White Paper: Harmonization Of Standards For Better Regulatory Compliance

Keeping abreast of the recent developments in the harmonization of standards is essential for better Regulatory Compliance. This white paper offers an opportunity for the Scientists or Analysts who are working in the Laboratories of Pharmaceutical industry to gain an interesting understanding of a harmonized framework as it relates to the Analytical Instrument Qualification Process. Analytical Instruments are being used in the laboratories of Pharmaceutical industries for testing various kinds of samples. The samples could be either from Research and Development or from Manufacturing activity. The Quality and Integrity of the Analytical Data is very important as they are playing a vital role in taking quality related decisions. Moreover, the Scientific Supporting Data generated by these Analytical Instruments are being used for the Regulatory Submissions. So the regulatory importance of ensuring the validated state for the Analytical Instruments through appropriate Qualification process is very high. It is mandatory to perform Analytical Instrument Qualification before deploying into regular laboratory use. This white paper provides a high level interpretation of both USP <1058> and ASTM E2500. It also depicts better regulatory compliance by applying some of the concepts of ASTM E2500 to the Analytical Instrument Qualification process as detailed in United States Pharmacopoeia's General Chapter 1058.