CGMP Practice Exam

Current Good Manufacturing Practices (CGMP)

About Current Good Manufacturing Practices (CGMP)

The FDA's Current Good Manufacturing Practices requirements are referred to as CGMP. Systems for ensuring effective manufacturing process and facility design, monitoring, and control are provided by CGMPs.

Since it frequently makes use of cutting-edge technologies, cGMP can be more expensive than standard GMP. cGMP products go through a lot more testing in addition to brand-new, in-depth testing. Beyond ensuring correct production, cGMP is also implemented to guarantee proper usage of newly made items.

CGMP helps companies able to export their goods and maintain quality standards. CGMP has gained immense popularity across the globe resulting in huge demand for certified professionals.

Why is Current Good Manufacturing Practices (CGMP) important?

Systems for ensuring effective manufacturing process and facility design, monitoring, and control are provided by CGMPs. By ensuring that drug makers properly supervise manufacturing activities, CGMP standards ensure the identification, strength, quality, and purity of drug products.

CGMP compliance helps companies offer quality products for exports. CGMP certified professionals, executives and managers are in high demand in companies across the globe.

Who should take the Current Good Manufacturing Practices (CGMP) Exam?

• Anyone who needs a good understanding of current Good Manufacturing Practices.
• Engineers
• PMs
• Quality assurance professional
• Quality control managers
• Regulatory affairs
• Auditors
• Production engineers and managers

Knowledge and Skills required for the CGMP

Critical thinking and communication skills helps candidate to gain quick success for career in CGMP.

CGMP Practice Exam Objectives

CGMP exam focuses on assessing your skills and knowledge in concepts and application of CGMP

CGMP Practice Exam Pre-requisite

There are no prerequisites for the CGMP exam. Candidates who are well versed  in quality management can easily clear the exam.

Current Good Manufacturing Practices (CGMP) Certification Course Outline

1. Introduction to cGMP
2. GMP Audit
3. Checklist for Drug Manufacturers
4. cGMP compliance
5. cGMP audit
6. Strategies for Compliance
7. Pharmaceutical quality control
8. Medical devices
9. Clean room technology
10. Design control and product validation and certification
11. Effective complaint system creation
12. Root Cause investigations for CAPA
13. Packaging of pharmaceuticals products
14. Modernization processes
15. Pharmaceutical process development and technology transfer
16. Processes to control the manufacture and distribution of pharmaceutical, biologic and medical devices
17. Application of the FDA regulations and recommendations
18. Modernization of Food Good Manufacturing Practice Regulations
19. Food CGMP Modernization  and best current Good Manufacturing Practices (cGMPs)

Exam Format and Information

Certification name – Certificate in CGMP
Exam duration – 60 minutes
Exam type - Multiple Choice Questions
Eligibility / pre-requisite - None
Exam language - English
Exam format - Online
Passing score - 25
Exam Fees  - INR 1199