Validation Articles

All pharmaceutical validation projects are labor and capital intensive, and each must be planned and managed carefully. Numerous tasks and activities must be identified early and then scheduled to support the project completion date. Stakeholders such as the Quality Assurance (QA) and Calibration–Metrology departments must be alerted to impending increased workloads under compressed time frames. Standard operating procedures (SOPs) and protocol formats must be developed, test equipment must be purchased or rented, and contractors must be evaluated and hired. Managers must decide whether the US Food and Drug Administration will participate in the design review process, and if so, what will be the agency's exact involvement and participation. Considering the set of activities and programs that require timely completion, pharmaceutical validation projects must be carefully organized, managed, and monitored.

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors, "What does this term validation really mean?"

"We don't know," they responded.

Much has changed in the past 18 years. So much has changed, in fact, that the current concept of process validation, once a fresh idea in quality control, and which later became accepted dogma, may now be ready for the trash bin. With companies achieving new levels of process understanding, what does it mean to validate a manufacturing process? Industry leaders and FDA are now examining that question and looking at new models to follow.

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WHO- EDM 1/2002 Validation Part 4 : Q.C. related validation

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WHO - EDM

Although the prevalence of IgE-mediated latex allergy has increased over the past decade, the circumstances which culminate in sensitization remain uncertain. The objective of these studies was to evaluate the role which sensitization route plays in the development of latex allergy using murine models representative of potential exposure routes by which health care workers (topical and respiratory) and spina bifida patients (subcutaneous) may be sensitized. BALB/c mice administered latex proteins by the subcutaneous, topical, intranasal, or intratracheal routes exhibited dose-responsive elevations in total IgE. In vitro splenocyte stimulation initially demonstrated specificity of the murine immune response to latex proteins. Subsequently, immunoblot analysis was used to compare latex-specific IgE production amongst sensitization routes. Immunoblots of IgE from subcutaneously sensitized mice demonstrated recognition of latex proteins with molecular weights near 14 kDa and 27 kDa.

R. A. Butler and G. Roesijadi
Toxicological Sciences 59, 101-107 (2001)
Copyright © 2001 by the Society of Toxicology

Pharmaceutical organizations have a training need for validation skills that cover the areas of protocol execution, protocol development, validation project management, and documentation control. This need can best be met through knowledge and skills training that is customized for individual organizations. Customized training is intended to enhance the transfer of knowledge and skills from the learning environment to the working environment. Critical to getting the greatest benefit out of customized-training dollars is selecting the best candidates for training, and providing immediate opportunities after training to use newly acquired knowledge and skills.

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John E. McEntire
BioPharm International, May 2002 Is your company gambling with analytical mehods and with your product's future? Play validation bingo and find out.

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The authors describe the measurement of the effusivity of blended and unblended commercial pharmaceutical formulations to effectively differentiate between materials and then to determine if the effusivity changed with blending time. Eight components of a commercially available formulation were tested to determine if their effusivity values were unique enough to permit them to be distinguished.Two aliquots were tested, and the variance between the two was
1.6%.The effusivity values indicated that the blend of the eight components was sensitive to uniformity. The eight components then were blended and samples were extracted at times ranging from 2 to 60 min.The results, when compared with assay results from the drug manufacturer, showed excellent agreement in terms of uniformity determination.

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