4.2 Documents should be designed, prepared, reviewed, 4.2 Documents should be designed, prepared, reviewed and Providing and distributed with care. They should comply with the distributed with care. They should comply with the relevant additional relevant parts of Product Specification Files, parts of the manufacturing and marketing authorisation guidance; Manufacturing and Marketing Authorisation dossiers, as dossiers. First sentence appropriate. The reproduction of working documents has been moved from master documents should not allow any error to be from clause 4.3; introduced through the reproduction process. Last sentence has been moved from clause 4.4 4.3 Documents containing instructions should be 4.3 Documents should be approved, signed and dated by Providing Minor approved, signed and by appropriate and appropriate and authorised persons. additional authorised persons. [Documents should have guidance; unambiguous contents and be uniquely identifiable.] Second sentence The effective date should be defined. of 4.3 has been moved from 4.4; Only the definition of effective date is a new inclusion 4.4 Documents containing instructions should be laid 4.4 Documents should have unambiguous contents; title, Providing Nil out in an orderly fashion and be easy to check. The style nature and purpose should be clearly stated. They should be additional and language of documents should fit with their laid out in an orderly fashion and be easy to check. guidance; intended use. Standard Operating Procedures, Work Reproduced documents should be clear and legible. The Last sentence of Instructions and Methods should be written in an reproduction of working documents from master documents 4.4 has been imperative mandatory style. moved to 4.2
4.2 Documents should be designed, prepared, reviewed, and distributed with care. They should comply with the relevant parts of Product Specification Files, Manufacturing and Marketing Authorisation dossiers, as appropriate. The reproduction of working documents from master documents should not allow any error to be introduced through the reproduction process. 4.2 Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorisation dossiers. Providing additional guidance; First sentence has been moved from clause 4.3; Last sentence has been moved from clause 4.4 4.3 Documents containing instructions should be approved, signed and by appropriate and authorised persons. [Documents should have unambiguous contents and be uniquely identifiable.] The effective date should be defined. 4.3 Documents should be approved, signed and dated by appropriate and authorised persons. Providing additional guidance; Second sentence of 4.3 has been moved from 4.4; Only the definition of effective date is a new inclusion Minor 4.4 Documents containing instructions should be laid out in an orderly fashion and be easy to check. The style and language of documents should fit with their intended use. Standard Operating Procedures, Work Instructions and Methods should be written in an imperative mandatory style. 4.4 Documents should have unambiguous contents; title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents Providing additional guidance; Last sentence of 4.4 has been moved to 4.2 Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx