Quality assurance — Good Manufacturing Practices

Several terms used in industrial and hospital production must be defined to enable the reader to follow this chapter. These definitions are given in sections 1.1.1 to 1.1.5. The inter-relationship between quality assurance, good manufacturing practice, quality control and in-process control is shown in Fig. 21.1. 

Fig. 21.1 The inter-relationship between quality assurance, good manufacturing practice, quality control and in-process control.

The basic concept of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. 

Good manufacturing practice (GMP) comprises that part of quality assurance which is aimed at ensuring that a product is consistently manufactured to a quality appropriate to its intended use. GMP requires that (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made. 

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. 

In pharmaceutical manufacturing, process validation is an exercise that requires the contribution from different departments, including quality assurance and quality control. It is a requirement for good manufacturing practice (GMP) to ensure that the final product produced is of the expected quality. 

WHO. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, vol 2, 2nd update ed. Good manufacturing practices and inspection. Geneva World Health Organization 2007. 

Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

One must also stress the importance of quality considerations during compounding and full adherence to current good manufacturing practices while producing parenteral products. Personnel responsible for the process design and scale-up of the equipment must assure proper documentation... 

These three factors, linked together by cGMPs (current Good Manufacturing Practices), provide the fundamental assurance to the quality of the data. In this chapter, a systematic approach to ensure the reliability of the instruments used in the analyses is presented. 

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. 

Byers, T. E. Role of product and process design in assuring quality, Good Manufacturing Practices Conference, Cherry Hill, NJ, Feb. 1977. 

A quality assurance system usually involves a matrix of written procedures. Good manufacturing practices (GMPs) are thus frequently equated with quality assurance systems. By similar lines of reasoning, validation, quality assurance, and GMPs are often associated with each other and even occasionally treated synonymously. 

Over 200 completed consensus standards and selected sections of additional draft standards that are not yet complete have been incorporated into guidance documents for applications for conducting clinical trials with investigational devices and applications for permitting devices to be marketed. These guidance documents are widely disseminated by the CDRH to all interested parties. Other standards used by the CDRH, or which the CDRH has helped to develop, concern measurement or test methods, or support good manufacturing practices and quality assurance. 

Concepts like quality, safety, and efficacy should be taken into consideration during process development, since it is not enough to inspect and test only the final product. Good Manufacturing Practice (GMP), as well as quality assurance systems are essential to guarantee safety, quality, and economic feasibility during the whole process and therefore to obtain a marketing license. 

Quality, efficacy, and safety of a medicine are attributes to be planned and established throughout the production process. This concept is especially valid for the production of biologies to assure the fundamental characteristics of efficacy and safety to the patient in each vial of every lot. Every step of pharmaceutical manufacturing should follow high standards intended for production consistency and product quality. The principles defining these standards are described in the Good Manufacturing Practices (GMP) publications. 

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