Schedule F, F(1), F(2), F(3), FF

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule F: 

Part I to Part XII-A– Omitted
Part XII B: 
Part XII-B describes the requirements for the functioning and operation of a Blood Bank and/or for preparation of Blood components.

I. Blood Banks/Blood Components

A. General
B. Accommodation for a Blood Bank
C. Personnel
D. Maintenance
E. Equipment
F. Supplies and Reagents
G. Good Manufacturing Practices (GMPs)/ Standard Operating Procedures (SOPs)
H. Criteria For Blood Donation
I. General Equipments and Instruments
J. Special Reagents
K. Testing of whole blood
L. Records
M. Labels
II. Blood Donation Camps
A Premises, personnel etc.
B Personnel for Out-door Blood Donation Camp
C Equipments

III. Processing of Blood components from whole blood by a Blood bank:

A. Accommodation
B. Equipment
C. Personnel
D. Testing Facilities
E. Categories of Blood Components
  • Concentrated Human Red Blood Corpuscles
  • Platelets Concentrates
  • Granulocyte Convcentrate 
  • Fresh Frozen Plasma
  • Cryoprecipitate
F. Plasmapheresis, Plateletpheresis, Leucapheresis, Using a cell Separator

Part XII C:
I. Requirements for manufacture of Blood Products
A. General Requirements
B. Collection and Storage of Plasma for Fractionation
C. Personnel
D. Production Control
E. Viral Inactivation Process
F. Quality Control
G. Testing of Blood Products
H. Storage of finished products
I. Labelling
J. Records
K. Master Formula Record
II. Requirements for Manufacture of Blood products from Bulk Finished products


Schedule F(I):
Part I: Vaccines
A. Provisions applicable to the production of bacterial vaccines
1. Definition
2. Staff of Establishment
3. Proper Name
4. Records
5. Combined Vaccines
6. Preparation
7. General Standards
8. Labelling
9. Storage
10. Date of manufacture

B. Provisions applicable to the production of viral vaccines
1. Definition
2. Staff of Establishment
3. Proper Name
4. Records
5. Tests
6. Storage
7. Condition of housing of animals
8. Labelling
9. Date of Manufacture

Part II : Antisera

Provisions applicable to the production of all Sera from Living Animals
1. Definition
2. Staff of Establishment
3. Proper Name
4. Records
5. Cultures
6. Quantity
8. Unhealthy or Infected Animals
9. Conditions and Housing of animals

Part III:Diagnostic Antigens

Provisions Applicable to the Manufacture and Standardisation of Diagnostic Agents (Bacterial Origin)
1 Definition
2 Staff of establishment-
3 Proper Name
4. Record
5. Preparation
6. General Standard:
7. Labelling
8. Storage
9. Date of manufacture

Part IV: General

Schedule F-II

Standards for surgical dressings

Schedule F-III
Standards for Umbilical Tapes
A. Standards for Sterilised Umbilical Polyster Tape.
B. Standards for Sterilised Umbilical Cotton Tape–

Schedule FF 

Standards for ophthalmic preparations.

Part-A: Ophthalmic Solutions and suspensions. 

Part B: Ophthalmic Ointments

For detail analysis refer drug and cosmetic act and rules

Author: Ajay Kamboj

Full Time Blogger, Part Time Entrepreneur and Partial Time Helper for New Start-UP's in Pharmaceutical, Ayurvedic and Nutraceutical Sector. Contact him at

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