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- Event Company Management, Organiser & Planner in Malaysia
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- JAKIM HALAL CERTIFICATION & CONSULTANCY IN MALAYSIA
- MUI & BPJPH Halal Certification in Indonesia
- BPOM in Indonesia for Foreign Companies
- HACCP, GMP & MESTI Certification in Malaysia
- Malaysian Good Agricultural Practices (MyGAP / GAP) Certification
- NPRA(National Pharmaceutical Regulatory Agency) Product Registration Services
If you are planning to offer food & beverages, pharmaceuticals, etc. for your product in Malaysia, then you will need to apply for HACCP, MESTI as well as GMP certification for your business. You can know more about the standard and guidelines, training and course which you need to attend, audit, compliance, food safety management system, and hygiene, system, principles, and plan, hazard analysis critical control point, and more. Most companies will engage a consultant or an agency to help them apply for these certifications from the start to finish.
HACCP in Malaysia
HACCP (Hazard Analysis and Critical Control Point) is a management system that addresses food safety issues through the analysis and control of biological, chemical, physical hazards and more.
In the ready-made food sector, Hazard Analysis and Critical Control Point ( HACCP) is extremely significant. And until it is consumed, the food produced should not be spoilt for a long time.
Degradation occurs to contaminants such as Clostridium botulinum generated by harmful microbes. While eating foods infected with these toxins can induce minor side effects such as diarrhea and vomiting and based on the intensity of the toxin, it can also result in severe liver injury and destruction.
Techniques that keep food in an oxygen-free form at this level, such as vacuuming, minimize the number of bacteria that cause wastage, but will not offer a comprehensive solution because, in an oxygen-free environment, bacterial pathogens can thrive. That is why there are strict regulations in the food production and preserve industry including their shipment to the final destinations and end-users both applied in a global context as well as by local authorities.
What is HACCP Certification?
As far as food safety is concerned, each country has legislation on microbiological requirements contained in its codex for the production of food. Other food safety evaluation frameworks that are globally recognized are also used. HACCP is one of these frameworks. Let us look at what this process is with a closer look.
HACCP is a strategy adopted for the first time in the 1960s to manufacture "zero malfunction" items for the US Army and NASA. It has been used by the FDA (US Food and Drug Administration) for authorized investigations since the 1970s.
It is a framework focused on the identification of hazardous situations from manufacturing to food distribution and the avoidance of these hazards in the process. Food safety vulnerabilities can be exemplified as chemical, physical, and microbiological dangers, which are aspects that occur from manufacturing to distribution and from distribution to consumption in any setting.
HACCP is a system for food safety that sets out the hygiene standards required for the development of healthy food products, satisfies these requirements, points out the factors that can place the customer's health at risk, and is focused on the removal of those reasons. As a globally applicable method valid for the management of diseases caused by different foods.
MS 1480:2019 Food Safety as per the HACCP System
In Malaysia, the Department of Standards released the Malaysian Standard MS 1480 to define health and safety criteria for foods under the Hazard Analysis and Critical Control Point (HACCP) framework to guarantee food safety and hygiene during planning, processing, producing, packing, storage, transportation, delivery, treating or offering for sale or procurement in any food industry business. The standards of HACCP define food safety framework specifications where a food industry company needs to show its capacity to track food safety risks to guarantee that food is healthy when it is consumed by customers. On 3 January 2019, the second version of MS 1480:2019 Food Safety According to Hazard Analysis and Critical Control Point (HACCP) System was released. It cancels this norm and replaces MS 1480:2007.
Seven Principles of HACCP System
There are 7 fundamental concepts of the HACCP framework. These concepts must not be implemented independently, though. This must be based on another framework for food protection. If we examine in more depth at these principles, details are provided below.
- Hazard Analysis Management
Hazards that may occur during the manufacture or preparation of products are defined by this theory. This idea involves listing the systems by which the nutrition is going to move and the potential hazards which may arise. At this stage, the formed HACCP team must concentrate on ways to remove hazards.
- Determination of Critical Control Points
The HACCP team establishes the control points at this stage that could generate possible dangers. To evaluate the control points, the HACCP decision-making scheme is used.
- Determination of Critical Limits
- In this, it is important to know the maximum and minimum values for the chemical, biological or physical effects to be recorded following the observations to be rendered at the control points. At each inspection, assessments have to be created. It is necessary, hence, to decide the limitations.
