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Guidance Document for Preparation of Good Manufacturing Practice (GMP) Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
Local Title:
GARIS PANDUAN PERSEDIAAN PEMERIKSAAN AMALAN PERKILANGAN BAIK (APB) BAGI PENGILANG PRODUK TRADISIONAL, SUPLEMEN KESIHATAN DAN KOSMETIK
Country/Region:
Malaysia
Competent Authority:
National Pharmaceutical Regulatory Agency
Type:
Regulation
Status:
Invalid
Release Date:
2021-08-04
Implementation Date:
2021-08-04
Document
Language Source Title Access
EN
 Official Guidance Document for Preparation of Good Manufacturing Practice (GMP) Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
Download
EN
 Official Guidance Document for Preparation of Good Manufacturing Practice (GMP) Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
Download
Summary

On Aug. 4, 2021, Malaysia NPRA implemented this guidance document which specifies the requirements and procedures for new cosmetic local manufacturers to apply for a pre-licensing, initial inspection or pre-approval inspection for existing manufacturers.

Main Content

  • Introduction

  • Purpose & Scope

  • Guidelines

  • Objective of Initial / Pre-licensing / Pre-approval Inspection

  • Regulatory Process Description

  • Rejection, Termination or Withdrawal of Inspection

  • Other Information

  • Abbreviations

  • Appendix 1: Pre-inspection Checklist: Initial / Pre-licensing / Pre-approval Inspection

History
2024-05-31
Guidance Document for Preparation of Good Manufacturing Practice (GMP) Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
In force
Release Date: 2024-05-31
Implementation Date : 2024-06-01
2021-08-04
Guidance Document for Preparation of Good Manufacturing Practice (GMP) Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
Invalid
Release Date: 2021-08-04
Implementation Date : 2021-08-04
2020-07-01
Guidance Document for Preparation of Good Manufacturing Practice (GMP) Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
Invalid
Release Date: 2020-07-01
Implementation Date : 2020-07-01
Noteworthy Information
User Guide