Publications

Best Practices • Guidances • Regulatory • Study Design

This article summarizes the collective views of industry participants at a Pharmaceutical Research and Manufacturers of America Analytical Research and Development Steering Committee workshop on acceptable analytical practices on the topic of forced degradation studies. The article includes an overview of available guidance and some suggestions for best practices.

Data Integrity • Laboratory Issues • Quality • Systems

Event Overview (This is an on-demand webinar): The increased use of electronic data and computerized systems has introduced new challenges to maintaining data integrity. With regulated companies under increased scrutiny by regulatory authorities, companies need to ensure they have a thorough understanding of their regulated systems and how to assess them for gaps. Waters will provide insight on the current focus for data integrity with specific examples of how to monitor Waters Empower data. We will also provide additional tools and services that can help prepare for internal and external audits.

Best Practices • Calibration • Chambers • Sample Control • Study Design

This presentation explains essential photostability testing requirements for small (traditional pharmaceutical) molecules and large (biotechnology products) molecules according to the ICH Q1B and Q5C guidelines. It also explains the basics of what needs to be tested (such as active pharmaceutical ingredient, final finished product, product as packaged, etc.), when it needs to be tested, the light exposure devices used per the ICH requirements, sample presentation and general tips.

Pharmacopoeia • Regulatory

This Free ON DEMAND Webinar provides an overview of the interplay of pharmacopoeias and a company’s quality assurance and regulatory affairs functional areas to assist in establishing effective processes, partnerships, and tools for pharmacopeia compliance. This course can also help you determine whether additional customized training – which is available through CfPA – could enhance your understanding and improve the approaches taken by your company to maintain appropriate and timely compliance with pharmacopoeia requirements.

Pharmacopoeia • Regulatory

This comprehensive 2-day course will provide an understanding, including practical examples of compliance with compendial requirements, as published by pharmacopoeias. The course includes an introduction to the pharmacopoeias, with an emphasis on the USP-NF, Ph. Eur. and BP. A global perspective is presented, with consideration also given to the pharmacopoeias in other important countries. Details of the content, organization and use of the pharmacopoeias are presented, along with regulatory considerations and applicability of compendial requirements. There is a detailed exploration of the development and revision processes for compendial standards, with real-life case studies offered. Efforts toward compendial harmonization are described, with information on the activities of the Pharmacopoeial Discussion Group (PDG) and prospective harmonization of drug substance/product monographs. The course concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and – ultimately – compliance with the requirements in the pharmacopoeias.

Methods • Testing

Many types of packaging materials are involved in the production and containment of drug products, such as the elastomeric closure, vials, or another containment device. Each of these items may impact the drug product over time. The typical process of evaluating E&L begins with identifying the extractables, which are chemical compounds that can be released from containers, closures, and packaging materials under exaggerated or extreme conditions. While extractable testing is a necessary starting point, it does not provide all the required information to determine drug compatibility. Therefore, further testing is needed to investigate leachables, which are the subset of extractables that migrate into the drug product under normal conditions. In an ideal situation, the only leachable compounds detected in a drug are compounds present in the extractables profile, however, the leachable profile can contain additional compounds. These additional leachables can be the result of environmental influences or reactions between compounds and the drug, generating new compounds not previously detected.

Best Practices • Calibration • Chambers • Operation • Preventive Maintenance • Qualification

In the pharmaceutical industry, stability chambers are designed to store the drug product or material in different storage conditions.

Let’s understand What are stability chambers in pharmaceuticals. How do stability chambers work? What is the purpose of stability chambers in pharmaceuticals?