Publications

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?