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.
To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.
Deficiencies in aseptic production have led to a Warning Letter to the Japanese company Takeda Pharmaceutical Company Limited. Part 2 of the News deals with deficiencies in the media fill. What sort of issues did lead to this Warning Letter?
The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.
The Swissmedic has been informed by the Brazilian Health Regulatory Agency ANVISA that Brazil has suspended all imports of medicinal products from three Turkish wholesalers. In this regard, an information for Swiss companies was published.