GMP for Food
Good Manufacturing Practice (GMP) contains requirements for food safety and hygiene adopted by food processing businesses to ensure the final products are suitable for human consumption. In Malaysia, MS 1514:2009 GMP is the requirement standards defined by Ministry of Health Section of Food Safety & Quality Division which aim to elevate the level of standards of domestic food manufacturer. GMP guidelines cover the manufacturing activities from receiving of incoming raw materials till the delivery of goods to customers.
GMP for Traditional Medicines, Health Supplements and Cosmetic
GMP system is used to ensure that traditional medicines, health supplements and cosmetic products are consistently produced and controlled in accordance with quality standards. GMP aims to minimize the risks involved in any production that cannot be eliminated through the final product test. In Malaysia, NPRA (National Pharmaceutical Regulatory Agency) will govern the manufacturing activities of traditional medicines, health supplements and cosmetic products.
GMP for Food
Food manufacturers must fulfill regulatory requirements related to hygiene and good manufacturing practices to market their products as safe successfully. GMP also serve as foundation and pre-requisite program (PRP) towards higher food safety management systems like such as HACCP and ISO 22000.
GMP for Traditional Medicines, Health Supplements and Cosmetics
GMP is a pre-requisite for the application of a manufacturing license as well as product registration under the categories of Traditional Medicines, Health Supplement and Cosmetics in Malaysia.
All products shall be registered under NPRA (National Pharmaceutical Regulatory Agency) or notified to NPRA in accordance to the Controls of Drugs and Cosmetics Regulation 1984. Also, by implementing GMP, manufacturers are able ensure that the quality requirements of all products are met and consistently maintained in order to protect public health.
GMP is suitable for manufacturers, processors, and packagers of foods, drugs, health supplements pharmaceutical, etc.
GMP for Food
Food manufacturers must fulfill regulatory requirements related to hygiene and good manufacturing practices to market their products as safe successfully. GMP also serve as foundation and pre-requisite program (PRP) towards higher food safety management systems like such as HACCP and ISO 22000.
GMP for Traditional Medicines, Health Supplements and Cosmetics
GMP is a pre-requisite for the application of a manufacturing license as well as product registration under the categories of Traditional Medicines, Health Supplement and Cosmetics in Malaysia.
All products shall be registered under NPRA (National Pharmaceutical Regulatory Agency) or notified to NPRA in accordance to the Controls of Drugs and Cosmetics Regulation 1984. Also, by implementing GMP, manufacturers are able ensure that the quality requirements of all products are met and consistently maintained in order to protect public health.
GMP is suitable for manufacturers, processors, and packagers of foods, drugs, health supplements pharmaceutical, etc.
Identify the gaps within your company’s current Management System in order to fulfil the best practices set by the international standards.
We believe every business is unique, we customise and deliver our consultation programme according to your business needs (And most importantly, we don’t just hand over the templates to you and let you survive on your own 😉)
Assist in developing a straight
forward and “easy-to-maintain” management system with minimal documentation.
Provide training and step-by-step guidance to your company personnel in, not just implementing the system, but even maintaining it after getting certified.
We review the compliance of your actual activities to GMP requirements and company records prior to your certification body audit.
Provide assistance and advice on preparation and external audit by your certification body.
Compliance with GMP regulations builds consumer trust and confidence in your products, contributing to your brand’s reputation and long-term success in the competitive food market.
GMP and HACCP are both essential food safety systems, but they serve different purposes. GMP focuses on overall manufacturing practices, ensuring quality, safety, and consistency in the food industry. It covers various aspects such as facility cleanliness, employee hygiene, and documentation.
On the other hand, HACCP is a systematic approach that targets critical control points in the production process to identify, assess, and control hazards related to food safety. It specifically addresses potential risks to prevent food safety issues.
GMP serves as a prerequisite for HACCP, and while GMP establishes essential manufacturing practices, HACCP represents a more advanced and comprehensive food safety program
Our comprehensive GMP implementation program includes:
Our step-by-step approach ensures your food company is well-prepared and successfully implements GMP practices, promoting safety, quality, and regulatory compliance in your operations.
Our GMP training includes an introduction to GMP principles, personal hygiene, facility and equipment maintenance, raw material handling, SOP development, documentation, quality control, contamination control, and personnel training.
