Our investigator observed specific deficiencies during the inspection of the API manufacturing facility, including, but not limited to, the following:
API: CGMP DEVIATION
1. Failure to manage laboratory systems with sufficient controls to ensure conformance to established specifications and prevent omission of data.
Our inspection revealed serious deficiencies related to your documentation practices, including missing raw data. It is a basic responsibility of your quality unit to ensure that your firm retains the supporting raw data that demonstrates your APIs meet specifications that they are purported to possess.Well, you know, I always have a junk drawer for my chromatograms.
For example, during the inspection, our investigator found a chromatogram related to [redacted], API in the trash, dated October 15, 2013, which reported an additional chromatographic peak when compared to the standard. During the inspection, your firm stated that the analyst discarded the chromatogram because it was present in the blank injection. However, the analyst was unable to retrieve the blank chromatogram from the system because it was overwritten by a subsequent injection.
In addition, the inspection documented that your firm made changes to integration parameters for the impurities test without appropriate documentation or justification. Your firm relied upon hand written notes on a chromatogram discovered in a drawer at the laboratory as the documentation for this change. Furthermore, your firm implemented this change without an audit trail that would have captured the date of the change and who made the change.
Other significant deficiencies noted in your laboratory system include:
a) Failure to have a written procedure for manual integration despite its prevalence.
b) Failure to use separate passwords for each analyst’s access to the laboratory systems.
c) Use of uncontrolled worksheets for raw analytical data in your laboratory.
d) Presence of many uncontrolled chromatograms, spreadsheets and notes of unknown origin found in a drawer.
The lack of controls on method performance and inadequate controls on the integrity of the data collected raise questions as to the authenticity and reliability of your data and the quality of the APIs you produce.