FDA Warning Letter for Canadian Drugmaker - HPLC and Data Integrity in the Focus
The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.
Outsourced Activities in the GDP Environment: When is a Contract necessary and what Aspects should be covered?
Many transport services in the distribution and supply of medicinal products are carried out by external logistics service providers, and also other activities in the GDP environment are often outsourced. In this context, the question arises in which cases it is necessary to sign a Technical/Quality Agreement, which regulatory requirements apply, and which aspects should be covered in such an agreement.
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the second revision of the common document "Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic". The update includes several new questions and answers from the GDP area, for example on the adaptations to the work of the Responsible Person (RP) and the use of equipment or newly authorised premises for storage and distribution with limited prospective qualification.
COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first revision of the common document "Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic". The update includes a question on GDP certificates and wholesale authorisations.
Fraud in the Supply Chain: Beware of false Offers during Corona Crises
During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective equipment. Unfortunately, this also brings up many fraudsters, as a case revealed by Interpol shows.
COVID-19: Temporary Regulatory Flexibilities for Wholesalers in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of temporary regulatory flexibilities on good distribution practices (GDP) that will be allowed to address the current exceptional circumstances during the coronavirus (COVID-19) outbreak.