Abstract

GOOD MANUFACTURING PRACTICES (GMP) COMPLIANCE IN HERBAL DRUG MANUFACTURING

Shubham Yadav* and Mr Awan Kumar Pandey

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Abstract

The quality and safety of these medications have grown to be a major issue for all regulatory bodies as the use of complementary and alternative medicine for sickness prevention and treatment has increased globally. The most often used type of supplementary and alternative medicine is herbal therapy. Worldwide, and much like conventional medication, the effectiveness and safety of herbal remedies mostly depend on their quality throughout the growing, harvesting, processing and final stages of processing. The quality of herbal medicine is directly impacted by their initial processing because of their intrinsic complexity, which frequently involves a variety of active components, the primary processing of herbal medicines has a direct influence on their quality. Because Good Manufacturing Practices are a crucial tool for preventing contamination, mix-ups, and deviations, quality concerns are the reason why pharmaceutical regulatory bodies require that manufacturers adhere to them scrupulously, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities suggested as a means of defending the expenses invested by business who want to invest in ongoing improvement and expand their market reach. To determine the kind and degree of GMP regulations violation for local herbal manufacturers in Uganda, the National Drug Authority examined 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers. The many GMP chapters and associated sub parameters made up the factors taken into consideration while analyzing standards compliance or noncompliance of the local herbal manufacturers’ frequent defaults on GMP parameters were detected, along with accompanying frequencies to determine the relationship between conformation and the question in each categories the Pearson Chi- square test was used separately for each category. Out of the 30 facilities that were inspected, only 22% were found to comply with GMP requirements as per National Drug Authorities (NDA) guidelines; the majority of facilities, (78%), were found to be noncompliant. Of the facilities inspected, 25 were undergoing their first GMP inspection.

Keywords: Herbal drugs, Drug regulation, Traditional medicine, GMP, Quality assurance, Regulatory affairs, GMP compliance.