GMP News - Pharmaceutical Technology


European Inspectors criticise Cross Contamination

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.



Restrictions for PTFE used in Pharmaceutical Plant Engineering?

Fluoropolymers have an extremely high chemical stability. However, this stability also means that once they enter the environment, they can remain there for a very long time and cause environmental damage. The EU plans to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.



ICH Q13: Final Version of Guideline for Continuous Manufacturing published

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.



Cross Contamination in Steam Steriliser at US Sterile Manufacturer

In October, the US FDA issued a Warning Letter to a US sterile manufacturer due to numerous GMP violations. The inspection, which had already taken place from March to April 2022, had revealed numerous deficiencies. The main reasons for the Warning Letter were cross contamination and microbiological contamination of products.



FDA Warning Letter to Drug Manufacturer in Puerto Rico

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.



Cross Contamination Risk: Production stopped

In April, the US FDA inspected a manufacturer of OTC products in Mexico. Due to the deficiencies found, in particular the unacceptable risk of contamination, the production was stopped.



What is the correct Maintenance of a Pharmaceutical Water System?

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?



Membrane Technology for Pharmaceutical Water - How often to sanitise?

Both in the production of purified water and in the production of WFI with membrane technology, reverse osmosis plays an essential role as the main barrier to impurities of all kinds. For pharmaceutical use the systems including the RO modules should be hot sanitisable. Chemical sanitisation of RO modules is no longer considered state of the art. But how often should hot sanitisation be carried out?



Is there a Specification for the Ozone Concentration in Pharmaceutical Water Systems

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?



How is Room Air Humidification of GMP Areas Performed?

Typically, the room humidity is also regulated and controlled in cleanrooms. For this purpose, the outside air is dehumidified in summer and humidified in winter, especially in dry cold weather, to ensure a minimum humidity in the cleanroom. So, how exactly is the room humidification for GMP-regulated areas carried out? What quality should the evaporated water or its condensate have? These questions are frequently asked and controversially discussed.



Air-Tightness of GMP Cleanrooms

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?



USP Article: In Vitro Test Methods for Continuous Manufacturing

The continuous manufacture of medicinal products is a young, spreading type of modern pharmaceutical production. In contrast to classical batch manufacturing, these processes run continuously, i. e. dosing and product withdrawal run uninterrupted and are continuously monitored. A recent USP article discusses what release testing might look like.



CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).



How often do terminal HEPA Filters need to be changed?

A frequently asked question concerns the time after which the terminal filters of the ventilation system in pharmaceutical cleanrooms must be changed.



GMP Deficiencies in the Sterile Area

In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.


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