Regulatory Trends: ICH Q12’s Impact on Product Life-Cycle Management
Cover: The ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” in November 2019. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the definition of a pharmaceutical or biological product, as well as both new molecular entities and authorized products.
Feature: Annex 2 is the GMP document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft revision of Annex 2 that was released for public consultation in September 2019.
Feature: The ISPE Regulatory Steering Council is an advisory group whose primary responsibilities are to develop, prioritize, and reconcile regulatory policy issues through ISPE on behalf of the pharmaceutical industry. This article shares the RSC’s latest initiatives and current goals.
Technical: Good Engineering Practice in Risk-Based Commissioning and Qualification Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification activities have evolved. Now more than ever, C&Q approaches based on quality risk management principles rely heavily on engineering and the application of Good Engineering Practice to provide documentation for the qualification package.
Technical: Solubility Enhancement of Ibuprofen by Porous Solid Dispersion Using a Flash Evaporation Method The solubility behavior of drugs remains one of the most challenging aspects of formulation development and is a key determinant of a drug’s bioavailability. This article describes research aimed to improve solubility of a poorly water-soluble drug (ibuprofen) by preparing a porous solid dispersion using a flash evaporation technique.