Pharmaceutical Compliance: What It Means for Your Lab Instrumentation
Pharmaceutical analytical lab equipment requires heavy quality assurance and replicable testing processes.
When it comes to pharmaceutical analytical lab equipment, Full Spectrum Group (FSG) has a lot of experience with regard to repair, maintenance, and calibration/qualification practices. FSG is ISO 9001 accredited and ISO/IEC 17025 accredited for specific testing. We’ve worked with hundreds of labs that both produce and test pharmaceutical products, and the importance of proper instrumentation care and servicing is impossible to overstate. The FDA exists to keep the general public safe by regulating human and veterinary drugs, along with vaccines and any other biological products. The FDA’s approval only comes with strict, consistent compliance efforts in the production, laboratory testing, and product release processes.
FDA approval is a lengthy process, and instrument qualification (or “calibration”) plays an important role.
When scientific equipment is used for the production or analysis of any drug, vaccine, or other biological product, the instrument(s) must go through scheduled maintenance and qualification to ensure regulatory compliance. FSG specializes in offering companies equipment maintenance, qualification, and calibration contracts and services for their pharmaceutical analytical lab equipment. We have been providing world-class services throughout the United States for three decades.
When lab instrumentation constantly runs as part of daily testing operations, the potential exists for instrumentation to be out of specification. This is why it is critical to have proper maintenance and care procedures. At FSG, we help our customers develop and implement appropriate processes for the highest level of instrument performance success. We understand that equipment maintenance and performance issues can be caused by a variety of situations that must be analyzed by a trained service engineer. Noisy baselines and unusual chromatograms can be the bane of any lab technician’s existence. The real importance of equipment qualification lies within the accuracy of the science — something many of the pharmaceutical labs we work with say is one of their biggest concerns. In order to ensure accurate science, it is critical to have an appropriate maintenance and calibration program in place that aligns with FDA regulations.
According to Title 21 of the FDA’s Code of Federal Regulations (Section 870.2 regarding inspection, measuring, and test equipment), there are some important regulations and compliance requirements to adhere to:
- (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment so that its accuracy and fitness for use are maintained. These activities shall be documented.
- (b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.
- (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
- (2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
Please note that the compliance regulations may have changed since this article was published. To get the latest information, you should always access the official U.S. Food and Drug Administration Code of Regulations.
Building a process around maintaining your pharmaceutical analytical lab equipment.
The first of these regulations is more of a blanket statement. Your instrumentation requires regular testing and maintenance, and there should be a documented process (SOP or “Standard Operating Procedure”) around when and how the instrumentation is maintained and qualified. Additionally, proper documentation is required to show that these procedures are being performed. Maintenance records should have the activities listed in detail, along with the date and time that they were completed as well as the name of the person performing the activities. The most important part of this will be the qualification documentation that shows the instrument is achieving reproducible results. All SOPs involving analytical maintenance and qualification should be evaluated at regular intervals to ensure compliance with regulatory requirements.
The specifics around lab equipment calibration (or “qualification” such as IQ/OQ/PQ).
Also covered under this code are details concerning calibration and qualification processes. Any instrumentation used to test or analyze pharmaceutical products must produce reliable data/results. This is a public health responsibility first and foremost, but it is also required if you want to fall within the FDA’s Code of Federal Regulations. There must be written procedures that outline specific directions and limits for measuring accuracy and precision. If any instrumentation falls outside specification, action must be taken. If maintenance or repairs are performed on the pharmaceutical analytical lab equipment, this must be logged in detail. The calibration work is only done when the instrumentation is achieving reproducible results within the documented limits.
Traceable calibration standards are required.
The measuring, testing, and inspection equipment calibrations need to match reproducible and traceable standards. Labs are traditionally okay with following national and/or international standards that have already been established. You can, however, create your own in-house standards if deemed necessary. Again, we can’t stress the importance of proper documentation. If you opt to create in-house standards, these details must be written out clearly and approved through the proper internal processes.
Not only do you need to document everything, but the documentation needs to be readily available and properly displayed.
Making sure all records and documentation is easily accessible to staff members, vendors, and inspectors are part of staying within the FDA’s Code of Federal Regulations. Each logbook should be displayed on or near the equipment for easy access by anyone who needs to review it. Creating records and SOP documentation is time-consuming and requires a lot of work, but it makes everyone’s job a lot easier in the long run.
Always make sure you are reviewing the OFFICIAL documentation.
It is critical to review the FDA’s official documentation regularly. The FDA routinely notifies the market of changes and updated regulations but making it a priority to review the documentation from time to time is important. Pharmaceutical compliance is a serious subject for which we have a lot of experience, but the final authority is the U.S. FDA. FSG offers a wide range of instrumentation services for pharmaceutical analytical labs across the country. Are you interested in learning more about our services?