June 2012 Quality Update

2012 Quality Update

At Pillar5 Pharma, our focus is providing availability and access to safe medications through our customers. Assisting in the health of patients is one of our most important priorities.

We strive for absolute compliance and continuous improvement to deliver high quality products in the most efficient manner.  Here are our most recent results and ongoing efforts:

Last summer Pillar5 hosted a one-week FDA inspection and with an outcome of zero 483’s!  The inspection was for a Pre-Approval Inspection of an NDA product which will launch in 2012, as well as a general cGMP inspection covering all quality systems and all aspects of solid dose manufacturing and testing.  Thanks to our great preparation and teamwork, the FDA Inspector said “this was the most stress-free inspection I have ever conducted”.

On the heels of the very successful FDA inspection, Pillar5 hosted a two-week Health Canada GMP inspection.  The detailed inspection covered all quality systems and aspects of sterile and non-sterile product manufacturing and testing. We were granted a “Compliant” rating, and received a low number of findings — our best result going back many inspections dating back to the 90’s!  The two Compliance Officers were very gracious for our efforts and stated that they “learned a lot from our very knowledgeable staff”.

Pillar5 uses a Continuous Improvement approach to quality systems.  Through our Six Sigma and Lean Manufacturing programs we increase our process knowledge and improve processes and quality systems.

 

In 2011 we focused our efforts on improving the following key quality performance indicators:

• SOP Reviews (target exceeded)
• Overdue CAPAs (target exceeded)
• Vendor Assessments (target met)

 

In 2011, our customers were privy to 34 Annual Product Review Reports and all of our colleagues attended at least 2 GMP classroom training sessions.

Pillar 5 was able to stay ahead of many regulatory expectations and hosted seven customer audits in 2011. Although hosting audits takes time and resources, we recognize the great value in learning and sharing the critical expertise of our customers.  Pillar5 will always welcome you!

To download a printable version, please click the following link: http://www.pillar5pharma.com/wp-content/uploads/Quality-Newsletter-June-20127.pdf