Beitrag aus der Ausgabe 1/2023 der Zeitschrift pharmind

Anforderungen an Audits in der Pharmaindustrie

Beispiel eines automatisierten Systems für Klima-Monitoring

Dipl. Wirt.Ing. (BA) Stefan Prothmann und B.Eng. Nicolai Denzel · Testo SE & Co. KGaA, Titisee-Neustadt

Wenn ein Produkt oder eine Dienstleistung z. T. oder gar nicht das leisten, was der Kunde erwartet, wird dies eine Kette von Reklamationen auslösen, denen in Extremfällen eine Klagewelle folgt. Daher gilt es solche Entwicklungen, die für das betroffene Unternehmen nicht nur finanziell ungünstig, sondern u. U. sogar eine Existenzbedrohung darstellen können, erst gar nicht entstehen zu lassen. Deshalb machen Gesetzgeber und ...

Beitrag aus der Ausgabe 1/2023 der Zeitschrift pharmind

Cleaning Validation in the Production of Active Ingredients and Medicinal Products from Herbal Origin

A Risk-based Approach

Jens Herkenrath¹, Dr. Katharina Robach², Philipp Römann³, Dr. Frank Poetsch⁴, Dr. Barbara Steinhoff⁵ · ¹Viatris Healthcare GmbH, Troisdorf ² · Deutsche Homöopathie-Union DHU-Arzneimittel GmbH & Co. KG, Karlsruhe ³ · Salus Haus Dr. med. Otto Greither Nachf. GmbH & Co. KG, Bruckmühl ⁴ · Bad Heilbrunner Naturheilmittel GmbH & Co. KG, Bad Heilbrunn ⁵ · Bundesverband der Arzneimittel-Hersteller e. V., Bonn

In accordance with Chapters 3 and 5 of the EU GMP Guideline [1,2] the use of clean equipment and the prevention of cross-contamination are basic principles of GMP. Besides the attention to the design of the premises and equipment, such preventive measures should be supported by attention to process design and implementation of any relevant technical or organisational measures. This includes effective and reproducible ...

Beitrag aus der Ausgabe 1/2023 der Zeitschrift pharmind

Monitoring raumlufttechnischer Anlagen von Reinräumen und reinen Bereichen

Flechl • Monitoring raumlufttechnischer Anlagen

Harald Flechl Wien

Das Pharmamonitoring der raumlufttechnischen Anlage dient der Messung, Registrierung und Speicherung von Daten, die für die Qualität von Arzneimitteln von Bedeutung sind und damit oft auch in die Chargendokumentation einfließen. Die qualitätsrelevanten Daten der raumlufttechnischen Anlage sind risikobasiert festzulegen und in der Kontaminationskontrollstrategie zu beschreiben. Während das Pharmamonitoring zur Überwachung qualitätskritischer ...

Beitrag aus der nächsten Ausgabe 2/2023 der Zeitschrift pharmind
(erscheint am 28. Febr. 2023)

Aktuelle Themen bei der Einführung von kalten WFIErzeugungssystemen in Europa / Teil 1

Seit 2017 darf gemäß Europäischem Arzneibuch auch in Europa mittels Membrantechnik Wasser für Injektionszwecke (WFI) hergestellt werden. Der Artikel betrachtet die dadurch möglich gewordene laufende Transformation der Mediensysteme in der pharmazeutischen Industrie – weg von den bisherigen Destillationsanlagen hin zu kalten (im Sinne von „bei Raumtemperatur arbeitenden“) Anlagen. Regulatorische und technische Besonderheiten und Probleme werden erläutert und Lösungswege aufgezeigt.

Beitrag aus der nächsten Ausgabe 2/2023 der Zeitschrift pharmind
(erscheint am 28. Febr. 2023)

Complaint management of a quality defect in a nanoparticulate Imiquimod formulation in an investigator initiated academic phase I/II clinical trial / Part 1

Complaint management related to pharmaceutical products is essential to protect the health of the public. It involves recording/ documentation, assessment, investigation, and review of complaints concerning quality defects of the pharmaceutical product with a potential recall of the affected batch(es) or withdrawal of the product from the market. Assessments and investigations of quality defects should be conducted applying quality risk management procedures and enabling decision making regarding the necessity to execute corrective and preventive actions (CAPA). The present work presents a case study on the handling of a complaint filed by a participating subject in a phase I/II clinical trial in which a novel Imiquimod formulation IMI-Gel is being investigated against the comparator product Aldara for the treatment of actinic keratosis (AK) (EudraCT: 2015-002203-28). IMI-Gel is a semi solid emulsion gel formulation containing nanocrystalline Imiquimod and a disperse oil phase (consisting of jojoba wax). The complaint concerned the quality of the product IMI-Gel with the complained tube revealing a rough, frizzy and irregularly rugged structure with the liquid phase leaking out of the formulation. The complaint was filed the day after the subject had received the IMP, was informed about the handling of the preparation and was about to initiate the treatment on his Study Day 1. As a root-cause analysis the stability of the pH, the integrity of the primary packaging and the structural stability of the IMP, both, at room temperature and at elevated temperatures were assessed by visual and rheological evaluation. Under such conditions, pH and the primary packaging were stable and unaffected. In addition, the IMP shows structural stability over the shelf-life period of 12 months when stored inside its primary packaging as a closed system, but shows quick phase separation when stored (1) outside its primary packaging or (2) inside the primary packaging with an opened screw-cap. From the studies performed, it was concluded that a handling error by the patient represents the most probable root cause.

Beitrag aus der nächsten Ausgabe 2/2023 der Zeitschrift pharmind
(erscheint am 28. Febr. 2023)

The Use of DMAIC to Deliver Value in Biotech QC Labs / A practical example from Merck KGaA

Merck Healthcare continuously refines its processes to improve its operations and capabilities in order to guarantee the development and market release of biotech products with less operational costs, resources and effort. Within the supply chain, Quality Control Laboratories play a crucial role in the market release of batches and conducting stability studies within the development of biotech products. To smoothly drive these operations, it is essential to have effective resource planning to deliver the product quality results according to the planned schedule of product market release or development timelines. Analytical results are key for the decision-making and by the reduction of overall cycle times, the efficiency of the operational process is increased. Towards the aim of operational excellence, the Lean Six Sigma (L6S) methodology is widely adopted in the era of competitive businesses, by systematically removing waste and reducing variation. Among the L6S approaches, the Design, Measure, Analyze, Improve and Control (DMAIC) cycle is used as a core tool for improving, optimizing, and stabilizing business processes. DMAIC tool is data-driven and specifically tailored to each case/project. This article showcases an example for improving the overall cycle time in running the analytical tests within the Quality Control Labs, using a rigorous L6S DMAIC tool. By applying the 5 phases of the DMAIC cycle, we demonstrate the delivery of its added value by identifying issues in the existing business processes and solving them with specifically tailored and proven tools, methods and concepts, with the additional advantage of having turned QC operators into change agents with a positive impact on business and people development. Our solution provided a hands-on reduction of 12 % i.e., “Analyst's Touch-Time”, as a key benefit.