Quality Assurance for Pharmaceuticals 20 Quantifying Pharmaceutical Requirements 21 Managing the Tender Process Distribution Use
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Part I: Policy and economic issues Part II: Pharmaceutical management Part III: Management support systems Selection Procurement 18 Managing procurement 19 Quality assurance for pharmaceuticals 20 Quantifying pharmaceutical requirements 21 Managing the tender process Distribution Use chapter 19 Quality assurance for pharmaceuticals Summary 19.2 illustrations 19.1 Pharmaceutical quality 19.2 Figure 19-1 Quality assurance framework 19.3 Pharmaceutical quality assurance framework • Defining Figure 19-2 Determinants of pharmaceutical quality 19.6 and assessing pharmaceutical quality • Consequences Figure 19-3 Critical elements in quality assurance for of poor pharmaceutical quality • Determinants of pharmaceutical procurement 19.10 pharmaceutical quality • Prevalence of poor-quality Figure 19-4 Sample medicine and supplier evaluation pharmaceuticals • Global quality-monitoring options form 19.19 19.2 Practical approaches to quality assurance 19.8 Table 19-1 Medicines found to have stability problems under tropical or high-temperature conditions 19.5 19.3 Obtaining good-quality pharmaceuticals 19.10 Table 19-2 Percentage of tracer medicines that failed Careful product selection • Careful supplier selection • quality testing in the public, private, and NGO Product certification • Product pedigrees • Batch sectors 19.8 certificates • DRAs and the procurement market Table 19-3 Comparison of certificates used in pharmaceutical today • Contract specifications procurement 19.14 19.4 Verifying the quality of shipped products 19.15 Product identification technology • Inspection of shipments boxes • Tiered pharmaceutical quality assessments • Laboratory Box 19-1 Some substances exhibiting potential bioavailability testing problems in conventional oral forms 19.5 19.5 Maintaining pharmaceutical quality 19.17 Box 19-2 Counterfeits and diversion from legal Appropriate storage and transport • Appropriate dispensing channels 19.9 and use • Pharmaceutical product presentations: treatment Box 19-3 WHO’s prequalification of medicines kits, co-packaging, and fixed-dose combinations program 19.12 Box 19-4 Therapeutic window 19.16 19.6 Monitoring pharmaceutical quality 19.18 Product problem reporting system • Product recalls country study 19.7 Personnel and training in the supply CS 19-1 Building quality assessment infrastructure in system 19.20 Tanzania 19.11 Assessment guide 19.21 annex References and further readings 19.21 Annex 19-1 Resource organizations 19.22 copyright © management sciences for health 2012 19.2 ProcUREMENT SUMMARY The purpose of quality assurance in pharmaceutical sup- A comprehensive quality assurance program must ensure ply systems is to help ensure that each medicine reaching the following— a patient is safe, effective, and of acceptable quality. A • Pharmaceuticals selected have been shown to be safe comprehensive quality assurance program includes both and efficacious for their intended use, are presented technical and managerial activities, spanning the entire in an appropriate dosage form, and have the longest supply process from pharmaceutical selection to patient possible shelf life. use. • Suppliers with acceptable quality standards are Established quality standards are published periodically selected. in pharmacopoeias and in some government publica- • Pharmaceuticals received from commercial suppli- tions. For the purposes of primary health care, the most ers and donors meet specified quality standards at important characteristics of a pharmaceutical product the time of delivery. are identity, purity, strength, potency, uniformity of dos- • Packaging meets contract and usage requirements. age form, bioavailability, and stability. • Repackaging activities and dispensing practices maintain quality. Pharmaceutical quality is affected by starting materials, • Storage and transportation conditions do not com- manufacturing process, packaging, transportation and promise product quality. storage conditions, and other factors; these influences • Product quality concerns reported by prescribers, may be cumulative. dispensers, and consumers are properly cataloged If a pharmaceutical does not meet established qual- and addressed. ity standards, passes its expiration date, or has been • Product recall procedures are implemented to degraded by storage conditions, the possible conse- remove defective products. quences are— A quality assurance program should include training and • Lack of therapeutic effect, leading to prolonged ill- supervision of staff members at all levels of the supply ness or death process and a suitable information system. Often, public • Toxic and adverse reactions officials must balance the costs of establishing and main- • Waste of limited financial resources taining quality assurance systems against the benefits of • Loss of credibility of the health care delivery system having safe and effective medicines. 