The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a GXP data integrity guide. GXP encompasses various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GPvP). The guidance aims to provide useful information on the core elements of a compliant data governance system across all GXP sectors. Read more “MHRA publishes GXP data integrity guide”
Health Canada has released a risk classification guide that aims to clarify the manufacturing site inspection process for drug manufacturers. The new guidance for good manufacturing practice (GMP) provides information to ensure a uniform approach that inspectors will use to assign one of three different risk classifications to each noncompliance observation noted during inspections of drug manufacturing facilities. The risk classifications are as follows: critical observation (Risk 1), major observation (Risk 2) or other observation (Risk 3). Read more “Health Canada releases risk classification guide for drug GMP observations”
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment, a move that will see increased collaboration in the area of medicine manufacturing site inspections. The FDA will now share full inspection reports that contain non-public and commercially confidential information with the EMA and European Commission.
A clinical evaluation report (CER) is a key supporting document in the steps to obtaining a CE mark. Whilst the initial CER is required at the start of the device lifecycle, many manufacturer’s often don’t appreciate that the report is a ‘live’ document and it must be updated periodically.
The Drug Supply Chain Security Act enacted on November 2013 established a requirement for a Product Identifier to be affixed to each package and homogeneous case of drug introduced into commerce in the USA, from 27th November 2017.
The submission of a variation application always leads to the possibility of validation issues or Notification with Ground (NWG) letter.
Validation issues can appear in many situations, from missing SmPC fragments (31%) to incorrect variation code (8%).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released details of GMP inspection deficiencies from last year.
Overall, the number of MHRA inspections increased by 7% in 2016 compared to 2015. Broken down, this equated to 3 more overseas inspections and 18 more UK inspections.
The report breaks down the most cited deficiencies, rated by numbers of critical, major and other findings.
In the latest blog from the MHRA’s Inspectorate, Mark Birse issues a reminder the about the importation of unlicensed and centrally approved medicines.
Centrally authorised medicines that have an EU marketing authorisations issued by the EMA, cannot be notified to the MHRA for importation as unlicensed medicines. EMA approval is valid in all Member States so these products should not be considered unlicensed. Only if importation is from outside the European Economic Area (EEA) for reasons of unavailability of the medicine throughout the EEA could such as an importation take place.