GMP NEWS 2020

The FDA has recently published a Warning Letter following an inspection conducted at a US-American manufacturer of ophthalmic sterile preparations, which revealed numerous serious deficiencies. These include environmental monitoring, lab data integrity, gowning procedures, media fill and maintenance/cleaning of production equipment.

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 MHRA GVP inspectorate recently published their latest pharmacovigilance inspection metrics report. The report includes remote inspections and lists critical findings in relation to risk management, the quality management system and the provision of information for inspections.

After a 15-month prison sentence, the owner of Immuno Biotech is now threatened with the seizure of GBP 1.4 million in connection with the manufacture, sale and supply of an unlicensed drug.

In our News dated 19.08.19, we had mentioned the draft of a new Ph. Eur. chapter  (5.28) regarding Multivariate Statistical Process Control. This chapter has now been adopted and will be published in the October 2020 issue.

Is there an FDA requirement to perform a success control after GMP training? Actually, the answer is no.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.

The MHRA recently shared their expectations regarding electronic systems used in clinical trials and what they want to see during a GCP inspection.

The U.S. FDA issued a Warning Letter to the US American contract testing laboratory “International Trading Pharm Lab Inc” due to significant violations of cGMP regulations and the inaccurancy of electronical data for Active Pharmaceutical Ingredients (APIs).