Schedule-T describes the good manufacturing practices for ayurvedic, siddha, and unani medicines. It aims to ensure raw materials are authentic and free from contamination in order to maintain product standards. Schedule-T has seven components that cover infrastructural requirements, working space, storage areas, machinery and equipment, standard operating procedures, health and hygiene, and documentation and records. These components establish guidelines for facilities, sanitation, personnel hygiene, production processes, quality control, and record keeping.

1. SCHEDULE-T
(DRUG AND COSMETIC ACT)
Presented by –
SALMAN KHAN
B . Pharmacy
JAIPUR NATIONAL UNIVERSITY

2. Schedule -T ?
It describes the good manufacturing practices for ayurvedic,
siddha and unani medicines.

3. • Raw materials used in the manufacture of drugs are authentic
• free from contamination.
• To maintain the standards.
• Adequate quality control measures are adopted.
Objectives :-
Why Schedule-T ?
Why Schedule-T ?

4. Components of GMP (schedule-T)
Components of GMP (schedule-T)
1. Infrastructural Requirements
2. Working space
3. Storage area
4. Machinery and equipment
5. Standard operating procedures
6. Health & Hygiene
7. Documentation and Records

5. 1. Infrastructural Requirements
Location and Surroundings
situated and constructed to avoid contamination from open sewerage,
drain, disagreeable or obnoxious odor, dust and smoke etc.
Buildings
hygienic conditions
Adequate light and ventilation facility
( conformity with provisions of factory act )
free from cracks and damp
proper drainage system
Sanitary fitting and electric fixtures shall be proper and safe.
Proper fire safety measures and proper exists should be there.
Water Supply
Water needed for manufacturing should be pure and of potable quality

6. 2. Working space
Manufacturing area should be adequate for orderly placement of --
• equipment,
• machinery; and
• material
used during manufacturing operations

7. 3. Storage Area
ü Store should have adequate space for independently and
separately store
• raw material,
• packaging material and
• finished products
ü Materials should be stored in
Organised form
ü Storage of some items need to be provided
specific conditions like Temperature and
protection from sunlight exposure

8. 4. Machinery & Equipment
• To carryout manufacturing process, adequate
machinery and equipment require.
• These machinery could be manually operated or semi-
automatic or fully automatic based upon your need
and investment.
• Maintenance of the machines and equipments

9. 5. Standard Operating Procedures
Satisfactory Quality control to facilitate easy and safe
working procedures
to minimize or eliminate any risk of mix-up between
different drugs, raw materials
to prevent the cross contamination during
• manufacturing,
• storage and
• handling operations

10. 6. Health & Hygiene
ü All workers should be healthy and should be free from any contagious diseases.
ü Proper uniform should be provided to workers according to nature of work and the
climates. It should be clean.
ü A uniform may include cloth or synthetic covering for hands, feet and head
wherever required.
ü Adequate facilities for personnel use should be provided like clean towel, soap etc.
ü Lavatories for men and women should be separate and should away from
processing and manufacturing area.
ü Changing room facility should also be provided for changing their clothes and to
keep their personal belongings.

11. 7. Documentation & Records
Batch manufacturing Records
Distribution Record
Record of Market Complaints
The manufacturer shall enter all data received on such market complaints,
investigations carried out by the manufacturers regarding the complaint as well as
any corrective action initiated to prevent recurrence of such market complaints shall
also be recorded.
Distribution record ( dispatch record ) should be maintained to facilitate process of
prompt and complete recall of the batch.

12. • Sources :-
--- main.ayush.gov.in
--- Wikipedia
--- Slideshare
--- pharmafranchisehelp.com
For your kind attention