Quality Assurance for Pharmaceuticals. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 19)
(2012; 23 pages)

Resumen

The purpose of quality assurance in pharmaceutical supply systems is to help ensure that each medicine reaching a patient is safe, effective, and of acceptable quality. A comprehensive quality assurance program includes both technical and managerial activities, spanning the entire supply process from pharmaceutical selection to patient use.

Established quality standards are published periodically in pharmacopoeias and in some government publications. For the purposes of primary health care, the most important characteristics of a pharmaceutical product are identity, purity, strength, potency, uniformity of dosage form, bioavailability, and stability.

Pharmaceutical quality is affected by starting materials, manufacturing process, packaging, transportation and storage conditions, and other factors; these influences may be cumulative.

If a pharmaceutical does not meet established quality standards, passes its expiration date, or has been degraded by storage conditions, the possible consequences are -

  • Lack of therapeutic effect, leading to prolonged illness or death
  • Toxic and adverse reactions
  • Waste of limited financial resources
  • Loss of credibility of the health care delivery system

A comprehensive quality assurance program must ensure the following -

  • Pharmaceuticals selected have been shown to be safe and efficacious for their intended use, are presented in an appropriate dosage form, and have the longest possible shelf life.
  • Suppliers with acceptable quality standards are selected.
  • Pharmaceuticals received from commercial suppliers and donors meet specified quality standards at the time of delivery.
  • Packaging meets contract and usage requirements.
  • Repackaging activities and dispensing practices maintain quality.
  • Storage and transportation conditions do not compromise product quality.
  • Product quality concerns reported by prescribers, dispensers, and consumers are properly cataloged and addressed.
  • Product recall procedures are implemented to remove defective products.

A quality assurance program should include training and supervision of staff members at all levels of the supply process and a suitable information system. Often, public officials must balance the costs of establishing and maintaining quality assurance systems against the benefits of having safe and effective medicines.

 
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