Oakdale, MN, April 9, 2012 – Pace Analytical Life Sciences (PLS) announces successful completion of a two-day site audit by ACLASS that resulted in re-accreditation and retention of ISO 17025 certification. The audit was hosted in the Oakdale laboratory during the first week of January, 2012 and included a thorough review of the PLS Quality Systems, facilities, training programs, and equipment maintenance and calibration records.
This audit was the third successful inspection of the Quality System at Pace Analytical Life Sciences within the past year. The Oakdale, Minnesota Laboratory hosted a four-day audit from FDA during February 2011, and the San German, PR, laboratory hosted a four-day audit from FDA during September, 2011. Both audits from FDA resulted in no FDA-483 observations.
The Quality System at Pace Analytical Life Sciences has now been rigorously inspected by ACLASS and two different FDA inspectors within the past year. A wide range of data including training records, facilities records, method validation, stability storage, stability testing, microbiology, raw material testing, medical device testing, equipment qualification/calibration/maintenance, software validation, and investigation records were reviewed during these audits.
“The results of these recent audits are very encouraging and are testaments to our ongoing commitment to providing our clients with defensible, quality data,” said Greg Kupp, Vice President / Chief Operating Officer of Pace Analytical Life Sciences. “Our quality systems have been audited to the highest GMP requirements and ISO standards. Our clients need us, their strategic laboratory partner, to maintain our quality systems to these highest standards and continue delivering thorough, complete and defensible data packages to meet their regulatory requirements.”
Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw material testing, stability testing and storage, product release testing, chemical characterization and residual chemical analysis. Pace Analytical Life Sciences operates two laboratories, one located in Oakdale, MN and the other in San German, Puerto Rico. Pace Analytical Life Sciences is FDA registered, DEA licensed and ISO/IES 17025 accredited.
Contact:
James Wheeler
Director, Business Development
james.wheeler@pacelabs.com
James Wheeler at (651) 738-2728