SCHEDULE T – GOOD MANUFACTURING PRACTICE OF INDIAN SYSTEMS OF

MEDICINE
COMPONENTS OF GMP (SCHEDULE - T) AND IT’S OBJECTIVES: GMP:
 Good Manufacturing Practice (GMP) is a production and testing practice that helps to
 ensure a quality product.
 GMP guidelines are not prescriptive instructions on how to manufacture products.
 These are a series of general principles that must be observed during manufacturing.
 When a company is setting up its quality program and manufacturing process, there may be
many ways it can fulfill GMP requirements.
 It is the company’s responsibility to determine the most effective and efficient quality process.
OBJECTIVES:
The Good Manufacturing Practices for ASU Drugs as described in Rule 157 of Drugs &
Cosmetics Rules1945 with conditions as specified in Schedule T/GMP are to ensure that:
 Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are
free from contamination
 The manufacturing process is as has been prescribed to maintain the standards
 Adequate quality control measures are adopted
 The manufactured drug which is released for sale is of acceptable quality
 To achieve the objectives listed above, each licensee shall evolve methodology and
procedures for following the prescribed process of manufacture of drugs which should be
documented as a manual and kept for reference and inspection.
 However, under IMCC Act, 1970 registered Vaidyas, Siddhas and Hakeems who prepare
medicines on their own to dispense to their patients and not selling such drugs in the market
are exempted from the purview of Good manufacturing Practice (GMP)
BASIC PRINCIPLES OF GMP:
 Many countries have created their own GMP guidelines & procedure. These GMP guidelines
remain more or less similar to the ultimate goals of safeguarding the health of the patient as
well as producing good quality medicine.
 Manufacturing processes are clearly defined and controlled. All critical processes are
validated to ensure consistency and compliance with specifications.
 Manufacturing processes are controlled, and any changes to the process are evaluated.
Changes that have an impact on the quality of the drug are validated as necessary.
 Instructions and procedures are written in clear and unambiguous language.
 Operators are trained to carry out and document procedures.
 Records are made manually or by instruments during manufacture that demonstrate that all
the steps required by the defined procedures and instructions were in fact taken and that the
quantity and quality of the drug was as expected. Deviations are investigated and
documented.
 Records of manufacture (including distribution) that enable the complete history of a batch to
be traced are retained in a comprehensible and accessible form.
 A system is available for recalling any batch of drug from sale or supply.
 Complaints about marketed drugs are examined, the causes of quality defects are investigated,
and appropriate measures are taken with respect to the defective drugs and to prevent
recurrence.
SCHEDULE T:
  Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unai drugs
 For getting a certificate of “Good Manufacturing Practices” of Ayurveda, Siddha-Unani
drugs, the applicant shall made application on plain paper, providing the information on
existing infrastructure of manufacturing unit, and the licensing authority shall after
 verification of the requirement as per Schedule “T” issue the certificate within a period of 3
months in form of 26-E
GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND UNANI
MEDICINES
COMPONENTS OF GMP
GMP schedule for ISM manufacturing units is quite elaborate and broadly covers each and every
component of manufacturing process. Different components of GMP are given below in order of
appearance in Schedule – T. The Good Manufacturing Practices (GMP) are prescribed as follows in
Part I and Part II.
PART-I
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. Office
6. Rejected goods/drugs store.
GENERAL REQUIREMENTS:
Factory Premises:
1. Location and surroundings
2. Buildings
3. Water Supply
4. Disposal of Waste
5. Containers Cleaning
6. Stores (Raw materials, packing materials, Finished goods stores)
7. Working Space
8. Health, Clothing, Sanitation and Hygiene of Workers
9. Medical Services
10. Machinery and Equipment
11. Batch Manufacturing Records
12. Distribution records
13. Record of Market Complaints
14. Quality control
REQUIREMENTS FOR STERILE PRODUCT:
1. Manufacturing area
2. Precautions against contaminations and mix
FACTORY PREMISES:
Location and surroundings:
1. Location and surroundings of the pharmacy should be situated where there is:
2. No open sewage
3. No drainage coming from public areas & pubic lavatory
4. No factory fume
5. No excessive soot and smoke and dust
Buildings:
1. Hygienic condition
2. No cobwebs/insects/rodents.
3. Adequate light & ventilation.
4. No dampness or Moisture on floor and walls.
5. Wall & floors should be even.
6. Premises used for manufacturing, processing, packaging and labeling should be in conformity
with the provisions of Factory Act.
7. Compatible with manufacturing Operations.
8. Adequate working space
 Logical placement of equipment to avoid risk of mixing, cross contamination and risk of
omission of a control step. Designed, constructed and maintained well to prevent entry of
insects/rodents.
 Interior surface should be smooth, easy for cleaning and disinfection.
 Mooring should be smooth and even so as not to permit retention or accumulation of dust or
waste products.
