Overview
For the rigorous analysis essential for herbal product registration with the Food and Drugs Authority (FDA), the Centre for Plant Medicine Research in Mampong-Akwapim stands as the foremost authority. Our institution is renowned for its meticulous approach to laboratory examinations, ensuring that all submitted products undergo thorough scrutiny to meet the highest standards of quality and safety.
Every product that reaches our laboratories undergoes a detailed and comprehensive analysis, encompassing various parameters such as purity, potency, and composition. Our team of experts employs state-of-the-art equipment and methodologies to meticulously assess each product, leaving no stone unturned in ensuring their adherence to regulatory requirements.
Furthermore, our efficient operations ensure timely delivery of analysis reports, with turnaround times typically within two months of submission. This promptness allows manufacturers and stakeholders to proceed with the necessary regulatory processes expeditiously, facilitating the smooth transition of products to market availability.
In summary, the Centre for Plant Medicine Research is dedicated to upholding the highest standards of quality and safety in herbal product analysis. Our meticulous approach, coupled with timely delivery and affordability, makes us the preferred choice for herbal product registration analysis by the FDA and industry stakeholders alike.
We conduct comprehensive laboratory analysis on all submitted products, focusing on three key areas:
1. Microbiology: This involves two types of tests:
a. Microbial load: Assessing the product’s wholesomeness based on acceptable microbial contamination levels outlined by the WHO for human consumption.
b. Anti-microbial activity: Evaluating the product’s efficacy against known microorganisms through zone of inhibition assays.
2. Pharmacology: This entails assessing the product’s LD50 and margin of safety by administering it to laboratory animals at varying doses and observing for toxicity symptoms over a 14-day period. LD50 values are determined, and a wide margin of safety indicates product safety.
3. Phytochemistry: Involves analyzing physical parameters such as pH, total solid residue, and color, ensuring adherence to WHO standards. Additionally, we assess phytochemical constituents to confirm plant origin and detect potentially harmful chemicals.
FAQ
MOST FREQUENT QUESTIONS AND ANSWERS
The cost for testing a product is GHs 615.00 for Ghanaian companies | Manufactures and $255 for foreign companies. This fee covers all three laboratory analyses. The fee must be paid in full when submitting the product for testing or when collecting your report after testing. The fee for a single lab analysis is GHs 410.00 for Ghanaian companies | Manufactures and $150 for foreign companies.
We carry out single lab analysis for clients who do not want to undertake all the three lab analyses. The fee for a single lab analysis is GHs 400.00 for Ghanaian companies | Manufactures and $150 for foreign companies.
For products that require all three lab analyses, it takes within three months to get the reports of analyses. If the product does not require pharmacological analysis, it takes within a month to get the reports of analysis.
No complex procedures are involved. Simply visit the Drug Analysis Unit of the Centre with a minimum of 10 product samples for testing. Provide your name, address, and contact number for record-keeping. Pay the required analysis fees, in full. Within three months, you will be contacted to collect your reports..