19.1 Pharmaceutical quality tests, and monitoring product performance. Managerial activities include selecting reliable suppliers, preparing As in most manufacturing processes, the quality of a contract terms, monitoring supplier performance, and per- final pharmaceutical product is determined by the start- forming inspection procedures throughout the distribution ing materials, equipment, and technical know-how that go network (Figure 19-1). into producing and packaging it. Unlike a steel bolt or Note that quality assurance in pharmaceutical supply is a tailored suit, however, a medicine is a dynamic prod- not the same as quality control in manufacturing. uct whose color, consistency, weight, and even chemical identity can change between manufacture and ultimate Pharmaceutical quality assurance framework consumption. A medicine that passes all laboratory tests upon receipt may be useless within a few months if the The following five elements are critical to achieving the packaging, storage, and transportation conditions are not expected treatment outcome. Using a pharmaceutical prod- maintained properly. uct to treat a patient presumes that the— The purpose of quality assurance in pharmaceutical sup- ply systems is to help ensure that each medicine reaching 1. Active pharmaceutical ingredient (API) has been a patient is safe, effective, and of appropriate quality. The shown to be safe and effective for this treatment quality of pharmaceutical products is ensured by the tech- 2. Product is of suitable quality to provide an effective nical and managerial activities of the quality system, which outcome includes evaluating pharmaceutical product documenta- 3. Prescriber has accurately identified the need for the tion, performing or reviewing quality-control laboratory treatment 19 / Quality assurance for pharmaceuticals 19.3 Figure 19-1 Quality assurance framework Document review Inspection of local/imported product samples, manufacturing sites, and marketplace Data analysis Decision making and evaluation and enforcement Product testing Reporting Source: CPM/MSH 2011. 4. Prescriber or dispenser has properly instructed the including API, have been illustrated in headlines about patient on how to use the product deaths caused by adulterated products such as cough syrup 5. Patient complies with the prescribed regimen correctly in Peru and heparin in the United States—both tied to ingredients from China. As a result, the U.S. Food and Drug The first two items are product-specific issues, which Administration (FDA) seeks to increase its global presence are the most easily addressed technically, whereas items to make monitoring foreign manufacturers easier and to three and four are practitioner-specific and depend on the strengthen its involvement with harmonization of pharma- practitioners’ education, knowledge, and skill as well as ceutical standards (FDA 2010). In addition, the FDA wants the rigorous enforcement of performance standards. Item to help build regulatory capacity in foreign counterparts. As five is a patient-specific issue that depends on the patient’s part of that international effort, the agency has opened per- knowledge and commitment and the patient’s access to manent offices in a number of cities around the world and services. has entered into dozens of agreements with other drug regu- The safety and effectiveness of an API may be established latory authorities (DRAs) to share inspection reports and either through a review of historical usage, such as in the other private information that can help improve the quality case of digoxin’s evolution from the foxglove plant (digi- of pharmaceutical products worldwide. talis purpurea), or through complex procedures established The pharmaceutical regulatory and quality assurance pro- for new chemical entities, such as those described by the cesses that should be addressed by a country’s DRA include International Conference on Harmonisation of Technical (WHO 2004b)— Requirements for Registration of Pharmaceuticals for Human Use (ICH). • Product registration: assessing and authorizing prod- After the safety and effectiveness of an API has been ucts for market entry and monitoring their safety and approved for marketing in an ICH market region, other effectiveness after entry regions of the world follow with little or no additional • Regulation of manufacturing, importation, and distri- assessment. The ICH economic zones (European Union, bution Japan, United States) perform almost 100 percent of the – Quality of manufacturing (good manufacturing pharmaceutical research and consume over 85 percent (by practices) value) of the pharmaceutical products