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...
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.
FDA’s efforts to continue streamlining approval pathways for medical devices was expanded when, on September 20, 2019, the Agency issued new Final Guidance as a means to help manufacturers understand how the Agency will determine substantial equivalence...
Falsified Medicines Directive 2011/62/EU was published by the European Parliament on 08-Jun-2011. The Directive was implemented to increase the security of the manufacturing and delivery of medicines across Europe, protect patients and prevent falsified...
On 5 June 2018, a plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia. More than 160 professionals from worldwide innovator and generic pharmaceutical companies, academia, and regulatory agencies attended....
