Responsible Person - London, United Kingdom - WALKER COLE INTERNATIONAL LTD

Description

• Ensure we have weekly warehouse/fridge/van temperature readings, and these are reviewed and signed off.
• All CAPAs/Change Controls/Deviations/Risk Assessments should be written up to GDP standards.
• Focus on the management of authorised activities and the accuracy and quality of records.
• Complete onsite temperature mapping of warehouse and vans
• Complete Validation and Qualification for new equipment where necessary
• MHRA GDP blogs should be read when they are released.
• Any FMD alerts from the MHRA should be acted upon as per SOP.
• Coordinate and promptly perform any recall operations for medicinal products.
• Coordinate and promptly perform any theft operations for medicinal products.
• Ensure that relevant customer complaints/returns/missing claims are dealt with effectively.
• Appropriate checks/forms should be filled in for any new suppliers/customers before trading commences.
• Customers/Suppliers audit forms should be filled in and returned to them when received.
• Ensure all outsourced activities are carried out. Service reports should be reviewed, signed off and stored securely.
• Decide on the final disposition of returned, rejected, recalled or falsified products customer returns/claims should be dealt with urgently.
• Revoked licenses should be checked when a MHRA notification is received.
• Suspended licenses should be checked when a MHRA notification is received.
• Review and file the portable fridge temperature sheets.
• Keep all GDP paperwork filed and up to date.

• Monthly expiry reports should be carried out. Short-dated stock should be quarantined.
• Sch 3 CD quantity checks should be carried out monthly.
• Staff should be trained on any updated regulation.
• Ensure all equipment is calibrated before it's expiry date (e.g. logtags, thermometers).
• Ensure all equipment is serviced when it is due (e.g. cooler, fridges, portable fridges).
• We should have a copy of the uptodate CD license for all wholesalers we trade CD lines with.
• Suppliers/Customers WDA(H) status should be checked on the MHRA list monthly.
• Monthly risk assessment of Mawdsleys transport vehicles/warehouses/routes should be carried out.
• Ensuring that selfinspections are performed monthly following a prearranged program and necessary corrective measures are put in place.
• Block any customers/suppliers on Robosol whom we have not traded with in more than 6 months.
• Suppliers/Customers WDA(H) SITE ID should be checked on the MHRA website monthly.
• Terminated MHRA licenses should be checked.

• Pharmacies/Surgeries status of whom we trade with should be checked on the national register quarterly.
• Sch 4/5 CD quantity checks should be carried out quarterly.

• Management Reviews should take place every 4 months

• Staff should have SOP training twice a year. Questionnaires should be used to assess their understanding.
• Ensure we take temperature readings from APC twice a year. This should be risk assessed

• RP and other relevant staff should attend MHRA-approved training events.
• For outsourced activities, contracts should be reviewed annually, and renewed before their expiry date
• All technical agreements with suppliers/customers should be reviewed annually.
• All technical agreements with transport couriers should be reviewed annually.
• The CD license should be renewed annually with the Home Office.
• The annual CD purchase/sales figures should be sent to the Home Office every January.
• Ensure the fridge thermometers are recalibrated before their expiry date.
• Ensure the log tags are recalibrated before their expiry date

• All SOPs should be up to date and reviewed.
• Suppliers and customers should be audited biennially.

• Temperature mapping of the warehouse needs to be carried out at least every 3 years.