WHO GMP CERTIFICATION
What is WHO GMP?
Good Manufacturing Practices (GMP, also referred to as ‘cGMP‘ or ‘current Good Manufacturing Practice‘) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented and that the personnel, premises, and materials are suitable for the production of pharmaceuticals and biologicals including vaccines.
GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
Benefits of WHO GMP Certification
Prevent Damage to Health
Improved Product Quality
Defined and Controlled Hygiene Protocols
Improved Processes and Production Environment.
Cut Profit Loss
Boost Export Opportunities
Who can be certified WHO GMP Certification?
Food & Beverages
Cosmetics
Pharmaceutical Products
Dietary Supplements
Medical Devices
Document required for WHO 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 WHO 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 WHO 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
- WHO 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 WHO 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
- WHO GMP certificates issued for 1 years
- Yearly Renewal Audit
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
Joint Commissioner (HQ) is authorized by Commissioner, Food & Drug Administration, Maharashtra State, to sign & issue the certificates under the WHO-GMP certification scheme online.