iSpeak

ISPE continues to work with a group of industry associations to assist the European Union (EU) and the European Medicines Agency (EMA) with implementation of revision of Annex 1, Manufacture of Sterile Products. Annex 1 is a key document in "The rules governing medicinal products in the European...

This virtual ISPE Global Pharmaceutical Regulatory Summit, held on 28 April 2021, brought together eleven regulators from different parts of the world to discuss how their approach to GMP inspections have adapted to the COVID-19 pandemic. Such a large number of regulators at a single forum is...

As a young Science graduate, I couldn’t think of anything worse than being stuck at the same desk, day in / day out, in a stuffy office, doing the same thing day after day, just to earn a living. There had to be more to life, right? I wanted to travel the world, see new places, not be defined by...

The main change can be seen on the imports of IMPs from EU/EEA to Great Britain starting 01 January 2022. Sponsors of United Kingdom Clinical trials will need to appoint a United Kingdom Manufacture & Importation Authorization (MIA) (IMP) holder who will be responsible for implementing an oversight...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from April 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

While Pharmaceutical development and manufacturing have focused for years on robust quality management systems (QMS), the application of quality risk management (QRM) applying digital tools and advances are critical to future success. Coupling controls, artificial intelligence, and associated...

ISPE’s quality management maturity program, Advancing Pharmaceutical Quality (APQ) has progressed significantly. The first Good Practice Guide in a series, Corrective Action, Preventive Action (CAPA) was published in December 2020. To assist practitioners, a complimentary webinar, Advancing...

Case studies demonstrating the link between knowledge and risk in technology transfer and commercial manufacture

Economic Operators Registration and Identification (EORI) Number Customs procedures also imply having an Importer of Record liable at destination as well as having each party, exporter, and importer, registered, and identified with its own EORI (from the Country it is based at). An XI EORI number...

Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during April 2021. Learn more about understanding cleanliness classifications, steam sterilization, and more from what visitors to the PE Online site were reading last month.

Quality is the strongest force multiplier for any organization’s growth. Attaining higher quality levels has a multi-dimensional effect throughout any organization. Creating and sustaining a passion for quality brings higher levels of responsiveness, confidence and flexibility to organization wide...

Early in March 2020, many around the world viewed the sight of collapsing intensive care units in Northern Italy, overwhelmed by COVID19, with great anxiety and we wondered how we might address the inevitable arrival of the virus at our doorsteps. This concern led to a home-grown initiative in...

ISPE is pleased to announce that its Drug Shortages Initiative Task Team is launching a new phase of work to focus on business continuity planning for the prevention of drug shortages. We invite your company to participate. The first activity is a benchmarking study that will launch in May 2021 and...

You are an active and engaged ISPE Member! You sit on the ISPE Board of Directors, the ISPE Foundation Board, and the Steering Committee of Women in Pharma®.  Can you share some of your experiences with ISPE and some of the many successes you have accomplished?

Prathiba Sampath, PMPFor me, both personally and professionally, 2020 started off as an incredible year. My husband and I were expecting the arrival of our first child in April. At work, I was being entrusted with increasing responsibilities and being groomed for a promotion, while having an...

The UK Entered a New Relationship with the European Union on 1 Jan 2021 The United Kingdom (UK) (England, Northern Ireland, Scotland and Whales) is no longer part of the European Union (EU) Customs Union. Simply put, it means movement of goods between the UK and the EU are now to be an import and...

Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during March 2021. Learn more about understanding cleanliness classifications, steam sterilization, and more from what visitors to the PE Online site were reading last month.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.