DRAP seeks international quality certification
It will help authority improve its SOPs
DRAP’s vision includes strengthening of the institutional capacity and increasing international acceptance as a measure of its stringent regulations to safeguard the availability of medicine as an essential part of public health. PHOTO: REUTERS
In a bid to improve its quality structures to better regulate medicines in the country, the premier drug regulator is seeking quality certification from the SGS United Kingdom.
According to a Drug Regulatory Authority of Pakistan (DRAP) spokesperson, International Standards Organisation (ISO) certified Quality Management Systems (QMS) are one of the many steps for acquiring international accreditations such as World Health Organisation (WHO) Global Benchmarking for National Regulatory Authorities, membership of Pharmaceutical Inspection Co-operation/Scheme (PIC/S) and WHO accreditation of its central drug-testing laboratory in Karachi.
By acquiring the QMS certification, the DRAP official said that the regulator hopes to improve the standard operating procedures (SOPs) of the authority, timeframes for application processing, complaint management system and strategies to implement a robust and efficient management system.
QMS certification will also facilitate DRAP in attaining maturity level III in WHO Global benchmarking apart from strengthening of its regulatory functions, which will ensure the availability of quality-assured, safe and effective therapeutic goods in the country.
The much-needed QMS certification will also facilitate manufacturers and importers of therapeutic goods in getting a timely response from DRAP regarding the regulatory documents required for local availability as well as import and export of pharmaceutical products.
DRAP’s vision includes strengthening of the institutional capacity and increasing international acceptance as a measure of its stringent regulations to safeguard the availability of medicine as an essential part of public health.
The authority is endeavouring to adopt the best international practices and strategising to enhance the capacity of the pharmaceutical industry of Pakistan to boost pharmaceutical exports, the spokesperson said.
Published in The Express Tribune, August 26th, 2019.
According to a Drug Regulatory Authority of Pakistan (DRAP) spokesperson, International Standards Organisation (ISO) certified Quality Management Systems (QMS) are one of the many steps for acquiring international accreditations such as World Health Organisation (WHO) Global Benchmarking for National Regulatory Authorities, membership of Pharmaceutical Inspection Co-operation/Scheme (PIC/S) and WHO accreditation of its central drug-testing laboratory in Karachi.
By acquiring the QMS certification, the DRAP official said that the regulator hopes to improve the standard operating procedures (SOPs) of the authority, timeframes for application processing, complaint management system and strategies to implement a robust and efficient management system.
QMS certification will also facilitate DRAP in attaining maturity level III in WHO Global benchmarking apart from strengthening of its regulatory functions, which will ensure the availability of quality-assured, safe and effective therapeutic goods in the country.
The much-needed QMS certification will also facilitate manufacturers and importers of therapeutic goods in getting a timely response from DRAP regarding the regulatory documents required for local availability as well as import and export of pharmaceutical products.
DRAP’s vision includes strengthening of the institutional capacity and increasing international acceptance as a measure of its stringent regulations to safeguard the availability of medicine as an essential part of public health.
The authority is endeavouring to adopt the best international practices and strategising to enhance the capacity of the pharmaceutical industry of Pakistan to boost pharmaceutical exports, the spokesperson said.
Published in The Express Tribune, August 26th, 2019.