- Quality
- Food
- Medical
GMP consultant in Malaysia for GMP certification
GMP certification in Malaysia for pharmaceutical, food and medical device manufacturers. Meet regulatory requirements with expert quality system guidance.
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- 17+ yearsexperienceconsultancy experience
- HRD Corpclaimableclaimable training
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Standard overview
About GMP
Good manufacturing practice (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
Business value
Key benefits
- Ensure product quality and safety.
- Meet mandatory regulatory requirements.
- Reduce risks of contamination and errors.
- Maintain consistent production standards.
Who needs this?
Pharmaceutical companies, food manufacturers, medical device companies, and organisations involved in the production of regulated products.
Certification, training and compliance requirements vary by tender, buyer and regulator. We confirm what applies to you during the free consultation.
How we support you
A clear path from questions to readiness
Assess your starting point
Gap analysis against the requirements, scope confirmed and a realistic roadmap agreed.
Build the required system
Documentation, processes and records developed around how your organisation actually works.
Prepare your team
Role-based training, internal audits and corrective action so evidence is complete.
Prepare for review
Management review and support through the certification body’s audit.
How we work with you
The right consultant for your GMP project
We match every project to an experienced consultant who knows your industry, and the same consultant stays with you until you’re certified.
- Matched to your industryWe pair you with a consultant who understands your industry and the standard you’re working towards.
- Experienced with the standardYour consultant knows the requirements in detail and what auditors look for, and prepares your team for the certification audit.
- One consultant, start to finishThe same person handles your gap analysis, documentation, internal audit and certification audit.
“DR ISO audit was a great experience. The audit team was professional, supportive, and highly skilled. Their structured approach, clear explanations, and constructive recommendations helped us validate our processes and identify meaningful opportunities for improvement”
Common questions
Before you enquire
How long does GMP take?
It depends on your organisation’s size, scope and current readiness. After the gap analysis we give you a realistic timeline for your situation.
What support is included for GMP?
For GMP, the main focus areas are premises, hygiene, and contamination controls, material and production controls, documented procedures and records, quality control and product release and deviations, corrective action, complaints, and recalls. Support is tailored to where you are now and can include a gap analysis, documentation, implementation, staff training, internal audits and preparation for the certification audit.
Is GMP HRD Corp claimable?
DR ISO Malaysia is an HRD Corp registered training provider, so the training in your project can be claimable for eligible employers. We confirm the programme details and supporting documents during your consultation.
Does GMP include a money-back guarantee?
Yes. The conditions are explained to you before you start and written into the agreement you sign, so you know exactly what is covered.
Explore further
Often combined with GMP
Get clear guidance on your GMP scope.
Book a free consultation or WhatsApp us. We reply within 24 hours.