Manufacturers must adopt good laboratory practices certification to ensure their products are of high quality
To ensure the validity of the results obtained, the assessment and testing processes for the safe use of medical devices must be undertaken under carefully controlled conditions. This assurance is provided by a Good Laboratory Practice (GLP) certification.
GLP is a collection of worldwide guidelines for ensuring the quality and integrity of non-clinical laboratory data and investigations. The Organisation for Economic Co-operation and Development (OECD) created these to ensure that items supplied to OECD countries meet specific quality standards.
The medical device sector is tightly regulated around the world; in the United States, for example, the Food and Drug Administration (FDA) regulates the industry. The Medical Device Authority (MDA) regulates the medical device business in Malaysia, and new laws requiring GLP compliance are likely to be implemented soon.
Medical device manufacturers are required to submit data of extremely high quality. SIRIM’s Industrial Biotechnology Research Centre (IBRC) General Manager, Dr Ahmad Hazri Ab Rashid described how the GLP process ensures this.
Boosting the product’s value
There were product claims that were not fully validated prior to the GLP. “Some data was ‘cooked up,’ rather than derived from the lab.” Dr Hazri indicated that there were trials that were not repeatable and data that had been tampered with.
As a result, the GLP assures that new medical devices are safe, satisfy minimal quality criteria, and serve patients as intended. “For example, if a producer claims that its medical implant is safe for use in legs, they must present the supporting data. Thus, it can be demonstrated that when a gadget is placed in a patient’s leg, it is safe and compatible with the patient’s body,” he said.
From a marketing standpoint, adhering to GLP principles boosts the product’s value by allowing the manufacturer to provide customers with assurance of quality.
“The items will have a higher value after they have been tested since they will be safe, compatible, and capable of doing what they are supposed to accomplish. In fact, it is the finest quality assurance programme there is!” he stressed.
Dr Hazri said local medical device manufacturers were well aware of the importance of GLP compliance, especially if they planned to export their products.
“Getting a medical device GLP-compliant can help manufacturers penetrate more advanced markets like the United States, Europe, Korea, Taiwan and the Middle East, in addition to certifying the safety element of the product.”
State-of-the-art technology
SIRIM, one of the few GLP-compliant testing laboratories in Malaysia, welcomes inquiries from local producers. “Almost all medical equipment can be subjected to GLP biocompatibility testing.
“Industry players must ensure that their products are of excellent quality in all aspects, including manufacture, packaging, and shipping. At SIRIM, we can provide them with advisory services to help them see what testing is required,” Dr Hazri added.
Typically, a company with a new product may contact SIRIM for guidance on the kind of testing required. Following receipt of SIRIM’s advise and quote, the company can decide whether to proceed with the testing, after which SIRIM will give it a study plan outlining what is required and how the testing will be carried out.
The company will send the samples to SIRIM for testing once the study strategy has been agreed upon and approved by the company. SIRIM will be available to provide consultation on interpreting the results and assisting with the reports that must be filed to the appropriate regulators even after the tests have been completed.
SIRIM’s GLP-compliant facilities are meticulously maintained throughout the year. “This is critical since all of the conditions, including humidity, temperature, and lighting, must be properly controlled and monitored throughout testing. Even animal husbandry must be done right.”
With many regulators requiring GLP compliance and Malaysian regulators joining in, he predicts that demand for GLP testing among medical device manufacturers would rise. “For industry players aiming to expand their market reach, GLP compliance is well worth the effort.
“They will feel assured that SIRIM will provide them with high-quality services in this area. In fact, customers are invited to come to us for advice and assistance if they have any issues about their products,” he said.
For further information about IBRC’s services, please visit www.sirim.my, contact +603-5544 6000, or e-mail
web@sirim.my. — The Health
