Many FDA-regulated manufacturers find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems requiring many hours of work to resolve.
In FDA-regulated manufacturing, genuine human errors do occur but they’re cited far more frequently than they probably should be.
In truth, most problems that appear to be caused by human error — especially those that occur multiple times — are actually rooted in processes or systems that when left unchanged, will keep producing the problem despite the convenient band-aids often placed over them.
When human error is identified more frequently than it should be expected to happen, it signals to investigators that problems aren’t being internally investigated thoroughly enough. This can quickly shift the investigator into problem-hunting mode and open your quality management system up to even greater scrutiny.Continue Reading
Inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of many deficiencies and observations found in Forms 483 and Warning Letters. And while specific SOP issues can often be traced back to poor communication, monitoring, and/or enforcement, a poorly written SOP can quietly grow into a host of other major compliance problems.
A well-crafted SOP offers clear direction and instruction specifically designed to avoid deviations––an absolute necessity for maintaining compliance and delivering quality products.Continue Reading
The differences between Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) aren't always obvious. Both share similar terminology and at times, somewhat similar applications.
But for those who apply these practices, or collaborate with those who do, the differences are important. Confusing one for the other can lead to serious compliance problems and rework.
This guide offers a quick and simple explanation of the differences, starting with the most pronounced.Continue Reading
For too many FDA-regulated companies, internal audits are just another procedural item to check off. It may get onto the calendar, but rarely gets circled as a high priority. The result? A moment of panic when you realize you only have a few weeks to complete your program.
This mindset ignores the reason regulators require internal audits in first place––to help you teach yourself how to identify and address issues before they need to do it for you.
A well-run internal audit doesn’t just provide protection, it lets you revisit your quality system and compare it to current regulations.
Have new requirements created gaps in your system that need to be addressed?
Are there opportunities to be more efficient?
These are the advantages of building an internal audit process that gives you valuable information in return for the work you invest in it.Continue Reading
This article is an abbreviated introduction to Chinmoy Roy's "The Data Integrity Triad." Read the full article on LinkedIn here.
The rise in Data Integrity warning letters are forcing companies to make a beeline for obtaining an understanding of data integrity. A close examination of management objectives where data integrity issues have unraveled indicates that they have been driven by the self-interest of profit.
They hesitate to switch out older equipment for newer ones with technical controls to enforce data integrity. They also hesitate to provide the required level of personnel resources for regular audit trail reviews, investigation of data integrity issues etc.
While regulatory agencies are actively hiring computer savvy personnel familiar with the intricacies of electronic data, business expediency dictates pharmaceutical industry management to shadow those efforts by ensuring that adequate budgets are allocated to hire personnel with the right blend of IT and compliance expertise.Continue Reading
Earlier this month, President Barack Obama signed new legislation that opens a new fast lane for medical device approval.
Just one of many new reforms affecting device companies, the 21st Century Cures Act will give manufacturers the option of reporting to just one FDA review board, saving the time and resources previously required to get permission from regional review boards near test subjects.
Supplier qualification processes aren't just recommended precautions to guard against compliance issues, they're a regulatory requirement for most FDA-regulated manufacturers.
"Qualifying" a supplier, in this case, should be thought of as a kind of quality system within a quality system.
Candidate suppliers and vendors should be thoroughly evaluated against your own quality requirements, compared with other options, physically evaluated and reevaluated on a regular basis to ensure compliance both now and in the future.
Although most drug and device manufacturers have a supplier qualifciation process in place already, one company's approach can look much different than another's.
We’ve laid out a clear and concise five-step supplier qualification process that can be integrated and expanded upon to meet your organization's unique needs.Continue Reading
For years, FDA-regulated manufacturers have tried to apply a one-size-fits all quality management approach to their entire roster of suppliers.
But with so much variability from one supplier to another, this approach can be woefully inefficient and downright dangerous when lapses in management allow potentially serious compliance issues to develop.
The increasingly popular risk-based approach to managing supplier quality allows manufacturers to craft a malleable quality management system that can be shaped to fit each supplier individually––enabling you expend the greatest effort toward mitigating the risks that pose the most damage.Continue Reading
In the age of outsourcing, drug and device manufacturers depend on their suppliers for critical activities, making them vulnerable to potentially devastating quality issues.
On top of this, many manufacturers continue to operate under the false assumption that by handing over duties to suppliers, so too go the responsibilities for maintaining regulatory compliance. This is not the case.
Although it's in suppliers' interests to keep themselves to a high standard of quality to attract clients, the regulatory burden ultimately rests on the company receiving their products or service.Continue Reading