Pharmaceutical companies typically require considerable resources, in terms of time, money, and specialized personnel, to validate a current Good Manufacturing Practice (cGMP) facility. This can be overwhelming to a small company or plant with limited resources. This paper identifies some of the key areas in a facility upgrade project that have been found to result in inefficiencies, project, and facility start-up delays. It seeks to demonstrate that the integration and streamlining of the design, construction, commissioning, and validation phases can accelerate the start-up effort, reduce the validation effort and costs, produce superior documentation, and ensure that product is produced in a cGMP-compliant facility. It will also prove that even though the original focus of validation was to satisfy regulatory expectations, facility validation has in fact become good business and engineering practice that enhances reliability, cost, and quality of the products.
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Monday, August 18, 2008
Facility Validation: A Case Study for Integrating and Streamlining the Validation Approach to Reduce
Modular Construction: Innovation, Flexibility, and Adaptibility by Design
Identifying issues in the factory that traditionally arise in the field minimized onsite equipment rework and subsequent qualification work.Risk is part of biopharmaceutical development. Planning for commercialization typically starts after completion of phase 1 trials. If you wait until the end of phase 3 to build a manufacturing facility, years of profitable sales will be lost. If you build a factory too early, you risk the possibility that the factory will be idle while waiting for product approval. After all, in today's regulatory and economic climate, the odds of successfully bringing a product from discovery through clinical development to commercial success are less than 1 in 100. Companies cannot be blamed for questioning when, or even if, they should build a new facility to manufacture a product for commercial launch. However, modular design can reduce this risk by reducing construction time and increasing flexibility.
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Validation of Sterile Filtration of Liquid Nitrogen
Liquid nitrogen (LN2) is widely used in the pharmaceutical,biopharmaceutical, and life sciences industries for lyophilization and quick-freezing of pharmaceutical preparations and storage of cells and microbial cultures.
As a refrigerant, LN2 can act as a vehicle for transmitting contaminant
microorganisms.Whether as the original source of contamination or as a conduit, LN2 has been reported as a potential biohazard (1). Fungal and bacterial contaminants have been found in both the freezers that use LN2 and the cultures stored in them (2). An outbreak of hepatitis B in patients undergoing
cytotoxic treatment has been traced to LN2, suggesting that contaminants can move both in and out of cryostorage containers (3). In other instances, storage tanks that use LN2 were reported to be contaminated by Bacillus (4), and storage tanks holding cryopreserved stem cells also were found to be contaminated (5).
Monitoring Blend Uniformity with Effusively
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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Validation Training: How Do You Do It?
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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Immunological Responses of Mice following Administration of Natural Rubber Latex
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. These protein sizes are consistent with the molecular weights of major latex allergens (Hev b 1 and Hev b 3), to which high percentages of spina bifida patients develop antibodies.
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Process Validation of Existing Processes and Systems Using Statistically .Part3
Andrew W. Jones, Technical Manager, KMI/PAREXEL LLC
ISPE, September 2001 Determine the Confidence Interval as compared to +/- 3S.D. With the +/- 3 S.D. ranges determined, it can be considered important to evaluate what confidence there is that the next data point will fall within this range. The rationale for determining this level is to justify that the +/- 3 S.D. range provides a confidence that 99% of the data is within that range. Similar to the +/- 3 S.D. range, the confidence interval is a range between which the next measurement would fall. This level is typically 99% or greater. Thus a 99% confidence interval means, "there is 99% insurance that the next value would be in the range."
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K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid... -
Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
