An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
1. DOCUMENT CONTROLS
In the past, FDA interpreted the 1978 GMP regulation so as to require manufacturers to implement document controls. Together, the regulation's sections on manufacturing specifications and processes (820.100) and on specification controls (820.100(a)(2)) have been used to compel manufacturers to establish controls for the review, approval, and distribution of documents, including the retrieval or control of obsolete documents. These requirements are now clearly stated in the document control section of the new quality system regulation (subpart D).
Because these requirements have been imposed for some time, manufacturers should find themselves already familiar with them and with the methods necessary to satisfy them. The requirements relating to document changes (820.40(b)), for instance, correspond to the change control paragraphs of the 1978 GMP regulation (820.100 and 820.100(a)(2)), which manufacturers have previously satisfied through the use of engineering change notices, document change notices, and so on.
One new mandate that may cause some concern is the requirement that document changes be reviewed and approved by individuals "in the same function or organization that performed the original review and approval, unless specifically designated otherwise" (820.40(b)). Although industry objected to this requirement, which first appeared in the November 1993 proposal, FDA has retained it on the grounds that those who first approve a document typically have the best insight into the impact of its changes. Another equally important reason for retaining the requirement was to maintain harmony with the ISO 9001 and ISO 9002 standards, where it is also a requirement. But FDA provides manufacturers with an out by adding the words "unless specifically designated otherwise." This loophole will permit manufacturers to simply define the departments that are authorized to approve various types of changes by means of a matrix or other document, and thereby avoid the burdensome restriction of the requirement.
One noteworthy aspect of the document changes section is that change records must include documentation of when the change(s) become effective. While this requirement was also in the 1978 GMP regulation, many manufacturers still have problems complying with it, and noncompliance often becomes an FDA-483 observation.
