By Laurie Meehan, Polaris Compliance Consultants, Inc.
There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all-important question: "Why?" How can you develop the best checklists possible and avoid relying on them too heavily?
By Paul Dupont, Ropack
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records, and conducting audits more frequently — up from .06 to .09 per year, according to Bloomberg News.
By Laura Studwell, Loma Systems
Prices for pharmaceutical products have been increasing at an accelerated rate for more than a decade. The increases are being driven by increased product competition coupled with the growing cost of research and development, the increase in patent laws, and greater government legislation, as well as the price transparency created by insurance companies worldwide.
By James Drinkwater, Bioquell Inc.
Biocontamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources.
By Paul Daniel and Jon Aldous, Vaisala
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity, we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, whether it is incubator, fridge/freezer, stability chamber, cold room, or warehouse.
By John Lewis, Market Development Manager, Cognex Corporation
As pharmaceutical manufacturers confront increased margin pressure in the coming years they will look for new ways to lower their costs to install and maintain production lines. Having the option to choose smart camera vision systems instead of being locked into PC-based vision systems at the machine level can be a tremendous advantage that often results in a solution that’s less expensive to install, less complex to validate, and less costly to maintain.