Documentation and Records: Harmonized GMP Requirements

摘要

‘If it’s not written down, then it didn’t happen!’ The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company’s documents and records. Effective documentation enhances the visibility of the quality assurance system. In light of above facts, we have made an attempt to harmonize different GMP requirements and prepare comprehensive GMP requirements related to ‘documentation and records,’ followed by a meticulous review of the most influential and frequently referred regulations.