Pharmaceutical product quality

Withering s discovery of the clinical use of digitalis was important, but it may well be that his contribution to the methodology of pharmacology and therapeutics was of even greater importance. His rejection of polypharmacy, his attention to pharmaceutical product quality and to the standardization of his remedy, and his development of the technique of dose-titration enabling a drug with the narrowest of therapeutic ratios to be used safely - were recorded in a way that seems as fresh today as it ever was. These aspects of his work, the careful and detailed nature of his clinical observations, and the aphoristic nature of his splendid Inferences continue to excite one s admiration today (see Mann, 1985). 

Pharmaceutical products quality must be consistent and meet the health and regulatory requirements. The pharmaceutical industry has the obligation to validate GMP to their process to be in compliance with GMP requirements. 

Abdul-Fattah A, Kalonia DS, I kal MJ. The challenge of drying method selection for protein pharmaceuticals Product quality implications. J Hiarm Sci 2007, Online ahead of publication. 

Govindarujan R, Suryanarayanan R. Processing-induced phase transformations and their implications on pharmaceutical products quality. In Hilfiker R, ed. Polymorphism in the Pharmaceutical Industry. Weinheim Wiley-VCH, 2006 333-64. 

This section shows how ideas about guaranteeing pharmaceutical product quality have developed over time. 

Analytical and control methods for acetic anhydride are fully discussed in reference 55. Performance tests are customarily used where the quality of the product is cmcial, as in food or pharmaceutical products. Typical specifications are ... 

D. Jaconia, Preservatives in Pharmaceutical Products in Quality Control in the Pharmaceutical Industry, Vol. 1. Academic Press, Inc., 1972. 

Product-quality improvement, as in air cleaning in the production of pharmaceutical products and photographic film... 

Although, even today, vacancy chromatography is rarely used in analytical laboratories generally, there are a number of applications where it appears it might be very useful. The technique, that was suggested by Zhukhovitski for quality control is a particularly interesting application. Consider a pharmaceutical product that contains... 

Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life. 

An essential utility for most sites is a water purification system that can generate water of appropriate quality. Two grades of water are used in pharmaceutical production ... 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

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. 

Pharmaceutical microbiology may be defined as that part of microbiology which has a special bearing on pharmacy in all its aspects. This will range fiom the manufacture and quality control of pharmaceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged fiom the chapter contents. 

The first chapter in this section provides a unique account of the ecology, i.e. distribution, survival and life-style, of microorganisms in the factory environment, and should enable process designers, controllers and quality control personnel to comprehend, trace and eradicate the sources of failure due to extraneous microbial contaminants in the finished product. Much of the information given here is applicable to hospital manufacture also, and this is extended in a contribution (Chapter 19) dealing with contamination in hospital pharmaceutical products and in the home. 

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

Pharmaceutical products are used in a variety of ways in the prevention, treatment and diagnosis of disease, hi recent years, manufacturers of pharmaceuticals have improved the quality of non-sterile products such that today the majority contain only a minimal microbial population. Nevertheless, a few rogue products with an unacceptable level and type of contamination will occasionally escape the quality control net and when used may, ironically, contribute to the spread of disease in patients. 

The sole objective of all hygiene and manufacturing controls is to ensure the quality of the pharmaceuhcal product for the safety and protection of the pahent. The manufacture of non-sterile pharmaceutical products requires that certain criteria of cleanliness, personal hygiene, produchon methods and storage must be met. Many such products are for oral and topical use and the question may fairly be posed as to the point of what are now quite stringent conditions. Nevertheless, some carefully controlled hospital studies have indeed shown that both types of medicine may be associated with nosocomial (hospital-acquired) infections and this risk can be minimized by the application of GMP principles. 

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

Each dmg regulatory function helps to ensure the efficacy, safety and quality of pharmaceutical products and their rational use. Dmg regulation should therefore be carried out in such a way that each function receives sufficient attention and resources. Yet experiences in the countries studied indicate that the different dmg regulatory functions receive varying degrees of emphasis. The disparities are found in three key areas. 

Although Modern Pharmaceutics continues to evolve, our basic goals remain those which we developed in the 1970s when we first delineated the concept of this comprehensive and integrated treatment of pharmaceutics, with a focus on drug product quality and performance. We are committed to producing an up-to-date, authoritative, multiauthored treatise on pharmaceutics, which can be used by both students and practitioners. 

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