Quality Control

Our stringent quality control standards begin right from the sourcing stage to ensure that the final product is safe for clinical use. 

The three pillars of an ideal Ayurvedic /herbal drug and their rational use are quality, safety and efficacy. They should be readily available, accessible and reasonably priced. Safety means that the drug should not present a “significant or unreasonable risk of illness or injury” and the products must have toxicity clearance unless traditionally used for long periods without side effects. Efficacy of health care products is measured by clinical evaluation. Quality has to be built into the final product starting from the raw materials to the finished product. Hence quality must be assured from the selection of propagation material to the final product and up to the time of use. Quality control needs development of specifications for standardization of raw materials, extracts and finished products. It is necessary to establish consistency and reproducibility of a particular extract to ensure guaranteed potency through acceptable levels of active compounds and this process can be carried out chemically, spectroscopically or biologically and currently involves complicated and complex procedures. Standardization is also necessary to implement quality assurance, ensure uniformity of dosage, check stability/expiration dating, detect substandard or adulterated drugs and contaminant. For total quality control of a Ayurvedic/ herbal drug the following practices are have to be followed.

Good Agriculture Practices (GAP)

Good Ethical Practices (GEP)

Good Collection Practices (GCP)

Good Procurement Practices (GPP)

Good Procurement Practices (GPP)

Good Storage Practices (GSP)

Essential steps to be followed for the production of standardized quality herbal products are

  • Identity – Authentication /purity/assay.
  • Species variation/environment factors
  • Harvesting time/post harvest treatment
  • Adulterants/contaminants
  • Pesticide residues/ microbial contaminants/ fungal metabolites/ fumigants
  • Ash value/ toxic metals/ heavy metals.

    For identification of raw materials Organoleptic evaluation (taste, odour, colour, texture), Macroscopic studies, Microscopic studies, Phytochemical studies, Physicochemical tests (Ash content, Alcohol content Moisture content, Total solid content), Gravimetric tests (Extractives), Chromatographic Tests (TLC-Densitometry, HPLC-Profiles, GLC-Profiles) have to be performed.

  • Standard Formula
  • GMP compliance equipments, Standard Operation Procedures (SOP), Trained and competent personnel,GMP and work environment.
  • Standard operating protocols for manufacturing the formulations (Grinding, sieving, mixing, extraction, boiling etc…)
  • Quality specifications for the final product/ standardised dose/ stability
  • Good storage conditions, good packaging, labeling, date of manufacturing, list of ingredients and dose.

For laying down quality specification of the final product, Organoleptic Evaluation Physicochemical tests (Ash content, Alcohol content, Moisture content, Total solid content, Heavy metals, Pesticide residues) Gravimetric tests, Chromatographic Tests (Finger prints) and Microbiology Tests(Microbial Contamination, Bacterial limits, Fungal limits) have to be conducted
Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards to minimize the risks involved in any pharmaceutical production. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff, SOP, work environment, packaging and storage
Thus, we see that sincere efforts have been made by the scientists for quality control of plant based drugs during past few years. For global acceptance of Ayurvedic /herbal medicines, the following measures have to be initiated:

  • Organic cultivation of medicinal plants (to assure biochemical consistency) under contract farming to meet the demand and establish linkage between farmers and drug manufacturers.
  • Improvement of the availability of good quality herbal drugs at affordable prices.
  • Enforcement of drug quality control measures and good manufacturing practices.
  • Realise fully the export potential of Ayurvedic /herbal drugs and identify the problems of industry in production, marketing and export of drugs.
  • Establishing alliances between Industry-scientist-practioners-researchers-academic institutions for boosting R&D on Ayurvedic drugs.
  • Create awareness among farmers, drug manufacturers, trade community, research institutes about the economic potential of Ayurvedic/ herbal drugs.

The Sri Lanka Ayurvedic Drugs corporation has launched a program of quality control of its products and has so far developed standards for over 40 drugs and hundred raw materials

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