- Critical Control Points Monitoring
Queries including how to take specimens from control points, which techniques will be evaluated, who are responsible to take specimens from the HACCP team, or how often the samples should be taken will be defined in this step.
- Corrective action assessment
Step 5 sets out the measures to be followed in the event of an incident preventing the safe processing of food or the application of the HACCP system.
Here, all measures taken are reviewed in compliance with HACCP. The configurations of the devices used are included in these measures. This move is commonly conducted by the audit team assembled within the HACCP team.
- Holding Notes and Records
All HACCP processes, specimens, effects, control points, and limitations are documented under this principle. In this manner, both the sustainability of the quality of food is assured and new workers are managed.
Application of HACCP
How does the process work?
Programs for pre-requirement: All the requirements and practices are needed for a healthy and safe product to be produced.
Food hygiene is offered as a result of the implementation by food companies of pre-requisite policies and procedures focused on HACCP principles.
Prerequisite services offer the organization the ability to adopt HACCP successfully and therefore should be introduced before developing HACCP practices.
Key programs and measures of Pre-Requirement:
- Development of buildings and environmental conditions
- Device and equipment specifications for facilities
- Requirements of raw material
- Requirements of raw material
- Treatment and sanitation
- Controls over raw materials
- Secure food handling (including packaging and transport)
- Cold storage protection
- Hygiene for staff and training
- Health status of workers
- Food waste sorting
- Systems to control pests
- Garbage and management of drainage
- Standard of water
- Procedures for surveillance and recall
- Procedures for pest control
- Regulation of operations
Benefits of HACCP Certification in Malaysia
The qualifications and attributes obtained by the enterprise with the successful HACCP are as follows:
- Increases client trust
- Ensures that the customers are confident that the items they buy as food are safe and stable
- Act according to the concept of preventive approach and avoids damage, restructure, and product recalls
- Increases the quality of the product by monitoring critical points that can endanger customer health
- Discloses your contribution to producing/selling stable and reliable food
- Helps to increase consumer/customer confidence and as well as distributors and government organizations
- Reinforces the brand/company image
- Supports you when subjected to government regulators / other supervisors audit
- Increases the current business/aspirations of new clients
- Offers the introduction of an efficient system of automated control
- Provides necessary compliance concerning customer demands
- Guarantees the implementation of regulatory requirements
The HACCP standard is both a system for food protection and a quality assurance framework. In manufacturing and distribution processes, if these requirements are met, it indicates that physical, biological, and chemical risks have been under control.
So, what do the standards of HACCP achieve? Operating in compliance with these guidelines, companies, and facilities reduce risks that can affect public health. They follow the strategy of the device and avoid the occurrence of possible risks. In compliance with international principles of quality control, they carry out their operations. They foresee the health and safety concerns that will arise and mitigate the financial and moral costs expended on addressing the issues. They raise public knowledge in the industry in Malaysia of food safety.
GMP (Good Manufacturing Practice) Certification in Malaysia
What is GMP Certification?
GMP (Good Manufacturing Practice) is a system used to ensure that products are consistently produced and controlled in accordance with quality standards. GMP aims to minimize the risks involved in any pharmaceutical production that cannot be eliminated through the final product test.
For a product to be effective and safe, GMP is a series of guidelines that must be enforced, beginning with necessary raw materials, before it reaches the customer. In GMP, experiencing zero defect is the objective and the purpose is to maintain adequate quality. Production standards for goods that have a direct effect on human health (food, pharma, medication, medical equipment, etc.) must comply with the rules of the GMP.
With the implementation of GMP (Good Manufacturing Practices), hygienic standards during production and distribution of food products can be maintained. GMP is a quality framework that guides manufacturers through good manufacturing practices to state in what and how conditions should be provided.
These GMP applications are among the fundamental concepts to the manufacture and distribution of food products and can be defined as a set of procedures that really should be continually implemented in the stages of raw materials, processing, product creation, manufacture, packaging, storage, and distribution to ensure quality standards.
GMP also serves as a standard justification for the standards, rules, and regulations established for active ingredients and pharmaceutical / medical products, products used within and outside the body, and producers of food.
GMP Certification in Malaysia
In Malaysia, MS 1514:2009 GMP is the specification established by the Food Safety & Quality Division of the Ministry of Health, aimed at increasing the level of local food producer standards for the production of healthier foods, cosmetics, and health supplements, as well as conventional medicine. Consequently, development in Good Manufacturing Practice is important to strengthen your brand awareness and boost consumer trust.
