Guest post by Edward Simpson, RS Calibration, Inc.
In biotech, biopharma and medical device industries, regular calibration is an important part of the FDA (U.S. Food and Drug Administration) approval process. Comparing measurements from a test device against a known reference or standard helps reduce measurement uncertainty and errors, bringing instruments within an accepted accuracy level.
Why is FDA Approval Important?
The FDA is responsible for ensuring public health and safety (and promoting innovations) in products intended for human or animal consumption, such as food, drugs, cosmetics, tobacco products, etc. It also regulates medical devices and other related products, to ensure they are safe, sanitary and effective for human or veterinary use.
In addition to medical devices, new OTC/prescription drugs, biological products (like vaccines), veterinary drugs, as well as food, drug or cosmetic additives/supplements/color also need FDA approval. This only happens if the benefits of these products are found to be higher than their potential risks, after they have been analyzed, examined and tested based on their intended use.
How Does the FDA Approval Process for New Drugs Work?
Before new drugs can be approved for use/sale:
- The compounds used in them must first be tested for safety and efficacy on various animal species, before clinical trials can be conducted.
- An IND (Investigational New Drug) application then needs to be submitted for the FDA’s review, with the results of these tests as well as compounds and manufacturing processes used.
- Clinical tests are approved if there is no unreasonable risk posed to human subjects from the proposed studies, and if there is adequate informed consent and protection.
There are three phases after the IND approval for clinical testing:
- In Phase 1, the drug is tested for side effects and how the human body processes it, typically using under 100 healthy volunteers.
- In Phase 2, the responses of larger treatment and placebo test groups (with hundreds of patients) are compared, to collect preliminary information about the drug’s effectiveness.
- In Phase 3, more data is gathered about the drug’s dosages, safety, effectiveness, interaction with other drugs, etc., using test groups with thousands of patients.
After clinical trials, drug sponsors need to submit an NDA (New Drug Application) with detailed data from animal and human tests, how the body processes it as well as the manufacturing processes. Within 60 days, the FDA will then decide if the NDA will be filed for review, evaluate the sponsor’s research and inspect production facilities, drug labelling, etc. If approved for marketing, periodic safety updates need to be submitted by the sponsor.
The regular inspection, validation, calibration, qualification and maintenance of equipment used in the production/testing process plays an important role in this regard.
FDA Requirements for Medical Device Calibration
Even the best measuring instruments and equipment are affected by wear and tear, environmental changes and other factors, losing accuracy over time. Calibrating them against known standards on a regular schedule is the only way to ensure that manufacturers retain control, maximize effectiveness and minimize risk.
FDA medical device calibration regulations are not set for specific measures, but have instead been devised to ensure that all inspection, measuring, and test equipment are able to meet their intended use and quality requirements. They also act as guidelines for manufacturers and distributors of medical equipment, defining the procedures, frequency and precision/accuracy standards to follow for calibrated equipment.
Proper documentation (when calibration was last performed, details of tests conducted, adjustments made, technicians responsible for calibration, accuracy and precision limits, etc.) and traceability (to accepted national, international or local industry standards) are especially important. Without these records, there’s no guarantee that medical devices or products are safe for public use.
How Do Calibration Services Help with FDA Approval?
Calibration of medical devices and manufacturing equipment needs to be performed on a routine basis, by trained and certified professionals. If errors are noticed, adjustments and repairs need to be made, followed by re-calibration to verify the accuracy of calibrated equipment.
It’s possible to perform calibration in-house, but specifically training technicians for it often requires an unjustified investment of time, effort and money. At the same time, manufacturers may still need to hire calibration laboratories or service providers for specific equipment tests or other kinds of calibration.
An accredited lab that offers high-quality calibration services can help with faster FDA approval for new drugs or equipment, help companies maintain calibrated equipment (used as standards for in-house calibration) for FDA audits, create a validation plan, assist with qualification, documentation, certification of traceability and much more!
Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines on his email firstname.lastname@example.org. He also invites people to visit his company www.rscal.com to learn more about the type of calibration work he does.