![]() ![]() Given the rapid acceptance of ‘as-a-service’ software models and significant outsourcing of previously in-house IT functions, there was a feeling that there was a need to assess and update the guidance. Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that.Īs ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” 1 ![]() Since 1991, GAMP ® – a community of practice within the International Society for Pharmaceutical Engineering (ISPE) – has set the tone for the validation practices necessary for regulated pharmaceutical companies to meet the computerized system expectations of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), the Medicines and Healthcare Regulatory Agency (MHRA) in the UK, the Chinese National Medicinal Products Administration and other global regulatory bodies. ![]()
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