The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States.

1. CODE OF
FEDERAL
REGULATIONS
Presented by
Ch. S S N D Balakrishna, M.Pharm
Department of Regulatory Affairs
Shri Vishnu College of Pharmacy (SVCP)

2. CODE OF FEDERAL REGULATIONS
The Code of Federal
Regulations (CFR) is the codification of the
general and permanent rules and
regulations published in the Federal
Register by the executive departments and
agencies of the federal government of the
United States.

3. 21 CFR PART 211
• 21 CFR
Governs Food And Drugs Within The United States
• 21 CFR PART 211
• Current Good Manufacturing Practice For Finished pharmaceutical
• There Are 11 Subparts (Identified By Letters A To K)

4. SUBPART-A : General Provisions
1. Scope
• Minimum cGMP.
2. Definitions
• Drug product
• Active ingredient
• Lot
• Strength

5. • Drug product
A finished dosage form that contains an active drug ingredient in
association with inactive ingredients.
• Active ingredient
Means any component that is intended to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• Lot
Means a batch, or a specific identified portion of a batch, having uniform
character and quality within specified limits.
• Strength means
The concentration of the drug substance

6. SUBPART-B : Organization and Personnel
1. Responsibilities of quality control unit.
2. Personnel Qualifications.
3. Personnel responsibilities.
4. Consultants

7. ➢ Responsibilities of quality control unit.
• Testing and Approval of components.
• Approving or Rejecting of the drug product.
➢ Personnel Qualifications
• Adequate number of qualified personnel
• Each person shall have the education, training, and experience to perform
assigned jobs.

8. ➢ Personnel responsibilities:
• good sanitation and health habits.
• Any person who have an apparent illness or open lesions that may adversely
affect the safety or quality of drug products and he shall be excluded.
➢ Consultants
• Consultants must have sufficient education, training, and experience.

9. Subpart C - Buildings and Facilities
1. Design and construction features.
2. Lighting.
3. Ventilation, air filtration, air heating and cooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance

10. Thank You