Development and Evaluation of a Local Herbal Product Standardisation Protocol for a Pharmaceutical Company in Enugu State, South East Nigeria

Standardisation of herbal pharmaceutical products is a prerequisite for regulatory approval by the National Agency for Food and Drug Administration and Control and for building consumer confidence in plant-based remedies manufactured and marketed commercially in Nigeria. This study develops and evaluates a standardisation protocol for a selected herbal product marketed by a pharmaceutical company in Enugu State, South East Nigeria. The herbal product, formulated from Ocimum gratissimum and Carica papaya extracts, is subjected to a comprehensive quality evaluation framework covering botanical identification, physicochemical characterisation, phytochemical profiling by thin-layer chromatography and high-performance liquid chromatography fingerprinting, heavy metal screening by atomic absorption spectrophotometry, microbial limit testing, and stability assessment under accelerated conditions. Batch-to-batch consistency is evaluated over five production batches using statistical quality metrics. The developed protocol is benchmarked against World Health Organization guidelines for quality control of herbal medicines and Nigerian Herbal Pharmacopoeia monograph requirements. Gaps between current company practice and the proposed standardisation protocol are identified, and a corrective action plan is formulated. Training recommendations for production chemists and quality assurance staff are included. Findings contribute a practical, institutionally relevant standardisation framework that can be adopted by other small and medium herbal pharmaceutical manufacturers operating in the South East geopolitical zone of Nigeria. Keywords: herbal product standardisation, pharmaceutical quality, Enugu, high-performance liquid chromatography, National Agency for Food and Drug Administration and Control