Significance and Importance of Quality Control and Assurance
Alike all other industrial products, pharmaceutical product is always subjected to very stringent and highly regulated Quality Control and Quality Assurance Tests. The whole purpose of these tests is to confirm and re-confirm “Quality”, “Purity”, “Efficacy” and “Safety in Use” of any pharmaceutical product. All these four parameters are equally important for any pharmaceutical product. One of the major drawbacks in popularization of plant based drugs is the inconsistent quality of the formulated preparations.
Quality Control – Present Scenario in Indian Herbal Industry
In India, we have over 8500 licensed Ayurvedic medicine Manufacturers. Over 80% of the medicinal plants requirements by Ayurvedic Industry are obtained from wild collection from forests and waste lands. In most cases supplies are made by Traders most of these do not have adequate knowledge of medicinal plants. The Trader organizes collection of medicinal plants through children and women in these forest areas who many times can not differentiate between related plant species. Therefore many times manufacturing units receive substituted or adulterated plant materials. The problem gets further aggravated since most of the Ayurvedic medicine Manufacturers do not have stringent methods of Quality Controls for these plant materials. Further, confusion occurs many a times due to vernacular/local names by which the traders supply. It is a known fact that local names of several medicinal plants have different botanical identity in the region of their occurrence. The Acceptance Criteria in most of these Ayurvedic medicine manufacturers is based on organoleptic characters and this can definitely be deceptive many a times since crude drugs are received in dry form and in many cases in broken condition like small pieces of barks, roots and rhizomes, powders of leaves and flowers etc. Therefore, if we start Quality checks from Inventories, by making it mandatory for Traders to supply the crude drugs with Certificate of Analysis and Quality, this problem can be overcome in a big way.
Another major problem faced is of non-homogeneity of the materials. Many times collection is done from different regions with the result that there is no homogeneity of these materials both in their organoleptic characters as well as in chemical constituents. Several times a mixture of mature and immature plant species are received which is difficult to separate. Pharmacognostic evaluation thus becomes difficult. Microscopic examination of several samples and that too in dried condition of broken plant part is very difficult and not practical method of quality control testing.
With this basic understanding of problems in performing Quality Control and Quality Assurance, when we see to apply Quality Control and Assurance Tests to Ayurvedic products, first ever fact that is realized that, there is a lack of Standardization of Raw Material and Manufacturing Processes. Another point related to hurdles in this, is a fact that Ayurvedic product is made from varied sources of raw materials which are of plant, mineral and animal origin. These raw materials can be tested for Quality Control and Quality Assurance by highly sophisticated analytical instruments like HPTLC (High Performance Thin Layer Chromatography). But a final product containing number of various plant materials, minerals, and animal products renders it difficult to prepare Quality Control Masterfiles for finished product, which is either polyherbal or many times herbo-mineral type. One more problem is that, interim products which are added in final product are manufactured by different manufacturing processes and hence uniformity even in basic physical properties such as color, odour and taste can’t be the same for the same interim product manufactured by different manufacturers by employing different manufacturing processes of their own choice and convenience. Hence, it can be firmly pointed out that, total Quality Control and Quality Assurance of Ayurvedic products are not possible without Standardization of Manufacturing Processes. Ayurvedic Formulary was published by concerned department in the past but it was not made mandatory to follow the manufacturing processes given in Ayurvedic Formulary. A new project to review old Ayurvedic Formulary with consideration of employing new sophisticated manufacturing techniques and standardizing these manufacturing techniques and processes is a Need of Time.
Quality Control and Quality Assurance of raw materials of Plant Origin can easily and effectively be done by HPTLC (High Performance Thin Layer Chromatography), High Performance Liquid Chromatography and Chemical Fingerprinting. With these methods, qualitative characterization and quantitative determination of mixtures of substances is very much possible.
WHO Guidelines for Quality Control of Herbal Drugs
WHO (World Health Organization), in 1992 has issued comprehensive guidelines for Medicinal Plant Materials and these guidelines are very useful for ensuring consistency of Herbal Products. However, not many Ayurvedic medicine Manufacturers have been able to undertake these tests for want of proper R&D and Quality Control Laboratories. WHO guidelines suggest elaborate test procedures for different types of plant materials. Apart from basic identification requirements, emphasis has been laid on stringent microbiological testing and absence of pesticide residue etc. Specific tests are suggested for certain materials with specific biological activity. Importance of chemical methods analysis including TLC has been well specified. Details of the procedures are covered under major headings such as – Sampling, Determination of Foreign Matter, Macroscopy and Microscopy, Thin layer Chromatography, Ash Values, Extractable Matter, Specific Tests, Pesticide Residues, Arsenic and Heavy Metals, Radioactive Contamination and Microbiological Tests. In an organized sector where Pharmaceutical Companies are involved in production of Ayurvedic Medicines, most of these guidelines are followed. However, since most of the traditional Ayurvedic medicine Manufacturers are in small-scale sector, they do not resort to such stringent tests. They mostly depend on the organoleptic characters and visual inspection. The limitations are mostly Inadequate Resources and non-availability of trained technical personnel to undertake systematic R&D and Quality Control Testing.
In conclusion, in order to ensure consistency in the Herbal Materials and ensure uniformity of Ayurvedic Products, it can be recommended to follow measures given below –
Ensure authentic plant materials – Quality checks on Inventories/Vendor Validation
Undertake proper sampling to ensure Homogeneity of the materials.
Undertake quality control tests as per specification.
Ensure compliance of process and product parameters – Process Standardization
Undertake Microbiological Tests to ensure complete absence of all pathogens.
Ensure complete documentation of all raw materials used along with quality control tests and production parameters – Quality Control Masterfile.