Schedule A B C D E F G H H1 I J K L 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
Part XIII
General
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