Learning from GMP
Inspections.
Richard Bateman
QA Specialist Pharmacist
East and South East England Specialist
Pharmacy Services
Overview
MHRA
Inspection
Process
Risk Based
Inspections –
2008 onwards
Learning from
deficiencies
NHS constraints
MHRA
publication of
summaries
London and
South East
collations since
2004
NHS specific
issues and trends
Sharing via local
and national
networks
The same
findings or are
there changes?
Have the
goalposts really
shifted?
Common Deficiencies
 What 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 Data
 No specific category for repacking / overlabelling
 Need to focus on specific areas and some not so
relevant – included to give “big” picture
Quality Management
Early years
data low
incidence
Now
generally
first or
second in
frequency
Change in
practices
or change
in
inspection
emphasis?
Increased
focus on
QMS and
RM (ICH Q
8/9/10)
Risk based
inspection
process
Quality
Systems
Self
Inspection
Complaint
and product
recall
Investigation
of anomalies
Quality
Management
CAPA
Change
Control
Quality
Management
(RM)
Quality Management
 CAPA – we may have systems but do we really do both
parts?
 Can we show this?
 RM should be proactive not reactive
 Statements on exception reports?
 Recalls – MHRA, Regional System, Company Alerts
and communications.
Training
and
training
records
Personnel
Key duties
Personnel
 Training Records – do we really show competency?
 Checking – evidence, logs and statistics?
 It is a simple process – until it goes wrong!
Design and
maintenance
of facilities
Control of
environment
Premises
and
Equipment
Design and
maintenance
of equipment
Calibration and
testing of
equipment
Premises and Equipment
 NHS Problem
 We know this – so do MHRA!
Manufacturing
Documentation
Sterility
assurance
Contamination
– microbial
Production
Contamination
– physical
Segregation /
clearance
Environmental
monitoring
In process
controls
Production
 Completion 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
Documentation
specifications
Finished
product testing
Computerised
systems
Quality
Control
Sampling
materials
• stability,
chemical &
microbial
Testing of
starting
materials and
packaging
components
Quality Control
 Starting Materials – approval, specification, contract
changes, out of stocks and substitutions
 Release procedures – sampling, testing
Technical
Agreements
with
suppliers /
contractors
Starting
materials /
APIs
Supplier /
contractor
audit
Materials
Management
TSE
compliance
Warehousing
/ distribution
Materials Management
 Starting materials – see QC
 Technical Agreements – customers, contracting for
services
 Contingency Arrangements
 Warehousing and distribution – GDP issues
Process
Analytical
Equipment
Validation
Computerised
systems
Cleaning
Validation
Master Plan
and associated
documentation
Validation
 Labelling systems – access, validation, checking
systems
 Barcoding?
 VMP
 Cleaning
 Equipment?
Regulatory Compliance
Failure to respond to previous
inspection findings
• NB resources, timescale, RBI process?
Non compliance with terms of
licenses
Related GDP Deficiencies
 General Storage – temperature control and monitoring
 Mapping, records, deviation handling, SOPs, returns
 Cold storage and transport – temperature control and
monitoring
 As above, in transit if applicable – receipt and dispatch.
NB returns?
 Systems for returns and recalls
 In house and MHRA / company led. Communication
within host organisation? Testing of SOP?
Related GDP Deficiencies
 Counterfeiting Issues and controls
 NHS contracting process gives good protection
 Supplier bona fides
 Destruction of packaging
 SOP
 Would staff receiving know what to look out for –
training and records
Questions revisited
 What 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?