Online Resource Latest Pharma Info

1
Presentation prepared by Drug Regulations – a not for profit
organization. Visit www.drugregulations.org for the latest in
Pharmaceuticals.
20-10-2015

This presentation is compiled from freely available
resource like the website of FDA and ICH.
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
2
Drug Regulations : Online Resource for Latest Information
20-10-2015

 This presentation will cover
1. Key changes to the Guidance as compared
to the one issued in 2000.
3
20-10-2015

 Key purpose of the guidance is to
support
◦ New drug applications (NDAs)
◦ Describe types of data are needed for
NDAs.
◦ Biologics license applications (BLAs).
4
20-10-2015

 Guidance deals with analytical methods used
to assess following for Drug Substance &
Drug Products.
◦ Identity
◦ Strength
◦ Quality
◦ Purity
◦ Potency
5
20-10-2015

 Analytical procedure is developed in order to test
a characteristic of a drug against an “established
acceptance criteria” for that particular
characteristic.
 Guidance extends beyond the operation of the
methods,
 Considers how to select, interpret and present
data collected from analytical methods.
6
20-10-2015

 Analytical methods development.  
 Content of analytical procedures.  
 Reference standards and materials.  
 Analytical method validation.  
 Statistical analysis and models.  
 Life cycle management of analytical procedures.  
 FDA methods verification.  
7
20-10-2015

 Scope is extended to biologics.
 Requirements of the guideline now apply to
◦ NDAs, abbreviated new drug applications (ANDAs),
◦ BLAs,
◦ Variation applications relating to these types of
application,
◦ Type II Drug Master Files.
8
20-10-2015

 Scope does not extend to investigational new
drug (IND) applications.
 The types of data needed for analytical
procedures and methods validation varies
according to the development phase.
9
20-10-2015

 Significantly less details about way to conduct
testing
 No list of recommended validation
parameters.
10
20-10-2015

 Keeps pace with change in GMP’s based on
the 21st century approach.
 Risk assessment at the center of approach
 Less prescriptive than in past
 User to determine what and how to assess
11
20-10-2015

 Guidance advises that analytical methods
should be reviewed during the life cycle of
the product
◦ Evaluate if methods require re-validation.
◦ This might occur should a process parameter drift
or be redefined.
◦ In relation to unanticipated drifts,
 The guidance recommends that representative library
samples be retained.
12
20-10-2015

 The change control process is an effective way
to capture both process and methodological
changes.
 Risk assessment is the recommended approach
to determine if any such re- assessment is
necessary.
 If modification of a method cannot be
attempted, then the guidance provides the
basis for the substitution of a new method.
13
20-10-2015

 Section 9 deals with the verification of
procedures in FDA laboratories.
 The section provides an indication to how
the FDA itself goes about qualifying
methods.
14
20-10-2015

 Immunological and biological assays are now covered
 These tests cover many biological assays, which require
complex animal models.
 The immunogenicity assessments also have many
unique features
 Therefore the guidance has little in terms of their
description.
 The broad principles of the guidance should still be
considered in relation to bioassays.
15
20-10-2015

 Guidance provides advice on how an analytical method
should be reported.
 The objective here is that the method should be able to
be reproduced under the same conditions by a different
analyst working in a different laboratory.
 To help with this, the guidance outlines 10 items of
“essential information” that need to be included for an
analytical procedure.
 These are given in subsequent slides
16
20-10-2015

 Principle/scope.
◦ This is a description of the basic principles of the  analytical
test/technology.
 Apparatus/equipment.
 Operating parameters.
◦ This refers to the optimal settings and ranges critical to the
analysis.
◦ For example instrument operating temperature or flow
rate.
17
20-10-2015

 Reagents/standards.
◦ Important things to include here are the description of the
standard, its source, purity, potency, storage conditions,
direction for use and shelf-life assessment.
 Sample preparation.
 Standards control solution preparation.
◦ This needs to include units of concentration and information
on stability of the standards.
 Procedure.
◦ The procedure should be written in such a way so that it is reproducible.
18
20-10-2015

