CURRENT GOOD MANUFACTURING PRACTICES

SCHEDULE B

CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY

WAY OF FORMULATION

SECTION-I
PREMISES
1. Location and Surroundings .
1.1 Location
1.2 Surroundings

2. Building Layout And Its Pre-Approval

3. Building Design And Construction (General)

3.1 General
3.2 Services
3.3 Protection Against Insects etc.
3.4 Surfaces

4. Storage Areas
4.1 Capacity
4.2 Design
4.3 Bays
4.4 Quarantine
4.5 Sampling
4.6 Rejected Materials
4.7 Special Materials
4.8 Packaging Materials
4.9 Weighing Area

5. Production Department
5.1 General Facilities
5.2 Dedicated Facilities for Production
5.3 General Requirements for Production Areas
(i) Layout
(ii) Adequacy
(iii) Surfaces
(iv) Services
(v) Drains
(vi) Environmental Controls
(vii) Packaging
(viii) Light

6. Ancillary Areas
6.1 Rest Rooms
6.2 Changing Rooms