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Article
Author(s)

Fábio Eduardo de Campos1, Efrain Araujo Perini1, Carlos Leonel Zapparoli Júnior1, Wilson Aparecido Parejo Calvo1 and Valeriia Niowaveinc Starovoitova2

Affiliation(s)

1. Nuclear and Energy Research Institute (IPEN), the University of São Paulo, São Paulo, SP 05508-000, Brazil
2. NiowaveInc, 1012 N Walnut St, Lansing, MI48906, USA

ABSTRACT

The worldwide GMP (Good Manufacturing Practices) guidelines issued for injectable pharmaceuticals globally agree that the vials filling operation must be performed under air cleanliness Grade A. The air cleanliness classifications adopted by the WHO (World Health Organization) define the particle diameter size, the sampling occupancy state and the limit concentration of viable particles. To reach conformity regarding the microbial limits foreseen at the GMP guidelines, a microbiological monitoring program must be stablished for selected sampling points such as active air sampling, passive air sampling (settle plate method), surfaces sampling (contact method), personnel sampling (gloves and clothes), compressed gas, materials and equipment that may interfere and compromise the product microbiological quality. The key elements for a GMP certification are directly related to a qualification and validation program for radiopharmaceutical manufacturers that must be clearly defined and documented by a validation master plan, foreseen by the manufactures Quality Assurance office. This study describes each qualification step and test for DQ (Design Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification) that must be carried out and carefully planned when it comes to hot cells and isolator systems in accordance with the GMP requirements foreseen by international regulatory and supervisory bodies.

KEYWORDS

Injectable radiopharmaceuticals, GMP, qualifications, regulations.

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