Proper documentation is an integral part of the quality assurance system and is a key element of the work in accordance with these Rules. In the manufacturer's quality management system, various types of used documentation and storage media should be clearly established. Documentation may exist in various forms, including paper, electronic or photographic media. The main objective of the applicable documentation system should be the creation, management, control and registration of all activities that can directly or indirectly affect all aspects of the quality of drugs. In addition to properly documenting the various processes and evaluating any observations, the quality management system should contain sufficiently detailed guidance. These guidelines contribute to a common understanding of the requirements so that their continued compliance can be demonstrated.
There are two main types of documentation: regulatory - instructions (instructions, requirements) and registering - records / reports. Appropriate appropriate documentation practices should be applied depending on the type of document.
Appropriate controls should be implemented to ensure the accuracy, integrity, accessibility and clarity of documents.
Regulatory documents should be available in writing and should not contain errors. The term “in writing” means recorded or documented on information carriers from which data can be obtained in readable form.
|Documentation of a QM system|
|Standard operating procedures (SOPs)|
|Site master file|
|Annual product review|