Introduction:

Overview
of
HPLC
in
a
GMP
Laboratory
Overview
of
the
conference
Role
of
HPLC
in
a
regulated
laboratory
FDA
Quality
Metrics

impact
on
the
laboratory?
FDA
issues
with
HPLC
data
integrity
Quality
by
Design
for
HPLC
analytical
procedures
the
proposed
USP
updates
Overview
of
the
proposed
changes
for
USP
<1058>
on
Analytical
Instrument
Qualification
Sampling
Sampling
Consequences
Sampling

Practices

for
sampling
the

for

documentation
of

Sample
Sample
Consequences
Validation
Coupling

for

the

Method

Translating
Minimizing
Maximising
Improving

external
HPLC
techniques

from

Approach
to
Pharmaceutical
Analysis
terminology:
QbD
in
analytics
requirements:
Analytical
Target
Profile
(ATP)
of
the
analytical
lifecycle
and
Understanding
Performance
Qualification
Performance
Verification
and
for
establish
make

Risk-based
Science
Proposed
Difference
Fitness
Qualification

Understanding
QbD-method
development
the
Method
Design
Space
a
robust
assay
to

Fast

and

equipment

of
Out
of
Specification
the
FDA
laboratory
retesting,
to
prevent
OOS
and
method,
data

HPLC

between
and

Validation
Validation
Identification
Evaluation
Sensible
Verification

Instrument
and
changes
to
the
proposed
and
for
purpose
validation
challenge

and
according

of
of
compendial

System
Suitability
Ph.Eur
and
Chromatographic
System
Adjustments
Continued
Monitoring

Requirements
USP

current

of

statistics
procedures,
for
HPLC
monographs

to
Ph.Eur.
chromatographic

chromatographic
performance

verification
SST

Interpretation
Data

of
Integrity

and

HPLC
Quality

of
do

you

judge
the
suitability

if

Good
Compliance
<1058>
<1058>
traceability
approach

HPLC
and
FDA
performance
validation
and
validation
USP
Chapter

suitability
of

Results
Guidance
investigations
resampling
results
trending

USP
versions
of
and
an
integrated

according
for

of
method

HPLC

Qualification:

Verification
to
ICH
relevant

of
use
of

Chromatography
changes
advantages
productivity

Investigation

strategies
of

sample
sample

Chromatography
the
the

of

HPLC
HPLC
analysis
preparation
preparation

Lifecycle

Traditional

FDA-conform

Robotic

the

efficiency

Efficient
and
Requirements
Efficient
Reanalysing,
Proactive
Controls

HPLC
simple
systems
procedures
training
responsibilities

it

for

of
of

Design
starting
point
method
parameters
to
components
that

the
critical
the

for
keep
recording
and
and
provider

clarity

for
robustness
automation

Design
and
with
process
measurement
concept
Design

Analysis
equipment
analysis
inspection

an

Documentation
maintaining
electronic
processes
responsibilities
internal
and

and
and
by

HPLC

during

Preparation
preparation

Method
ATP
as
Identification
of
Understanding

Practical
Ensuring
Basics
How
Setting
System

Pitfalls

areas

Supporting
Minimizing
Use
Standardizing
Operator
Servicing

Quality
Alignment
Defining
3-Stage
-Method
-Method
-Continued

and
and

the
chromatogram
integration
for

of

Procedures
Guidelines
parameters
results
software
<1226>
and

USP
techniques
parameters
requirements
conditions

data

Chromatograms:
Results
integration
is
OK?
parameters
integration?

Ensuring
HPLC
and
CDS
Data
Integrity
Hear and understand the ten compliance requirements for chromatography data systems and the benefits they will bring to your
laboratory
Learn from the mistakes of others: Able Laboratories, Ohm Laboratories, Ranbaxy, Wockhardt and many other worthy organisations

Reference
Different
Requirements

Standards
types

for
reference
a

of

and

how

to

quality

HPLC
standards
standard

reference

Practical
Interpretation
of
Electronic
Records
for
a
CDS
Defining the main electronic records for a CDS to comply with 21 CFR 11 and EU GMP Chapter 4
Additional
e-records
that
can
be
created
depending
on
your
ways
of
working
Further
e-records
created
depending
on
your
HPLC
equipment
Effective
protection
of
the
electronic
records
to
meet
regulatory
expectations
Paper
or
electronic
records
are
our
raw
data?
Effective
Determining
Assigning
Secrets
Standardising
Regulatory
Risk
Based
Understanding
Eliminating
Plan
Understanding
Validation
Case

Analytical
of

Validation
for
the
of
study

of

including

Transfer
requirements
responsibilities
transfer
process
issues

method
the

Implementing

Electronic
working

Signatures

for

Productivity
practices
process
signatures
signatures
documentation
gains

Excel
from
the
electronic
working
including
electronic
regulatory
requirements
for
electronic
the
CDS:
expected
examples
of
productivity

WORKSHOP
Risk
Assessment
for
Topics
to
be
Understanding
the
Facilitated
discussion
Workshop
and

WORKSHOP
HPLC

CDS
your

Target
requirements
and
selection
into

Method

Technology

successful
harmonising

and

Exercise
From
Analytical
Measurement
Precision
Method
Translation

WORKSHOP
Common
Examples
Discussion
What
What

Method

Profile

(ATP)
for

Accuracy

to
the
of

to
HPLC
Analytical
covered

HPLC

Assay
Performance
Quality
Attribute
the
reportable
meet
the
Assay
performance

Instruments
in

discussion

Validation

a
for

Problems

and

from

How
published

in
are
are

I
Systems
are:
methodology
instrument
systems

and
Computerised
the
workshop
assessment
simple
more
complex

risk
for

the
possible

System

WORKSHOP
Identifying the Common Pitfalls in the Validation of a Chromatography Data System

Suitability

to

Criteria
Assay
result
ATP
criteria

II
Them
papers
groups:
mistakes?
improvements?

Troubleshoot

III
Tests
IV