Second person verification is an essential part of GMP compliance. The job of the second person is to ensure the integrity of the data by reviewing the information recorded by the first person. There are several instances in the CFR where a second person is required to check information:
- 21 CFR 211.101(c): weighing, measuring or subdividing of components
- 21 CFR 211.101(d): adding of components to a batch
- 21 CFR 211.103: calculation of yields
- 21 CFR 211.122(g)(3): verification of labeling
- 21 CFR 211.186(a): preparation of master and control records
- 21 CFR 211.194(a)(8): verification of lab records.
A company recently received the following observation:
….. Each container of component dispensed to manufacturing is not examined by a second person to assure that the component was released by the quality control unit, the weight or measure is collect as stated in the batch records and the containers are properly identified.
Specifically, you do not have a system for second person verification of component identification, release status, and quantity added during manufacture of intermediate components of … and bulk drug product … Furthermore, your manufacturing batch records for … lack instructions and documentation for … verification of components added to the batch. For example: The manufacturing batch record for … Lot Number … and raw material additions to the batch on … lacks documentation of …. verification of components added to the batch. … Lot Number …, was packaged and released for distribution.
For more information on good documentation practices, refer to the following documents: PIC/S Guidance: Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments, July 2021, WHO Technical Report: Guidance on Good Data and Record Management Practices and ICH Q9 Quality Risk Management
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