Current Good Manufacturing Practices (cGMP)
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
Product Quality
Safety Assurance
Reduce safety risk in product quality
Improves customer confidence
Improves efficiency and lower costs
Timely detect production and management problems
Who can be certified cGMPD Certification?
Foods
Cosmetics
Dietary Supplements
Beverages
Storage
Packaging
Document required forcGMP 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:
Time Frame
Task
Process
Day 1
GAP Analysis
Certification Body
Selection
Cost Estimates
- Finding the cGMP between existing system related to GDP 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 tocGMP 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
- Yearly Renewal Audit
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
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).