Good Laboratory Practices

Good Laboratory Practices

Good Laboratory Practices is the set of principles that are performed for the assurance of the quality as well as the integrity of the nonclinical laboratory studies. These studies are considered as the marketing permits and also support research for new products. This is most commonly connected with the pharmaceutical agencies and required for the approval of the new drug products with the help of non-clinical animal testing. However, GLP is also associated with many other agents (non- Pharmaceutical) that include medical devices, food additives, food contamination limits, and food packaging.  These are the accepted method to carry out different activities in the laboratory. According to all the organizations and authorities, this is the way to ensure the safety related to the research done for new products. These practices also show a positive impact on the quality of the result.

When is GLP necessary and Unnecessary for Medical Devices:

The different type of studies of GLP for pharmaceuticals and bio pharmaceuticals are clear, but GLP studies for the medical devices is not that clear or less obvious. To make GLP more understandable it is important to consider intrinsic safety. If the device is intrinsically safe for the humans then they can be unsafe if you are using them unsterile on the human’s wound.  An intrinsically unsafe device will be made from the highly toxic material. No amount of sterilization will make that device harmless to use in humans. With this understanding, we have three classes of studies to discuss that when GLP should apply to those studies.

Biocompatibility Studies

Biocompatibility studies are performed for the safety and to evaluate the effect of the device on a biological system. Biocompatibility studies according to GLP are required for PMA submissions. Biocompatibility studies performed to support 510(k) submissions are done according to GLP also.  

Validation Studies

This study will validate the process that will be used to make the device free from all the microorganisms to make them suitable for the use of humans. However, these studies are not helping to know about the intrinsic safety of the medical device. For this study GLP is not that necessary.

Chemical Characterization Studies

According to the GLP regulations, there is no classification of the other studies available as it is done for nonclinical laboratory studies.  These other studies can be including exploratory and physical or chemical properties determination studies. These types of studies don’t require GLP to followed, but these studies need to support PMA or 510(k) submission.

 Standard Operating Procedure:

The purpose of the Standard operating procedure is for distributing task, roles, and responsibilities while performing the clinical trials with a medical device. The medical device can be anything that can be used for the purpose of monitoring, treatment, diagnosis, investigation, and prevent any injury.  The Standard operating procedure will ensure that everything was done according to the laws and regulations.

Scope:

The standard operating procedure (SOP) applicability for the clinical trials of the medical devices is decided on the bases of CE marking. Standard Operating Procedures for Good Clinical Practice has organized into eight sections:

•   General Administration: This section gives the outline of the infrastructure of the activities of the clinical research program. 

•    Regulatory Affairs: This section tells about the rules and regulations according to FDA and this will also tell about the supplements, reports, and submissions that are required to send to the FDA.

•    Clinical Protocol:  It includes all the required approval, other related documents as well as a review for protocol development.

•    Study Startup:  This step includes the selection for the investigative for the initiation of the study at different research sites.

•    Project Management: This step describes the processes that help to manage the clinical investigation that includes required documentation study and investigation product management.

• Subject Management: To the protection of the research subjects there is a need for procedures that are provided by subject management.

•    Data Management: This handles and manages the collection of data after sites study and the use of EDC or Electronic Data Capture systems for clinical investigation.

• Quality Assurance: It provides procedures for conducting internal audits, auditing investigative sites, managing an FDA inspection and assisting a Clinical Investigator in preparing for an FDA inspection.