GDP
GOOD DISTRIBUTION PRACTICES
Smart Way of Distributing Goods.
Success through management excellence
Good Distribution Practice is a system for ensuring that medical devices are consistently produced and being distributed according to national & international guidelines or standards. Additionally, it is designed to minimize the risks involved in any medical devices that is distributed through the assigned channel of supply-chain system safely.
Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Specifically, various people and entities are generally responsible for the handling, storage, and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. Moreover, the objective of these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation, and record-keeping practices.
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White Paper - GDP
Good Distribution Practice (GDP) Certification
Description: Good Distribution Practice (GDP) certification is a voluntary scheme for interested companies seeking certification attesting to its conformity with the standards described in local or international guidance standards on GDP.
Application: Specifically, it applies to the storage and distribution of therapeutic products, medicinal products, or active pharmaceutical ingredients.
Eligible Parties: Moreover, interested parties may include third-party logistics companies, etc.
GDP Certificate Issuance: Furthermore, a GDP Certificate is issued when the company’s quality system has been audited and found to comply with said GDP Standard and is valid for 3 years from the date of audit.
Re-certification Requirement: Upon the expiry of the GDP Certificate, a fresh application is required to be submitted if the company is interested in re-certification.
Guide to Critical and Important Controls
Objective: However, this guide aims to describe the critical and important controls appropriate for the storage or distribution of these products.
Relevance of Controls:
Additionally, not all the controls described will be relevant to every situation. Furthermore, it is recognized that some controls are not applicable to certain companies or environments.
Adaptation of Controls: Therefore, the controls should be adapted to meet individual company’s needs where necessary. Moreover, the relevance of any control should be determined taking into consideration the specific risks the company is facing so that the desired standards of quality are achieved.
GDP Covers and Requires:
1. Record Keeping
2. Personnel Qualifications
3. Equipment Verifications
4. Distribution Mapping and Identified Controls
5. Sanitation
6. Cleanliness
7. Process Validation
8. Complaint Handling
9. Supply chain mapping
10. Criteria for selecting supply chain or external providers
11. Handling of external providers
White Paper - GDP - Good Distribution Practices
BENEFITS OF GDP
In so many benefits few can be listed to understand the advantages of GDP as broad.
1• Ensures principles of GDP are applied throughout the supply chain
2• Maintains product integrity and patient safety
3• Helps achieve consistency
4• Reduces the risk of falsified medicines entering the supply chain
5• Distribution complaints
6• Improves customer confidence
7• Expensive mistakes
8• Improves efficiency and lower costs
9• Wastage reduces
10• Improves margins
11• Creates a culture of continual improvement
12• Increases market share
13• Involves, motivates and assists in the training of staff
14• Helps market the organisation effectively
15• Puts the organisation in a position to exploit new market sectors and territories
© Global Standards. All rights reserverd for this documented information shared for reading purpose only.