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Our state-of-the-art manufacturing facilities uphold the highest standards of quality, safety, and authentic Ayurvedic excellence.
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Shree Dhootapapeshwar Ltd. is one of the first few Ayurvedic Industries to receive the GMP certification.
GMP (Good Manufacturing Practice) is an accepted norm for various industries all over the world today. It is recognized as a robust methodology to control and manage the manufacturing operations and quality control testing of raw materials as well as the finished products. It covers each and every aspect of manufacturing and testing. GMP certification ensures that the products coming from GMP certified units comply with the specified set of standards for Quality and Purity.
Naturally the equipment and methodology used to manufacture the products also needs to be of a particular quality. Documentation of every aspect of processing operations and testing activities involved in the manufacturing of the product needs to be perfect and clear. GMP ensures that these documents are followed diligently to ensure and demonstrate that the end product is of acceptable quality and the contaminants are within specified limits. It is because of these norms that the tractability of the product can be established.
Ayurved talks in great details about how the manufacturing unit should be, where it should be located along with the entire methodology of preparations of medicines – starting from the selection of the raw material to storage of the finished product. It also deals with other aspects such as the sanitation, ventilation of the manufacturing unit, hygiene of the workers and other relevant details regarding manufacturing unit as well as manufacturing process. However, the terminology used then is to be interpreted and understood in the current context.
The Department of AYUSH and Food and Drugs Administration, Government of India, have prescribed the requirements of GMP standards under Schedule T of the Drugs and Cosmetics Act, 1940, which are mandatory for the Ayurvedic Industry.
Ayurved has defined specifications of a good product mainly on the basis of organoleptic tests. Now that the Ayurvedic manufacturing has moved from the hands of an Ayurvedic physician who used to make his own medicines to those of a large scale manufacturer, it is imperative that nothing is left to individual subjectivity and discretion.
Specific acceptance criteria therefore need to be evolved not only for the raw material selected through the well laid out meticulous selection process but also for the processes carried out at critical stages of product manufacturing and the finished product that goes to the end consumer.
There are various standards that are specifically mentioned in various Government publications. However, in today's competitive world the end consumer expects much more from a product in terms of Quality and Purity requiring thorough approach and diligent scrutiny.
Keeping this in mind, Shree Dhootapapeshwar Ltd. has taken appropriate steps in this direction and has evolved standards based on globally acceptable parameters. All of these have been compiled as monographs which has made it possible for 'Shree Dhootapapeshwar Ltd'. to produce products meeting these rigid standards of Quality and Purity. Quality Standardized logo has been inscribed on the label of the product as a guarantee of this Quality to the end consumer.
We strive not just to meet International Specifications but we also try to excel in what we call 'Shree Dhootapapeshwar Benchmark'. One of our associate organization and major vendor Om Pharmaceuticals Ltd, Bengaluru, became the first Ayurvedic manufacturing unit in India and in the world to be certified under the guidelines of ISO-9001.
Ensuring Excellence Through Rigorous Quality Standards.
Shree Dhootapapeshwar Ltd's Quality team ensures the delivery of high standard products by conducting step by step reviews. Our internal quality parameters include not only systems and instruments, but also well trained and responsible staff to execute the entire processing in highly calibrated, sophisticated analysers.
Advanced, sophisticated machineries and instruments
Comprehensive quality policies and procedures
Competent, enthusiastic and dedicated staff
Continual monitoring by dedicated quality assurance team
Controlled computerized systems.
Evaluating Every Detail for Consistent Excellence.
It includes evaluation of Shodhita i.e purified raw materials, Kadhas i.e decoction for Bhavana (specialized process in preparation of Ayurvedic medicine) , Bulk for tableting etc. as per established in-house standards.
It includes evaluation of finished products like Arogyavardhani, Chandraprabha, Gold containing products etc. as per established in-house standards, which include:
Ensuring Consistency Through Proven Standards and Processes.
Standards for about 221 herbal raw materials have been set. Photo documented thin layer chromatography profile has been updated for 94 Herbal Raw Materials. Unique Monograph Number which corresponds to the product code has been generated for all the plant materials. The standard describes Official name, Botanical name and General name of herbal raw materials, macroscopic properties, physico-chemical characteristics viz. foreign matter, Ash, Acid Insoluble Ash, Extractive values & photo documented ‘Thin layer chromatography’ profile.
Looking into the increased concern of Safety, we have included the limits of Contaminants viz. Pathogens, Heavy Metals, Pesticide Residues & Aflatoxins in the monographs of herbal raw materials which complies WHO Guidelines.
The complex composition of herbo-mineral drugs has been a major challenge for quality control. Specifications of herbal raw materials have been fixed on contents of complete part of plant and drug which includes the active marker compounds and also other inert substances. While we have considered geographical and seasonal factors such as age and origin of the herbal/mineral, time of harvest, method of drying, storage etc. which influence the proportion of various components in the herbo-mineral materials.
51 Mineral & Animal Raw Materials have been standardised. Standardised profile includes General name, Chemical formulae, diagnostic features, Elemental assay of main ingredients and trace elements. XRD profile incorporated for few compounds.
Total 153 products are under Traditional Ayurvedic Pharmacopoeial & Proprietary Formulations of Shree Dhootapapeshwar Ltd. Standard Monograph of these includes the product code, text reference, shelf life, physico-chemical characteristics, Elemental Assay, Chromatographic profile highlighting batch to batch consistency, Ayurvedic tests of bhasmas and Acute toxicity of selected products. The development of Quality Manual included sourcing of vital analytical data from the recent past. No compromise has been made on limitation of toxic impurities. Looking into the increased concern of safety, we have included the limits of Contaminants viz. Pathogens, Heavy Metals, Pesticide Residues & Aflatoxins in the monographs of formulations. The compendial standards have been set to comply with the expiry date under specified storage condition.
It comprises of total 32 products. The products have been standardized in terms of ‘Thin layer chromatography’, shelf life, physico-chemical characteristics, Elemental Assay, Chromatographic profile highlighting batch to batch consistency and acute toxicity of selected products.
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