February 2007 Issue
The DQ is a critical, yet often overlooked part of the process of developing and validating any new pharmaceutical PAT process. It is a strategically important time, where process engineers, material scientists and physical chemists can get together to develop meaningful materials characterization standards.
Applying systematic methods can improve results and increase value, whether on the corporate or on the local operational level.
Science-based calibration (SBC) mechanizes the calibration process by removing choices and by forcing the user to substantiate each of the inputs with scientific backup information
Most pharmaceutical industry professionals are relatively happy with their careers, but many long for more challenge, training and growth opportunities, according to our survey.
Projected increases in M&A activity demand careful risk vs. benefit analysis, and not only on the ledger sheet
What was once viewed as a necessary evil or a cost of doing business is increasingly being seen as a key competitive advantage, although hurdles remain.
Manufacturers and consumers would bear most of the risks and the costs of importation.
Like adolescents, compounds in Phase III require nurturing, but a real world approach.
A growing number of quality management and compliance packages can help you seize control of processes and documentation, and prepare for FDA audits.
As counterfeiting continues and regulatory pressures increase, pharma companies must act to secure their own supply chains.
Addressing misconceptions, fostering a culture of compliance and patient-focused behavior and refocusing sales and marketing activities can restore and strengthen the industry
Business pressures are bringing pharmaceutical companies to a realization that some other industries have had for years: profesionals with operations management skills are vital to the success of the enterprise.