Certainly! We perform audits for: 

• Pre-inspection assessment of your site and processes 
• Audits of contractors 
• Comprehensive GDP audits for your site and processes 
• Audits of third-party sites 
• Supplier audits 

Feel free to Contact us for additional information.

Certainly! As part of our services, we offer assistance with Standard Operating Procedures (SOPs). We can provide advice and guidance to help you design and implement effective SOPs. Additionally, we offer templates and support in creating SOPs tailored to your specific needs, whether you’re starting from scratch or refining existing procedures.

If your business is seeking to acquire a Wholesale Dealers Authorisation (WDA) and requires advice or support in this regard, we can assist you throughout the entire process. Whether it’s guidance during the application phase, support through inspections, or assistance in maintaining and undergoing re-inspections, we offer a range of solutions to optimise and streamline this process for your convenience.

GDP training is essential for individuals across various roles in the pharmaceutical wholesale environment. The level of awareness required may vary depending on the specific role. We offer customised training tailored to your business needs, catering to everyone from operational staff to senior management. Our training portfolio extends to comprehensive and tailored Responsible Person (RP) training. Additionally, we provide training on specific topics such as Quality Risk Management, Root Cause Analysis, and Effective Transport Provision. 

Feel free to contact us to discuss your specific training requirements.

Absolutely! We specialise in providing contract Responsible Person (RP) and Responsible Person for Import (RPi) services. Typically, a contract RP/RPi is not present onsite full-time but assumes crucial oversight and responsibility for ensuring adherence to Good Distribution Practice within the wholesale operation. This includes managing interactions and approvals related to third parties that the licence holder engages with. If you require such services, we are well-equipped to meet your needs.

The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the regulatory body overseeing all medicines and medical devices in the UK, ensuring their efficacy and acceptable safety standards. As an executive agency of the Department of Health and Social Care, the MHRA is entrusted with several key responsibilities, including:

1. Ensuring that medicines, medical devices, and blood components for transfusion adhere to relevant standards of safety, quality, and efficacy.
2. Safeguarding the safety and security of the supply chain for medicines, medical devices, and blood components.
3. Advocating for international standardisation and harmonisation to guarantee the effectiveness and safety of biological medicines.
4. Educating the public and healthcare professionals about the risks and benefits associated with medicines, medical devices, and blood components, thereby promoting safer and more effective usage.
5. Supporting innovation and research and development that contribute to public health benefits.
6. Influencing regulatory frameworks at the UK, EU, and international levels to ensure they are proportionate to risks and effective in safeguarding public health.

Good distribution practice (GDP) sets forth the baseline requirements that wholesale distributors must fulfil to guarantee the quality and integrity of medicines throughout the supply chain. Adherence to GDP ensures:

1. Authorisation in accordance with European Union (EU) legislation for medicines in the supply chain.
2. Proper storage conditions for medicines, including during transportation.
3. Prevention of contamination by or of other products.
4. Facilitation of an adequate turnover of stored medicines.
5. Timely and satisfactory delivery of the correct products to the intended recipient.
   

Wholesale distributors are also obligated to establish a tracing system for identifying faulty products and implement an effective recall procedure. GDP extends its principles to cover the sourcing, storage, and transportation of active pharmaceutical ingredients and other components essential in the production of medicines.

A QMS, or Quality Management System, in the context of Good Distribution Practice (GDP), encompasses the integration of people, processes, facilities, equipment, and information technology, extending beyond a mere set of Standard Operating Procedures (SOPs). It serves as a comprehensive framework that ensures compliance and quality in pharmaceutical distribution.

Maintaining an effective QMS is crucial for staying in compliance with regulatory standards. It should seamlessly incorporate all facets of GDP within your business, allowing for the effective monitoring of compliance trends and enabling corrective actions.

Well-implemented QMS is a key consideration for MHRA (Medicines and Healthcare products Regulatory Agency) inspectors, reflecting a commitment to maintaining high standards of quality and compliance.

As part of our services, we offer a QMS design and audit service. If you seek further information or wish to discuss this service in detail, please feel free to contact us

Do you deal with European suppliers or customers? if so you will need to check EUDRA, in the context mentioned, stands for the European Union Drug Regulating Authorities. Specifically, EUDRAGMDP refers to the European Union Drug Regulating Authorities Clinical Trials Database and is part of the EudraGMP (Good Manufacturing Practice) system.

EUDRAGMDP serves as a repository for licences and (non) compliance certificates related to manufacturers and wholesale dealers within the pharmaceutical industry. It provides a centralised database containing information on the regulatory status of these entities.

If your business engages with European suppliers or customers, checking EUDRAGMDP can be crucial. This tool proves extremely useful for verifying the bona fide status of manufacturers and wholesale dealers, ensuring that you are interacting with entities that meet regulatory standards and compliance requirements. Regularly consulting EUDRAGMDP can be a proactive measure to maintain the authenticity and reliability of your partnerships in the European pharmaceutical market.

As a Wholesale Dealers Authorization (WDA) holder, it is mandatory to conduct qualification checks on both suppliers and customers. This is essential to verify that they operate securely and in adherence to regulations, ensuring the integrity of the legal supply chain. The process involves rigorous due diligence checks, and there are three primary steps for effectively qualifying suppliers and customers:

1. Confirm that the authorised supplier/customer possesses a valid manufacturing or wholesale dealers license or holds the necessary entitlement to receive medicinal products.
2. Ensure that the authorised supplier/customer complies with Good Distribution Practice (GDP), with the availability of a GDP certificate as evidence.
3. Conduct comprehensive due diligence checks, including the evaluation of on-site audits when applicable, to thoroughly assess the legitimacy and adherence to regulatory standards by the supplier or customer.

Temperature mapping in Good Distribution Practice (GDP) refers to the process of systematically assessing and recording temperature variations within storage areas used for pharmaceutical products. This practice is essential to ensure that the storage conditions maintain the required temperature range throughout the distribution chain, from manufacturing to the end-user.

By conducting temperature mapping, businesses can proactively identify and address potential temperature-related issues, implement corrective actions, and enhance the overall integrity of the cold chain in the distribution of pharmaceutical products.