At GMP Healthcare we specialise in preparation for MHRA regulatory inspections and customer audits. We have Contract Responsible Persons available who take ownership for the application of Good Distribution Practice on site and will ensure that all licensable activities you undertake remain compliant.
We work to prepare and submit applications to achieve a WDA. Our Responsible Persons work to develop a tailor-made Quality System to cover the wholesaling of medicines in compliance with Good Distribution Practice as evidenced by successful MHRA inspections and satisfied clients.
With extensive experience acting as Responsible Person Services for a number of clients, you can be assured that we will provide up-to-date advice, service level and compliance with the EU regulations. All our Responsible Persons are experienced in fronting regulatory and customer audits and have been trained by the Cogent Gold Standard for Responsible Person Medicinal Products.
- Remediation Support
- WDA & MIA Licence Application
- Facilitating Inspections
- Facilitating Gap, Risk and Route Assessment
- Quality Management System Activities (Deviation, CAPA & Change Controls)
- Training Responsible Persons (Cogent)
- Good Distribution Practice (GDP) Training
- Temperature Control Mapping
- Supply Chain Mapping
- Cold Chain Activities
- Data Loggers
- Security System Verification
- Recall and Returns Management
We strive to provide a comprehensive service – tailored to your organisation’s needs. We can conduct pharmaceutical audits of your facilities and any contracted warehouses and transportation companies according to the provisions of Good Distribution Practice.
Execution of audits to Marketing Authorisation Holders, Distributors, Shippers, Logistics Operators, Distribution Centres, Warehouses and Freight Forwarders according to current guidelines for Good Distribution Practice of medicinal products for human use.
The GDP guide Chapter 2 defines: “All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme.”
The training course is aimed at new starters and existing staff as part of their ongoing GDP training to provide an overview of what GDP is, why we have GDP and an overview of its main requirements for pharmaceutical wholesalers and distributors, logistics, transport and delivery companies, brokers, clinical trials staff, pharmaceutical manufacturers, pharmaceutical suppliers, medical device manufacturers, warehousing, bio-pharma companies and any company that requires a Wholesale Distribution Authorisation.
Our trainers are professionals and industry experts who can generate training packages with real life experience, to ensure that the training is clearly delivered to the trainees. We can create and provide a wide range of training packages that are custom made to ensure you get the desired benefit. Our training enables the person with diligence, fortitude and competency to ensure and exercise Good Distribution Practice. We have spent over £100K in the last few years to train our internal team in a world class training environment. We provide MHRA-recognised Cogent training for Responsible Persons.
We customise our gap analysis for each client’s unique needs to define deficiencies and eliminate the variance between compliance requirements and the client’s operations. Our team of experts can help you to identify areas for improvement that will benefit the client’s operations on all levels by determining the root cause along with implementing and executing the corrective action preventive action plan.
Our experienced team are on hand to help with the pre- and post-regulatory inspection remediation activities, to plan, prepare and execute corrective and preventative actions for inspection findings and respond to the respective regulatory authority.