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

Rubrik: Originale

(Treffer aus pharmind, Nr. 03, Seite 294 (2023))

Pielenhofer J | Meiser S | Gogoll K | Ciciliani A | Klak M | Lang B | Staubach-Renz P | Grabbe S | Schild H | Radsak M | Spahn-Langguth H | Langguth P

Complaint management of a quality defect in a nanoparticulate Imiquimod formulation in an investigator initiated academic phase I/II clinical trial / Part 2*Part 1 of this article was published in Pharm. Ind. 85, Nr. 2, 182–186 (2023) · Pielenhofer J¹, Meiser S¹, Gogoll K², Ciciliani A¹, Klak M³, Lang B⁵, Staubach-Renz P⁵, Grabbe S⁵, Schild H⁶, Radsak M⁴, Spahn-Langguth H¹, Langguth P¹ · ¹Biopharmazie und Pharmazeutische Technologie, Institut für Pharmazeutische und Biomedizinische Wissenschaften (IPBW), Johannes Gutenberg University Mainz, Mainz und Boehringer Ingelheim, Ingelheim am Rhein und Sanofi-Aventis Deutschland GmbH, Frankfurt und Department of Internal Medicine III, Johannes Gutenberg University Medical Center, Mainz und Department of Dermatology, Johannes Gutenberg University Medical Center, Mainz und Institute for Immunology, Johannes Gutenberg University Medical Center, Mainz und und
Figure 1 demonstrates the procedural steps taken concerning the complaint for the IMP IMI-Gel. Following that procedure captured in a Standard Operating Procedure (SOP) within the existing QM system, the first action after being noticed of the complaint was a site visit at the study center to investigate which tube(s) or batch(es) were affected. There, it was observed that during the whole study and from all the batches manufactured and used only 1 single tube of 1 single batch was affected, yet revealing a clear quality defect related to the physical (in)stability of the IMP IMI-Gel as shown in fig. 3 . ...

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

Rubrik: Originale

(Treffer aus pharmind, Nr. 02, Seite 182 (2023))

Pielenhofer J | Meiser S | Gogoll K | Ciciliani A | Klak M | Lang B | Staubach-Renz P | Grabbe S | Schild H | Radsak M | Spahn-Langguth H | Langguth P

Complaint management of a quality defect in a nanoparticulate Imiquimod formulation in an investigator initiated academic phase I/II clinical trial / Part 1 · Pielenhofer J¹, Meiser S¹, Gogoll K², Ciciliani A¹, Klak M³, Lang B⁵, Staubach-Renz P⁵, Grabbe S⁵, Schild H⁶, Radsak M⁴, Spahn-Langguth H¹, Langguth P¹ · ¹Biopharmazie und Pharmazeutische Technologie, Institut für Pharmazeutische und Biomedizinische Wissenschaften (IPBW), Johannes Gutenberg University Mainz, Mainz und Boehringer Ingelheim, Ingelheim am Rhein und Sanofi-Aventis Deutschland GmbH, Frankfurt und Department of Internal Medicine III, Johannes Gutenberg University Medical Center, Mainz und Department of Dermatology, Johannes Gutenberg University Medical Center, Mainz und Institute for Immunology, Johannes Gutenberg University Medical Center, Mainz und und
Imiquimod Actinic keratosis Topical treatment Nanoparticles Semisolid o/w emulsion gel Quality control Medicinal products for human use are required to be manufactured to ensure that they are suitable for their intended use, comply with the requirements of the Marketing Authorization or Clinical Trial Authorization and do not place patients at risk due to inadequate safety, quality or efficacy [1]. Particularly for investigational medicinal products (IMPs) being tested in clinical trials, their quality is of high concern due to yet limited know-ledge on the safety or efficacy of the product. To achieve this quality objective, the implementation of a Pharmaceutical Quality ...

Computer-aided Assurance of Risk Documentation within an Existing FMEA Landscape

Rubrik: IT

(Treffer aus pharmind, Nr. 06, Seite 851 (2019))

Gattig P | Langguth P

Computer-aided Assurance of Risk Documentation within an Existing FMEA Landscape / Gattig and Langguth • Risk Documentation · Gattig P, Langguth P · ¹Department of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg University Mainz and und ²Boehringer Ingelheim, Focus Factory Respimat, Ingelheim am Rhein
Appropriate risk management methods and tools have been an integral part of industry for many years and are required by regulatory authorities [ 1 ][ 2 ][ 3 ]. They provide the risk identification and evaluation, the quality assurance, the know-how retention in the company, the process planning as well as the proof of a structured and complete consideration of the process [ 4 ]. Failure Mode and Effects Analyses (FMEAs) are well suited to accomplish these tasks. The creation of an FMEA is a team effort by members of various disciplines. In addition to the moderator, who does not ...