GDP QMS Package
Build the Quality system behind your pharmaceutical distribution activities. The OZQA GDP Distribution QMS Package is designed for pharmaceutical companies distributing medicinal products while outsourcing physical storage and warehouse operations to qualified logistics partners. Establish the Quality framework needed to manage distribution, maintain GDP oversight and control the activities performed on your behalf.
QMS FOR PHARMACEUTICAL DISTRIBUTION
You do not need to operate your own warehouse to be responsible for pharmaceutical distribution. The OZQA GDP Distribution QMS provides a complete Quality framework for companies operating as pharmaceutical wholesale distributors while using qualified external warehouses and logistics providers. Choose whether to customise and implement the system internally or with support from OZQA’s Quality experts.
Build a GDP QMS on your own or with our help.
COMPLETE
GDP
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BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete GDP QMS with an audit-ready documentation package.
Ideal for
Organisations with outsourced warehouse establishing pharmaceutical distribution activities with internal quality resources available to customise and implement the QMS.
Package Includes
Pre-written SOP's
Ready to use log forms
COMPLETE
GDP
___
BUILD A QMS
WITH SUPPORT
Starting from scratch? Let's help you build a complete PV system with our pre-written GxP compliant documentation. OZQA's experts can guide you all the way to audit-readiness.
Ideal for
Organisations that need a complete GDP quality framework and support adapting it to their distribution model and outsourced warehouse operations.
Package Includes
Pre-written SOP's
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
GOOD DISTRIBUTION PRACTICE
A QMS designed for pharmaceutical distribution
GDP is about more than transporting medicinal products from one location to another. The Quality system must protect the quality and integrity of medicinal products throughout the distribution chain and provide appropriate control over the activities, organisations and records involved. For organisations using an outsourced warehouse, this means establishing clear responsibilities and effective oversight of the logistics partners physically storing and handling the products. The EU GDP Guidelines require wholesale distributors to maintain a Quality system covering responsibilities, processes and risk management principles related to their activities. The OZQA package translates these requirements into a practical QMS for a distribution model with outsourced warehousing.
OUTSOURCE THE WAREHOUSE. NOT THE OVERSIGHT.
Maintain control of your distribution activities.
Your 3PL or external warehouse may physically receive, store, pick, pack and dispatch your medicinal products. But outsourced GDP activities need to be defined, agreed and controlled. EU GDP requires a written contract defining responsibilities, and the contract giver remains responsible for assessing the competence of the contract acceptor and ensuring appropriate compliance and oversight.
Documents included in the complete package
All Products
Your GDP Quality system should support:
GDP roles and responsibilities
Responsible Person activities
Document and record control
Personnel training
Supplier qualification
Customer qualification
Qualification and oversight of outsourced warehouses
Quality and Technical Agreements
Transportation and shipping controls
Storage requirements
Temperature management
EU GDP specifically assigns the Responsible Person responsibilities including maintenance of the Quality system, training, recalls, complaints, supplier and customer approval, approval of outsourced activities and self inspections.
ALREADY HAVE A CORE QUALITY SYSTEM?
Add documentation to your existing QMS.
If you already have a quality foundation in place OZQA provides pre-made QMS packages including all SOPs and forms needed to stay compliant. Choose to update your QMS with your own internal personnel or get hands on support from our expert consultants.
ADDITIONS
PV
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UPDATE PV SYSTEM
YOURSELF
Update your current QMS yourself. Add the processes required to evolve your existing system with 98% pre-written GxP compliant documents.
Ideal for
Companies with an established MAH or pharmaceutical QMS and internal Quality resources available to implement the GDP module.
Package Includes
Pre-written SOP's
Ready to use log forms
ADDITIONS
PV
___
UPDATE PV SYSTEM
WITH SUPPORT
Already have a foundational QMS but don't have the resources to implement the documents yourself? Let's help you all the way to GxP compliance.
Ideal for
Companies with an established pharmaceutical QMS that need support preparing their organisation for GDP distribution activities.
Package Includes
Pre-written SOP's
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
CONNECT YOUR COMMERCIAL QUALITY SYSTEM
From MAH to distribution.
For pharmaceutical companies that both hold the Marketing Authorisation and distribute their products, MAH and GDP responsibilities should operate within a connected Quality framework. OZQA allows you to build the system around the activities your organisation actually performs.
Pharmaceuticals
Wholesale distribution of medicinal products in the EU is subject to authorisation, and wholesale distributors must comply with applicable GDP requirements. The QMS therefore needs to reflect not only the written GDP requirements, but the way your organisation will actually operate once distribution activities begin.
Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance. Ensure regulatory, product and Quality documentation is aligned before commercial distribution begins.
BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider quality system.
PAPER TO DIGITAL QMS
Use your existing eQMS or let us help you choose one.
The OZQA QMS is system independent. You are not required to purchase a specific software platform to use our documentation. The system can be implemented within an appropriate existing system or eQMS. If you are moving from a simpler setup into a dedicated electronic QMS, OZQA can also help define your requirements and assess suitable solutions. The system should support your quality processes and regulatory responsibilities – not dictate them.
GXP DEVELOPED STANDARDS
Built by life science QA professionals
OZQA combines practical quality and regulatory experience with ready to implement QMS documentation. Our approach is designed for organisations that need a compliant and scalable quality framework without building unnecessary complexity into their operations. Whether you are developing your first therapeutic candidate or preparing to move towards clinical development, we help you implement the level of quality management that is appropriate for where you are today.
 GMP |  GVP |
|---|---|
 GCP |  GDP |
CHOOSE WHAT YOU NEED
Three ways to build your QMS.
OZQA provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.
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FREQUENTLLY ASKED QUESTIONS
FAQ
Building a GDP QMS often raises practical questions. How much documentation do you actually need? Which SOPs should be implemented first? Do you need an electronic QMS?
The right answer depends on your organisation, outsourced activities and regulatory roadmap. A GDP QMS should therefore be proportionate to the activities you perform today, while providing a foundation that can grow with your organisation.