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  • hruship101 replied to the topic Discussion Topic: GMP's in the forum Introduction to Project Management 8 years, 12 months ago

    In today’s world of manufacturing, it is essential for a company to have regulatory laws in place. Good Manufacturing Practises (GMP’s) are regulations placed to meet the company’s quality standards and production standards. More importantly, GMP’s regulation sets the company standards higher and also plays a role in the market. For example, if I were to give a contract to manufacture medical parts to a company, I would look for GMPs before signing the contract. GMP’s can affect each phase of manufacturing when creating a new product. In the Initiation and planning phase, it is important to create a step by step instruction on how the project will be done. In addition, project manager creates an estimated timeline of the project. Next, is the regulatory phase in which one gathers all the certification of the materials that will be used to create that product. Traceability becomes important here because FDA requires that all parts included in the manufacturing of medical parts must be able to trace it back to its original source. Lastly, is the Monitoring and Controlling phase in which security measures are placed to avoid mixing up manufacturing lots and to reduce scraps. This process is further controlled by CAPA process which controls or prevents the same mistake from happening again. Finally, a quality rep looks at the paper works and signs off before leaving the company and into the market.