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Pharma Capsules
Brief pharmaceutical news items for August 2009.

Pharmaceutical Technology
Volume 33, Issue 8, pp. 60

Milestones

ICDD Names Fellow

The International Centre for Diffraction Data (ICDD) named John A. Anzelmo of Anzelmo and Associates a fellow for his leadership in ICDD's educational programs. Anzelmo, the X-ray fluorescence (XRF) education program director for ICDD, began teaching at the XRF clinics held at the State University of New York in the 1980s and continued in this role as the clinics were transferred to ICDD in 1991.

Anzelmo has helped develop the clinic's curriculum and customize course instruction. He launched the specialized annual workshop "Specimen Preparation for XRF," a hands-on training program, in 2006. John's years of experience have provided him with theoretical and practical knowledge that he shares through his interactions with students during lectures, workshops, and one-on-one networking discussions.

FDA Approves Confab Facilities

Following a good manufacturing practice inspection of Confab Laboratories's (Saint-Hubert, Canada) facilities, systems, and procedures, the US Food And Drug Administration classified the sites as acceptable. No objectionable items were issued.

The inspection was pursuant to the filing of several drug applications by Confab's clients. The inspections covered all aspects of the company's services, including manufacturing, packaging, and analytical laboratories, and also marked the first FDA inspection of Confab's internal quality-control laboratory.

CML Adds Pilot-Plant Capacity

Cambridge Major Laboratories Europe (CML, Weert, The Netherlands) completed a major expansion in pilot-plant capacity that included the addition of 40% in available reactor volume. Work on the expanion started in November 2008, and commissioning took place in March 2009.

CML chemists and engineers designed the new high-efficiency particulate air-filtered 1000-L reactor suite to be flexible. The multipurpose set-up is designed to work under pressures as high as 6 bars and withstand temperatures from -25 to 160 C. The installation is fully qualified for manufacture according to good manufacturing practices. CML intends to support clients as the volume of their projects increases.

Azopharma Expands Cytotoxic Suites

Azopharma Product Development Group (Hollywood, FL) expanded its cytotoxic and highly-potent compound facilities at its Hollywood location. The expansion adds 7000 ft2 of space to Azopharma's capacity and includes three manufacturing suites with dedicated equipment, analytical instrumentation, and staff. The expansion will help Azopharma manufacture and process cytotoxic and highly potent compounds for pharmaceutical development.

Earlier this year, the company completed 11 new manufacturing suites, two aseptic-processing suites, and two explosion-proof suites. Azopharma now has 29 manufacturing suites that include state-of-the-art equipment.

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Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
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Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
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