GMP Consultancy

Zero Hassle, Zero Risk, 100% Guaranteed Success

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Benefits of ISO 9001

100% success or 100% your money back!
Thorough analysis with a strategic plan.
We guide you from A to Z.
“Easy-to-maintain” management system.
Straightforward with minimal documentation.

Easy ISO 9001 with us:
Hassle-Free, Risk-Free, Guaranteed!

Why GMP? Who needs GMP?

Food manufacturers must meet hygiene and GMP regulations to ensure product safety. GMP serves as a foundation for higher safety management systems like HACCP and ISO 22000.

GMP for Traditional Medicines, Health Supplements and Cosmetics

The regulatory body responsible for overseeing GMP for Traditional Medicines, Health Supplements and Cosmetics in Malaysia is the National Pharmaceutical Regulatory Agency (NPRA). Manufacturers of Traditional Medicines, Health Supplements and Cosmetics are obligated to implement GMP principles as outlined by the NPRA to ensure that their products meet established standards and do not pose risks to consumers.

GMP is essential for licensing and registering products in Malaysia, ensuring compliance with regulations. It serves as a guarantee for product quality, playing a crucial role in protecting public health. This standard is applicable to manufacturers across various industries, including foods, drugs, health supplements, and pharmaceuticals.

Benefits of GMP

Enhance cleanliness of manufacturing environment
Deliver high degree of confidence to the consumers
Access to new market and meet prerequisites for some business sectors
Ensure that the organization meets legal compliance
Demonstrate commitment to produce safe and quality products

Getting Certified Easier, Faster & Hassle-free

Skip the guesswork! Our ISO consultant analyzes your business, guiding you step-by-step to ISO certification and standing out from the competition!

Here’s what you’ll get at your 100% free consultation:
  • A gap analysis where we identify the areas for meeting the ISO best practices.
  • A-Z roadmap and the steps you need to take for getting ISO-certified.
  • The fundamentals for making your business ISO-compliant.

Be quick! FREE spots are almost gone for this month!

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Trusted Across Industries

MSM Logo
JEBSEN & JESSEM
ICCL logo
tokyo chem logo
KCC logo
green building index logo
wake the crew logo
moonlight logo
mapc logo
the daily broth
today logo
Leeden gases logo
cplasa logo
kang xiang logo
hexalab logo
D Calysta logo
isabella logo
olumes
ethereal logo 1
Newgenic logo
Givaudan logo
stonbike logo
yu logo
jin ji logo
signature logo
orion phama logo
adventpac logo
staycare logo
ken logo
t & d logo
THREE60 ENERGY ASIA
SSS HYDRAULICS SDN BHD
MASTER CRAFT GROUP SDN BHD
HENGHE SA SDN BHD
MANI MEDICAL DEVICE MALAYSIA SDN BHD
LUNAR GROUP SDN BHD
KAZZUE VISION CARE
EXCEL ENVIROTECH RESOURCES SDN BHD
DODO VENTURES SDN BHD
CENTURY ASSET HOLDINGS SDN BHD
Glyness Industries
Medifusion Solution She natural lab
Miyabi Aromatic
Miracle in Food Sdn Bhd
Polobun
AX Global (Malaysia) Sdn Bhd
MedikHub Sdn Bhd
J. Arhur Healthcare
Superb Cold Chain Logistics Sdn Bhd
Y Online Optical Econmed Marketing
Biofunction Marketing (Nutrin life, duoleaf, pharma reform)
Biofunction Marketing (Nutrin life, duoleaf, pharma reform)
Pusat Latihan Memandu Cemerlang
UPT Forwarding & Transport Sdn Bhd
CN Loyal
Qpack Industries Sdn Bhd
SRF Fast Management Sdn Bhd

100% Certified
or Your Money Back!

Worried about failing your ISO Certification audit? Or concerned about hiring a consultant who leaves you hanging, requiring you to tackle everything solo?

Fear not! We guarantee your certification, or we work for free. It’s a zero-risk investment. If, despite following our guidance, you don’t pass the audit, we’ll refund 100% of your payment, no questions asked!

Flexly ISO Consulting - We make it a whole lot easier, faster and smarter!

