Biologics

Vaccine Lot Release

Guidelines

Document Name Updated
Guidance Document for Biological Lot Release (effective May 2025) May-2025
Guidance Document for Lot Release of Biological Products Manufactured in Malaysia Apr-2021

Application Forms

Document Name PDF MS Word Updated
Lot Release Application form for Imported Products   1 Nov 2022
Sampel Submission Application Form for Imported Products   1 Nov 2022
Vaccine/Plasma Product Arrival Report for Cold Chain Inspection   Apr-2021
Lot Release Application Form for Biological Products Manufactured in Malaysia   1 Nov 2022
Sample Submission Form for Biological Products Manufactured in Malaysia   1 Nov 2022

Directives

Document Name Updated
Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia Apr-2021
Direktif Keperluan Ujian Fizikal untuk Lot Release - Tahun 2020 May -2021
Direktif Pelaksanaan Plasma Products Lot Release - Tahun 2016 May-2021
Direktif Pelaksanaan Vaccine Lot Release - Tahun 2015 May-2021

OECD Good Laboratory Practice (GLP) Documents

(below are documents on GLP from the OECD for your quick reference:)

 

Directive on the Appointment of NPCB as the Malaysian Compliance Monitoring Authority (CMA):  [ English | Bahasa Malaysia ] 

Document Name
OOECD Principles on GLP 
Guidance for GLP Monitoring Authorities - Procedures for GLP
Guidance for the conduct Labt. Inspection and Study Audit
Quality Assurance and GLP
Compliance of Laboratory Suppliers with GLP Principles
The Application of the GLP Principles to Field Studies
The Application of the GLP Principles to Short Term Studies
The Role and Responsibilities of the study Director in GLP Studies
Guidance for the Preparation of GLP Inspection Report
The Application of the Principles of GLP to Computerised System
The Role and Responsibility of the sponsor
Requesting & Carrying Out Inspections & Study Audits in Another Country
The Application of the OECD Principles of GLP to the Organization and Management of GLP
The Application of the OECD Principles of GLP to in-vitro studies 2004
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
Guidance on the GLP Requirements for Peer Review of Histopathology
Application of GLP Principles to Computerised Systems
OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025

OECD Good Laboratory Practice (GLP) Documents

OECD Good Laboratory Practice (GLP) Documents

(below are documents on GLP from the OECD for your quick reference:) 

Directive on the Appointment of NPRA as the Malaysian Compliance Monitoring Authority (CMA):  [ English | Bahasa Malaysia ] 

Document Name
OOECD Principles on GLP 
Guidance for GLP Monitoring Authorities - Procedures for GLP
Guidance for the conduct Labt. Inspection and Study Audit
Quality Assurance and GLP
Compliance of Laboratory Suppliers with GLP Principles
The Application of the GLP Principles to Field Studies
The Application of the GLP Principles to Short Term Studies
The Role and Responsibilities of the study Director in GLP Studies
Guidance for the Preparation of GLP Inspection Report
The Application of the Principles of GLP to Computerised System
The Role and Responsibility of the sponsor
Requesting & Carrying Out Inspections & Study Audits in Another Country
The Application of the OECD Principles of GLP to the Organization and Management of GLP
The Application of the OECD Principles of GLP to in-vitro studies 2004
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
Guidance on the GLP Requirements for Peer Review of Histopathology
Application of GLP Principles to Computerised Systems
OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025

Recent Updates

Recent Updates