The QMN Weekly Bulletin

Colombian Health Ministry Issues GLP Guide on Testing Drug Quality

April 5, 2013

Colombia’s Ministry of Health and Social Protection has issued a manual defining good laboratory practices (GLP) for laboratories that test the quality of medicines marketed in the country.

The GLPs, which are intended to complement good manufacturing practices adopted in 1995, are based on the World Health Organization’s (WHO) Technical Document No. 6, “WHO Good Laboratory Practices for Pharmaceutical Quality Control.”

The GLPs apply to both national and international labs. Domestic laboratories seeking to market medicines in Colombia must apply to the National Institute of Food and Drug Vigilance. International labs may submit certification from any of the following countries or from governments that have agreements with those countries: the U.S., Canada, Switzerland, France, UK, Denmark, the Netherlands, Sweden, Japan and Norway.

Documentation from the FDA, the European Medicines Agency or WHO will also suffice.

The 98-page manual outlines the goals, recordkeeping, equipment and personnel standards that a qualifying laboratory must meet. It also describes the quality procedures — such as testing and documentation — that labs must follow and security procedures for laboratory employees. The final section lists kinds of equipment that must be present at facilities of different sizes, along with checklists to aid in self-evaluating compliance.

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