Why Producers Should Apply GMP?
GMP certification offers a high degree of confidence that the foods, cosmetics, and medicines developed with effective, beneficial, and quality methods. Items that are manufactured following GMP also become in compliance with market requirements.
GMP enhances the quality of production and prepares it for sectoral criteria. Inspection is an aspect of GMP, but it does not mean a high degree of quality assurance without GMP separately.
This is the best manufacturing methodology that guarantees the production of healthy and secure goods by maintaining the competent performance of employees of the food industry. GMP certification process investigates a company with all its elements, that is, with its fundamental characteristics and various criteria for each manufacturing process. GMP certifying bodies determine and regulate the performance and consistency of the manufacturing facility, infrastructure, machine-equipment and production methods, staff, and raw materials. GMP, which regulates the pharmaceutical, cosmetic, and food sectors, guarantees that 'cosmetics' are recognized as detergent, and cleaning products are also included within this investigation scope. Besides, there are several guidelines to be followed in the manufacture of medical goods for human and animal use (medicines, cosmetics, etc.).
Thanks to this certification stamp, a certain degree of reliability, and credibility will be incorporated into your business, hence, the GMP Good Manufacturing Practice Certificate helps your brand become more attractive in the competitive market. The product is constantly controlled and provided to the consumer in the healthiest way under this quality management system.
What are the Key Points of GMP (Good Manufacturing Practices)?
- Quality assurance and Quality Control
- Strong product production practices
- Hygienic practices and Sanitation
- Qualifying and Validating
- Recall of Commodity
- Contractual manufacturing and testing
- Audits of internal control and efficiency
- Training courses for good manufacturing practices
- Hygiene for Workers
- Equipment and services
- Practices in manufacturing
Why GMP Audits Are Required?
GMP contributes to the production and trade of healthy food and GMP creates more trust in the customer.For food producers/processors, GMP aligns with the legal requirements needed. By having the GMP, it will improve the operating performance and, by seamless procedures, eliminates improper practices. Furthermore, the GMP forms the foundation for the institution's certification of many other requirements for food safety and HACCP.
What are the GMP Principles?
- Personnel and structure
- Construction, services, equipment, and materials
- Receipt of raw product, manufacturing of the product, handling, and transportation
- Quality management and assessments of competence
- Proof of all transactions and permission
- Recalls and defects
- Error examination, follow-up after use of manufactured products
- Sample storage, elimination of problematic, returned goods
- Internal and external control
MESTI Certification in Malaysia
A renamed framework to substitute the 1 Malaysia Food Protection Scheme (SK1 M) is MeSTI, or Makanan Selamat Tanggungjawab Industri Certification Scheme has been introduced. Under the 2009 Food Hygiene Regulation, every food processing, producing, and packaging facility owner and occupant is expected to plan and maintain a Food Security Assurance Program. This certification is also mandatory for an entity that has no other Food Safety Management System in place, as MeSTI meets the basic criteria to ensure that food provided by the manufacturer is safe inside Malaysia. The other certifications are globally acknowledged food safety systems namely HACCP, GMP, and ISO 22000.
Before qualifying for JAKIM Halal certification in which we also provide consultancy services, it is also necessary for your business to follow MESTI. An organization must adhere to a broad spectrum of basic hygiene standards for MESTI qualification, which emphasizes effective procedures, hygiene & sanitation, quality control, and records management.
MeSTI theoretically provides the necessary grounds for small and medium enterprises (SMEs) to achieve acceptable food production and processing standards. The reason behind this is that many small firms have a long way in front of them in terms of having sufficient infrastructure, resources, technical capabilities, and expertise to acquire Food Safety Assurance Programs that are globally accepted such as HACCP and GMP.
But it works in vice versa. MeSTI certification also provides a fast and relatively easy certification process for companies who already have HACCP, GMP, or Packaged Drinking Water, Natural Mineral Water, or Ice licenses recognized by the Ministry of Health.
What is the purpose of MeSTI Certification in Malaysia?
With the MeSTI qualification, before being awarded certification, the food operators are directed and obligated to establish and enforce PJKM (2010), the' Food Safety Assurance Program.' Under this PJKM, businesses must build a framework with a national framework of expected and reported activities. Premise access, control activities, and traceability are among the major themes of the successful PJKM.
