Guidelines - GMP
Guidance Document Foreign GMP Inspection, 10th Edition
Document Name Download Updated Guidance Document Foreign GMP Inspection, 10th Edition DOWNLOAD December - 2025
Document attached
Content category
Guidelines - GMP
16 records
2025
Guidelines - GMP
OBSOLETE_ Good Tissue Practice Guideline
Document Name Download Updated OBSOLETE_Good Tissue Practice Guideline DOWNLOAD October - 2025
Document attached
Guidelines - GMP
Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025
Document Name Download Updated Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025 DOWNLOAD May - 2025
Document attached
Guidelines - GMP
Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products (3rd Edition, March 2025)
Guidance Document Updated Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products (3rd Edition) March 2025 Garis Panduan Permohonan Lesen Pengilang, Lesen…
Document attached
2024
Guidelines - GMP
Garis Panduan Penilaian Kesetaraan Taraf Amalan Perkilangan Baik (APB) Pengilang TMHS Luar Negara, Edisi Pertama, September 2024
Garis panduan ini diwujudkan sebagai panduan untuk pemegang pendaftaran produk (Product Registration Holder, PRH) mengisi GMP Guide Equivalency Form dengan lengkap semasa permohonan penyenaraian…
Document attached
Guidelines - GMP
Garis Panduan Persediaan Pemeriksaan APB Bagi Pengilang Pengilang Tradisional, Suplemen Kesihatan dan Kosmetik, Edisi Keempat, Jun 2024
Berkuatkuasa 1 Jun 2024, dokumen berikut perlu dimuat naik ke dalam sistem QUEST semasa permohonan pemeriksaan awal/ pra-pelesenan/ pra-kelulusan APB: 1. Fail Induk Pengilang terkini 2. Surat…
Document attached
Guidelines - GMP
Guidance Document For Preparation of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements and Cosmetics Manufacturers, Fourth Edition, June 2024
Effective 1st June 2024, the following documents need to be uploaded into the QUEST system during the application of initial / pre-licensing/ pre-approval GMP inspection: 1. Latest Site Master File…
Document attached
2023
Guidelines - GMP
Site Master File Third Edition 2014
Document Name Download Updated Site Master File Third Edition 2014 DOWNLOAD Jan-2014
Document attached
2022
Guidelines - GMP
Guidance Document Product Quality Review (PQR) for Traditional Medicines & Health Supplements Manufacturers
Document Name Download Updated Guidance Document Product Quality Review (PQR) for Traditional Medicines & Health Supplements Manufacturers DOWNLOAD August - 2022
Document attached
2021
Guidelines - GMP
Guidance Document GMP Inspection on Medicinal Gases Manufacturers
Title Date Guidance-Document-GMP Inspection on Medicinal Gases Manufacturers-in Malaysia_Aug-2021_ August 2021
Document attached
2020
Guidelines - GMP
Guidance Document on Verification of Translated Official Document
Document Name Download Updated Guidance Document on Verification of Translated Official Document DOWNLOAD Dec-2021
Document attached
2018
Guidelines - GMP
Cold Chain Inspection
National Pharmaceutical Regulatory Division (NPRA) has implemented Cold Chain Inspection (CCI) to be carried out on each lot of registered vaccine or plasma product that is imported to Malaysia since…
Document attached
Guidelines - GMP
Garis Panduan Pemeriksaan Amalan Perkilangan Baik (APB) bagi Premis Pengilang Produk Veterinar Berdaftar
Document Name Download Updated Garis Panduan Pemeriksaan Amalan Perkilangan Baik (APB) bagi Premis Pengilang Produk Veterinar Berdaftar DOWNLOAD July-2018
Document attached
Guidelines - GMP
Guideline on Good Distribution Practice (Third Edition, 2018)
Document Name Download Updated Guideline on Good Distribution Practice (Third Edition, 2018) DOWNLOAD Jan-2018
Document attached
2015
Guidelines - GMP
Guidance Note for Cell and Gene Therapy Products (CGTPs) Manufacturing Facility in Malaysia
Document Name Download Updated Guidance Note for Cell and Gene Therapy Products (CGTPs) Manufacturing Facility in Malaysia DOWNLOAD Jul-2021
Document attached
2008
Guidelines - GMP
Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements
Document Name Download Updated Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements DOWNLOAD Jan-2008
Document attached