Pharmacy preparation quality system

American Society of Health-System Pharmacists. ASHP guidelines on quality assurance for pharmacy-prepared sterile products. American Journal of Health-System Pharmacy 57 1150-1169, 2000. 

The costs of materials, duration of preparation, quality control, investment in premises, training, quality assurance et cetera determine the basic cost of pharmacy preparation. As with the reimbursement of licensed medicines there is a distinction between in-patient and out-patient supply. Pharmacy preparations used in hospitals could be considered to be part of the reimbursement for the therapy as a whole. Anyhow, the hospital pharmacist normally has to find his payment within the hospital organisation. In community pharmacy most pharmacy preparations are reimbursed by the health insurer, according to the Tax price with a surcharge according to the performance cost system. Reimbursement for... 

Before preparation, a risk assessment should always be carried out in order to define the level of the quality assurance system which should be applied to the preparation of the medicinal product. And The Product dossier should therefore state the considerations about the risk of pharmacy preparation versus unavailability of the product and should contain more information for products with a higher risk. The Risk Assessment should refer to ... 

With the development ICH QIO (see Sects. 35.5.9 and 35.7.4) as a standard for a pharmaceutical quality system, the process approach (maintenance as well as improvement) was emphasised. QIO states as well that a PQS should cover the whole product life cycle. This section describes the product life cycle of medicines, for preparation in pharmacies as well as for industrial production. A medicine whether developed in a pharmacy or in industry is designed to meet the needs of the patient and starts with clarifying that need. The product life cycle consists of a series of processes that need to be controlled and continually improved in order to deliver products with the intended quality. 

The quality characteristics of medicinal products and quaUty objectives of a preparing pharmacy or manufacturer are generally and sometimes in detail covered by European and national legislation and guidelines. A quality system for medicinal products will therefore have to connect with the appropriate legislation and professional guidelines that are meant to support their quality. 

This Standard has no clear relation to EU GMP but gives attention to three processes of pharmacy preparation prescription assessment, design of formulation and preparation process. It might be useful for structuring a quality system for pharmacy preparation (see Sect. 35.7.6). 

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... 

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. 

A validation report or the therapeutic assessment of a pharmacy stock preparation exists and needs to be accessed and up to date as soon as related activities are performed. Providing availability and readability has to be an element of the quality system. It would mean for instance that a file system has to be developed whether physically or digitally. In case of digital storage care has to be taken that the documents remain accessible when programs are updated. 

The general model for a Quality Management System for healthcare establishments ISO 9001/EN 15224 is applicable to the pharmacy as a whole, including pharmacy preparation. All pharmaceutical specificities have to be created, for which the Swiss system [8] may be useful if updated to EN 15224. The 7 Pillars model is applicable to the whole pharmacy as well. If used to preparation terminology, this system offers the advantage of using familiar terminology. 

Table 35.4 Suitability of models and standards upon which a quality systems for pharmacy preparation may be based...

The knowledge and application of pharmaceutical and clinical calculations are essential for the practice of pharmacy and related health professions. Many calculations have been simplified by the shift from apothecary to metric system of measurements. However, a significant proportion of calculation errors occur because of simple mistakes in arithmetic. Further, the dosage forms prepared by pharmaceutical companies undergo several inspections and quality control tests. Such a luxury is almost impossible to find in a pharmacy or hospital setting. Therefore it is imperative that the health care professionals be extremely careful in performing pharmaceutical and clinical calculations. In the present chapter, a brief introduction is provided for the three systems of measurement and their interconversions ... 

If computer systems are applied to support the small scale preparation in a pharmacy, they have to be validated in the same way as all preparation equipment or preparation processes do, see Sect. 34.15. All forms of automation ultimately may have an impact on the quality of the product. Therefore it is advisable to validate all systems used in advance and to validate any changes ahead of their introduction. 

A quality management system (QMS) is an important tool for process control and continual improvement. After a brief section about development of the quality principle in the preparation of medicines over the years, this chapter lists the processes in preparation and in the manufacture of medicines that have to be controlled. A medicine, whether developed in a pharmacy or in industry, starts with defining the needs of the patient. Then the formulation and the method of preparation are designed to meet product specifications. The next step of the product life cycle is the production, including quality control and release. 

In practice pharmaceutical quality management systems (PQSs) may follow the structme of quality standards for medicines, mainly GMP, PIC/S-GPP, and QIO to which GMP is referring. These standards are described as well as standards that are more applicable to preparation in the pharmacy i.e. the Ph. Eur. monograph Pharmaceutical Preparations, the Council of Europe (CoE) Resolution and USP Compoimding Standards. If a PQS has to cover the complete life cycle of the product, preparation in pharmacies or even all pharmacy activities then a more universal structure such... 

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