The requirements for approving GCP documents should be defined in the quality management system (QMS). Everyone who are required to approve the document, as defined in the QMS, should be included in the document.
It is important to have a clear understanding of the meaning of each signature. This again should be defined in the QMS.
If someone is approving a document they should understand it and be able to explain its contents.
Generally a document should be signed off by:
Reviewer, this is a technical review to ensure the document is technically correct
Approver, This should be done by the heads of all departments affected by the document and should ensure the document is acceptable to the respective department.
Authorised by the quality assurance department. This is to assure that the document complies with all regulatory and company requirements.
It is important that all documents are signed off in a consistent manner as any inconsistencies can attract audit observations.
Dr David Trew
BSc (Hons), PhD, CChem MRSC
David Trew Consulting Ltd
Consultancy services for chemistry based businesses
and laboratory service sectors.