MeSTI is a food safety program initiated by the Ministry of Health to introduce a food hygiene management and operations management system that involves food safety protection and food quality and safety. The MeSTI certification logo is implemented through this program as food safety adherence and is a safety regulation for micro, small and medium-sized enterprises (SMEs ) in Malaysia to become a major exporter or producer of food products whilst also enabling food safety standards implementation.
How does the MESTI Certification Process Work?
In training on the criteria for MeSTI certification, businesses will be trained and driven. These include the basic course on Mesti food production standards, a workshop, Good Manufacturing Practices (GMP) course for the food processing business.
The auditors will perform audits of the production premises. Visuals from the production facilities will be used during the audit process to disclose suggestions for change. All assessments and audits will be performed on evidence. Specially trained auditors assigned by the Ministry of Health will be the person in charge of your company’s certification process. They will check whether the necessary MeSTI elements are provided, meet the desired limits or expectations, and implement all required elements in operation all the time to provide consistent quality. After the field audit, there will be a follow-up audit to give companies time to resolve nonconformances within 3 months.
After the certification of MeSTI, these institutions will also be controlled afterward through monitoring audits to protect their certification eventually. This Food Safety Program is a system and also a framework provided to small and medium companies operating in the food industry to ensure that any of the processed or manufactured products will not be harmful to their consumers.
The recording tasks in respect of the audit would include the following:
- Completion of forms for Safe Food Industry Responsibility (MeSTI)
- Manually filling files with the Food Safety Assurance Program (PJKM) to demonstrate the general PJKM records
- FoSIM Filling Information Form (MoH Registration of Locations) and MeSTI by Location Manager
- Provision of the appropriate document list for MeSTI qualification
The Benefits of MeSTI Certification in Malaysia
- Fast track food assurance certification with easy access
- Fulfilling the requirements stated by the Food Hygiene Regulations 2009
- Ability to market your products as supermarkets as well as KR1M and COOP1M markets
- Achievement of Free Sales Certificate
- Receiving coaching from the Ministry of Health
- MeSTI logo on your product labels will increase customer confidence and trust
- Additional promotional activities thanks to the reliability achieved by this certification
Do not forget that your company should be registered in Malaysia, recorded at the Ministry of Health, and your facility should be licensed by local authorities. All application details, documents and proofs should be submitted to the local District Health Office where your facility is located.
What are the Difficulties Encountered in the Certification Processes?
It should be assured that the work is completed according to written and proper instructions before beginning any operation. Information should be obtained from the right authorities and sources, and external aid should be obtained if necessary. At all times, these guidelines should be followed, with absolutely no omission. It should be turned into corporate culture to operate in a way that eliminates risks.
You should be prepared for mistakes, accidents, and unpleasant incidents always and they should be reported immediately. Ensure that the records kept, and the checks conducted are accurate.
HACCP, GMP, and MESTI Consultancy in Malaysia
Mandreel is a third-party organization that offers consulting services and assistance to HACCP, GMP, and MeSTI certification and verification for companies working in the food, pharmaceutical, and cosmetics industries. Certifying the food safety management system with Mandreel for HACCP, Good Manufacturing Practices and MESTI standards offers clients an ideal way to prepare for the inspections of regulatory authorities and other stakeholders. The method will help you maintain compliance with regulations while showing your awareness of the value of producing and trading healthy, high-quality food. To learn more about the process of certification for HACCP, GMP, and MeSTI, do not hesitate to contact us.
The Mandreel agency offers training and advisory services for the HACCP, MESTI, and GMP systems. From the original intention to the development and effective execution of management systems, we provide advanced skills and comprehensive functional knowledge to help people in establishing these management systems.
What do We do for HACCP, GMP, and MESTI Certifications for Our Customers?
In your current Management Framework, we first recognize areas needing change or growth. Then, in coordination with the business staff, create a strategic plan. To enhance awareness and provide them with the requisite knowledge and skills in the implementation, we offer the necessary training for your company.
During the process, guidance and recommendations on the design and implementation of systems, such as the compilation of documents, will be provided. We help with the production of protocols and preparation for internal auditing. Then, leading up to the final audit by the certification body, we perform an independent investigation to ensure the successful implementation of the management framework. We also plan a Meeting to review management system results and identify areas for enhancement to be completely prepared for real audits.
We look forward to working with your business and gaining the necessary MESTI, HACCP, and GMP certification to help you grow your business, our team would be glad to help you with some more details you need.
You can send us an email for any questions about our services and we will get back to you as soon as possible or in one working day. For a quick reply, please give us a call or send us a Whatsapp message. Thank you.