DON'T JUST TAKE OUR WORD FOR ITTake A Look At What Our Clients Are Saying

I’m really satisfied & understand very clear in all the explanation given. Top star guidance and support from the team.
Priya RamanJebsen & Jessen Malaysia
Mr Koh had been very professional and helpful since we first engaged him with consult in GDPMD Audit.
Ashley ChenOJC Marketing Sdn Bhd
Absolutely a great pleasure to work with Koh. His company offer complete customised ISO systems for your company. Not "copy pasted" templates. What truly amazed me was I requested for fast certification due to tender requirements, he managed to get everything completed within 1 month. Highly recommend Koh to anyone looking for flexible and fast ISO certification. We will definitely be using his service again!
Dato’ Jacky Lee Director of JJ Mining Resources Sdn Bhd
Overall, I am very pleased working with Mr. Koh for getting my company ISO 9001 certified. My friend recommended him to me. Although he is young, but he is obviously very knowledgeable and his ability to develop the necessary documentation and demonstrate its professionalism assisting us to pass the audit the first time. We’re grateful for his flexibility in his consultation programme keeping the tedious paperwork and documentation to minimum level. One thing I am most happy about is my team did not complain about having more paperwork.
Ken EeDirector of Ee Osteocare & Acupunture Sdn Bhd
We have just completed our external audit with Certification Body and we have passed with no nonconformity's identified. The consultant work diligently to ensure that we have everything we need for our audit and the audit really has transformed from being a very stressful and daunting experience to hassle-free and easy process. Thank you Koh for the help.
Ms. Goh CEO of Hong Long International Group Sdn Bhd
Initially we get ISO certificate just for the sake of meeting customer requirements, apart from that, we didn’t really expect any other benefit out of this project. We didn’t really believe when we were told about how the ISO standard can help improving product quality or company processes. Everything changed after the implementation. We experience less product quality issues and reduced customer complaints. Now we do believe ISO isn’t just a piece of certification. Great job!
Chin YeeDirector of Joy & Wellness Sdn Bhd
The training provided was very thorough and the content was relevant to our industry. Can feel that the trainer did preparation and research about our industry before the training to give more training examples.
Mr. ChiaCBS Enterprise Sdn Bhd
Flexly Consulting - Don't Just Take Our Word For It
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How Can Flexly Consulting Help?

The Top 5 Must-Knows Before Applying GMP (Food) Certification

01
How can GMP practices in the food industry ensure the safety and quality of our products?
  • Strict hygiene and sanitation practices reduce the risk of contamination and foodborne illnesses.
  • Proper documentation ensures traceability of ingredients and processes, facilitating timely recalls if necessary.
  • Employee training in GMP principles ensures adherence to best practices, leading to consistent product quality.

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.

02
What is the difference between GMP and HACCP?

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

03
How does your GMP consultant team assist food companies like ours in implementing GMP?

Our comprehensive GMP implementation program includes:

  • Factory Review – to establish a GMP-compliant facility layout.
  • Development of Food Safety Management System based on GMP guidelines – including SOPs and best practices.
  • GMP Training – to train the operational team on GMP requirements
  • GMP Internal Audits – conduct an internal assessment to evaluate GMP compliance.
  • GMP Certification Audit – provide support until successful completion of GMP certification

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.

04
What specific topics and modules does your GMP training cover to equip our workforce with the necessary skills and knowledge for compliance?

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.

05
How will obtaining GMP certification with your guidance elevate our brand reputation and instill confidence in our consumers?
  • Demonstrating Commitment: GMP certification showcases your commitment to upholding the highest standards of manufacturing practices, emphasizing product safety and quality.
  • Consumer Trust: The GMP certification label on your products assures consumers that your processes adhere to industry best practices, fostering trust in your brand.
  • Competitive Edge: GMP certification differentiates your brand from competitors, positioning you as a reliable and responsible choice in the market.
  • Regulatory Compliance: GMP certification ensures compliance with food safety regulations, providing assurance to consumers and regulatory bodies alike.

