Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.
Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.
An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.
The updated version of the paperback "ICH Q7 Side-by-Side Comparison", which lists and compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs, is now available.
In view of the recent need for the fast development of medicinal products for COVID-19, the World Health Organization (WHO) published a new guideline on Good Manufacturing Practice (GMP) for development batches. According to the WHO, there are currently no regulatory guidelines available which address this matter.
In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".
Cleaning is an important process step in the field of pharmaceutical production. So what are the requirements for GMP-compliant cleaning from the perspective of the authorities? A current FDA Warning Letter provides information on this.
The French Ministry of Health has published the specifications and quality requirements for medical cannabis in the pilot phase. The document covers flowers, extracts and finished products for oral, sublingual and inhalation use (including devices).
With the coming into force of the FDA Process Validation Guideline 2011 and the revision of Annex 15 (2015), the process life cycle has become state of the art in the field of validation. What does this mean in practice?
Some companies still might think that only deviations lead to corrective and preventative actions (CAPA). But that is not true, as a recent FDA Warning Letter points out.