A Full Guide To GMP Certification For Food In Malaysia (MS 1514)

In Malaysia, Good Manufacturing Practice (GMP) certification by the Ministry of Health (MOH) acknowledges a food manufacturing premises can ensure their products are consistently produced according to standards as set out in MS 1514. 

While not mandatory by law, it is effectively a requirement for food manufacturers who want to be competitive domestically and internationally, and below, we break down everything businesses need to know to handle their own application.

Here’s how we’ve broken it down:

• certification fees
• eligibility requirements
• your GMP manual
• steps in the application process
• the various audits to prepare for
• addressing non-conformities
• validity periods and renewals
• a brief note on the MeSTI-GMP-HACCP link

Of course, you’re welcome to skip the guide and get in touch for help!

Otherwise, let’s begin.

Certification fees

MOH uses a tiered fee structure based on industry size for GMP certification:

Size	Criteria	New GMP Application Fee
Big Industry (BI)	>150 workers and annual turnover >RM25 million	RM4,700
Small & Medium Industry (SMI)	5 – 150 workers and annual turnover RM250,000 – RM25 million	RM3,500
Micro-enterprise	<5 workers and annual turnover <RM250,000	RM2,300

Payments are strictly non-refundable even if your application is rejected or canceled, so make sure you lay all the groundwork before submitting it!

Eligibility requirements

To begin with, your facility must fulfill the following:

• the premises must be registered as a food premise with FoSIM
• valid registration with SSM
• valid PBT composite license
• audited accounts or recent bank statements (for companies less than one year old)
• MOH ice preparation license (if applicable)
• MOH packaged drinking water / natural mineral water license (if applicable) 

However, the most crucial requirement – and the hardest to meet – is that your premises must fully implement the GMP system for a minimum of three months prior to application.

This must be proven with maintained records that show corrective actions during this period so that by the time you apply, your facility is already able to identify, document, and fix issues before they reach the consumer.

All that you have learned and put into practice should be documented in your GMP Manual.

Your GMP Manual

The GMP Manual is how you turn MS 1514 standards into facility-specific protocols – just as no two facilities are alike, no two GMP Manuals are the same either, but all comply with GMP requirements just the same. 

Per MOH requirements, your manual must include 11 mandatory sections:

1. Background: Must provide a comprehensive company profile and detailed plant layouts.
2. Design and Facilities: Must detail location and equipment layouts to prevent cross-contamination and ensure hygienic flow.
3. Control of Operations: Must demonstrate rigorous control over hazards, incoming materials, and water quality.
4. Maintenance, Cleaning, and Sanitation: Must outline scheduled programs for pest control and waste management.
5. Personal Hygiene: Must establish strict standards for staff health, cleanliness, and visitor access.
6. Training: Must document awareness programs to ensure all personnel understand their hygiene responsibilities.
7. Product Information and Traceability: Must define lot identification and specific recall procedures.
8. Transportation: Must specify conditions required to maintain food safety during transit.
9. Internal Inspection: Must detail protocols for self-inspection and internal audits.
10. Management Review: Must prove that executive leadership regularly audits the system for effectiveness.
11. Documentation and Records: Must standardize how all safety data is captured and archived.

This requires understanding MS 1514 requirements, your facility, making necessary changes, and documenting procedures. It’s not something you should rush, or you will spend more time addressing MOH concerns later on.

This document must be formally signed and dated by management with executive responsibility to signify top-down accountability, and is a key supporting document during the application submission.

Application steps

An application for GMP certification has six main steps.

Two of them are time sensitive, so if you see a time frame, it means you need to follow it or risk automatic cancellation!

Step	Stage	Description
1	Online Registration	Log into the FoSIM portal and register the premises.
2	Submission Protocols	Submit the online form together with the mandatory supporting documents, including SSM documents, licensing documents, audited accounts, and the GMP Manual.
3	Completeness Check	MOH reviews the submission. Time frame: Submit required amendments within 14 working days of notification to avoid cancellation.
4	Make Payment	Upon approval of documents, MOH issues a quotation. Time frame: Payment for certification fees and auditor expenditures must be made within 1 month.
5	Auditor Appointment	MOH appoints at least two auditors to conduct audits.
6	Committee Evaluation	Following the audit, the final report is reviewed by a formal Committee which determines the application’s approval.

There are two audits you will need to pass between Steps 5 and 6 in this process.

Adequacy audit

Your submitted GMP Manual is reviewed to check it against MOH requirements. The  lead auditor collates the team’s comments and sends them to you. You must respond to those comments before or during the on-site audit.

On-site audit

This is a physical, on-site inspection of your manufacturing premises where the two auditors will visit your premises to verify that the protocols documented in your GMP Manual are actually being practiced. 

The lead auditor then submits the report to the Committee for final approval and certificate granting – or more likely, to highlight issues!

Addressing non-conformities

No matter how carefully you try to follow GMP requirements, chances are that auditors will identify areas that need improvement and report them to the MOH Committee, which will then notify you through Corrective Action Requests (CARs).

These range from minor to major, each with its own required response timeframe:

• within 2 weeks: respond to the CARs following the on-site audit.
• within 2 weeks: serious non-conformities must be satisfactorily corrected and closed.
• within 1 year: new applications must resolve and close all other CARs.
• within 6 months: renewal and surveillance applications must resolve and close all CARs.

You make the changes as needed, and a follow-up audit or document verification will then be conducted to confirm the corrective actions have been implemented.

If the follow-audits reveal no further issues the committee should issue your GMP certificate, which will be valid for three years – woohoo!

Surveillance audit

Once certified, GMP-certified premises must pay for a mandatory surveillance audit to verify that GMP systems continue to be properly implemented and maintained. The fee is a flat RM1,600 across all three industry sizes and must be conducted at least once during the certificate’s validity period.

Validity and renewal

This kind of falls outside the scope of this guide, but we’ll touch on it briefly – renewals must be applied for six months before expiry or it must be made as a new application.

The fees are as follows:

• Big Industry (BI): RM3,500
• Small & Medium Industry (SMI): RM2,600
• Micro-enterprise: RM1,800

Since your GMP Manual was already approved during your initial certification, a renewal goes straight to the on-site renewal audit where auditors inspect your active processing lines to ensure your physical practices still match your manual.

The GMP – MeSTI – HACCP link

Let’s start this section by establishing what these three food quality assurance standards mean:

1. MeSTI is the entry-level
2. GMP is the mid-tier standard
3. HACCP is the most demanding

Because of this, GMP certification gets you MeSTI automatically, while HACCP certification gets you both GMP and MeSTI automatically, with the same application. 

However, a HACCP application requires you to have GMP controls already in place at your premises, documented and genuinely practised – your GMP system and manual are part of what the auditors assess.

So our advice is to apply for the highest certification you ultimately need. If that’s HACCP, implement GMP properly then apply for HACCP directly. 

That’s all from us, and we wish you all the best with your certification application 😊

Let MISHU assist your GMP certification application

Directly and through our partners, MISHU regularly assists food operations in Malaysia with applying for various licenses from district and federal agencies. Speak to us today if you’d like help getting your food manufacturing business GMP-certified!