Pharmaceuticals quality assurance

Quality (Q) addressing chemical and pharmaceutical quality assurance. 

Figure 11.6 Pharmaceutical quality assurance system principles.

Several key issues have to be addressed in the downstream processing of biopharmaceuticals regardless of the expression system. The removal of host cell proteins and nucleic acids, as well as other product- or process-related or adventitious contaminants, is laid down in the regulations and will not differ between the individual expression hosts. The identity, activity and stability of the end product has to be demonstrated regardless of the production system. The need for pharmaceutical quality assurance, validation of processes, analytical methods and cleaning procedures are essentially the same. 

Conventional pharmaceutical quality assurance procedures should be applied to gene therapy products as well as appropriate infectivity tests for self-replicating, living vectors. 

Organization of the Pharmaceutical Quality Assurance Microbiological Testing Laboratory... 

Anthony M. Cundell, Ph.D. Direetor, Microbiologieal Development, Wyeth-Ayerst Pharmaceuticals, Pearl River, New York Pharmaceutical Quality Assurance Microbiology Laboratories... 

Purity and potency are two of the metrics that pharmaceutical quality assurance (QA) departments emphasize to determine if a batch may be released. To do this they typically employ HPLC and/or mass spectrometry to determine gross composition, and to verify the absence of any contaminants. However, only a small subset of tablets in a batch is tested because the tests destroy the sample. While these methods offer some insight into sample consistency, they provide no information on the distribution of the components in an individual finished form. Dissolution testing is used to indicate the manner and... 

C. Hatfield, E. Halloran, J. Habarta, S. Romeno, and W. Mason, Multi-product robotic sample preparation in the pharmaceutical quality assurance laboratory. In Advances in Laboratory Automation Robotics 1984 (J. R. Strimaitis and G. L. Hawk, Zymark Corp., Hopkinton, MA, 1984, p. 105. 

ORGANIZATION OF THE PHARMACEUTICAL QUALITY ASSURANCE MICROBIOLOGICAL TESTING LABORATORY... 

Tomamichel, K. Pharmaceutical quality assurance basics of validation. Swiss Pharma 1994, 16 (3), 13-23. 

Bayer, 1., and T. Paal. 1984. Pharmaceutical Quality Assurance in Hungary. Trends in Analytical Chemistry. 3 4, Vl-VIl. 

Q = Quality topics, that is, those relating to chemical and pharmaceutical Quality Assurance. Examples Q I Stability Testing, Q3 Impurity Testing. 

Cross-cutting pharmaceuticals — quality assurance issues... 

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