GXP is a generic acronym used by those in the field of quality assurance of medicinal product development. The words "G" and "P" represents Good and Practice, respectively. While X is a variable whereby "L" for laboratory, "C" for clinical and "M" for manufacturing. Thus, the GXP includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). In the field of agrochemical product development, the variable includes "A" for "agricultural" and "E" for efficacy, i.e representing Good Agricultural Practice (GAP) and Good Efficacy Practice (GEP).
The GXP is documented internationally (e.g. OECD, ICH and ISO) and enforced under national legislation (e.g. FDA). The requirements of GMP and GCP compliance have been enforced by government of Malaysia for decades under the national Drug Control Authority (DCA) that is administered by National Pharmaceutical Regulatory Authority (NPRA), previously known as National Pharmaceutical Control Bureau (NPCB). The 1st January 2018 marks a history whereby NPRA executes the decision by DCA for preclinical safety data of medicinal product that being submitted to adhere the GLP requirement. The decision is consistent with the role of NPRA as the National GLP Compliance Monitoring Authority for medicinal products category.
As the outcome, today requirement for all three of quality assurance systems namely GLP, GCP and GMP in medicinal product development has been implemented. Hence, consumer in Malaysia can look forward to medicinal solution of acceptable safety, efficacy and quality including those developed locally. Below is the letter of the GLP implementation notice.
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