• 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.

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

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.

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.

• 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.

• 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

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.

• 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.

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.

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.

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.

• 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.

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

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.

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.