The Foss NIR System and Vision 2.50 to ensure 21 CFR Part 11 compliance

NIR and Good Automated Manufacturing Practice(GAMP)

The first example of using NIR is in the implementation of 21 CFR Part 11. Increasingly, the FDA is requiring companies to comply with the regulations delineated here on the safe keeping of electronic records. Following GAMP, FOSS created Vision 2.50 to cover both the software and hardware compliance elements of 21 CFR Part 11. Vision is also compatible with Subpart C, Electronic Signatures for closed systems.

Vision 2.50 compliance features can be turned on or off allowing for convenient software operation in both 21 CFR Part 11 compliant and non-compliant environments. In either environment, all changes are logged into an Audit Trail.

The Audit Trail is a built-in feature that stores all activities and changes on projects, calibrations, libraries, operations methods and security.

It also logs the date and time of each change, the user making the change, a description of the change or activity and the reason for the change. Only system managers and developers have access to the Audit Trail.

Vision 2.50 comes with both a certificate of compliance and a table of compliance criteria. The combination of these two elements supplies the documentation necessary to demonstrate 21 CFR Part 11 compliance to regulatory authorities.

a NIR raw material library

The second example relates to raw material identification, a major application of NIR. To carry out raw material identification routinely with this technology, it is necessary to have a validated spectral library that contains all the substances that the user wishes to identify. Furthermore, the library must be populated by multiple batch lots of each substance in order to represent the natural variation in the material in question.

For the smaller manufacturing facility, which has to accomplish this unaided, it can take many months before sufficient variation in its raw material batches is seen. Every sample used in the library has to be identified by conventional methods, which can be a considerable strain on the laboratory. Meanwhile, the clock hasn't started ticking on the payback period.

Foss are now able to provide users with a raw material library, which is a complete package consisting of commonly used excipients allowing pharmaceutical users to begin scanning samples and obtaining results immediately with a fully validatable library. The raw materials included in this library are represented by multiple lots, and sometimes multiple manufacturers, of the materials.

external validation

All of the materials in the library have been authenticated by an independent cGMP certified laboratory. The user simply downloads the library into FOSS Vision software then adds his or her own external validation to complete a validated method.

Regulatory support is provided in the form of a method development protocol template, SOP templates, a method validation report for the library, instructions on how to add the external validation set (challenge set) containing positive and negative controls and an addendum template for adding the challenge set data to the final report. The entire library and all support documentation are available on CD.