Answer :
Final answer:
The question appears to be a mix-up, as it references airport operations under Part 139, but the info provided pertains to FDA regulations in 21 CFR Part 211, specifically around pharmaceutical records and reports. Subpart J outlines the requirements of record-keeping and the maintenance of records for a minimum duration for compliance and product integrity.
Explanation:
The question 'What does Part 139 Subpart B offer guidance on?' may actually be a misunderstanding. The provided information references regulations, but it pertains to topics under the Code of Federal Regulations (CFR) related to the Food and Drug Administration (FDA), rather than airport operation which is what Part 139 would typically refer to. However, I can provide information on 21 CFR Part 211 which is related to pharmaceutical good manufacturing practices. Subpart J of this section covers Records & Reports and specifies requirements for the maintenance and retention of records. Records must be kept for at least one year after the expiry date of the product or two years after the product is distributed, whichever is longer.
Subpart J consists of several subparts which include:
- Subpart F: Test and Control Articles - Chain of Custody
- Subpart G: Protocol for and Conduct of a non-clinical Laboratory study - Formal study protocol, and study documentation
- Subpart J: Records & Reports - Information needed in the final study report and the storage of study records
This regulation ensures that thorough documentation and record-keeping practices are in place, which are vital for product integrity and regulatory compliance.
