Quality control is one of the important aspects of GMP. Raw material identification, monitoring process, quality checks, control of finished products, packing and packaging material and water under use are the responsibility of quality control laboratory.
Quality control testing can be done either in own premises or by Government approved testing laboratory. In house quality control laboratory should have minimum 150 square feet covered area. Technical persons holding degree qualification in Ayurveda, siddha and unani, pharmacy, farmacognosy and chemistry are to be employed for laboratory work.
Testing procedures to be adopted as per pharmacopoeia requirement for manufacturer’s specifications. Samples of finished products of each batch will be kept for 3 years.
Labelling, packing and limit of alcohol in Ayurvedic or Unani drugs
Asvas and Arishtas form an integral part of Ayurvedic medicines and the labelling, packing and limit of alcohol in any Indian system of medicine drug including Ayurveda, siddha or Unani has been clearly specified in the first schedule of GMP act as under.
There shall be conspious display on the label of container or package of an Ayurvedic (including siddha) or unani drug, the actual list of all the ingredients used in the manufacturer of the preparation together with the quality of each of ingredients incorporated therein and reference to the method of preparation thereof as detailed in standard text and Adhikarans as are prescribed in the the authoritative books specified in the first schedule of the GMP act.
If the list of ingredients contained in the medicine is lengthy and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be displaced to this effect on the level.