Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.
Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements.
Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.
Much has been written about millennials — how they think, what motivates them, and their outlook on life. How can we best prepare them for today’s pharma/biotech manufacturing environment so they are successful?
All information is good information during an event investigation (EI). It is important that the EI is not performed in a bubble — that it is completed in a safe, blameless environment where the community follows specific steps and procedures, and is focused on finding a root cause of a problem rather than conducting a witch hunt.
A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.
Lack of proper training remains a systemic problem. However, proper training can ensure that employees integrate quality and agency requirements into everyday activities.
How can pharmaceutical companies encourage a quality culture that empowers employees to own quality, so they operate in ways that allow maximum performance and safe, effective products?