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Pharmaceutical Online

 •  January 17

By Kip Wolf, Tunnell Consulting FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in...

Pharmaceutical Online

 •  January 16

This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities. Industry Insights Improving Compliance And Manufacturing Efficiency In Life Sciences White Paper | By Dan...

Pharmaceutical Online

 •  January 16

Oral solid dosage form is the most preferred route because of ease of administration and patient compliance. With the emphasis on developing treatments for complex diseases, the nature of the molecules in the global pharmaceutical pipeline is changing and formulating an oral dose has become more challenging - currently, 90% of NMEs are poorly water...

Pharmaceutical Online

 •  January 15

The hurricane season of 2017 will be remembered as one of the worst, with some of the strongest tropical cyclones ever witnessed creating havoc in the Atlantic basin. The financial impact of these storms is still being measured, but of the more obvious outcomes are: major disruptions to large U.S. ports (Port of Houston was out of commission for...

Pharmaceutical Online

 •  January 15

A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in real-time. Acronyms are independent monitoring system (IMS) or environmental monitoring system (EMS). Software presents that data as information; real-time alarms...

Pharmaceutical Online

 •  January 12

Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and...

Pharmaceutical Online

 •  January 10

This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This...

Pharmaceutical Online

 •  January 10

A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase III study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided...

Pharmaceutical Online

 •  January 9

Industry Insights New Smart Valves Reduce Pneumatic Energy Use By 40% Article | By Steve Bain, Festo Corporation Discover how new smart valve technology can automate your pneumatic energy savings, tamper proof your equipment settings, and enable flexible automation. Volumetric Imaging Technology For Blister Packaging Seal Integrity Testing Article...

Pharmaceutical Online

 •  January 8

This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. Facilities and equipment represent a broad range of risk to...