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GMP

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.

GMP in Ayurved

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.

Quality Control at SDL

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.

Salient features of the Quality Control Laboratory: 

  • 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.

At SDL, we carry out quality evaluation as per specifications laid down in Ayurvedic Pharmacopoeia of India and established in-house standards i.e. SDS.

We follow Quality Norms and Protocols as per:

  • Ayurvedic Pharmacopoeia of India
  • Indian Pharmacopoeia
  • Quality Standards of Indian Medicinal Plants (ICMR – Indian Council of Medical Research)
  • Quality Control Methods for Medicinal Plants (World Health Organisation)
  • American Herbal Pharmacopoeia
  • British Herbal Pharmacopoeia
  • AOAC (Association of Analytical Chemists)
  • ICH ( International Council for Harmonisation)
  • BIS (Bureau of Indian Standards)

Ayurvedic Pharmacopoeia of India

Indian Pharmacopoeia

Quality Standards of Indian Medicinal Plants (ICMR – Indian Council of Medical Research)

Quality Control Methods for Medicinal Plant Materials – World Health Organisation

American Herbal Pharmacopoeia

British Herbal Pharmacopoeia

Association of Analytical Chemists

International Council for Harmonisation

Manufacturing Excellence

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.

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