As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS). Understanding the necessary technical controls to implement and manage analytical operations is crucial to ensure regulatory compliance. Pharmaceutical Technology will present a live educational webcast, “Achieving Regulatory Compliance When Moving to ICP-MS for Elemental Impurity Analysis,” on Wednesday, November 6, 11:00 AM to 12:00 PM EST to provide insight from leading industry experts on ICH, USP, and EMA guidelines for elemental impurity analysis and best practices and strategies to optimize the analytical workflow, data management, and data reporting when using ICP-MS. Read more »
Archive for the 'Analytics' Category
Product quality is of paramount importance to pharmaceutical manufacturers, and implementing a strategy for impurity control is crucial. Organic impurities cover a wide spectrum of compounds that have varying structures, behaviors, and characteristics. Organic impurities can result from the manufacturing process, storage conditions, or degradation resulting from light, heat, and other external factors. Deciding what technology or analytical methods to use to detect and measure organic impurities is a challenge. Pharmaceutical Technology will hold a live educational webcast, “Meeting Regulatory and Technical Requirements for Organic Impurity Analysis, on Tuesday Sept. 24 at 11:00 AM EDT to 12:00 PM EDT to provide insight on the regulatory, compendial, and ICH requirements for organic impurity control and analysis as well as best practices in analytical method development, method selection, and method validation for detecting and quantifying organic impurities in drug substances and drug products.
The panelists for the webcast will be: Timothy Watson, PhD, and research fellow in the GCMC Advisory Office at Pfizer and a member of the PhRMA Expert Working Group on the ICH Q11 regulatory guidance document for drug substances; Mark Argentine, PhD, senior research advisor, analytical sciences R&D with Eli Lilly; and Hildegard Bruemmer, PhD, operational laboratory manager, SGS Life Science Services, Berlin. The panelists will provide insight on the regulatory and compendial requirements for organic impurity control and analysis in drug substances and drug products. They will also share insight on selecting the appropriate analytical methods for the detection, analysis, and quantification of organic impurities and offer related case studies on how best to ensure product quality.
Audience members may ask questions of the panelists during the live webcast. Information on how to register for the webcast, “Meeting Regulatory and Technical Requirements for Organic Impurity Analysis” for Tuesday Sept. 24 at 11:00 AM EDT to 12:00 PM EDT and for on-demand viewing is available here.
Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »
Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.
Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand here.
Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at firstname.lastname@example.org. (*Note: We will keep your name and company affiliation anonymous.)
Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.
• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?
Guest blog by Ben Comer of Pharmaceutical Executive.
The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly, but they are – at least Big Pharma is – spending more on so-called inbound social media software and analytics, which lets them listen to what is being said online about brands and unmet needs and match that up marketing strategies. Read more »
The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures (<232> and <233>) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).
According to the latest update from the USP website, the new chapters will be published in the Second Supplement to USP 35–NF 30 (official Dec. 1, 2012). Conformance with these chapters will be required by May 1, 2014. In the interim, all references to USP General Chapter <231> Heavy Metals will be removed from monographs in the compendia.
The International Conference on Harmonization (ICH) Working Group on Elemental Impurities is simultaneously working to develop a harmonized approach for controlling these impurities, including risk-assessment recommendations and safety limits for specific metals, that meet testing and regulatory filing requirements at the global level. USP has noted that its expert panel is not waiting for the final recommendations from the ICH Q3D Expert Working Group but does note that the limits in the new General Chapter <232>, except for mercury, are in line with those in the stage 2 draft of the Q3D guideline. “At a future date, the Expert Panel intends to revisit General Chapter <232> relative to the Step 4 outcome of ICH Q3D deliberations,” says the USP elemental impurities webpage.
PharmTech is hosting and moderating a free educational webinar about the revised USP chapters on June 14, 2012, with a specific focus on new testing procedures and practices for detecting elemental impurities. Instrumentation, key challenges, best practices, and will be addressed.
Register for the free webinar
This blog post was written by Lynn D. Torbeck
Textbooks and journal articles treat common cause variation as if it is an inevitable fact of nature and beyond our control: “In any production process, regardless of how well-designed or carefully maintained it is, a certain amount of inherent or natural variability will always exist. This natural variability or ‘background noise’ is the cumulative effect of many small, essentially unavoidable causes” [Emphasis added]. This attitude cuts off thoughts of trying to reduce variation. But, with some reflection, there are several ideas and techniques that can begin to help reduce common cause variation. Read more »
Biopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar. Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration. Read more »
As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »