Calibration and qualification of equipment are key requirements in GMP guidelines (EU GMP Guide, Annex 15 to EU GMP Guide, and FDA’s Code of Federal Regulations, 21 CFR Part 211). These requirements also apply to instruments and systems in analytical laboratories of the pharmaceutical industry. Besides calibration and qualification, the validation of computerised systems is another key issue. The software components associated with the instruments and systems must be shown to be fit for their intended purpose. Computer validation requirements and guidances for the pharmaceutical industry are laid down, amongst others, by the EU (Annex 11 to EU GMP Guide, the PIC/S (Good Practices for Computerised Systems in Regulated “GXP” Environments”), GAMP® (Good Automated Manufacturing Practice), and FDA’s Part 11.
The United States Pharmacopoeia (USP) has adopted the General Chapter <1058>, Analytical Instrument Qualification, in 2008. This General Chapter <1058> is currently under revision.
The objective of this course is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and the software validation of computerised systems and to give practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems. Key requirements of the important USP General Chapter <1058> will be presented and discussed.
The course will cover the following instruments and systems amongst others:
UV/VIS Spectrophotometers,, Disintegration and Dissolution)
Balances and Masses
HPLC and GC
Chromatographic Data Systems
Excel® - Spreadsheets
Interactive workshops will allow the participants to discuss key areas of interest and to exchange practical experiences.