IntroductionThis assignment will explore the areas of production, how they are regulated and controlled. It explores the rules governing pharmaceutical production. For example, it provides guidelines on how to monitor, prevent and control cross-contamination within pharmaceutical factories. Production operation, validation, raw materials from purchase to manufacturing, packaging materials and operation. Also the quality of finished product, rejection of raw material or final product and returned materials. Due to the word limit of this mission, exploration of each of the above will be brief. Discussion 1-Prevention of cross contamination Cross contamination in pharmaceutical production should be avoided 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 drugs with harmful effects that may affect the purity and quality of pharmaceutical products. » [1] Cross-contamination can occur either through introduction of microorganisms to the product or through other pharmaceutical products in the mixed manufacturing facility. Studies have shown that the main contamination within pharmaceutical production occurs through people, air, equipment, water and/or raw materials. [1]The severity of drug cross-contamination depends on the route of administration. Contamination of parenteral products poses greater risks to the patient and can result in serious consequences ranging from serious illness to death. [2]Cross contamination must be avoided by strict measures and guidelines summarized as follows:• In accordance with good manufacturing practices g...... middle of paper ......accurate documentation of the condition of the material (seal on packaging, labeling) must be carried out. Sampling of the material should then be carried out and the sample should be transported to the laboratory to test for purity and removal of contamination. Move the sample to the storage area where the required appropriate storage conditions must be met. The sample materials then labeled with the name of the material, the batch number where this material will be used, the test results and the expiration date. In some cases, certain starting materials will not be tested by the manufacturer for reasons of danger, the supplier will then have to provide a quality certificate with each batch. [5]Starting materials will be weighed and distributed appropriately by a designated individual.Works CitedDMSJ;19(2)17-19www.pewhealth.orgChapter 2,3,4 of the Eudralex Technical Report SeriesApps.who.int/ medicinedocswhonon 902,2002