Vaccines 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…
A 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…
Dry 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…
After 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…
Investigations (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…
Within various aspects of a quality management system, there is a directive to evaluate the root cause of an issue – this could be risk management, investigations, non-conforming material, corrective actions, etc. There is a specific process to this concept, along with methods to achieve the answers. A root cause is a factor, or combination…
Background A medical device manufacturing facility in Carlsbad, CA has two ISO Class 8 cleanrooms, an ultra low temperature freezer with epoxies, and a home style fridge. One cleanroom is temperature only, and the other is temperature, humidity and differential pressure. For Quality Control, the cleanrooms and the areas outside of them are required to…
The next logical discussion is the second half of the Corrective and Preventive Action (CAPA) subject. According to ISO 9001 section 8.5.3, Preventive Actions identify and eliminate the causes of potential nonconformities in order to prevent occurrence. These are proactive measures, instead of the reactive steps taken for a Corrective Action. The main goal for…
The Virginia Cooperative Extension has released a publication discussing the validation of blue crab retort processes. The development and implementation of a Hazard Analysis Critical Control Point (HACCP) plan is a required step for these retort processes. In the publication, we learn about: What a retort cook process validation is Why this process matters How…
Following the installation of your CM system is when the fun really begins! Throughout the project definition and pre-implementation planning stages, system requirements were defined based upon user needs. Now that the system has been installed, end users will need to begin the full process of transitioning from the legacy system to the new system…