4983/)