ThePillar5 Pharma inspection was the most stress-free inspection I have ever conducted. - FDA health inspector
Arnprior, Ontario (PRWEB) July 17, 2012
Last summer Pillar5 hosted a one-week FDA inspection and received an outcome of zero Form FDA 483s (meaning the inspectors did not find any violations of the Food, Drug and Cosmetic Act). 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 great preparation and teamwork, the FDA Inspector stated: “ThePillar5 Pharma inspection was the most stress-free inspection I have ever conducted”.
On the heels of this 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. Pillar5 Pharma was granted a “Compliant” rating, receiving a low the best result going back many inspections dating back to the 1990s.
Pillar5 uses a Continuous Improvement approach to quality systems. Through Six Sigma and Lean Manufacturing programs, we increase our process knowledge and improve processes and quality systems. In 2011, Pillar5 focused our efforts on improving the following key quality performance indicators: SOP Reviews (target exceeded), Overdue CAPAs (target exceeded), and Vendor Assessments (target met).
Pillar5 Pharma takes pride in staying ahead of regulatory expectations, and achieves these results through hosting ongoing customer audits and our Continuous Improvement approach to our systems and processes. In 2011, 7 customer audits were performed, customers were privy to 34 Annual Product Review Reports, and staff attended at least 2 GMP classroom training sessions.
For further information, contact:
Jody Franklin, BA, CCPE
Pillar5 Pharma Inc.
Manager, Sales and Marketing
365 Madawaska Blvd.
Arnprior, Ontario K7S 0C9
Office: (613) 623-1210