Detailed information and condition regarding procedures under which test facilities inspections and study audits are performed can be found in the NPRA GLP Compliance Programme Manual.

Dec 4, 2020 · The manual describes the quality system of the National Pharmaceutical Regulatory Agency (NPRA) as the national Compliance Monitoring Authority (CMA) for compliance monitoring of the Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP). This manual is supplemented by relevant documents.

Jul 6, 2015 · The GLP Compliance Programme will help our Test Facilities gain the acceptance of their non-clinical health safety studies into OECD countries and others members who adhere to OECD, thus reducing duplicative testing and shortening time-to market for new products.

If a study/test facility has not been performed or operating in accordance with Principles of GLP and GLP CP requirements, JSM will inform the OECD Secretariat through Malaysia’s coordinator (NPRA), relevant local/international Regulatory Authority and/or foreign CMA of …

Mar 5, 2023 · The Good Laboratory Practice (GLP) Compliance Programme Manual outlines the NPRA's role as the national Compliance Monitoring Authority in Malaysia, detailing policies and procedures for GLP compliance based on OECD principles.

Featuring expert speakers from the National Pharmaceutical Regulatory Agency (NPRA), the programme equips industry professionals and academics with comprehensive knowledge and practical guidance on NPRA's registration and notification methods.

Mar 27, 2025 · To engage and coordinate with the Compliance Monitoring Authority (CMA) of National Pharmaceutical Regulatory Agency (NPRA) or surveillance inspections, test facility visits, meetings, training and many more.

To obtain GLP Certification in Malaysia, you must complete and submit a form to the NPRA. The NPRA will then observe your laboratory to ensure it meets GLP requirements. Be inspected via a GLP tracking authority.

Sep 25, 2024 · Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence (BE) studies called the "Malaysian Guideline for Bioequivalence Inspection".

Nov 4, 2022 · NPRA GLP Manual Version 4 November 2022 - Free download as PDF File (.pdf), Text File (.txt) or read online for free.