A Risk- and Science-Based Approach to the Acceptance Sampling Plan Inspection of Protein Parenteral Products.
J Pharm Sci
; 107(9): 2306-2309, 2018 09.
Article
em En
| MEDLINE
| ID: mdl-29859961
ABSTRACT
The requirement for visual inspection of pharmaceuticals has been a compendial expectation for over a century, with some advancement of visible particle control strategies in recent years. Current philosophies include a 100% inspection and an Acceptance Sampling Plan inspection. The particles found during these inspections are normally categorized simply by particle size (visible vs. subvisible), particle source (intrinsic vs. extrinsic) and particle type (inherent vs. extraneous). We believe that a more risk- and science-based approach is attainable, which is grounded in forensic data, toxicological/medical opinions and prior knowledge. We have provided an outline for how to determine patient safety impact of visible particles found in parenteral products and potential actions that could be taken within the quality system regarding lot disposition. We believe this approach focuses efforts on patient safety risks, enhances the use of prior knowledge and improves consistency in how particle observations are handled.
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Base de dados:
MEDLINE
Assunto principal:
Tamanho da Partícula
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Química Farmacêutica
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Contaminação de Medicamentos
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Soluções de Nutrição Parenteral
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Agregados Proteicos
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article