 System suitability.
◦ This refers to the array of tests necessary to demonstrate that
the system (equipment, electronics, and analytical operations
and controls to be analysed) will function correctly as an
integrated system at the time of use.
 Calculations.
 Data reporting.
◦ The calculations and reporting sections make reference to
appropriate methods for statistical analysis and models.
◦ Statistical tools listed include analysis of variance (ANOVA), R
squared (coefficient of determination) and linear regression.
19
20-10-2015

◦ For non-compendial methods (that is one not
described in the USP), the guidance describes
what is required.
◦ Data relating to the method validation must be
produced under a protocol.
◦ The NDA needs to contain details about the
validation study and provide the results.
20
20-10-2015

 Results should be assessed in relation to
the following assay characteristics:
◦ Specificity
◦ Linearity
◦ Range
◦ Accuracy
◦ Precision (repeatability, intermediate precision,
and reproducibility), and
◦ Detection limit.
21
20-10-2015

 Verification, rather than validation, is required for
compendial methods.
 Necessary to demonstrate the method is
appropriate across pre-determined acceptance
criteria.
 Of the criteria listed, arguably the most important
are given in following slides
22
20-10-2015

 Limit of detection:
 The lowest concentration of the standard solution
will be determined by sequentially diluting the
sample.
 Limit of quantitation:
 Establish the lowest concentration at which an
analyte in the sample matrix can be determined
with the accuracy and precision required for the
method in question.
23
20-10-2015

 Robustness:
 Robustness measures the capacity of an
analytical method to remain unaffected by
small but deliberate variations in method
parameters.
 Here, robustness provides some indication of
the reliability of an analytical method during
normal usage.
24
20-10-2015

 Robustness
 The essential thing is to demonstrate that the method
can detect changes in a quality attribute.
 There are different ways to approach this.
◦ One common example is to challenge the method by using
samples spiked with target analytes and various interferences.
◦ To this can be added
 Samples that have undergone various laboratory stress conditions;
 Product samples that are aged naturally, which have been stored under
accelerated temperature and humidity conditions.
25
20-10-2015

 The guidance describes the importance of
reference standards.
 New reference standard is introduced into a
laboratory,
◦ A new batch of reference standard materials must be
qualified against the current standards before being
implemented.
 This is a key point because all information
about any reference standards used must be
included within the drug submission.
26
20-10-2015

 The guidance addresses the problematic issue
of re-validation.
 When and how often to re-validate is
something that the pharmaceutical industry
has yet to define in a clear policy.
 The guidance indicates that when a change is
made to an analytical procedure, then re-
validation of all or part of the analytical
procedure needs to be considered.
◦ Such as a change in equipment or reagent
27
20-10-2015

 Such consideration should also be given in
light of any manufacturing process changes.
 Method re-validation should focus on the
critical performance characteristics of the
method, such as
◦ Specificity,
◦ Precision and
◦ Accuracy.
 The scope of re-validation should be risk
based.
28
20-10-2015

 A sufficient number of representative
samples should be used by both the
originating and receiving laboratories to
perform comparative studies.
 These studies should evaluate accuracy and
precision, noting the extent of any inter-
laboratory variability.
29
20-10-2015

This presentation is compiled from freely available
resource like the website of FDA and ICH.
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
30
Drug Regulations : Online
Resource for Latest Information 20-10-2015

31
Presentation prepared by Drug Regulations – a not for profit
organization. Visit www.drugregulations.org for the latest in
Pharmaceuticals.
20-10-2015

Online Resource Latest Pharma Info

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (20)

Similar to Online Resource Latest Pharma Info

Similar to Online Resource Latest Pharma Info (20)

More from GMP EDUCATION : Not for Profit Organization

More from GMP EDUCATION : Not for Profit Organization (20)

Recently uploaded

Recently uploaded (20)

Online Resource Latest Pharma Info