Preparing for GLP Guideline Regulations in Medical Device Development
As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must consider in the early stages to ensure your device can ultimately be approved by the relevant regulatory body, make it to market, and improve the health and healthcare of patients all over the world. One of these important elements is the eventual, but necessary, compliance with good laboratory practice (GLP) guidelines. While they are most relevant to the post-development phase of your product lifecycle, there are steps you can take in the design and development stages to position your product for success.
What is GLP?
Good Laboratory Practice (GLP) is a set of guidelines to ensure the quality of nonclinical laboratory studies for planning, performing, and reporting nonclinical safety. Nonclinical study reports are essential information needed to produce high-quality integrated documentation. Nonclinical study reports present the results of studies individually and support a medical product’s development and registration. Nonclinical report formats may vary. These nonclinical studies include things like biocompatibility, sterilization, and animal testing for medical devices. While GLP is not explicitly outlined in regulation, it is a critical element to include when considering how to prepare for an FDA inspection and approval with the U.S. Food and Drug Administration, as well as other regulatory bodies worldwide. GLP guidelines are outlined in21CFR58 under FDA regulation and in the Organization for Economic Co-operation and Development in the European Union.
How to Prepare for Good Laboratory Practice Guidelines.
Before and during your post-development phase, there are steps you can take to make sure you are poised for success in incorporating GLP guidelines into your submission package to regulatory bodies, including:
Design and development When designing and developing your medical device, it is important to consider how your device will perform during nonclinical tests and include features that will pass those tests when the time comes to conduct them. For example, selecting the right material is essential to ensure you pass biocompatibility tests for implantable or other devices that come in contact with the human body, so they won’t cause harm to the patient. When your product undergoes sterilization testing, you also much consider how the encapsulation and packaging will survive through the process.
Choosing a laboratory When applicable, each testing facility should be of suitable size and construction to facilitate proper conduct of nonclinical laboratory studies. As you research and select a lab to conduct your preclinical medical device testing, it is essential to choose one that is compliant with good laboratory practice guidelines. It is recommended that you utilized laboratories accredited to one, or more, of the following, as appropriate: ISO 9001, ISO 13485, and ISO 17025. You will also want to ensure that the lab follows the applicable testing standards for each element of your device.
Conduct of a Nonclinical Laboratory Study The nonclinical laboratory study should be conducted in accordance with the procedure. The test systems should be monitored to be in conformity with the procedure, Specimens should be identified by test system, study, nature, and date of collection. Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically.
GLP reports Compliance with the GLP regulations is required by FDA in the U.S. and the Conformite Europeenne (CE) mark in the European Union for GLP reports as part of the submission. Both regulatory bodies require thorough, in-depth reports that prove that you utilized good protocol, maintained your test articles, documented your test results, have the proper controls in place for nonclinical laboratory testing, and accounted for your medical device history record. Some companies mistake taking the lower-cost approach of purchasing a report that only proves the device passed its nonclinical testing, but that is not enough to meet regulatory responsibility. Study reports should be sufficient to allow the agency to be confident in the conclusions.
Understanding standards and guidelines, including GLP guidelines, and submitting a medical device for regulatory clearance or approval can be an overwhelming and confusing process with numerous interconnected aspects. At Sterling, we are regulatory compliance experts, and we can help relieve the stress of the process for you – from medical device prototype development to achieving your regulatory goals. Please contact us today.
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