Good Distribution Practices - Guide to GDP certification
Good distribution practice is a set of methods and guidelines that helps organizations which are into sourcing, handling, storage, and transportation of pharma products that ensure the products are withholding the quality requirements as required by the GDP standard.
What is good distribution practice? Be an Industry Leader
Good distribution practice it’s a set off regulations and guidelines that inform the organizations which are involved in distribution and transportation activities including storage of pharmaceutical products. The GDP certification is not limited to pharma products it can be applied to other delivery of products as this is internationally acceptable standard that provides quality delivery services as required by your customers. This is a voluntary certification and it’s not mandatory to be certified with.
Why is GDP certification important? Why do we need Good Distribution Practices
When we address public health one of the major concerns is the medicines that are delivered to the public so any mistakes in the supply chain in all will lead to hazards and major concerns affecting the health of the end user.
The major reason for GDP certification to be acquired by organizations is to enhance its product race ability which play a major role during incident investigations of quality issues or involving of falsified medicines into the market.
The organizations will always benefit from the GDP standards as it helps to build the reputation of the organizations drastically and helps it to get recognized in the market.
Who Needs GDP certification?
The wholesale distributions of medicinal products in the European Economic Area need to get certified with GDP certification similarly anyone in the United Kingdom who is involved in supply chain of these medicinal products needs to comply with GDP requirements.
Principles of good distribution practices (GDP) – Core of GDP Certification
It is very crucial for industries to understand the principles of GDP guidelines as developed by World Health Organizations for pharmaceutical products and European medical agency
Quality Management System
it is essential for the organizations to develop quality management system requirements and address them with proper documentation in form of procedures, policies, responsibilities, and accountability such that the quality in supply chain is evident. Analysis of risks is very crucial for the organizations who intends to develop GDP requirements, identifying and addressing the risks is very crucial for the success of Good Distribution Practices certification.
Responsible Leaders
An organization has to recognise the leadership requirement when implementing the GDP compliance, it needs to recognise crucial people in its organizations at all levels and associate them with certain roles and responsibilities which help in product security, product identification, recognition and segregation of falsified medicinal product, illegal medicinal market.
The role of these leaders within the organizations is not limited to the above they also have to incorporate good methods which provide quality structure and helps in achieving the GDP objectives.
GDP training is the only way in which an organization can build its leaders competency by making them understand the standard and the requirements of GDP so that they can incorporate these practices in their day-to-day work life.
Approved Suppliers
All medicinal wholesale dealers need to clarify that they engage in business with only approved suppliers who have proper licence and practice good distribution in their facility, the suppliers need to be recognised by an organization or an institute to prove the authenticity of the medicinal products they supply.
An organization has to develop a supplier management module in which it analyses the supplier for all the qualitative and legal requirements prior to engaging in business with the recognised supplier, periodic review of the performance of the supplier also needs to be taken into account.
Storage Facilities
the storage or warehouse facilities that are connected in the supply chain needs to be having high hygiene standards which also include temperature regulators and humidity levels that need to be constantly reviewed such that they are in accepted limits. Precautions against unauthorized access to the premises prohibition of food and drink inside the facility. Implementing first in and first out (FIFO) practices is accepted by organizations because of complying to GDP requirements.
Transportation
During GDP certification it is essential that the organizations have proper transportation resource were in the shipping containers or the trucks which carry these medicinal products are having certain requirements being met during the transportation.
Proper labelling and recognition of the transportation containers is very crucial and association of trace ability in each product is most important factor involved during transportation.
Documentation
An organization must implement a set of policies, procedures and keep relevant records of execution under documentational requirements of GDP. The organizations must ensure that they have proper records to evidence the complete trace ability of a product from start to end through this documentation wherein the document needs to be identified specifically for an activity, approval requirements, change management system, author and date of documentation needs to be clearly specified in the GDP documentation.
Recalls and Complaints.
During GDP certification the organizations needs to demonstrate their capabilities to handle recalls due to faulty products or falsified medicinal products so that the end user is not affected due to the above reasons, the organizations need to demonstrate their capability of bringing the product back from the delivered point without hassle.
The organizations also need to emphasise on customers satisfaction, with effective complaint handling system being developed and implemented during the GDP certification process. Addressing the complaints at the right time is very crucial for GDP certification.
Self-inspections
Regular self-evaluation is very crucial for an organization to continuously improvise its implemented good distribution practice requirements as this provides the organizations with overview of success that they have reached while implementing the GDP. Internal audit process must be understood by each process owners and the organizations must periodically assess the efficiency of the implemented GDP controls in their organizations so that they are in part of continual improvement.
GDP Certification with CertBureau
Implementing and achieving GDP certification can be challenging for few companies as there are multiple factors involved in achieving the GDP certification, it is crucial to engage with the right certification partner hence third Bureau plays the right important role that you have been looking forward to getting GDP certified. We provide policies, procedures and guideline templates which help your organizations to implement the GDP in a short time, GDP training is an added advantage with CertBureau as this is compulsively provided by our organizations.
Choosing the right GDP certification provider is very crucial and our expertise lies in this field as we have worked with numerous organizations across the globe especially in Europe and in North America where in GDP certification provided by CertBureau has the highest recognition in the market.
You can try our demo session regarding GDP certification wherein we provide you with the basics of GDP and provide knowledge about the GDP certification process which would help you to choose the right GDP certification partner.
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