GDPMDS for medical devices – Ensure quality, safety and performance of medical devices
Overview of GDPMDS – Good Distribution Practice for Medical Devices
To kick start with, the medical devices act 2012 has mandated that all the entities that are engaged in operations must be in compliance with the Good Distribution Practice for Medical Devices (GDPMD). This will help the entities to set up and maintain a quality management system.
In addition, this certification will ensure that the companies dealing with medical devices will have a Quality Management System (QMS) achieved to maintain the device quality and the distribution process throughout. It is suggested that the wholesale license and authorisation holders must hold the GDP compliance to ensure security and better supply chain practices of pharmaceutical products.
Why Good Distribution Practice is important?
Public health! This is one factor that greatly recommends the companies to hold the compliance of GDPMDS. Any error in the device quality, shortages, or delays will bring a huge impact in the medicinal market. Also, from pharmaceutical perspective, GDP will help in product traceability – a huge factor for official investigations of quality issues or incidents that involve pharmaceutical products.
GDPMDS provides your organization with multiple benefits like:
- Guarantees you a facility that has the capability to ensure quality, safety and functionality of the medical devices that are under the control of organisation.
- Effectively regulates the healthcare equipment and monitoring can be performed across the distribution network, which is another level of safety and functionality from user perspective.
- The stakeholders can get a confidence by showing the accreditation which initiates the stronger capability of organisation from the functionality level.
- Helps the companies to comply with the requirements of establishment license.
Inspections carried under the risk-based compliance program:
The manufacturers and the wholesalers of medical devices must prioritise the inspections for higher ratings and scores. During inspection, the GDP will thoroughly examine the systems used to manufacture and distribute the medicines.
They will evaluate on the basis of:
- Compliance report
- Internal information extracted from the previous inspection
- Organisation changes
Information about the gradings of inspection findings:
According to the deficiencies that are found during the inspection process, the gradings are segregated into 3 levels. They include,
Critical deficiency – This type of deficiency produces a product that can be very harmful to the humans or can result in sedimenting a harmful residue in a food-producing animal. The deficiency can be a critical risk to patients and even it increases the risk of counterfeit medicines that the patients intake.
Major deficiency – This is a kind of non-critical deficiency that can bring harm but doesn’t comply with the marketing authorisation. It is considered as a major deviation from GMP or GDP in terms of manufacturer license.
Others – This category can be considered as either critical or major, at the same time, it also indicates a departure from good distribution practice only.
Supplier and customer qualification:
The potential suppliers must ensure that they have this wholesale authorisation before selecting them. The observations will include the reliability of the supplier, the reputation that they hold, the nature of pharmaceutical product that is offered, the quantity of the pharmaceutical product offered, and other out-of-range prices.
Why Global Quality Services?
Global Quality Services ensures that their customers are going through a risk-based inspection programmes that will make them remain unchanged. Our professionals will guide you in the process of regulatory authorities and other recognition agreements. We always ensure that the existing mutual recognition or the scope of GDPMDS certification remains unchanged.
Want to learn more about ISO certifications? Contact us or drop an email to [email protected] or reach out to this number +65 9344 1973, PHILIPPINES +63 9765 356917
We offer services across Singapore, Australia, New Zealand, Penang, Batam, Hongkong, Manila, Batangas, Laguna, and any location in the Philippines, Maldives, Thailand, South Korea, Myanmar, and Indonesia. Find out more here: Safety, Health, and Environment / Quality / Food Safety
If you want to learn more about other certifications, head on to our blog section.