GMP Packaging & SS620:2016

HMLY’s certification portfolio goes far beyond standard compliance; it is a holistic assurance that you are partnering with an ethical, safe, and quality-driven organisation. These certifications translate directly into reduced risk, superior quality control, and brand protection for you.

When you choose a certified partner, you are outsourcing critical aspects of your supply chain, like packaging and distribution, to a system that has been rigorously audited by independent, third-party bodies. This eliminates the burden of building and maintaining these complex systems yourself.

Our key certifications include:

• ISO 9001:2015 – Quality Management System (QMS)

Process Reliability: Ensures consistent, documented, and continually improved service delivery across all functions. You get predictable, high-quality results every single time.

• ISO 22000:2018 – Food Safety Management System (FSMS)

 Consumer Trust: Guarantees a globally-recognised system is in place to prevent food-related hazards during handling, storage, and packaging. Your consumers can trust the safety of your product.

• bizSAFE Level 3 – Workplace Safety and Health (WSH)

Business Continuity: Signifies a robust risk management system, ensuring a safer work environment for the team handling your goods. Fewer accidents mean zero service disruption for you.

• GMP Packaging – Good Manufacturing Practice

Product Integrity: We follow stringent hygiene, control, and documentation practices, minimising contamination and errors during packaging of sensitive goods (e.g., medical and food).

• SS 620:2016 – Medical Device Good Distribution Practice (GDPMDS)          

Regulatory Shield: Mandated by HSA for medical device handling. We ensure your products maintain safety and integrity from import to final delivery, protecting you from non-compliance.

• Tripartite Standard & Sedex – Progressive Employment & Ethical Sourcing

Ethical Assurance: Certified in fair workplace practices (Age-friendly workplace practices, Grievance handling, Recruitment practices) and Sedex (ethical trade). This protects your brand from association with unethical labour practices in the supply chain.

The standard’s requirements for Quality Management (Clause 4) and Premises (Clause 7), as well as general packaging (GMP) standards, are enforced rigorously during our packaging services to safeguard your product’s integrity. The goal is to ensure the medical devices packaging remains intact and the device itself is protected.

Our Operational Controls:

• Personnel Competency & Hygiene: Only personnel who have received documented, specific training in handling sensitive products, hygiene protocols, and relevant standard requirements are permitted to perform secondary assembly. This focus on “People” (a key pillar of GMP) minimises the risk of human error or biological contamination.
• Material Suitability & Control: While the manufacturer supplies the primary packaging, HMLY ensures any secondary packaging materials (boxes, shrink-wrap, labels) do not adversely affect the device or its primary packaging. For temperature-sensitive devices, we use materials and methods compliant with maintaining cold chain integrity.
• Defined Work Instructions: Our QMS ensures every packaging job has clear, documented work instructions. For example, for shrink-wrapping, the temperature setting and dwell time are validated to ensure the film shrinks effectively without damaging the device’s original label or causing excessive heat exposure.

• Segregation and Containment: Specific, designated areas are used for packaging activities to prevent cross-contamination between different products, a key requirement of both SS 620:2016 and GMP.

Traceability is critical for rapid Field Safety Corrective Actions (FSCAs), and any repackaging or relabelling activity creates a new data point in the device’s history that must be captured.

Our Traceability Guarantee:

• Link to Original Data: When a new label (e.g., promotional or multilingual) or outer package is applied, HMLY maintains an unbroken chain of custody, linking back to the original manufacturer’s batch/lot number and label/packaging information.
• Accuracy Verification: Clause 9 requires accurate records. We implement verification steps (often a dual-check process) to ensure that the correct new label is applied to the correct device and that the new medical devices packaging accurately reflects the contents and expiry information. Any relabelling activity is performed based on explicit, documented authorisation from the client to meet the standard’s control over documentation.

• FEFO Control: The packaging process itself includes controls to ensure that devices are assembled and released based on the First Expiry-First Out (FEFO) principle, preventing expired or near-expiry devices from being mixed into the usable stock.

The packaging is the device’s first line of defence, and maintaining its integrity is our foremost operational commitment. Under SS 620:2016 (Clauses 7 and 10) and GMP, we take full responsibility for ensuring the packaging is not compromised while under our care.

HMLY’s Packaging Integrity Commitment:

• Visual Inspection on Receipt and Dispatch: Our procedures include a documented visual inspection of the device’s packaging before and after any assembly or re-packing service. We check for signs of damage (e.g., punctures, tears, compromised seals) as required under Clause 10 to ensure the device is not adulterated or unwholesome.
• Risk Mitigation During Process: We use equipment and handling techniques designed to protect the integrity of the sterile barrier or primary packaging. For instance, we use cushioning materials and methods to prevent movement and abrasion that could compromise the primary packaging during subsequent transport and handling.

• Immediate Segregation: If any packaging is found to be damaged during the assembly process, it is immediately segregated and labelled as “Not for Use,” and the client is notified, ensuring that compromised products are stopped before they can enter the supply chain.

By outsourcing your packaging and distribution-related activities to a certified partner like HMLY, you satisfy the requirements of Clause 14 (Outsourced Activities), which dictates that you must assess and monitor the competence of your partners.

Protection through Certified Outsourcing:

• Protection against Regulatory Fines: HMLY’s valid SS 620:2016, ISO 22000, and ISO 9001 certificates serve as robust, objective evidence to authorities (like HSA) that your outsourced activities are managed to the highest standard. This directly satisfies the requirement for you to assess and monitor the competence of your partners, significantly reducing your compliance workload and liability.
• Assurance of Safety and Quality: Our certification to ISO 22000 (Food Safety) and GMP (Good Manufacturing Practice) ensures that your product quality and integrity are prioritised throughout the supply chain, protecting consumers and your brand reputation from quality failures.
• Guaranteed Ethical Sourcing & Employment: Our adoption of the Tripartite Standard (specifically for Age-friendly workplace practices, Grievance handling, and Recruitment practices) and our Sedex membership (ethical trade) means we are continually audited on our social and ethical performance. This gives you peace of mind that your supply chain partner upholds fair labour practices, protecting your corporate social responsibility (CSR) standing.
• bizSAFE 3 for Operational Reliability: Achieving bizSAFE Level 3 means our facility has a formal Risk Management plan in place. This commitment to safety reduces the chance of accidents and service interruptions, giving you the assurance that our operations are stable and reliable.