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Paul Liberatore
Introduction
Good Manufacturing Practice (GMP) or current Good Manufacturing Practice (cGMP) was
introduced to ensure public safety by regulating manufacturing practice of pharmaceutical,
veterinary, food and cosmetics industries. The guidelines in GMP ensure that products
are consistently produced and controlled to the quality standards appropriate to their
intended use. Good Laboratory Practice (GLP) follows similar guidelines to GMP and
although it was initially developed for toxicity testing, its scope has been broadened
to include all scientific disciplines, in particular those which perform analytical
measurements. The most significant difference between GMP and GLP is in archiving
requirement for test samples and data. Most QA/QC laboratories today need to
operate under GLP/GMP guidelines.
Analytical method validation is an essential component for compliance with GLP/GMP.
The objective is to obtain accurate and precise results in a properly functioning
measurement system, as well as documenting all results and procedures to allow
for independent auditing. Today there is a growing demand for analytical
instruments that can be validated as more laboratories are required to adhere
to the strict regulations imposed by GLP/GMP.
Performance Specification of UV-Visible spectrometers
A range of performance tests for UV-Visible spectrometers is specified by a number of
regulatory bodies including the German, French, British, US, and European Pharmacopoeia
and the Australian Therapeutic Goods Association. The specifications defined by these bodies
are the minimum set of criteria for general purpose UV-Visible spectrometers.
The fundamental parameters associated with the performance evaluation of
UV-Visible instruments include stray light, wavelength accuracy, photometric
accuracy, baseline flatness and resolution. It is essential to conduct the
calibration verification over the entire range of spectral wavelength and
absorbances that may be encountered when the spectrometer is used for its
intended applications.
Cintra range of UV-Visible spectrometers
The GBC Cintra range of UV-Visible spectrometers, along with the Windows based
Spectral operating software has been designed with the requirements of regulatory
bodies in mind. Features of the Cintra hardware include: An instrument serial
number in the firmware for positive instrument identification. Optical performance
that ensures compliance with the requirements of the regulatory bodies.
Spectral Software
The Spectral software simplifies the tasks of validation and documentation by offering
the following features: Password protection on method files to prevent accidental
or unauthorised modification of validated methods. Complete assurance of data
integrity. Each spectrum is automatically date and time stamped and includes
the instrument serial number and a log of any further manipulation (fig 1).
A dedicated GMP software application for quick and easy validation of the
instrument performance.
Fig 1. Results data includes time date and operator ID for traceable analysis
The GMP application in the Spectral software semi-automates all the tests specified by
the various regulatory bodies (fig 2). This saves valuable time and increases productivity.
Fig 2. Standard tests ensure optimum performance of instrument and compliance with regulatory bodies
Minimum operator involvement is required to perform instrument validation.
To initiate the GMP test, the operator only needs to insert the test solution,
followed by a simple click on a mouse button. Automating this test reduces
the possible sources of errors, as the operator is guided through a sequence of
operations. At the conclusion of the test, the results are reported with the relevant
instrument operating parameters, as well as the time and date.
A certified reference kit, traceable to National Institute of Standards and Technology
(NIST) standards is also available to further simplify the verification of
instrument performance.
While GMP tests are required by the regulatory authorities, these tests may also be
used by the analyst for checking the instrument performance on a regular basis.
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