Schedule F, F1, F2, F3, FF

Schedules: Schedule ASchedule BSchedule CSchedule DSchedule E1Schedule FSchedule GSchedule HSchedule H1, Schedule I, Schedule JSchedule KSchedule L1Schedule MSchedule M1Schedule M2Schedule M3Schedule NSchedule OSchedule PSchedule QSchedule RSchedule SSchedule TSchedule USchedule V, Schedule W, Schedule XSchedule Y


Schedule F:
Schedule F (Rule 78 and Part X) describes requirements related to Blood and Blood Components. We are describing general heading about schedule. This will give you Idea about schedule structure and matter.

Part XIIB: Requirements for the functioning and operation of a blood bank and / or for preparation of blood components.
I. This section describes details about Blood Bank and Blood Components
  • General
  • Accommodation for a Blood Bank
  • Personnel
  • Maintenance
  • Equipment
  • Supplies and Reagents
  • Good Manufacturing Practices (GMP’s) and Standard Operating Procedures (SOP’s)
  • Criteria for Blood Donation
  • General equipments and Instruments
  • Special Reagents
  • Testing Whole Blood
  • Records
  • Labels
II. This section describes the details about Blood Donation Camps
  • Premises, personnel etc
  • Personnel for Out-door Blood Donation Camp
  • Equipments
III. This section describes the details about processing of blood components from whole blood by a blood bank
  • Accommodation
  • Equipment
  • Personnel
  • Testing Facility
  • Category of blood components
  • Plasmapheresis, plateletpheresis, leucapheresis, using a cell separator

Part XIIC:
I. Requirements for manufacturing of blood products
  • General Requirements
  • Collection and storage of plasma for fractionation
  • Personnel
  • Production Control
  • Viral Inactivation Process
  • Quality Control
  • Testing of Blood Products
  • Storage of finished products
  • Labelling
  • Record
  • Master Formula Records
II. Requirements for manufacture of blood products from bulk finished products

Part XIID: Requirements for collection, processing, testing, storage, banking and release of umbilical cord blood derived stem cells
i. General Requirements
ii. Collection and storage of processed umbilical cord blood component
iii. Personnel
iv. Air Handling System
v. Quality Control
vi. Screening Test
vii. Storage
viii. Reference Samples
ix. Labelling
x. Record or Documents
xi. Cord Blood Release

Part XIII:
I. General


Schedule F(I):
Part I: Vaccines
I. Provisions applicable to the production of bacterial vaccines
Part II: Antisera
I. Provisions applicable to the production of all Sera from Living Animals
Part III: Diagnostic Antigens
I. Provisions Applicable to the Manufacture and Standardisation of Diagnostic Agents (Bacterial Origin)
Part IV: General

Schedule F (II) (Rule 124-C):
  • Standards for Surgical Dressings

Schedule F(III) (Rule 124-D):
  • Standards for Umbilical Tapes

Schedule FF (Rule 126-A):
  • Standard for Ophthalmic preparations
  • Part A: Ophthalmic Solutions and suspension
  • Part B: Ophthalmic Ointments

Comments

Contact Form

Name

Email *

Message *

Popular posts from this blog

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

State Pharmacy Council, Its Constitution and Composition and Functions

Pharmacy Council of India, Its Constitution and Composition and Functions