Alina Sepeda L.Ac., Dipl. O.M., M.S.
Good Manufacturing Practices (GMP)
At Alina Sepeda Herbal Medicine, the quality and safety of our herbs is paramount. We only work with manufacturers that make and process their herbs in facilities that have been certified with the rigorous GMP stamp. To truly understand how rigorous and thorough this certification is, keep reading.
Good Manufacturing Practices
Good Manufacturing Practices (GMP) certification lets you know that the site where the herbs are made and processed and the methods used in production have been subjected to a thorough quality control investigation by a qualified third party organization or a government agency. The site and the methods are then certified to be in compliance. Through GMP, the traceability of ingredients, the transparency of the manufacturing process, and most importantly, the safety and quality of products can be ensured.
Furthermore, the GMP certification process is comprehensive by evaluating every element of manufacturing including the handling and processing of raw materials, the product manufacturing process, the training of personnel, inspection of the building and grounds, the air and water purification systems, the operation and cleaning of equipment, and quality control testing and documentation. Because of this, you can be rest assured that when GMP guidelines are adhered to, every batch of product and therefore every herbal formula is safe and of the highest quality.
In-house labs exist at every GMP certified facility of our manufacturing partners. There, extensive quality control analysis is performed such as basic organoleptic and microscopy to higher-level analytical techniques including High Performance Thin Layer Chromotography (HP-TLC) and High Performance Liquid Chromotography (HPLC). These tests confirm correct identification of the herbs, ensure their potency, and test for active constituents when necessary.
Before any processing or use begins, all raw herbs are inspected and the species is confirmed. Every batch of finished product undergoes microbiological testing. Additionally, chemical tests are conducted to identify heavy metals and pesticides while physical tests are performed to determine dissolution time and moisture content. Once the herbs have completed the extensive in-house testing process, products are then randomly selected and tested at third party labs to ensure and thereby confirm that all safety and quality standards have been met.
In-House Quality Control
Every batch of herbs from our manufacturing partners’ warehouses is first quarantined. Each product is then sampled and compared with past batches for consistency. Furthermore, the Certificate of Analysis is verified. These certificates are available for every product that Alina Sepeda Herbal Medicine sells and prescribes because they report the results of all testing done and attest to the product being within each of our manufacturing partners’ specifications. Finally, the herbs are inspected using sensory protocols and confirmed against standard references when necessary to confirm species and quality.
3rd Party Laboratory Testing
After all in-house testing has been performed at the manufacturing sites, heavy metal testing is conducted once more at 3rd party labs to confirm results already found and ensure that the rigorous standards of safety and purity of the herbs are met. Aristolochic acid testing and chloramphenicol testing are more sophisticated tests that are also performed.