Wholesale distributors of medicinal products need to ensure that they can demonstrate Good Distribution Practice (GDP) compliance.
We assist in establishing, implementing, and maintaining a quality management system proportionate to your activities including quality risk management, corrective and preventative actions (CAPA) to address deviations, change control and measurement of performance indicators and management reviews.
We help you to establish, implement and maintain written procedures, including Standard Operating Procedures to cover all your operations, including supplier and customer qualification, demonstrating compliance with GDP, complaints, returns, falsified medicinal products, recalls, control of outsourced activities, transport validation, etc.
We assist you in ensuring that appropriate standards of GDP are maintained for your premises and contracted storage premises.
We help you to set up and implement systems to maintain records for the repair, maintenance, calibration, and validation of equipment including computerised systems.
We help you to ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
We help you to ensure that initial and continuous training programmes are implemented and maintained, including training in GDP and the risks of falsified medicines.
AEQEA Consulting
International House 24 Holborn Viaduct, London EC1A 2BN, United Kingdom
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