QUALITY CONTROL

Quality Control



Quality Control

At the Third Pan American Conference on Drug Regulatory Harmonization, in April 2002, the outcomes of the study of the position of the authorized pharmaceutical value command laboratories and the investigates of the external value command program were presented. In supplement, there were accounts on the teaching methods that are being developed. The seminar endorsed the undertakings conveyed out in this program.

Availability of authorized quality  control  laboratories that function effectively is advised absolutely crucial for pharmaceutical quality  assurance. In Latin America distinct activities associated to the reinforcing of value command laboratories have been conveyed out; in the 1980s with the support of PAHO a Pan American Network of Quality Control Laboratories was established. The constituents of that mesh conveyed out two actions: development of measures of good lab perform and establishment of an external command value program. The mesh worked inside the structure of subregional pharmaceutical tasks in Central America and was hardworking all through that task, until roughly 1992. Due to the deduction of those tasks, the yearly report of the mesh of that year, offered at the Meeting of Ibero-American Regulatory Authorities Network, demonstrated that its continuity was subordinated under a program of work and coordination of those identical laboratories, which was not conveyed out.

Continuing with the EQCP, in 2003 investigation of chosen goods from the pharmaceutical market in the district was begun. The first of them was acyclovir made both by pharmaceutical businesses constructing the initial merchandise and by those producing the generic product. Participating in the enquiry were 21 authorized value command laboratories in 19 countries; 22% were established in Group 1, 33.5% in Group 2, and 44.5% in Group 3.

In 1996 PAHO, with the collaboration of the United States Pharmacopeia (USP), set up a discussion of professionals on the development of pharmacopeia measures for the Americas, one of whose objectives was to talk about the capability of value command laboratories in the public and personal sectors. Participating in this gathering were professionals from Argentina, Brazil, Chile, Colombia, Jamaica, and Mexico, who offered their positions with consider to association, human assets, goods subject to command, major difficulties pertaining to value, causes of quotation measures, and computer systems.

In 1997 at the First Pan American Conference on Drug Regulatory Harmonization, main concern facets of the methods of harmonization were recognised and the require for having unified criteria for accreditation of laboratories for analytical command of pharmaceutical trials was recognized.

In 1998, for the reason of advancing and harmonizing command of pharmaceutical value in the whole hemisphere PAHO and USP suggested establishment of an electrical devices mesh for exchange of data amidst the authorized value command laboratories of the Andean area.

In 1999, at the gathering of the Directing Council of the Central American Committee on Social Security Institutions (COCISS) the evaluation of eight authorized value command laboratories in the Central American locality and the Dominican Republic was presented. Only two of the eight laboratories assessed were in compliance in more than 80% of the facets assessed, clues ...