What is cGMP?
In the United State, Current Good Manufacturing Practices known as CGMP, refer to legislation that falls under the purview of the U.S. Food and Drug Administration (FDA). These laws ensure that all pharmaceuticals and most food and beverage, cosmetic, and dietary supplement companies follow industry and best practices like hygiene, quality control, and more to ensure all products manufactured are safe and effective. Current Good Manufacturing Practices are not limited to companies located within the U.S. Foreign companies that produce food, medical, and cosmetic products for distribution in the U.S. must comply with these standards. The World Health Organization (WHO) has Good Manufacturing Practice guidance in place for pharmaceuticals and biological medicinal products. While the WHO is a separate organization from the FDA, these guidelines help ensure the global supply of medication and medical products meets safety guidelines.
Benefits of cGMP Certification
Acquire ANSI/ESD S20.20 and IEC 61340-5-1 certification
Achieve anti-static control
Meet the requirements and improve processes
Improves customer confidence
Improves efficiency and lower costs
Reduce the risk of electrostatic discharge
Check out the Who can be certified cGMP Certification Video
Who can be certified cGMP Certification?
Aerospace Equipment
Home appliances
Electrical appliances
Automotive electronics
Consumer electronics
Document required for cGMP Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of cGMP Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Day 1
GAP Analysis, Certification Body, Selection, Cost Estimates
• Finding the GAP between existing system related to cGMP requirements
• Selecting the appropriate certification Body
• Based on the scope of your business & certification Body you choose
Week 1
Developing Documents
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
• cGMP Awareness training for the top management and staff
• Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
• Internal audits identifying nonconformities related to cGMP requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the certification body
Week 12
Certification Body
• cGMP certificates issued for 1 years
Year on Year
Yearly Compliance
• Support of Yearly documentation for audit
FAQ
Current good manufacturing practices (CGMPs) are general practices and procedures recommended by the Food and Drug Administration (FDA) to ensure product safety and quality. CGMPs help prevent food safety hazards in your facility and ensure that your food products are safe to eat.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
CGMPs can be applied to any food manufacturing, packing or storage operation, regardless of the type of food or manufacturing process. In contrast, each HACCP control plan is specifically designed for a particular food or a related group of foods or food processes.
CGMP is the main regulatory standard for ensuring pharmaceutical quality. This includes over-the-counter and prescription small-molecule drugs and biopharmaceuticals like vaccines, therapeutic blood products, gene therapies, antibodies and cell therapies (e.g. stem cell therapies).