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Good Manufacturing Practice

Good manufacturing practice (GMP) is a simple concept: certain products are manufactured and controlled considering the desired quality standards. In other words, the GMP system ensures the product's development is consistent without un-following the quality standards.

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21 cfr part 11 compliance

21 CFR Part 11 is the guideline of the FDA defining the criteria in which the electronic records and signatures are considered to be reliable and equivalent to the paper records. It stipulates the guidelines and rules for copying, storage, and permissions, tracking, and audit logs.