Introduction This assignment will explore the areas of manufacturing, how this is regulated and controlled. It is exploring the rules that govern pharmaceutical manufacturing. It provides guidelines, for example, on how to monitor, prevent and control cross-contamination within pharmaceutical plants. Production operations, validation, initial material from purchasing phase through to production, packaging materials and operation. Also the quality of the finishing product, the waste of the raw material or the final product and the returned materials. Due to the word limitation of this assignment, the exploration of each of the above topics will be brief. Discussion 1-Prevention of cross-contamination Cross-contamination in pharmaceutical manufacturing should be prevented at all stages of production. It is defined as: “The process by which foreign chemical, microbial, or physical substances are unintentionally transferred from a substance or object to medicinal products with harmful effects that could affect the purity and quality of pharmaceutical products.” of microorganisms in the product or from other pharmaceutical products in the production of mixed plants. Studies have shown that the primary contamination in pharmaceutical manufacturing occurs via people, air, equipment, water and/or raw materials. [1]The severity of cross-contamination of medicines depends on the route of administration. Contamination of parenteral products poses greater risks to the patient and can lead to serious consequences ranging from serious illness or even death. [2]Cross contamination should be avoided by adopting strict measures and guidelines summarized as follows:• According to good manufacturing practices g...... half of the paper ......uate documentation of the condition of the material (seal on packaging, labelling). Sampling of the material should then be carried out and the sample taken to the laboratory to test for purity and freedom from contamination. Move the sample to the storage area where the required appropriate storage conditions must be met. Sampling materials must then be labeled with the name of the material, the lot number in which the material will be used, test results, and the expiration date. In some cases, some starting materials will not be tested by the manufacturer for risk reasons, the supplier will therefore need to provide a quality certificate with each batch. [5]Initial materials will be weighed and appropriately distributed by a designated person.Works CitedDMSJ;19(2) 17-19www.pewhealth.orgChapter2,3,4, of the Eudralex Technical Report SeriesApps.who.int/medicinedocswho report series technician 902,2002