When it comes to ice cream and desserts, I must admit the more the better in my opinion. The same, however, doesn’t hold true for laboratory testing and the resultant data. All testing performed and data generated must be accountable to ensure the integrity of the data. Performing extra testing, even if with all good intentions, is a very risky practice, offering little to no reward. Unlike schoolwork, there is no extra credit for extra testing, just an additional burden of accounting for the resultant data. The FDA, in a recent August 12, 2019 update to “Questions and Answers on Current Good Manufacturing Practices—Laboratory Controls,” has added further clarity around chromatographic practices involving materials used as instrument calibration standards, materials used for system suitability, and “trial injections of samples.” This additional guidance is supportive of the December 2018 FDA Guidance “Data Integrity and Compliance with Drug cGMP – Questions and Answers Guidance for Industry.”
The main points clarified are:
- Calibration standards obtained from a chemical supplier or produced in-house should be purified and characterized using validated purification processes and validated characterization methods. Use of finished dosage forms for standards should be avoided.
- Finished dosage forms or APIs (if not qualified as a reference standard) should not be used for system suitability testing.
- All data — including obvious errors and failing, passing, and suspect data — must be in the CGMP records and subject to review and oversight. Records must be complete.
- “Trial Injections” of sample preparations are not acceptable; all data from analysis of product samples must be retained and reviewed.
Beyond “trial injections,” three additional scenarios of extra testing and extra data often observed in pharmaceutical testing laboratories are:
- Data generated for method transfers on previously tested batches currently in commerce
- Duplicate testing performed as part of routine testing practices
- Use of previously released batches still in commerce as control samples
These practices can lead to unwanted data and the potential to obtain OOS results affecting product in commerce.
The “take home” message is to ensure that you have well-established procedures for performing chromatographic analysis and construction of chromatographic sequences. Extra testing must be fully accountable and should be avoided.
For further information and assistance on the topics of laboratory compliance enhancement and regulatory inspections, please contact Ron George, Ph.D. at email@example.com, Tim Rhines, Ph.D. at firstname.lastname@example.org or Mary Oates, Ph.D. at email@example.com.