GMP CERTIFICATION - GOOD MANUFACTURING PRACTICES
What is GMP?
GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing, and overall quality of pharmaceutical products. It defines certain guidelines that talk about the quality assurance approach. GMP certification ensures that products are produced following the quality standard norms.
Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.
GMP requirements are not peculiar in any sense instead they are open-ended and easy to implement also these requirements give liberty to the manufacturer to decide individually how to efficiently implement the necessary controls.
Benefits of GMP Certification
Empower certification holders to opt great creation
Helps boost export opportunities
Compliance with important laws and guidelines
Improve overall credibility and public image
Reduce safety risk in product quality and safety
Cost saving
Who can be certified GMP Certification?
Food & Beverages
Cosmetics
Pharmaceutical Products
Dietary Supplements
Medical Devices
Document required for GMP 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 GMP 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 GAP between existing system related to GMP 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
- GMP 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 GMP 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
- GMP certificates issued for 1 years
- Yearly Renewal Audit
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The application for GMP certification must be made by an approved individual within the organization looking for the confirmation. This is typically one with obligation, for example, a Production Manager, a Quality Assurance Manager, a Quality Control Manager or the Managing Director.