Through the GMP training, we ensure that your team is well-prepared to uphold GMP standards, fostering a culture of food safety and quality within your organization.
Aspect | GMP (Food) | GMP (Cosmetic) |
Scope | Manufacturing, processing, and handling of food products for human consumption | Formulation, manufacturing, and packaging of cosmetic products for skin and hair applications |
Ingredients | Emphasis on food-grade ingredients, proper cooking, and processing methods | Focus on cosmetic ingredients, formulation, and stability |
Labelling and Claims | Accurate ingredient labelling, nutritional information, allergen warnings | Labeling accuracy, ingredient listing, prohibition of false/misleading claims |
Regulatory Oversight | Regulated by Ministry of Health Malaysia (MOH) and Malaysian Food Safety Standards | Regulated by National Pharmaceutical Regulatory Agency (NPRA) under MOH |
Certification Body | MOH and private accredited certification bodies | NPRA only |
Applicable to | Food manufacturers, processors, distributors, retailers, hotels & restaurants, central kitchens, logistics providers etc. | Cosmetic & skincare manufacturers
Examples of products: Moisturizers, Shampoos, Lipsticks, Sunscreen, Foundation, Perfumes, Eye Shadows, Nail Polish, Facial Cleansers, Bar Soaps, Face Masks etc. |
Common reasons include inadequate documentation and record-keeping, non-compliance with GMP guidelines, improper facility layout, use of improper renovation materials for flooring, walls, ceiling, and other facility components, insufficient quality control measures, lack of employee training, and failure to implement corrective and preventive actions following previous inspections or audits.
Key requirements include:
GMP requirements for cosmetics manufacturing cover personnel hygiene, rigorous documentation, facility maintenance, production control, stringent quality control, precise labeling, batch traceability, effective sanitation, and more.
In Malaysia, GMP (Good Manufacturing Practices) serves as a mandatory license for cosmetic manufacturers. Without GMP, it can be considered illegal manufacturing. Additionally, GMP is a prerequisite for notifying cosmetic products before they are placed in the market.
Aspect |
GMP (Health Supplements) |
GMP (Cosmetic) |
Scope |
Dietary supplements, vitamins, minerals |
Skincare, haircare, personal care products |
Emphasis |
Purity, potency, accurate labeling |
Ingredient safety, formulation, labeling accuracy |
Product Types |
Health supplements, capsules, powders |
Creams, lotions, makeup, toiletries |
Regulatory Focus |
Health benefits, nutritional content |
Ingredient safety, product efficacy, consumer use |
Quality Control |
Product testing, potency verification |
Stability testing, safety assessments |
Consumer Use Considerations |
Dosage instructions, health effects |
Usage instructions, skin compatibility |
NPRA Guidelines |
Guidelines on GMP for Traditional Medicine and Health Supplements (First Edition, 2008) |
Guidelines for Control of Cosmetic Products in Malaysia (Second Edition, 2022) |
Regulatory Oversight |
Regulated by National Pharmaceutical Regulatory Agency (NPRA) |
A GMP-compliant health supplement manufacturing facility integrates key elements such as a well-designed layout for efficient workflow, stringent hygiene practices, calibrated equipment, controlled raw materials, documented processes, rigorous quality testing, transparent documentation, batch traceability, accurate labeling, quality assurance checks, and ongoing personnel training
All manufacturers will be inspected routinely. The frequency for inspection is determined according to the risk level of the product manufactured, as well as the latest GMP compliance rating.
It typically spans a few months to over a year, contingent on factors like facility status, process intricacies, and quality control readiness. This entails activities such as facility assessment, procedure establishment, equipment calibration, quality control integration, staff training, and comprehensive documentation. Engaging knowledgeable GMP consultants can expedite the process, ensuring a well-paced journey towards GMP compliance within a feasible timeframe.
100% HRD Corp Claimable.
No Upfront Payment Required.
We are a registered HRD Corp training provider, all of our certification training is claimable under HRD Corp SBL Khas scheme.
Human Resource Development Corporation (HRDCORP), or previously known as Human Resource Development Fund (HRDF) is an agency under the purview of the Ministry of Human Resources Malaysia governed by the Pembangunan Sumber Manusia Berhad Act 2001 (PSMB Act 2001).
All registered employers with HRDF and have paid the levy for the first month of registration are liable to apply for the training grant, subjected to the existing rate of financial assistance and terms and conditions.