The management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and archiving of all GMP documentation and records used within one site’s department or unit.
Document owners are required to ensure that the documentation and record systems for which they are responsible are specified in the form of detailed SOPs, including all aspects of documentation and records management as described above.
All associates have the responsibility to ensure that all GMP activities are performed according to the official SOPs, any deviations in procedure are reported to their supervisor and are adequately documented.
The local Quality Assurance unit has the responsibility to ensure via organisational measures and auditing that GMP documentation and records systems used within the Operational Unit are complete and comply with the relevant GMP requirements, and that the requirements of the SOPs are followed.
Requirements for specific documents or record including ownership, content, authorisation and change control procedures are described or cross referenced in the Quality Modules which relate to the subject of the document.
General requirements, applicable to all documents are:
Good documentation constitutes an essential part of the quality assurance system. Clearly written procedures prevent errors from spoken communication and clear documentation permits tracing of activities performed.
Documents must be designed, prepared, reviewed and distributed with care. They must comply with the relevant parts of the marketing authorization dossiers.
Documents must be approved, signet and dated by appropriate, competent and authorised persons.
Documents must have unambiguous contents: title, nature and purpose should be clearly stated. They must be laid out in an orderly fashion and be easy to check. Reproduce documents must be clear and legible.
Documents must be regularly reviewed and kept up-to-date. When a document has been revised, systems must be operated to prevent inadvertent use of superseded documents (e.g. only current documentation should be available for use).
Documents must not be hand-written, although where documents require the entry of data, these entries may be made in clear legible handwriting, in a suitable indelible medium (i.e. not pencil). Sufficient space must be provided for such entries.
Any correction made to a document or record must be signed or initialled and dated, the correction must permit the reading of the original information. Where appropriate, the reason for the correction must be recorded.
Record must be kept at the time each action is taken and in such a way that all activities concerning the conduct of preclinical studies, clinical trials, and the manufacture and control of products are traceable.
Storage of critical records (e.g., GMP relevant must be secure, with limited access only for authorised persons. The storage location must ensure adequate protection from loss, destruction or falsification, and from damage due to fire, water, etc.
Records which are critical to regulatory compliance, or to support essential business activities can be duplicated on paper, microfilm or electronically, and stored in a separate, secure location, in a separate building from the originals to mitigate the risk of an accidental loss and consequent field actions .
Date may be recorded by electromagnetic or photographic means, but detailed procedures relating to the system in use must be available and the accuracy of the records should be checked. If documentation in handled by electronic data processing methods, only authorised persons should be able to enter or modify data in the computer, access must be restricted by passwords or other means an entry of critical data must be independently checked.
It is particularly important that, during the period of retention, the data can be rendered legible within an appropriate period of time.
If data is modified, it must be traceable.