Topic > Pharmaceutical Manufacturing: Prevention of Cross Contamination...

Prevention of Cross Contamination: Contamination is the presence of unwanted 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 they represent a high risk effect on patient safety and should be considered right from the design stage. You can prevent this from happening by implementing, monitoring and following the rules which are: - The SOP must be followed at all times. - Any changes to the SOP must be documented and registered (GDP). - The SOP must be detailed (should include equipment name and number, type, approval date, revision number, modification history, if any, process and operational steps, name, etc.) - PPE must be always worn. - Do not eat or drink in the production area. - Only trained and competent personnel should operate the equipment. - Equipment must be labeled and identified correctly. - Raw materials must be inspected and tested before and after 'use.- Tests must be performed at every stage of the process, so as to safely guide cross-contamination. If this happens, it will be easily identifiable at that stage, when, where and what could have gone wrong. - After manufacturing, equipment must be properly cleaned and tested for cross-contamination (GMP). - Air entering and leaving production should be controlled using filters, for example HEPA. - The final product must be tested, to ensure that there is no contamination in the product. - Packaging and labeling must be done correctly. Validation: is the documented act of demonstrating that an activity will consistently lead to the expected results while complying with regulatory requirements. Requires a minimum of 3 batches to run concurrently with one error. If an error occurs... half of the paper... tedWhy Validation Matters: A Brief Guide to a Critical Aspect of the Pharmaceutical Manufacturing LifecycleJune 3, 2013Barry Peters and Heather D. Ferrence | Telerx (opened 04/13/2014 at 2:00 pm) (http://www.pharmacompliancemonitor.com/why-validation-matters-a-brief-guide-to-a-critical-aspect-of-the-pharmaceutical -manufacturing -lifecycle/4983/)Validation of Pharmaceutical Packaging Lines Afshin Hosseiny, Ph.D. Tabriz Consulting Limited http://www.commissioningagents.com/clientuploads/directory/Documents/Integrating%20C&Q%20ISPE%20GL%20newsletter. pdf http://apps.who.int/medicinedocs/en/d/Jh1792e/20.5.2. html#Jh1792e.20.5.2http://apps.who.int/medicinedocs/en/d/Jh1792e/20.7.2.htmlReferencesGood Manufacturing Practices: Supplementary Guidelines for the Manufacturing of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, attached 5