Quality, drug

STANDARD PROCEDURES FOR VALIDATION OF DRUG QUALITY CONTROL METHODS... 

Each of the countries operates a quality analysis system for post-marketing control of drug quality, albeit with vast differences in capacity. Data on the outcome measure for drug quality— the number of dmg samples that failed quality tests compared with the total number of samples collected— are available in all the countries, except the Netherlands. Failure rates are high in some countries, e.g. Tunisia and Uganda. In Australia, high failure rates are found for herbal and other complementary products, compared with prescription dmgs. Empirical data on sanctions applied in such instances are not available. 

Centro para el control Estatal de la Calidad de los Medicamentos [National Centre for Drug Quality Control (NCDQC)](Cuba)... 

FDA. (1971). FDA Introduction to Total Drug Quality. U.S. Government Printing Office, Washington, D.C. 

D Aguanno, W. (1973). Guidelines of reproduction studies for safety evaluation of drugs for human use. In FDA Introduction to Total Drug Quality, DHEW Publ. (FDA) 74-3006, DHEW/PHS/FDA. 

Shanley, A., Thomas, P., Wagner, M. V., Ciurczak, E. Lessons from Heparin. Avoiding future drug quality disasters will require closer control over raw materials, use of more powerful analytics and IT, and a Quality by Design approach. Pharmaceutical Outsourcing, 2008. http //www.pharma manufacturing.com/articles/2008/123.html. Accessed on 17th July 2012. 

Regulatory authorities such as the FDA have prepared guidelines on comparability protocol, Comparability Protocols—Chemistry, Manufacturing and Controls Information, to enable manufacturers to follow a plan to establish and substantiate that changes to postapproval processes do not affect drug quality. 

To support the development activities, accurate and sensitive analytical methods are required. With progress in development, increasing method validation work is performed and the acceptance criteria for drug quality and test method precision are tightened. 

Modern Forums for Harmonization of Drug Quality Standards... 

Thus despite the much higher cost of a new psychotropic drug. Quality of Life assessments, which take into account the true cost of treatment, consistently show that new antidepressants and antipsychotics are superior to the older, and cheaper, medications. Most importantly, when optimal total care is provided for the patient, the quality of life is substantially improved which surely must be the aim of clinical psychopharmacology. 

Figure 10.1. Drug quality and quantity conditional on producing the drug.

The lack of information on quality as it applies to groups of consumers reduces the effectiveness of market mechanisms in ensuring that the most valuable drugs command the highest prices, that is, that high quality receives hnancial rewards. Because of a lack of good comparative information on drug quality, demand-side constraints in pharmaceutical markets are insufficiently effective currently (Reinhardt, Chapter 2), which has led a few countries to implement formal public economic evaluation processes (Drummond, Chapter 11). 

Over the past few years, many guidelines have been developed to address (1) drug quality, (2) efficacy, (3) safety, and (4) regulatory communication. The ICH has developed more than 170 proposed guidelines 64 of them have been adopted by the regulatory agencies in the United States, European Union, and Japan. 

Ajaz Hussain. FDA s Initiative on a Drug Quality System for the 21st Century A Once in a Lifetime Opportunity . AAPS Meeting Presentation, October 2003. 

United States Pood and Drug Administration (2006) Drug quality assurance, in FDA Compliance Program Guidance Manual, Ch. 56, United States Food and Drug Administration, pp. 1-28. 

Semine, A., S. Phanouvong, L. Chanthap, R. Tsuyuoka, N. Nivana, and N. Blum. 2004. Antimalarial Drug Quality in Mekong Region. A poster presentation at the International Conference on the... 

Convention, Inc., which also publishes the USP (United States Pharmacopeia). The purpose of the NF is to ensure the uniformity of drug products and to maintain and upgrade standards of drug quality, packaging, labeling, and storage. In 1980, all NF responsibility for white oil classification was transferred to the USP. 

It is clear today that the issue discussed above should be taken into account by pharmacopoeial committees and regulatory bodies involved in drug quality assurance for harmonization of requirements to analytical results and improvement of their quality, first of all while developing the reference standards. 

---