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Quality Control for ASU (Ayurvedic, Siddha and Unani Manufacturing Unit):
Every ASU (Ayurvedic, Siddha and Unani Manufacturing Unit) is
required to provide have quality control section in his own premises or through
Government approved testing laboratory. The test shall be as per the Ayurveda,
Siddha and Unani pharmacopoeial standard.
Where the tests are not available, the test should be
performed according to the manufacturers ‘specification or other information
available.
The quality control section shall verify all the raw
materials, monitor in-process quality checks and control the quality of
finished product being released to finished goods store/warehouse. Preferably
for such quality control there will be a separate expert. The quality control
section shall have the following facilities:
- There should be 150 sq. feet area for quality control section.
- For identification of raw drugs, reference books and reference samples should be maintained.
- Manufacturing record should be maintained for the various processes.
- To verify the finished products, controlled samples of finished products of each batch will be kept till the expiry date of product for 3 years.
- To supervise and monitor adequacy of conditions under which raw materials, semi- finished products and finished products are stored.
- Keep record in establishing shelf life and storage requirements for the drugs.
- Ayurveda Manufacturers who are manufacturing patent and proprietary Ayurveda, Siddha, and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.
- The record of specific method and procedure of preparation, that is, Bhavana, Mardana and Puta and the record of every process carried out by the manufacturer shall be maintained.
- The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.
- All raw materials will be monitored for fungal, bacterial contamination with a view to minimize such contamination.
Qualification for Quality control section should have a minimum of:
(i) Qualification
- Expert in Ayurveda or Sidha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act 1970; or
- Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; or
- Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University;
(ii) The manufacturing unit shall have a quality control
section. Alternatively, these quality
control provisions will be met by getting testing etc., from a recognized
laboratory for Ayurveda, Siddha and Unani drugs; under Rule 160-A of the Drugs and Cosmetics Act. The manufacturing company will maintain all the record of
various tests got done from outside recognized laboratory.
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