Remove 2022 Remove Labelling Remove Process Improvement
article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). For purpose of illustration used throughout this article, labels have been assigned to each CQA. ISPE Regulatory. Langer, and R.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). For purpose of illustration used throughout this article, labels have been assigned to each CQA. ISPE Regulatory. Langer, and R.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Accessed 3 December 2022. 7 November 2022. www.weforum.org/agenda/2022/11/3-ways-healthcare-systems-carbon-footprint/ 5 European Commission. Accessed 3 December 2022. Feroz, and S.

article thumbnail

Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements.