As regulatory agencies invite public comment on a new or revised regulation or guidance they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we can provide...
ISPE participated in the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise Regulatory, Technical, and Workforce elements favorable to creating a more robust and sustainable domestic...
ISPE was selected as one of a limited number of focused stakeholders to provide comments on nine questions posed by PIC/S on the draft GMP Guide Annexes 2A for Advanced Therapy Medicinal Products (ATMPs) and 2B for Biological Medicinal Substances. ISPE...
A committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) is conducting a study with the aim of producing a consensus report that identifies emerging and upcoming technologies that have the potential to...
The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....
Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable...
Annex 2 is the Good Manufacturing Practices (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...
On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances...
The internet has led to an increase in e-commerce of prescription and over-the-counter (OTC) medicinal products; one in four adults has purchased medicines online.Orizio, G., A. Merla, P. J. Schulz, and U. Gelatti. “Quality of Online Pharmacies and Websites Selling Prescription Drugs: A Systematic...
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines.
