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Ph. Eur. Requests Comments on Inhaled Drug QC Methodologies

The Inhalanda Working Party of the European Pharmacopoeia issued an inquiry in August, seeking comments and/or data on Abbreviated Impactor Measurement(AIM) and Efficient Data Analysis (EDA) methodologies for the quality control of inhaled drugs. The working party is looking for information that shows whether AIM and/or EDA can be effectively used in the quality control […]

USP Official Chapter <787> and <1787> for Particulate Matter

USP issued a new official general chapter <787> in early August on particulate matter for sensitive protein formulations. Chapter <787> includes a testing framework for issues regarding the immunological effects of sub-10µm particles. Informational chapter <1787> accompanies the general chapter to provide guidance on sub-visible particles in the 2 to 100µm range and will become official […]

EDQM Revises CEP Requirements Guideline

EDQM has revised its “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” to include the requirements of the revised EU guideline on “Stability testing for applications for variations to a marketing authorization” and to describe the type of change to be submitted when a Certificate of Suitability (CEP) for […]

Healthcare Veteran John Bournas to Head ISPE

ISPE named John Bournas as its new president and CEO in late July, succeeding Nancy Berg who has held the position since the beginning of 2012. Bournas is a veteran in the healthcare field, having served in management positions at the American College of Cardiology and Cardinal Health, and most recently as CEO/Executive Director for […]

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Processes

Incomplete media fill information for aseptic processes and an inadequate comparison between production and validation conditions for terminal sterilization are among the microbiology concerns in regulatory submissions that most frequently generate information requests and deficiency letters from FDA’s Center for Drug Evaluation and Research (CDER)....

IPQ Monthly Update, June 2014

In focus are: ● FDA’s new process for risk-ranking ANDAs ● an update on other FDA efforts under GDUFA to clarify and streamline its generic drug review process ● the pressure coming from industry to establish an independent review process for new and modified excipients ● advice from FDA compliance experts on proactive GMP communications, and ● the compelling results of Amgen’s eight-year effort to upgrade its nonconformance investigations and follow-up processes to find and address root causes....

FDA Funds PAHO Cooperative Agreement

In early July, FDA’s Office of International Programs (OIP) announced the granting of funds to support a single source cooperative agreement with the Pan American Health Organization (PAHO) to foster cooperation and strengthen regulatory systems in the Americas. This cooperative agreement will support collaboration and investigation in the following areas: ● developing and applying regional/global […]

Japan and Korea Invited to Join PIC/S

The PIC/S Committee, following a meeting in Rome in mid-May, invited the health agencies of Japan (PMDA) and Korea (MFDS) to join PIC/S at the beginning of July as the 45th and 46th members. Both Japan and Korea had applied for membership in 2012. Applications from the health agencies of Brazil, Hong Kong, Iran, the […]

FDA Deploys Risk Ranking Process to Streamline ANDA Review

FDA’s generics office has developed a risk assessment algorithm for the review of abbreviated new drug applications (ANDAs) to help address the challenges of balancing more extensive quality-by-design-based submissions with the foreshortened review timelines mandated under the Generic Drug User Fee Act (GDUFA)....
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