GMP News - Pharmaceutical Technology

In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.

In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.

Already in 2018, the ICH had started working on a Guideline entitled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS - Q13". A draft was published in mid-2021. Now ICH has approved the final version.

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

To keep a pharmaceutical water system in the qualified state, a suitable maintenance strategy with appropriate maintenance intervals is required. This is demanded by GMP and also makes sense from an operational point of view. Maintenance intervals are already determined in the design phase based on the criticality of the individual components and are specified and controlled in the subsequent commissioning and qualification steps. But which procedures and specifications make sense for the maintenance of a pharmaceutical water system?

Ozone is an effective means for sanitising PW, HPW and WFI systems. But how high should the concentration of ozone be so that the sanitisation effect is sufficient?

There are various directives and standards that define the air-tightness of rooms and their testing in different ways. For example, for the tightness of ventilation ducts there are the tightness classes A to D according to DIN EN 15727, which have nothing to do with the EU GMP cleanroom classes A to D according to Annex 1. VDI Guideline 2083 Sheet 19 lists leakage classes from 0 to 7. So, how tight do rooms or ventilation systems actually have to be for GMP production?