Companies that supply a manufacturer with components are a critical part of your manufacturing process. If you manufacture medical devices, there are numerous requirements for control of these suppliers. The FDA essentially considers a supplier an extension of the manufacturer, meaning that the service/material supplied must meet pre-established specifications. According to 21 CFR 820, “Each…
DetailsWhile we hope that it never occurs, a disaster or emergency can happen unexpectedly. Establishing a disaster or emergency recovery plan is an important element of a standard operating procedure (“SOP”). Emergency Contact List In the event of an emergency, it’s important to know where emergency contact information is and to follow the established notification…
DetailsThe FDA has a requirement, in 21 CFR 820.20, for a Management Representative. This individual “irrespective of other responsibilities, shall have established authority over and responsibility for: Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and Reporting on the performance of the quality system to management with…
DetailsAn extension of on-going support for your Continuous Monitoring (CM) system is to complete regular alarm checks and perform preventive maintenance. These two activities are vital to ensuring the integrity, quality and reliability of the system. Regular Alarm Checks Regularly scheduled alarm checks should be completed for: (1) all monitored parameters (temperature, humidity, differential pressure,…
DetailsEnvironmental Monitoring (EM) is a basic requirement throughout numerous industries; food, cosmetics, drugs and medical devices. It is intended to measure the cleanliness of an area, therefore verifying the biological safety of products being manufactured. The depth of your EM program will be determined by the industry you’re in, whether or not you claim your…
DetailsVaccines are critical tools in maintaining the health of our communities. The logistics of delivering vaccines and verifying that they consistently maintain their recommended temperature has always been a difficult task. At times, vaccines were found being stored outside of the manufacturer’s recommended range. Prolonged temperature excursions can result in the vaccines becoming ineffective. In…
DetailsA deviation is described as a departure from an approved procedure or specification. It represents a failure to meet requirements in the manufacture of product, in-process specifications or production requirements. There is a difference between a planned or unplanned deviation. Planned deviations have been approved before execution, whereas unplanned deviations (also called incidents) are technically…
DetailsDry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle…
DetailsAfter your CM system becomes the production system of record and has gone “live,” there’s certainly reason to celebrate and recognize what has been accomplished. There can also now be a misconception that the system will “run by itself,” that it is “automatic,” and you can “set it and forget it!” However, like any complex…
DetailsInvestigations (also known as GMP Failure Investigations) are a requirement of 21 CFR 820. It is expected that medical device manufacturers immediately conduct an investigation on all non-conforming or out-of-specification (OOS) products. There are three phases to an effective investigation process: Phase 1: As soon as a non-conformance happens, the individual performing the task should…
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