The GMP regulations do not provide any concrete specifications for the calibration of weighing instruments. They refer to suitable measuring and weighing ranges and the required accuracy. Regular maintenance and calibration are also required. So how can these general formulations be interpreted?
The FDA has clear expectations about cGMP compliance in an analytical laboratory. Read more about what the cGMP-compliant running of chromatographic systems in a quality control laboratory should look like.
The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.
The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).
The ISPE Baseline Guide Vol. 5 on Commissioning & Qualification has been in place since 2001 and was thus no longer up to date. Recent developments, e.g. towards a lifecycle model, were not reflected in the document. Now the ISPE Baseline Guide Vol. 5 has been completely revised.
In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.
The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.
Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.
The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.
New GPD Non-Compliance Reports have been published in the EudraGMDP database, leading to a suspension of the WDA of the inspected companies.