Restated, the question is asking whether Part 11 applies to API manufacturers. This question
should be addressed from both the legality and practicality perspectives. Part 11 is the
regulations that set forth the criteria under which the FDA considers electronic records, electronic
signatures and handwritten signatures executed to electronic records to be trustworthy, reliable,
and generally equivalent to paper records and handwritten signatures executed on paper. Section
11.1(b) states that the regulation applies to records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted, under any records requirements set
forth in agency regulations; and electronic records submitted to the agency under
requirements of the Federal Food, Drug and Cosmetic Act and the Public Health Service Act,
even if such records are not specifically identified in agency regulations (this generally applies to
NDA’s or ANDA’s submitted electronically to the agency)
Herein lies the legality issue. Part 11 cannot be imposed on API manufacturers because in the
United States we lack a GMP regulation specifically covering the production and control of active
pharmaceutical ingredients that sets forth records requirements. Q7A is industry guidance, not a
regulation. It is not legally binding and does not establish requirements. .
However, from a practical standpoint, I would not run to the bank with this. If you are an API
manufacturer with an established paper record and manual signature system and are
contemplating or engaged in converting to an electronic records and electronics signatures
system, would you not consider it prudent to assure that this new electronic records system is
trustworthy, reliable, and generally equivalent to your paper records and handwritten signatures
executed on paper? If so, would it not make sense to follow Part 11 as guidance to provide this
assurance?
Section 5.4 of Q7A includes the following expectations for computerized systems:
- Computerized systems should be validated
- Installation and operational qualifications should demonstrate the suitability of hardware
and software - Controls to prevent unauthorized access or changes
- Record of any data change made, the previous entry, who made the change and when
the change was made - Change control for modifications to hardware, software and any other critical components
In addition Q7A gives you some flexibility as it allows for recording of data by a second means in
addition to the computer system. This allows you for example to manually record temperature on
a batch record in addition to the instrument recording.
