Biologics

Plasma Product Lot Release

Guidelines

Document Name Updated
Slides Pembentangan Pilot Study Interim Report for Plasma Product Lot Release in Malaysia 14-Jun-16
Guidance Document for Plasma Product Lot Release in Malaysia 2nd edition 1 Dec 2016 Dec-16
Slides Pembentangan Taklimat PPLR 31 Julai 2015 31-Jul-15
Slides Pembentangan Taklimat Cold Chain 31 Julai 2015 31-Jul-15
Guidance Document for Biological Lot Release (effective 1st January 2020) 13-Nov 2019
Slide-1 Pembentangan Taklimat Extension of Lot Release Activities 12 Nov 2019 13-Nov 2019
Slide-2 Pembentangan Taklimat Extension of Lot Release Activities 12 Nov 2019 13-Nov 2019
Guidance Document for Lot Release of Biological Products Manufactured in Malaysia Apr-2021

Application Forms

Document Name PDF MS Word Updated
Application Form Plasma Products Lot Release version 2 Nov-2016
Lot Release Application form (New)   Nov-2019
Sampel Submission Application Form (New)   Nov-2019
Lot Release Application Form for Biological Products Manufactured in Malaysia Apr-2021
Sample Submission Form for Biological Products Manufactured in Malaysia Apr-2021

Directives

Document Name Upated
Direktif untuk Pelaksanaan Plasma Products Lot Release ke atas Semua Produk Plasma yang Berdaftar di Malaysia 29-Jun-16
Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia Apr-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