Regulatory consequences of data integrity failures
Data integrity inadequacies can easily lead to a statement of non-compliance, with serious regulatory consequences, and not only for the manufacturer concerned.
Revisions made to European Pharmacopoeia sterilisation chapters
Methods of sterilisation and the assessment of sterilisation using biological indicators represent important areas of regulatory concern.
Predicting production tablet properties from small scale manufacture
With growing use of the laboratory press system, the ability to predict production tablet properties from lab scale data becomes important. In this article, Michael Gamlen describes how this can be done.
Qualification of visual inspection of parenteral products
Commission SFSTP: F. Caire-Maurisier, F. Dumontier, P. Grel, C. Jolly, É. Levacher, S. Marcq, F. SliwinskiJim Polarine and Beth Kroeger
Visual inspection of parenteral products is required by both pharmacopoeias and good manufacturing practice. The SFSTP Commission have described the various methods and apparatuses commonly used in the pharmaceutical industry for visual inspection.
What a Qualified Person must know about the recent cleaning validation updates
Walid El Azab
The QP must make sure that the pharmaceutical quality system in place is capable of alerting the company to any changes in the regulatory requirements for the manufacturing or cleaning processes that may impact product quality.
Seizing the biosimilar opportunity
Biosimilar medicines are increasing access for patients and will drive significant savings for the NHS. Warwick Smith, Director General of the British Biosimilars Associations, assesses the opportunities to maximise their impact.
New USP guidance provides a useful insight into the interpretation of compaction data and understanding tablet compaction. Correctly used, the guidance will help you make better tablets.
Start-up of cleanrooms, initially and after a worst case event
Jim Polarine and Beth Kroeger
Understanding areas where issues may arise and having a plan in place for prevention and corrective action demonstrates to regulatory agencies how well systems and management react under stress. This article shares best practices for prevention and correction of cleanroom events.
Why pharmacists should study compaction: Part 2 – Making better tablets
Improving tablet quality using a new lab test methodology.
Raising awareness of the dangers of fake medicines: the making of a World Health Professions Alliance video
In 2016, the World Health Professions Alliance, as part of its long-term work against fake medicines, released a campaign video “Counter the Counterfeits”. This article shares how this project — led by the International Pharmaceutical Federation — came to fruition.
Cyberattacks on the pharma industry
Dr Nicola Davies
Cyberattacks in the pharmaceutical industry – why are they so easy and how can they be prevented?
Why pharmacists should study compaction: Part 1 – Introduction
Tablets remain the largest pharmaceutical dosage form by volume and number. This article discusses the history of the measurement during the compaction process, and the equipment required for the study of compaction in academic, research and development and production environments.
Joint supply chain actors statement on information and medicinal products shortages
AESGP, EAEPC, EAHP, EFPIA, EIPG, GIRP, Medicines for Europe, PGEU
The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages.
What Brexit means for British Qualified Persons
Malcolm E Brown
British senior pharmacists who are also QPs think Brexit has substantial implications for British QPs and have urgent questions for the British government and the Royal Pharmaceutical Society.
Compatibility of materials in contact with parenteral preparations: risk analysis and strategy
Commission SFSTP, N Sehnal, D Chevaillier, M Feuilloley, S Genot, C Lacaze, A Laschi, Y Legras, I Uettwiller
Compatibility studies on materials in contact with parenteral preparations are designed to demonstrate the absence of alteration of the quality of the finished product due to incompatibilities. This study proposes information and methods to perform the relevant studies in accordance with regulatory requirements and to anticipate possible interactions or elucidate certain quality defects.
Formulation technology can enable oral delivery of new generation medicines for inflammatory bowel disease
Peter Timmins and Neil Mathias
This article describes emerging therapeutic agents for inflammatory bowel disorders and delivery technologies being investigated to target medicines within the gastrointestinal tract. The opportunity to match these newer drugs to appropriate delivery technologies is discussed.
