The basic rules in any good manufacturing practice (GMP) regulations postulate that the pharmaceutical manufacturer must maintain appropriate documentation and records. Documentation helps to build up a detailed interpretation of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a base for planning what it is going to do in the future. Regulatory evaluators, during their inspections of manufacturing sites, often devote much time on examining a company’s documents and records. Effective documentation boosts the visibility of the quality assurance system.
GMP, 21 CFR, Part 210 and 211, Documentation, Regulations Agencies
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