THIS is in response to the letter on the first independent drug testing laboratory in Pakistan (July 27). There are a few issues that I wish to clarify. This is the first private independent pharmaceutical testing laboratory established in Pakistan, although such laboratories exist in many countries. There was a mistake with respect to in-vivo disintegration; it should be in-vitro dissolution.
This laboratory is only performing pharmaceutical, physical, chemical and microbiological tests on drugs and not performing any bio-equivalence studies. The testing of impurities/related substances of active pharmaceutical ingredients and drug products is performed in this laboratory and does not require certification of good laboratory practices (GLP). The stability studies are performed by these laboratories, complying with the ICH requirements.
The lab, if it is part of the manufacturing unit, is required to be inspected at least by its own national regulatory authority in compliance with GMP requirements. Being the first private independent drug testing laboratory, pre-qualified by WHO, it can perform quality testing, which is acceptable by international regulatory authorities. I am not sure why the capacity issue has been mentioned by the author in his publication.
Dr Ambreen Amir
Chief Operating Officer
Published in Dawn, August 4th, 2020