Regenerative medicine: energising technology evolution towards future medicine
Cecilia Van Cauwenberghe and Sudeep Basu
Although still demanding more specialisation for both scientists and clinicians, regenerative medicine is destined to address the most concerning challenges of current medical therapies.
How a student association prepares its members for the professional world
This article focuses on the projects EPSA carries out in collaboration with the EIPG, such as Mentoring Project and Chat with Professionals.
News From The EIPG
An alternative approach to antibiotics
Bjorn Herpers and Johan Frieling
With the spotlight firmly set on antibiotic resistance, the authors examine the role an innovative antibiotic alternative can play in halting the spread of resistance.
Antibiotic Research UK response to World Economic Forum joint declaration on superbugs
Urgent need for action as the World Economic Forum and Lord O’Neill’s antimicrobial resistance review highlight the challenges of increasing antimicrobial resistance.
Pharmacy in 2050 – forces that will shape practice
This paper takes a look 30 years into the future and attempts to predict how different forces will influence the practice of pharmacy in 2050. Biotechnology, IT and demography among others are identified.
New USP requirements for weighing (Nouvelles exigences USP en matière de pesage)
Commission SFSTP, D. Louvel, B. Baute, M.-D. Blanchin, M.-C. Bonenfant, X. Dua, R. Dybiak, G. Goller, C. Lebranchu, J.-J. Poulain, I. Sabalic, M. Vandenhende
This paper results from the work of the SFSTP commission “Petit matériel” and is intended to enlighten balance users on the new USP requirements for weighing. The reader will find in this document a basis for updating in-house procedures and to carry out initial and on-going balance performance qualifications.
News From The EIPG
Antibiotic resistance in future drugs: EUCAST is vital in creating definitions for a global consensus
An overview of antimicrobial resistance and how the EUCAST system is vital in creating a global consensus on antimicrobial susceptibility testing.
Production processes in the pharmaceutical industry
This article explains how and why optimising production processes in the pharmaceutical industry are key to protecting the end consumer, ensuring the traceability of sensitive products, and remaining on top in a highly competitive market.
Virtual fish ecotoxicology laboratory
Jon Timmis, Mark Coles, Jason Snape, Stewart Owen, Lina Gunnarsson and Alistair Boxall
A virtual laboratory incorporating evidence-based computer-based simulations to better predict environmental risks associated with APIs, reducing the need for animal testing and time and cost of drug development.
Case study: remote blood glucose profiling in diabetes – streamlining the clinical trial process for diabetes trials
New solution from eClinicalHealth streamlines clinical trials by capturing patient data remotely and enabling research that requires no physical site visits.
Biocidal Products Regulation – ‘cleaning’ up the marketplace
The implementation of the BPR has significant implications. By February 2017, all hydrogen peroxide biocides from manufacturers who haven’t submitted a technical dossier will be illegal.
News From The EIPG
The EU-FMD clock is ticking!
This article examines key requirements of the “Safety Features” Delegated Regulation and discusses the implications for pharma manufacturers and other participants in the European pharma supply chain.
New perspectives for gene detection
Birgit Oberleitner and Antonio Manetto
The “ClickGene“ European Network (Horizon 2020) is committed to educating next generation researchers in the assessment of new pathways for personalised medicine and innovative diagnostic applications.
Immuno-oncology: the new weapons fighting cancer
Peter Murphy and Kelly Lambrinos
Recent immuno-oncology developments in PD-1/PD-L1 checkpoint inhibitors, CAR-T therapies and cancer vaccines mean we appear to be on the verge of a treatment paradigm shift in medical history.
Transforming Big Pharma fortunes by replacing patents with patients
As Big Pharma is pummelled for staggeringly high drug prices and poor R&D productivity, this article digs deep to unearth the underlying cause of the issues—the crack of the patent gun. It then proposes radically new ideas to transform this industry in crisis.
News From The EIPG