FDA Revisions Affect 503A and 503B Compounders

The FDA recently released the September 2018 revision to its Insanitary Conditions at Compounding Facilities guidance.

It includes changes that affect both 503A and 503B compounding facilities. One notable modification begins at line 104 in the document:

Note that the examples of insanitary conditions described in this guidance for products intended to be sterile can exist in cleanroom and associated controlled environments, as well as segregated compounding areas (SCAs), as described in United States Pharmacopeia (USP) Chapter <797> (USP <797>). However, when a compounding facility other than an outsourcing facility produces drugs in a SCA, FDA generally does not intend to take action with respect to certain conditions described in this guidance identified with an asterisk (*), provided that the compounding facility: (1) complies with all criteria for an SCA in USP <797>; (2) assigns beyond-use-dates that do not exceed 12 hours when stored at room temperature and 24 hours when refrigerated or frozen; and (3) does not have any additional insanitary conditions.

It is important that everyone who compounds pharmaceuticals read this document. Understanding of these changes will lead to continued product and patient safety.

 

2018 Events

Sneak Preview of ALG on Worldwide Business with Kathy Ireland

Mark your calendars, Analytical Lab Group makes its television debut on June 3. Worldwide Business with Kathy Ireland is a business and health show featuring industry leaders discussing in-depth solutions to current issues. Their ALG segment features CEO Alan Roth and explores how ALG provides comprehensive testing solutions for infection prevention.

Click to watch the clip below for a sneak preview of the full interview.

“The work they are doing is phenomenal,” J.L. Haber, Vice President of Programming, said in a press release. “Anything that helps keep infections and disease at bay from harming the general public is a step in the right direction.”

The complete segment airs at 4 p.m. Central on Sunday, June 3, as sponsored content on Fox Business Network.

Celebrate World Hygiene Day with ALG

Good Hygiene is a Cause to Celebrate

According to the World Health Organization, hand hygiene saves millions of lives every year when performed at the right times in health care. The simple act of washing your hands removes many transmittable infectious microbes.

Yet about 70% of health care workers and 50% of surgical teams do not routinely practice hand hygiene. And surgical site infections are the most frequent type of infection in low- and middle-income countries, with sepsis estimated to affect more than 30 million patients every year worldwide.

May 5 is World Hygiene Day. To celebrate, help reverse this trend.

  • Develop requirements for hand washing and hand sanitizer use.
  • Ask your care provider to wash their hands before examining you.
  • Be sure to wash your hands before handling food or touching communal objects.

Watch ALG on Worldwide Business with Kathy Ireland

This week, Analytical Lab Group CEO Alan Roth spent some time in California recording a segment for Worldwide Business with Kathy Ireland. The business and health show features industry leaders discussing in-depth solutions to current issues.

The episode featuring Roth and ALG will air later this spring on Fox Business Network and Bloomberg. But you can get a sneak peek below.

Analytical Lab Group at Forefront of Growing Cleanroom Sector

Analytical Lab Group remains at the forefront of the growing cleanroom sector. ALG laboratories on both the East and West coasts provide cleanroom and environmental monitoring services. Learn more about specific test offerings from Microbiology Research Associates and Microbiology & Quality Associates by visiting their websites. 

You also can learn more about the cleanroom sector’s growth in this article by Cleanroom Technology.

Analytical Lab Group Announces Acquisition, Appointment of Chief Executive Officer

 

Analytical Lab Group has recently completed an expansion of its laboratories by acquiring Microbiology & Quality Associates in the San-Francisco Bay area. In addition, ALG has appointed Alan Roth as Chief Executive Officer as the company continues to pursue additional growth opportunities.

Early on, ALG made two key investments to establish its service offering. In 2015, ALG acquired Microbiology Research Associates, based in Acton, Mass., and in 2016, ALG acquired Accuratus Lab Services, based in Eagan, Minn. The acquisition of MQA broadens ALG’s service offering and provides ALG a strategic West Coast presence.

MRA is an industry leader and has provided microbiology testing, consulting, and research services to the pharmaceutical, cosmetic, medical device, biotechnology and health care industries for more than 25 years. MRA is also the leader in on-site environmental monitoring of hospital compounding pharmacies in New England. MRA has a state-of-the-art ISO 5 cleanroom with isolator and is FDA and DEA registered.

ALS is the leading global provider of antimicrobial and biocide testing services and has provided a comprehensive range of microbiology, virology, and product chemistry services to the developers, manufacturers, and users of antimicrobial products for more than 25 years.

MQA has similar testing capabilities as MRA and has provided microbiology and environmental monitoring testing services to the pharmaceutical and biotechnology industries for nearly 15 years. MQA also has capabilities for cell bank production and testing services. MQA is FDA registered and ISO 17025 accredited.

“We are excited about bringing the benefits of a West Coast presence to our existing customers, and we look forward to work with MQA to grow and expand its services to both existing and new pharmaceutical and biotechnology companies,” Roth said. “MQA has a strong reputation and has a talented team working in its lab.”

“We are excited to appoint Alan as CEO,” said Matt Scherrer, managing director of Thompson Street Capital Partners, which is the majority owner of ALG. “Alan has a great track record for successfully integrating acquired businesses and executing successful growth strategies through combining internal growth with select acquisitions, and we look forward to having him lead ALG from the front as CEO.” Roth previously served as COO and CFO of ALG portfolio companies.

Just like ALG’s previous acquisitions, MQA’s management team, lab, and brand will remain the same. There is no need for customers to redo any service agreements, and the customers will see the same great service from the same team and lab, just as MQA has always delivered. MQA CEO Juan Munoz said, “We are excited to join with the other ALG portfolio companies; the combined scientific experience and quality systems of the ALG portfolio companies and commitment to invest the necessary capital to continue to grow and provide adequate facilities positions MQA well to meet the needs of the growing biopharmaceutical and medical device industries that MQA has historically serviced.”

About Analytical Lab Group: Analytical Lab Group portfolio companies provide a comprehensive range of microbiology, virology, product chemistry, and environmental monitoring services to the antimicrobial, pharmaceutical, medical device, and health care industries.  Analytical Lab Group has laboratories throughout the United States and its portfolio companies consist of  Accuratus Lab Services (Eagan, Minn.), Microbiology Research Associates (Acton, Mass.), and recently acquired Microbiology & Quality Associates (Concord, Calif.). For more information, visit www.analyticallabgroup.com.