Researchers say that as the number of organ transplants continued to increase throughout the world, the number of organ transplant recipients developing skin cancer are increasing, too. The results of a study on this topic were presented this month In an address to the 66th Annual Meeting of the American Academy of Dermatology (Academy).
At the end of 2007, the FDA announced an amendment to its current GMP regulations for finished pharmaceuticals. Will your organization be affected by this final rule?
Especially for Pharmaceuticals
For medical device companies the new MDUFMA is likely to result in shorter application cycles and more efficient communication with the FDA.
Especially for Medical Devices
Technology is moving to the next level in hospital laboratories and blood banks. With the current shortage of qualified medical technologists, hospitals are introducing instrumentation and automation techniques into the blood bank.
Especially for Blood / Biologics
Establishing and Operating an Effective GMP Auditing Program
By Robert L. Dana
“Hi, I’m from the Corporate Auditing Group and I’m here to help.” This popular phrase,
appropriately modified to reflect the place from where the “helper” comes, is often heard
and sometimes associated with Corporate Auditors and Corporate Auditing Groups. No
one likes to have their work reviewed and evaluated by an outside pair of eyes, especially
when those eyes belong to someone who has been trained to be critical and look for
operational inconsistencies and examples of regulatory non-compliance - and worse yet,
report on those examples to one’s superiors and senior management. Yet performing an
independent assessment of operations, identifying an area of potential concern and
ensuring that appropriate and effective corrective actions are taken is critical to ensuring
that firms maintain a solid compliance posture and that management is aware of any
potential compliance concerns. So who are these Corporate Auditors, how did they come
to be what they are, and how do world class auditors and audit groups operate?
To begin with, audit programs should be structured so that the auditors have complete
independence of the functions they are auditing. They must also have the complete
support of management to ensure they are free to evaluate what they see and hear, and
report on their findings without fear of retribution. Corporate audit programs should
report to components that are reasonably high within the company organization, again to
ensure they have the ability to engage in dialogue with other senior management of their
company on an equal footing.
Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes
The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (CAPA, customer complaints, audits, deviation management, change control, training, purchasing, etc.). This eliminates errors due to human oversight and ensures FDA compliance, which requires that strenuous controls be in place for ensuring the identity, strength, quality, and purity of drugs (Section 211.100).
Automated solutions expedite communication with support service companies, external partnerships, and vendors. They reduce the time that must be spent in meetings by providing instant access to the most current data and information available. With a web-based system, current data and information can be accessed from virtually any location in the world. Automated solutions also help keep executive management well informed by providing access to all company activities, 24-hours a day. This enhances compliance and helps ensure smooth operations. With some systems, managers and other authorized users can even view critical path workflows in real time to help avoid potential bottlenecks.
Moreover, companies that automate their processes accelerate the development of new products and reduce the time-to-market for products currently under development.