Teva CFS Book English

Leading the Way GMPs (Good Manufacturing Practices) are the guidelines for the manufacturing and testing stages that affect the quality of the finished product. Many countries set and implemented their own GMP practices, but the basic characteristics are identical and their goal is to ensure the quality of the pharmaceutical product in order to protect the end-user's health. • All the manufacturing processes must be defined, controlled, and all the critical processes must be validated to ensure consistency and compliance with the regulations. • Any change in the process needs to undergo the requisite tests and every change affecting the quality of the finished product requires proof of its necessity. • All the instructions and processes must be written in clear and unambiguous language (Good Documentation Practices). • The manufacturing employees are required to be proficient enough in order to execute the required processes. • The manufacturing process of each batch (including the shipping) must be documented in a clear and accessible manner. • Shipping must be carried out in a way that will not harm the product's integrity. • Complaints about the finished product require investigation and optimization of the product accordingly, in order to prevent recurrence of the event. What are GMP procedures? * ◄ 17