Navigation Links
New White Paper Details What Compounding Pharmacies Must Know to Prepare for FDA Inspections
Date:4/16/2013

AGAWAM, Mass., April 16, 2013 /PRNewswire/ -- In anticipation of new US Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection. Titled, "Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA," it is available to download at http://www.microtestlabs.com/whitepaper from Microtest Laboratories.

"The FDA requires all compounding pharmacies to comply with USP section <797>, which outlines the different standards and regulations for environmental control, testing, and personnel training. Currently, the operations of large-scale compounders do not fall under the scrutiny and regulation of the FDA. However, these facilities may now face inspections from both the state regulatory authorities and the federal government," said white paper author Steven Richter , Ph.D., president and scientific director of Microtest Laboratories -- and a former FDA official.

In the white paper, Dr. Richter advises compounding pharmacies on the critical issues to resolve prior to an FDA or state inspection, including sterile compounding regulations, quality testing, sterility testing of compounded articles, disinfectant validations, and endotoxin testing.

"In the aftermath of the NECC case, FDA and state actions regarding compounding pharmacies are relatively certain: regulations and inspections will both tighten and increase. The FDA, in some instances, will assume the role of lead auditor for the compounding pharmacy's operations," Dr. Richter said. "It is critical for compounding pharmacies to maintain a state of control in their controlled environments. While there may always be excursions, it is the actions that are undertaken after the excursions that will influence an inspector's responses and observations during an on-site investigation and inspection."

Download a copy of "Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA," at http://www.microtestlabs.com/whitepaper. Or, request a copy by calling Microtest Laboratories 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest Labs' environmental sciences group helps clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Available Topic Expert: For information on the listed expert, click appropriate link.
Steve Richter , Ph.D.
https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest Laboratories
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. New White Paper, "Five Biggest Myths about Medical Products Outsourcing," Finds OEMs Concerns are Often Unfounded
2. Long-Term Use of Blood Pressure Medications that Promote Sun Sensitivity May Increase Risk of Lip Cancer in Non-Hispanic Whites
3. Pharma IQs Laboratory Informatics Whitepaper
4. Lance Armstrong Update: Arrogant Even After Conceding Doping Charges, Asserts Former White House & WADA Spokesman Robert Weiner; Victory for Clean Sport but "Dark Message" Is Science Must Catch Up to Masking Agents Allowing Cheating
5. New Jensen Dental White Paper Reveals How Dental Laboratories Can Increase Productivity, Profitability with a Multi-Function Pressing Furnace
6. White Paper Details Five Things to Consider Before Buying Spiral Bevel Gear Drives
7. MEI Pharma Announces Retirement Of Chairman Bryan Williams From Board Of Directors And Appointment Of Christine White As Lead Director
8. Heraeus Expands Its Venus White Line of Whitening Maintenance and Oral Care Products
9. Scott & White to Open Emergency Hospital in Cedar Park
10. TeamHealth White Paper Examines Telemedicine Risks, Risk Management Strategies
11. Disinfectant Qualification Questions are Answered for Sterile Drug Manufacturers in New White Paper
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
Breaking Medicine News(10 mins):