Pharmaceutical products quality assurance

In pharmaceutical technology, quality assurance of the pharmaceutical formulation is important. When a pharmaceutical formulation is produced, on-line quality monitoring and control has to be performed in order to check the quality of the outgoing products. Methodology to perform this task is Statistical Process Control (SPC) and is not included in this book. Good text books in the area of SPC exists [6-9]. In this book the focus is on off-line quality control, e.g. how to make products that are intrinsic robust against process variations. 

The World Health Organization (WHO), the United Nations Children s Fund (UNICEF) and many other organizations are involved in the procurement of pharmaceutical products. In particular, the supply of pharmaceutical products used in the treatment of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria and tuberculosis has become a major concern at both the international and country levels. Commitments by the European Commission and G8 countries, among others, offer the potential for significant increases in funding for efforts to combat communicable diseases. Low-cost pharmaceutical products of assured quality have the greatest potential for maximizing the impact of these efforts. The need for a model quality assurance system... 

Production. All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the finished product. Quality Assurance. See Part One. 

A validation programme should be co-ordinated by a multidisciplinary committee comprised of the different functions that are involved in the programme. Typically, the members of the validation committee would be drawn from departments such as production, quality assurance, microbiological and analytical quality control, pharmaceutical development, engineering, and maintenance. The committee approves and issues written protocols, and reviews the data obtained in order to approve or reject the programme results. 

See also Distillation. Liquid Chromatography Overview Chiral Pharmaceutical Applications. Quality Assurance Primary Standards Reference Materials Production of Reference Materials. Solvents. Sublimation. 

Some tolled products can be reworked if they fail quality assurance tests. In these cases the production cost may go up, but the product is not a complete loss. However, other tolled products, some pharmaceuticals for example, could be completely ruined by similar processing mishaps. Losses in these cases can be quite extensive. Test runs and approved rework procedures for such products may help avoid these losses. 

To facilitate industry application of modern quality management techniques, including the implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance. 

Observable effects of microbial attack on pharmaceutical products 3 Quality assurance and the control of... 

Medicinal products and bulk pharmaceutical chemicals are produced mainly in batch processes. Controlling these products and chemicals at the end of their manufacturing processes is not in line with the general principle of quality assurance, which is that quality should be built into the product. It is then necessary to ensure that appropriate good manufacturing practices are adhered to throughout the manufacture of both bulk pharmaceutical chemicals (active ingredients as well as excipients) and medicinal products. 

For pharmaceutical purposes, oue of the maiu problems will be to defiue the botanical origin of the different olibanum resins. Up to now, there are no scientifically current pharmaceutical monographs on olibanum, and pharmaceutical companies that want to develop new medicinal products have an urgent need of analytical methods for the botanical identihcation and quality assurance of the resins. Attempts had been made by Hahn-Deinstrop et al. [2]. 

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. 

Materials purchased for the purpose of mixing with other materials in the preparation of pharmaceutical products are called raw materials. Pharmaceutical companies often purchase solid raw materials as powders in large drums. Quality assurance laboratories require samples of the material in the drums for the purpose of performing quality tests to see if the raw materials meet the specifications required for the company s products. 

Simethicone is an antigas ingredient in many liquid and solid pharmaceutical preparations, and FTIR is used in quality assurance laboratories to determine whether its concentration is at the specified level. A sample of the product is dispersed in an HC1 solution and the simethicone extracted from this solution with toluene. The toluene solutions are then run on the FTIR using a liquid sampling cell. For the quantitative analysis, a simethicone absorption band that is free from interference from the toluene absorption bands is used in a manner similar to that of the isopropyl alcohol band in Experiment 26. 

The textbook on Pharmaceutical Drug Analysis would enormously serve the undergraduates, postgraduates, researchers, analytical chemists working in the Quality Assurance Laboratories, new drug development, production and control, teaching, or regulatory authorities. 

Several in vitro tests are currently employed to assure drug product quality. These include purity, potency, assay, content uniformity, and dissolution specifications. For a pharmaceutical product to be consistently effective, it must meet all of its quality test criteria. When used as a QC test, the in vitro dissolution test provides information for marketing authorization. The dissolution test forms the basis for setting specifications (test, methodology, acceptance criteria) to allow batch release into the market place. Dissolution tests also provides a useful check on a number of physical characteristics, including particle size distribution, crystal form, etc., which may be influenced by the manufacturing procedure. In vitro dissolution tests and QC specifications should be based on the in vitro performance of the test batches used in in vivo studies or on suitable compendial specifications. For conventional-release products, a single-point dissolution... 

A pharmaceutical company has to adopt a proactive policy of validation for its facilities, production processes, production equipment and support systems, analytical methods, and computerized systems. A properly validated approach will help to assure drug product quality, optimize the processes, and reduce manufacturing cost. 

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