SCHEDULE-T (1).pptx

Schedule T

1. SCHEDULE-T GMP REQUIREMENTS

2. DRUG AND COSMETICS ACT PROVISION Herbal drugs are regulated under the Drug and Cosmetics Act 1940 and rules 1945 in India where regulatory provisions for AYURVEDA,UNANI,SIDDHA medicine are clearly laid down. Department of AYUSH is the regulatory authority and mandate that any manufacture or marketing of herbal drugs have to be done after obtaining manufacturing license,as applicable. The D and C Act extends the control over licensing,formulation composition,manufacture,labelling,packing,quality and export.

3. Schedule ‘’T’’ of the act lays down the good manufacturing practice(GMP) requirements to be followed for the manufacture of herbal medcines . In India traditional medicines are governed by D&C Act 1940 and drug and cosmetics rules 1945 they regulate the import,manufacture,distribution and sale of drugs and cosmetics.

4. Overview of Ayurvedic Drug Manufacturing license Approval steps Approval of Plan of Premises Submission of application with documents to licensing authority for grant of license Inspection of premises by Inspector and Reporting to Licensing authority for taking action. Grant of license by Licensing authority Appeal in case of rejection of application Renewal of license Additional product Permission

5. Additional of new category in License Technical Person approval

6. PART-I GOOD MANUFACTURING PRACTICES Factory premises:the manufacturing plant should have adequate space for 1 Receiving and storing raw material 2 Manufacturing process areas 3 Quality control section 4 Finished goods store 5 Offices 6 Rejected goods/Drug store

7. Requirements for GMP 1.Location and surroundings 2.Buildings 3.Water supply 4.Disposal of waste 5.Containers cleaning 6.Stores 7.Raw materials 8.Packaging Material

8. 9.Finished goods stores 10.Working space 11.Health,clothing,sanitation and hygiene of workers 12.Medical services 13.Machinery and equipment 14.Batch Manufacturing record 15.Distribution record 16.Record of market complaints 17.Quality control

9. LOCATION AND SURROUNDINGS Avoid contamination Bad odour Excesssive dust

10. BUILDINGS The buildings used for factory should have hygienic conditions and should be free from insects and Rodents Should have adequate provision of light and ventilation,floors,and walls should not be moist.

11. WATER SUPPLY The water used in the manufacture shall be pure and of potable quality. Adequate provision of Water Disposal of Water

12. CONTAINERS CLEANING Containers such as glass bottles,vial jars should be properly washed,cleaned and dried. They should be properly identified with the label Status of raw materials such as “ UNDER TEST ’’or “ APPROVED ’’ or “ REJECTED ’’ Labels must be written on Drugs.

13. WORKING SPACE Space for orderly placement of equipment and material used in any of the operations for which these employed so as to facilitate easy and safe working and to eliminate cross contamination of one drug by another drug.

14. HEALTH,CLOTHING,SANITATION AND HYGIENE OF WORKERS Workers must be free from contagious disease The clothing of the workers shall consist of proper uniform suitable to the nature of the work and the climate and should be clean. Workers will also be provided facilities for changing their clothes and to keep their personal belongings.

15. MEDICAL SERVICES The Manufacture should also provide a.Adequate facilities of first aid b.Medical examination of workers at the time of employment and periodical check and records shall be maintained.

16. MACHINERY AND EQUIPMENTS It is depending on the size of operatn and the nature of product manufactured,suitable equipment either manually operated or operated automatically or fully automatic machinery shall be made available. These equipments have to be properly installed and maintained with proper cleaning.

17. Batch Manufacturing Records Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store,tests,conducted during the various stages of manufacture. It should be essential to maintain the record of date,manpower,machine and equipments used and to keep in process record of specific use.

18. Distribution Records Records of sale and distribution of each batch of AYURVEDA,SIDDHA,and UNANI drugs shall be maintained in order to facilitate and complete recall of the batch,if necessary. The duration of record keeping should be the date od expiry of the batch. Records need to be maintained upto five years of the exhausting of stock.

19. Record of Market complaints Quality control Labelling Requirements