What is GDP?
Good Distribution Practices (GDP) is a quality system for warehouses and distribution centers dedicated to medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants to the final shipment of finished drugs to the end-user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.
Benefits of GDP Certification
Maintains product integrity and patient safety
Helps achieve consistency
Reduces the risk of falsified medicines entering the supply chain
Improves customer confidence
Improves efficiency and lower costs
Reduces wastage
Check out the Who can be certified GDP Certification Video
Who can be certified GDP Certification?
Pharmaceutical Products
Cosmetics
Pharmaceutical Products
Dietary Supplements
Medical Devices
Document required for GDP 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 GDP 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 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
• GDP 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 GDP 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
• GDP certificates issued for 1 years
Year on Year
Yearly Compliance
• Support of Yearly documentation for audit
GDP should be assessed by the customers who ship medicinal products with certain transport companies. 5) Who does issue a GDP Certificate? The so called competent authorities in Europe have to issue the GDP certificate.
The GDP Passport and all GDP training certificates are valid for a period of 2 years. GDP Champions can attend a one-day Refresher training. Drivers and Operations staff will need to complete online training again after two years.
Basic requirements of GDP:
• Always record the entries at the time of activity simultaneously.
• Always record date with the signature in GMP records.
• Always use an indelible ballpoint pen to record data in GMP records.
• Always enter the data directly into the GMP records in the English language.
Good Distribution Practices (GDP) Certification for Pharmaceuticals demonstrates your dedication to good distributive practices and quality in every aspect of your service. Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines.