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Learning from GMP Inspections.
Richard BatemanQA Specialist PharmacistEast and South East England Specialist Pharmacy Services
Common DeficienciesWhat do you think the most common deficiencies are?
Are there new / emerging topics at inspections?
Can / should we share information to increase learning?
What are the barriers to addressing deficiencies effectively and in a timely manner?
MHRA Inspection DataNo specific category for repacking /
overlabellingNeed to focus on specific areas and some not
so relevant – included to give “big” picture
Quality ManagementCAPA – we may have systems but do we
really do both parts?Can we show this?RM should be proactive not reactiveStatements on exception reports?Recalls – MHRA, Regional System, Company
Alerts and communications.
PersonnelTraining Records – do we really show
competency?Checking – evidence, logs and statistics?It is a simple process – until it goes wrong!
ProductionCompletion and accuracy of batch
documentation – signatures, timeliness of completion, accuracy re suppliers
Segregation and line clearances – records, checking?, how thorough?
Products and leaflets – packing line, photocopier, storage areas
Don’t forget storage areas as well
Quality ControlStarting Materials – approval, specification,
contract changes, out of stocks and substitutions
Release procedures – sampling, testing
Materials ManagementStarting materials – see QCTechnical Agreements – customers,
contracting for servicesContingency ArrangementsWarehousing and distribution – GDP issues
Related GDP DeficienciesGeneral Storage – temperature control and
monitoringMapping, records, deviation handling, SOPs,
returnsCold storage and transport – temperature
control and monitoringAs above, in transit if applicable – receipt and
dispatch. NB returns?Systems for returns and recallsIn house and MHRA / company led.
Communication within host organisation? Testing of SOP?
Related GDP DeficienciesCounterfeiting Issues and controlsNHS contracting process gives good
protectionSupplier bona fidesDestruction of packagingSOPWould staff receiving know what to look out
for – training and records