Pharmaceutical quality system elements

QRM finds its way into medicines regulations as it is seen as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. A structured and documented management of risks is a requirement in EU GMP as well as in the European Pharmacopoeia (Ph. Eur.). A guideline with a description of QRM elements together with appropriate tools is to be found in ICH Q9, mainly directed at manufacturing. Finally implementation of QRM in the Pharmaceutical Quality System is briefly elaborated. 

Table 35.3 gives the chapter titles of ISO 9001 with some subchapters that may be relevant for preparation of medicines as well as those health care elements added from EN 15224. The last column tries to connect the ISO structure to quality system elements common to pharmaceutical quality systems, including specific items for pharmacies. 

Table 35.3 Connections between ISO 9001, EN 15224 and elements common to Pharmaceutical Quality Systems ...

The major elements of the quality system model described in the FDA s pharmaceutical QS guidance document are consistent with existing quality system standards. These elements are as follows ... 

If the answer to question 1 is yes, is there a need for a pharmaceutical company engaged in the R D, manufacture, or supply of drug products to add the elements of an ISO quality system that are not covered by GMP ... 

After reviewing model quality systems like ISO, Malcolm Baldrige, or the European Quality Award, it is evident that cGMPs fall short of being a true quality system. They lack many elements common to these quality models such as leadership, planning, process orientation, and continuous improvement. A corollary concern is sometimes expressed that the pharmaceutical business is so regulated that a best practice quality system like ISO is not sufficient. However, a central... 

This section is about common elements of a PQS, with focus on pharmacy preparation as a process and community and hospital pharmacies as the organisations. For industrial production the same principles are valid but more elaborate literature exists. Most elements are common to any Quality Management System and are for instance described and strucmred in ISO 9001 (see Sect 35.7.2). Some elements are closely related and are therefore seen as pharmaceutical quality subsystems. They are combined in mie subsection, for instance internal audits, inspection and external audits... 

It is recommended that procurement agencies involved in any of the key activities of procurement develop and implement their own internal quality assurance systems on the basis of the Model, including the elements described and technical details specified. It is important to ensure that the system is adapted to reflect the activities of each speciflc procurement agency. The system should cover all aspects of the agency s activities and should be comprehensive enough to ensure that interrelated activities which impact on the quality of pharmaceutical products are linked. 

Pharmaceutical care is a process of drug therapy management that requires a change in the orientation of traditional professional attitudes and re-engineering of the traditional pharmacy environment. Certain elements of structure must be in place to provide quality pharmaceutical care. Some of these elements are (1) knowledge, skill, and function of personnel, (2) systems for data collection, documentation, and transfer of information, (3) efficient work flow processes, (4) references, resources and equipment, (5) communication skills, and (6) commitment to quality improvement and assessment procedures. 

Many solid dosage forms are designed for controlled dissolution or liberation of the drug substance, controlled in the sense that its release is slow compared with the rate of systemic absorption. Dissolution testing using pharmacopoeia and other methods is an essential element of the pharmaceutical development process. There are still arguments about its relevance to the in vivo situation and there are still those who maintain that it cannot be anything other than a quality control tool to ensure batch to batch consistency. 

The pharmacist not only has to manage risks of insufficient product quality or loss of availability, but also other risks, such as health risks of his personnel or financial risks. EU GMP focuses on the risks to product quality. QRM is an element of the Quality Management System in parallel to requirements of EU GMP Chap. 1 (see Sect. 21.6.1). Even though e.g. health and safety of the operators and environmental risks are equally important in a societal perspective, these considerations, from a GMP viewpoint, have to be taken care of in other ways. For an illustration of this opinion, compare the warning for pharmaceutical inspectors Inspectors should be cautious when reviewing assessments which include other business-related risks (e.g. environmental, occupational health safety) in addition to quali risk assessments. As whilst these factors are important in a holistic sense there is a danger that they may compromise quality [7]. 

Pharmaceuticals and drugs] ruggedness test, 848-864 system suitability test, 865 ralidation data elements specific to TLC, 848 mobile phase selection, 822 quality assurance of experimental data and documentation, 865-867 role of TLC in drug analysis, 868-873 chromatqgrapliic identification. 871 spectroscopic identification, 871-873 role of TLC in pharmaceutical analysis, 867-868 sensitivity to experimental conditions 821-822 stationary phase selection, 822 types of analytical aims in pharmaceutical analysis, 823... 

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