The impact of GMP on your job and work environment Essay

The impact of GMP on your job and work environment - Essay Example Ps are the current good manufacturing practices followed by pharmaceutical and biotech firms to ensure the products produced meet specific requirements for identity, quality, and purity. The cGMPs are regulated by FDA under 21 Code of Federal Regulations Parts 210 and 211. Subpart G of part 211, covers the aspects of labeling and packaging control. The failure to comply with any regulation in manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. Packaging is the art, science and technology of manufacturing goods for sale in a cost effective manner. In the context of pharmaceuticals the packaging must preserve the product from degradation or contamination and, leakage. The particular type of packing should able to identify the product. Every individual employed in the packing of a drug product shall have education, training, and experience, or any combination thereof, to facilitate the person to perform the assigned functions. Adequate number of qualified personnel are required to perform and supervise the packing processes. It is a requirement of GMP, that owner of manufacturing authorizations set up procedures for their packaging operations to minimize the risk of cross-contamination, mix-up or substitutions. Written procedures are indispensable for the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials. These materials are representatively sampled and examined before use. An authorized packaging instructions for each product is required. These should normally include name of the product, description of its pharmaceutical form and strength, where applicable, the pack size, description of packaging operation, including any subsidiary operations, and equipment to be used. It should also comprise in-process controls, with instructions for sampling and