The Top 7 Must-Knows Before Applying GMP (Cosmetic) Certification

01
How is GMP for Food different than GMP for Cosmetic?
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.

02
What are the steps involved to obtain GMP for my skincare and cosmetic company?
  • Factory Layout Evaluation: Assess your facility’s layout to ensure it meets GMP requirements, including proper zoning, segregation of production areas, and adequate sanitation facilities.
  • GMP Factory Layout Submission: Submit your GMP Factory Layout for approval to NPRA prior to any renovation or modification.
  • Facility Upgrade: Modify/ renovate your facility to meet GMP requirement
  • Establishment of Quality Management System: Develop comprehensive SOPs outlining precise manufacturing procedures, quality control measures, and hygiene protocols.
  • Submission of Application for GMP Inspection: Apply for a pre-licensing / initial inspection/ pre-approval inspection through the QUEST system
  • NPRA Inspection: NPRA conducts an on-site inspection of your facility to verify compliance with GMP standards.
  • Approval and Certification: Upon successful evaluation and inspection, NPRA will grant GMP certification
03
What factors might lead to the failure of GMP inspection conducted by NPRA?

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.

04
What are the costs involved in applying GMP cosmetic?
  • Submission of GMP Layout to NPRA: RM 1000 processing fee for layout approval.
  • Facility Renovation: Vary based on the size and complexity of your factory
  • NPRA Inspection: RM 1000 for a one-day inspection.
  • GMP Consultation Fee: Determined by the size and complexity of your factory. Contact us to find out more https://flexlyconsulting.com/contact-us/
  • Product Testing: Costs for Microbiological Testing, Stability Testing, Heavy Metal Testing etc.
05
What are the infrastructure and facility requirements for a GMP-compliant cosmetic manufacturing facility?

Key requirements include:

  1. Clean and Controlled Environment: proper ventilation, air filtration, and controlled temperature and humidity.
  2. Hygienic Flooring and Walls: easy-to-clean materials for walls and flooring
  3. Separation of Areas: Segregate production, packaging, storage, and quality control areas
  4. Equipment and Utensils: Suitable equipment and utensils that are resistant to corrosion and easy to clean
  5. Water Quality: High-quality water for product formulation
  6. Quality Control Laboratories: Equipped with necessary instruments for testing and analysis of raw materials, in-process products, and finished cosmetics.
  7. Personnel Hygiene: Implement strict hygiene practices by allocating hand-washing area, changing room, air shower etc.
06
What are the specific GMP requirements and regulations for cosmetics manufacturing?

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.

07
Why is GMP required for cosmetic manufacturer in Malaysia?

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.

The Top 5 Must-Knows Before Applying GMP (Health Supplements) Certification

01
What is GMP (Health Supplements)? How is that different than the GMP (Cosmetic)

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)

02
How do I apply for GMP certification for my health supplement manufacturing facility?
  • Factory Layout Evaluation: Assess your facility’s layout to ensure it meets GMP requirements, including proper zoning, segregation of production areas, and adequate sanitation facilities.
  • GMP Factory Layout Submission: Submit your GMP Factory Layout for approval to NPRA prior to any renovation or modification.
  • Facility Upgrade: Modify/ renovate your facility to meet GMP requirement
  • Establishment of Quality Management System: Develop comprehensive SOPs outlining precise manufacturing procedures, quality control measures, and hygiene protocols.
  • Submission of Application for GMP Inspection: Apply for a GMP inspection
  • NPRA Inspection: NPRA conducts an on-site inspection of your facility to verify compliance with GMP standards.
  • Approval and Certification: Upon successful evaluation and inspection, NPRA will grant GMP certification.
03
What are the key elements of a GMP-compliant manufacturing facility for health supplements?

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

04
How often are GMP inspections conducted for health supplement facilities?

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.

05
How much time is needed to achieve GMP compliance for health supplements?

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.

No risks, only results and simplified! We assure 100% success or work for FREE

Say goodbye to uncertainties and trust us to guide you seamlessly through the ISO certification experience.
Your success is not just a goal, it’s our promise.

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Need Certification Fast?

Many small-medium businesses need quick certification to hit deadlines for proposal submittal, government contracts, and other urgent needs. We pride ourselves on our ability to meet your goals.
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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.

01
Who is HRD Corp?

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).

02
Who is eligible to attend training using the HRDCORP / HRDF fund?

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.

How Can Flexly Consulting Help?