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How to Get GMP Certification in Malaysia

By April 7, 2025No Comments

How to Get GMP Certification in Malaysia?

Good Manufacturing Practice (GMP) certification ensures that food, pharmaceuticals, and cosmetics are consistently produced and controlled according to quality standards. In Malaysia, GMP certification is essential for businesses aiming to comply with local and international safety regulations.

Steps to Obtain GMP Certification in Malaysia

1. Understand GMP Requirements

  • GMP guidelines are regulated by Malaysia’s Ministry of Health (MOH) and the National Pharmaceutical Regulatory Agency (NPRA).
  • The certification ensures compliance with hygiene, production processes, and quality control standards.

2. Identify Your Industry Category

  • Food Industry – Regulated under the Food Safety and Quality Division (FSQD).
  • Pharmaceuticals & Health Supplements – Overseen by NPRA Malaysia.
  • Cosmetics & Personal Care – Compliance with GMP ASEAN Cosmetic Directive.

3. Prepare GMP Documentation

  • Develop a GMP-compliant Quality Management System (QMS).
  • Prepare Standard Operating Procedures (SOPs) for production, hygiene, and quality control.
  • Maintain records of ingredient sourcing, manufacturing, and storage conditions.

4. Conduct Internal Audits & Gap Analysis

  • Perform an internal audit to assess GMP readiness.
  • Identify gaps in current practices and implement corrective actions.
  • Engage a GMP consultant for expert guidance.

5. Employee Training

  • Train staff on GMP principles, hygiene practices, and SOPs.
  • Ensure ongoing compliance with food safety and quality assurance.

6. Apply for GMP Certification

  • Submit an application to the MOH, NPRA, or other relevant authorities.
  • Provide required documents, including facility layout, production records, and hygiene plans.

7. Undergo GMP Inspection & Audit

  • Regulatory bodies will conduct an on-site inspection of your manufacturing facility.
  • Auditors evaluate cleanliness, equipment, documentation, and quality controls.
  • Address any non-conformities before final approval.

8. Receive GMP Certification

  • If the facility meets all GMP standards, a GMP Certificate is issued.
  • Certification is valid for a specific period and requires renewal and ongoing compliance.

Benefits of GMP Certification

✔ Ensures product safety and quality for consumers.
✔ Increases market access to local and international buyers.
✔ Compliance with Malaysian regulatory requirements.
✔ Enhances brand reputation and customer trust.
✔ Facilitates export opportunities to global markets.

Cost & Duration of GMP Certification in Malaysia

  • Cost: Varies based on industry, facility size, and consultant fees.
  • Timeframe: Typically 3 to 6 months, depending on facility readiness.

Conclusion

GMP certification in Malaysia is a critical step for businesses in food, pharmaceutical, and cosmetic industries. By following the required steps, maintaining proper documentation, and undergoing audits, companies can achieve GMP compliance and gain a competitive edge in the market.

Need help with GMP certification? Contact us today for expert guidance!

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