Performance qualification , Good Manufacturing Practice

Calibration, in current Good Manufacturing Practices (GMP) terminology, refers to instrument qualification or performance verification... 

Calibration, in current Good Manufacturing Practices (cGMP) terminology, refers to instrument qualification or performance verification of the HPLC. Note that neither any internal instrumental adjustment nor detector response curve for quantitation is intended here as in the common usage of the terminology. In most pharmaceutical laboratories. 

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

Samples applied with the ATS 4 can be positioned for normal, double-sided, or circular chromatographic development. Analyses performed with this applicator, combined with densitometric chromatogram evaluation controlled by the same PC with Windows-based WinCats software, comply with good manufacturing practices/ good lab practices (GMP/GLP), installation qualification (IQ)/operational qualification (OQ), and 21 Code of Federal Regulations (CFR) Part 11 (drug analysis) requirements. 

The Technical Director is responsible for compliance with Good Manufacturing Standards. He shall have the legal qualifications. He.shall have experience in the production and control of drugs, so as to permit him to have prompt understanding of the practical problems encountered in the performance of his functions and to make independent professional decisions founded on the application of scientific principles as well as on effective legislative standards. 

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