Learning from GMP Inspections. Richard Bateman QA Specialist Pharmacist East and South East England Specialist Pharmacy Services.

Learning from GMP Inspections.

Richard BatemanQA Specialist PharmacistEast and South East England Specialist Pharmacy Services

Overview

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!

Premises and EquipmentNHS ProblemWe know this – so do MHRA!

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

ValidationLabelling systems – access, validation,

checking systemsBarcoding?VMPCleaning Equipment?

Regulatory Compliance

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

Questions revisitedWhat do you think the most common deficiencies are?

Are there new / emerging topics at inspections?

How can we improve the way we share information to increase learning?

How can we overcome the barriers to addressing deficiencies effectively and in a timely manner?