1. HHM 5014 NUTRACEUTICAL FORMULATION TECHNOLOGY
CURRENT GMP (cGMP)
Fatin Husna Fadhilah Fairoza

2. DEFINITION
Refer to the Current Good Manufacturing Practice regulation enforced by the US Food Drug Administration
Provide for systems that assure proper design monitoring and control of manufacturing processes and facilities.

3. WHY ARE CGMPs ARE SO IMPORTANT
A consumer usually cannot detect (through smell, touch or sight) that a drug product is safe or if it will work.
While CGMPs required testing, testing alone is not adequate to ensure quality

4. Help to assure the safety and efficacy of drug product.
IMPORTANT
To assure that quality build into the design and manufacturing process at every step.
Help to assure the safety and efficacy of drug product.
To make sure the drugs are manufactured under conditions and practices required by the GMP regulations.
To assure the facilities that are in good condition, equipment that is properly maintained and calibrated

5. COMPONENT OF cGMP
GMP is a part of QA.
GMP’s main function is to produce quality product consistently.
GMP must meet legal requirements of country.
GMP must meet both production and related issues.

6. Personnel
Premise
Equipment
Sanitation
Raw Materials
Batch Manufacturing Record
Label and other printed material QA
GMPs COVERS

7. PERSONNEL

8. PREMISES

9. EQUIPMENT

10. SANITATION

11. CONCLUSION
CGMP is important to ensure products are safe and have the “identity and strength to meet the quality and purity characteristics” they should possess.
It also can protect the consumer from purchasing a product which is not effective or even dangerous.
If the CGMP is not followed, the product maybe:
Adulteration
Cost in production
Product poor in quality and safety