Particulate Matter in Inhalation Products, Parenterals and Ophthalmic Solutions

Rubrik: Originale

(Treffer aus pharmind, Nr. 09, Seite 1236 (2019))

Daub W | Jahr T | Leiner S | Rodó T | Küstner B | Ziemek R | Auer M | Eichinger T | Kuhlmann L

Particulate Matter in Inhalation Products, Parenterals and Ophthalmic Solutions / Best Practices for Handling – Part 2*Part 1 see Pharm. Ind. 2019;81(8):1116–1128. · Daub W, Jahr T, Leiner S, Rodó T, Küstner B, Ziemek R, Auer M, Eichinger T, Kuhlmann L · ¹Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim und Merck KGaA, am Rhein und Novartis Pharma AG, Darmstadt und Novartis Pharma AG, Basel, Schweiz und Sanofi-Aventis Deutschland GmbH, Rudolstadt und Frankfurt und
The overall goal of the compliance process is to consistently prevent occurrence of foreign particles (FP) or, if that is not possible, to reduce their presence to a level as low as technically feasible. Reduction of the number of particles may include their effective elimination; however, preventing occurrence of foreign particulate matter (FPM) complies more with the intention of cGMP than elimination after occurrence. In addition, effectivity and robustness of an elimination process are critical and need to be proven even for a large number of units. Therefore, elimination of existing particles is a second-choice option only. Particulate matters are ...

Particulate Matter in Inhalation Products, Parenterals and Ophthalmic Solutions

Rubrik: Originale

(Treffer aus pharmind, Nr. 08, Seite 1116 (2019))

Daub W | Jahr T | Leiner S | Rodó T | Küstner B | Ziemek R | Auer M | Eichinger T | Kuhlmann L

Particulate Matter in Inhalation Products, Parenterals and Ophthalmic Solutions / Best Practices for Handling – Part 1 · Daub W, Jahr T, Leiner S, Rodó T, Küstner B, Ziemek R, Auer M, Eichinger T, Kuhlmann L · ¹Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim und Merck KGaA, am Rhein und Novartis Pharma AG, Darmstadt und Novartis Pharma AG, Basel, Schweiz, und Sanofi-Aventis Deutschland GmbH, Rudolstadt und Frankfurt und
Foreign particulate matter Control strategy Particles Inhalation Parenteralia Ophthalmica Foreign particles (FP) or FPM (both terms are used syn„onymously in this document) are defined as contaminant in any pharmaceutical dosage form. Historically, FP have been of interest mainly for oral and for parenteral liquids, as evident from respective GMP requirements and from specifications, set in pharmacopoeia monographs [1–3]. This was followed by ocular dosage forms [4] and, starting mid-1990s, by the requirement to limit FP in inhalation forms [5,6]. Most recently, discussion started about the limitation of FP in solid dosage forms, in active pharmaceutical ingredients (API) and in excipients [7–9]. The interest in ...