Water Supply:
The water used in manufacturing should be pure and of potable quality. Adequate supply of water is
required for washing the premises and containers.
Disposal of Waste:
In the manufacturing section and laboratories the waste water and residues which might the
prejudicial to the work as well as public health shall be disposed of after suitable treatment as per
guideline of pollution control to be followed.
Containers Cleaning:
In factories where operation involving the use of containers such as glass bottles, vials and jars are
conducted. Adequate arrangement for washing, cleaning & drying of containers.
Stores:
It should provide adequate space for stores of different type of material such as raw material, packing
material and finished products. Store should have proper ventilation and should be free from
dampness
Raw Materials:
Raw material store should have appropriate containers which would protect the quality of raw
materials and prevent from contamination or rodents and Insect infestation.
Suitable cabins for raw material of
 Mineral origin
 Metallic origin
  Animal origin
 Fresh herbs
 Dry herbs or plant parts
 Excipients, Volatile oils/perfumes and Flavors
 Plants extracts, Exudates/Resins etc.
Each container used for raw material storage should be properly identified with the label which
indicates name of the raw material, source of supply and will also clearly state the status of raw
material such as UNDER TEST or APPROVED or REJECTED.
Label of raw material should clearly indicate Batch No or Lot No, and date at receipt of the
consignment.
All raw materials shall be sampled and got tested either by the in-house quality control technical
person or by laboratories approved by the Government and should be used only on approval after
verifying.
Records of the receipt, testing and approval or rejection should be maintained.
Packing Materials: All packing materials such as bottles, Jars, capsules etc. should be stored properly.
All Container and Closure lids should be properly cleaned and Dried before packing the products.
Finished Goods Stores:
 The finished goods transferred from the production area after proper packaging should be
stored in proper shelves within an area marked Quarantine.
 After the quality control laboratory: and the experts have checked the correctness of finished
goods with reference to its packing/labeling as well as the finished product quality described,
then it will be Moved to Approved Finished Goods Stock area.
 Only approved finished goods should be dispatched as per marketing requirements.
Distribution records should be maintained as required. Specific storage conditions should be
provided for special drugs.
Working Space:
 The manufacturing area shall provide adequate space (manufacture and quality control) for
orderly placement of equipment and material used in any of the operations.
 Facilities for easy and safe working, facilities to minimize or eliminate mixing up of the drugs
should be provided. To prevent cross contamination of one drug by another drug that is
manufactured, stored or handled in the same premises.
 Health, Clothing, Sanitation and Hygiene of Workers:
 Workers should be free from contagious diseases.
 Workers should use proper uniform suitable to work.
 Hands should be covered with cloth or synthetic covering.
 Personal cleanliness, clean towel, soap, scrubbing brushes, separate lavatories for men and
women and facility for changing of clothes and cupboards to keep clothes/belongings should
be maintained.
Medical Services:
 Annual medical check-up of all employees should be done to ensure freedom from Infectious
diseases.
 First-Aid facility should be available.
 Health record of all the employees should be maintained.
Machinery and Equipment:
  Equipment should be according to the size of operation, nature of product manufactured.
 Suitable Machinery manually operated; semi- automatic or automatic should be available in
the manufacturing unit.
 These may include machines for use in the process of manufacture such as crushing, grinding,
powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labeling and packing
etc.
 To ensure ease in movement of workers and orderliness in operations a suitably adequate
space will be ensured between two machines or rows of machines.
 These Equipment have to be properly installed and maintained with proper cleaning.
 Proper standard operational procedures (SOPs) for cleaning, maintaining and performance of
every machine should be laid down.
Batch Manufacturing Records:
 Ayurvedic, Siddha, Unani drug manufacturer should maintain batch manufacturing record of
every manufacturing.
 List of raw materials used, Quantity obtained from the store, tests conducted during the
various stages of manufacture like taste, color, physical characteristics and chemical tests as
may be necessary or indicated in the approved books of Ayurvedic, Siddha and Unnai.
 These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in
the raw material or in the process material and in the finished product.
 Details of transfer of manufactured drug to the finished product store along with record of the
finished product, packaging etc. should be maintained.
 All manufacturing records should be duly signed by Production and Quality Control
Personnel respectively.
 It should be essential to maintain the record of date, manpower, machine, equipment used
along with in process record of various shodhana (purificatory procedures of poisonous
drugs), Bhavana (trituration) in terms of internal use.
Distribution Records:
Records of sale and distribution of each batch of Ayurveda, Siddha and Unani Drugs should be
maintained in order to facilitate prompt and complete recall of the batch, if necessary.
Record of Market Complaints:
 Manufacturers should maintain a register to record of the complaints as well as corrective
action initiated to prevent recurrence regarding the products.
 Once in a period of six months, the complaint records have to be sent to the licensing
authority.
 Register should be available for inspection during any inspection of the premises.
 Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha, Unani drugs
should be maintained in separate register.