Navigation Links
AAIPharma Services Builds Compliance Record at Lab, Manufacturing and Packaging Operations
Date:6/30/2011

WILMINGTON, N.C., June 30, 2011 /PRNewswire/ -- AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, announced that it has passed inspection of its Durham analytical lab by the Food and Drug Administration (FDA) with no inspectional observations. The May 2011 audit is the fourth since 2003 during which these laboratory operations have not been issued an FDA-483 citing any inspection concerns. The FDA conducted its audit this year in the Durham lab's new location at 4620 Creekstone Drive, which AAIPharma Services moved into in 2010.

"Once again passing the FDA inspection without issue reflects the strong focus on compliance and accurate documentation that is the legacy of AAIPharma Services," said Christopher Smith, vice president of Corporate Quality Assurance and Regulatory Affairs. "Having this laboratory testing facility thoroughly audited is a reassurance to our global clients that their pharmaceutical products developed and tested here for clinical and commercial uses will be of the highest quality and meet regulatory standards."  

Smith also noted that the successful FDA audit in Durham comes on the heels of two Good Manufacturing Practices (GMP) certificates issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to AAIPharma Services Corp. The European Union (EU) GMP Certificates followed audits of the company's Charleston, S.C., manufacturing and lab operations for parenteral products and its Wilmington, N.C., inspection, labeling, packaging, shipping and lab operations supporting Charleston.

Chief Executive Officer Pat Walsh said, "Earning these EU GMP Certificates lets our global clients know they will have no issues shipping pharmaceuticals from these facilities into Europe, or into countries such as Canada and Australia that have mutual recognition agreements (MRAs) with the EU. It gives our clients confidence in AAIPharma Services as their preferred provider of drug product development and manufacturing, from compound to clinic around the world."

AAIPharma Services Corp.

AAIPharma Services Corp. is a leading provider of services that encompass the entire pharmaceutical drug development process from early development through commercialization. The company, which has the benefit of more than 30 years of experience, specializes in analytical chemistry, formulation development, clinical packaging, oral drug delivery and contract manufacturing. AAIPharma Services serves more than 300 large pharmaceutical and biotechnology companies. It is headquartered in Wilmington, North Carolina. For more information, visit our website at www.aaipharma.com


'/>"/>
SOURCE AAIPharma Services Corp.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AAIPharma Services Appoints Maffuid as EVP Operations
2. AAIPharma Services Announces Promotion of Dean Shirazi
3. AAIPharma Services Announces Compendial Testing Facility Expansion
4. AAIPharma Services Corp. Names Patrick Walsh Chief Executive Officer
5. Concord Medical Services Files 2010 Annual Report on Form 20-F
6. TeleHealth Services and Sentara Healthcare Partner to Reduce Readmissions Through Interactive Patient Care
7. Flextronics Global Services Budapest Receives ISO 13485 Medical Certification
8. ImpactRx Names Kjell Nygren Vice President, Analytical Services
9. Radiation Therapy Services Holdings, Inc. to Present at the Wells Fargo Securities 2011 Healthcare Conference
10. Texas & U.S. Drug Treatment Gap to Be Highlighted at News Conference 11 a.m. June 23 By Former U.S. Drug Czar, U.S. Music Industry/Grammys Addiction Services Leader, Miss Texas 2007, San Antonio Police Chief, Nations Leading Treatment CEO, Experts
11. Dr. Assad Al-Ammar Joins Irvine Pharmaceutical Services as the New Minerals Analysis Manager in Response to the Growing Needs for USP Elemental Impurities Testing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... --   , Total Sales ... Sales  Clinical sales grow 16% year-over-year  , ... OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser ... quarter ended March 31, 2016 and provided an update ... strategy. First Quarter 2016 Revenue Results by ...
(Date:4/27/2016)... , April 27, 2016 ... titled, "Skincare Devices Market - Global Industry Analysis, Size, ... to the report, the global skincare devices market was ... anticipated to expand at a CAGR of 10.1% from ... 2023. Browse the full Skincare Devices Market (Treatment ...
(Date:4/27/2016)... NEW DELHI , April 27, 2016 ... CSR initiative to save newborns ... ,s hospital for women & newborns in collaboration with Breast ... has launched the first Pasteurized Human Milk Bank, ,Amaara, in ... the best nutritional food source for infants and should be ...
Breaking Medicine Technology:
(Date:4/29/2016)... Atlanta, Georgia (PRWEB) , ... April 29, 2016 , ... ... 60 rural hospitals across the Southeast, celebrated the signature of Gov. Nathan Deal on ... by Rep. Geoff Duncan (R - Cumming), offers a 70% tax credit to individuals ...
(Date:4/29/2016)... ... 29, 2016 , ... The White House announced efforts yesterday ... information about their loan terms and accounts, and more protections for borrowers. The ... and private loans, has reached $1.3 trillion, with 43 million Americans holding student ...
(Date:4/29/2016)... ... 29, 2016 , ... A new study by a Johns ... hernia have better survival rates if surgery is performed early. Approximately one in ... diaphragm fails to form completely, letting abdominal organs into the chest cavity and ...
(Date:4/29/2016)... ... 29, 2016 , ... Mobility Designed is redefining mobility with their patent ... M+D Crutch evenly distributes body weight from the elbow to the forearm. In ... crutches than with other crutches. , Co-founders Max and Liliana Younger were inspired to ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... Melanoma is the deadliest type of skin ... blame for the majority of skin cancer deaths. More than 10,000 people are expected to ... at diagnosis is 62, it is the one of the most commonly diagnosed cancers in ...
Breaking Medicine News(10 mins):