The guidelines provide a framework for the analysis of pharmaceuticals in order to assure the reliability, quality and integrity of the work performed. They provide guidance on the quality management system within which the analysis of these products is performed to demonstrate that reliable results are obtained.
The guidelines are applicable to any pharmaceutical quality control laboratory within manufacturing facilities as well as governmental, non-governmental or commercial laboratories. While the Agency’s mandate is not to regulate laboratories in Nigeria, it relies on accurate and reliable results to make regulatory decisions in order to ensure access to good quality, efficacious and safe pharmaceutical products to the populace. Therefore, the Agency requires that all laboratories that provide analytical data in submissions made to the Agency must comply with these guidelines. They do not include guidance for those laboratories involved in the testing of biological products, e.g. medical devices, vaccines and blood products for which separate regulations apply.
These guidelines were adapted from WHO Good Practices for Pharmaceutical Quality Control laboratories and WHO guidelines for Pharmaceutical Microbiology Laboratories which are consistent with the requirements of the WHO guidelines for Good Manufacturing Practices and the International Standard ISO/IEC 17025:2005.
Continue at: http://apps.who.int/medicinedocs/documents/s23029en/s23029en.pdf
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