IMPACT OF ENABLERS AND BARRIERS FOR COMPLIANCE WITH INTERNATIONALLY ACCEPTED QUALITY STANDARDS IN THE PHARMACEUTICAL INDUSTRY OF PAKISTAN
Keywords:
pharmaceutical quality standards, GMP compliance, pharmaceutical industry Pakistan, regulatory compliance, quality management systems, pharmaceutical regulationAbstract
Introduction: Drug safety, product reliability, and international market access rely on compliance with internationally accepted pharmaceutical standards of quality. In the case of developing nations like Pakistan, the pharmaceutical companies tend to have issues with adoption of superior regulatory frameworks as a result of financial, technological and institutional limitations. It is hence important to come up with an understanding of what affects compliance in order to enhance quality assurance practice in the pharmaceutical industry.
Purpose: The purpose of the study was to investigate the enablers and limitations influencing the adherence to internationally recognized quality standards in pharmaceutical industries in Karachi, Pakistan.
Methodology: A qualitative research design was followed through replica study. The interviews showed that 20 professionals working in the quality assurance, production management, regulatory affairs, and quality control departments in pharmaceutical companies were interviewed semi-structurally and using interviews. Thematic analysis was adopted to analyse the obtained data, to reveal major patterns associated with the regulatory awareness, organisational practices, barriers, as well as enabling factors contributing to compliance.
Findings: The findings revealed that the biggest barriers to compliance were financial constraints, lack of skilled labor force, technological constraints and regulatory delays. Meanwhile, organisational facilitators like employee education, executive buy-in, internal quality inspection and technology improvements were also significant towards the compliance with global standards. The familiarity with WHO GMP was rather high and the familiarity with more stringent international standards of GMP like EU GMP and US FDA standards was relatively low.
Conclusion: The paper concludes that to enhance pharmaceutical quality compliance in Pakistan, it is important to enhance workforce training, as well as organisational quality management systems, and regulatory transparency and institutional support.
