CERTIFICATION IN INDIA

GDP CERTIFICATION - GOOD DISTRIBUTION PRACTICES

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

Who can be certified GDP Certification?

Pharmaceutical Products

Document required for GDP Certification

The extent of Documented Information differs as per:

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:

Time Frame

Task

Process

Day 1

GAP Analysis
Certification Body
Selection
Cost Estimates

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Certification Body
Audit
N-C Closing

Week 12

Certification Body

Year on Year

Yearly Compliance

FAQ

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.