I attended the first joint GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) MHRA Laboratories symposium held on the 30th Sept in Birmingham. Presentations were given by five inspectors working within the inspectorate division covering GCP, GLP and GDP. The topics covered were in relation to clinical trial samples and boundaries between GCP and GLP and which regulations apply.
Although GCP does not mention clinical samples per se, one of the GCP principles states that ‘systems with procedures that assure the quality of every aspect of the trial should be implemented’. This principle extends to activities that include analysis of clinical trial samples. It isn’t a legal requirement to use GLP laboratories for sample analysis but there must be standards in place to assure the quality of the samples and the data generated, with written procedures for all of the steps involved in such activities. This also includes evidence of training and record keeping. There was also a lot of emphasis on what constitutes ‘source data’ and the introduction of ‘metadata’ and discussion on issues like ‘print outs’ from the equipment are unlikely to considered as the source data.
The presentations covered the following topics:
• Quality and technology in the regulatory laboratory
• A risk-based quality assurance programme
• Data integrity for GLP and GCP laboratories
• The GCP Laboratory: requirements and inspection findings
The key focus of the MHRA is data integrity and most of the day was spent going through the requirements stated in the following 3 key guidance/reflection documents:
• Guidance for GLP facilities on the implementation and maintenance of a risk based quality assurance programme’ (Sept 2015). Link here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
• MHRA GMP Data Integrity definitions and guidance for industry (March 2015). Link here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
• EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (Feb 2012). Link here: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_proc...
At the symposium the MHRA also announced that their document entitled: ‘Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples (July 2009), is now superseded, and we need to be referring to the EMA Reflection paper listed above.
To learn more on the above topic, OCTRU are running a training bite on the 20th October, see the OCTRU website - events tab for more details.