Risk-based analysis in
pharmaceutical procurement
and market analysis
Vivienne Christ
Therapeutic Goods Administration
Australia
Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in
respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009
Outline
 Pharmacopoeial and other tests
– General requirements
– Microbiological and chemical tests
– Tests for various dosage forms
 Risk assessment (analysis)
 An approach to targeted sampling and testing
 Example of a risk-based assessment
– To assist your with hands-on exercise
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Pharmacopoeial and other tests
 British Pharmacopoeia (BP)
 European Pharmacopoeia (Ph Eur)
 United States Pharmacopeia (USP)
 International Pharmacopoeia IP)
 Other validated methods (ISO17025, ICH Guideline)
• ICH Tripartite Guideline Validation of Analytical Procedures: Text and
Methodology Q2(R1) http://ich.org/LOB/media/MEDIA417.pdf
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
General monograph requirements
 Visual examination
–
–
–
–
Packaging
Labelling
Product appearance, particulates, integrity
Storage conditions
 Microbiological tests
– Sterile products
• Test for sterility and endotoxin test for parenterals
– Non-sterile products
• Microbial attributes tests
 Chemical tests
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Microbiology laboratory
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Microbiological testing
 Sterility testing
 Endotoxin testing
 Microbial attributes
– Total aerobic microbial count (TAMC)
– Presence/absence testing
 Preservative efficacy testing
 Microbiological bioassay for potency
– Eg. nystatin, gentamicin
 Disinfectant efficacy testing
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Chemistry laboratory
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Chemical tests
 Uniformity of mass, - dose, - content
 Disintegration and Dissolution tests
 pH and moisture content
 Presence of heavy metals
 Identity tests
–
–
–
–
IR spectrophotometry, TLC + UV detection
Colorimetry
Absorption spectrum (AA)
Optical rotation (useful for natural products)
 Assay of active(s)
–
HPLC, UV, AAS, GC (for volatiles)
 Related substances for organic chemicals
–
–
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For process impurities and degradation products (HPLC, TLC)
Organic volatile impurities (GC)
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Access to Chemical Reference Substances
 Pharmacopoeial CRS
 International Chemical Reference Substances (ICRS)
 Used to validate test methods and test results
 Used as primary standard to calibrate secondary
standards
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Dosage forms
 Parenteral products
 Ophthalmic products
 Oral dosage forms
– Tablets, capsules, powders
 Rectal products
– Suppositories
 Inhalation and nasal products
 Topical products
–
–
–
–
10 |
Creams, gels
Ointments
Transdermal patches
Suppositories, pessaries
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Parenteral products (SVP & LVP)
 Supplied as
– Vials, ampoules, bottles, bags, pre-filled syringes, etc
– Solutions, freeze dried powders or emulsions
– Single or multidose presentations
 Test for Sterility
– Terminal sterilization? Parametric release?
– Aseptic processing?
 Pharmacopoeial bacterial endotoxin/pyrogen test
– LAL test
 Pharmacopoeial microbiological bioassay for potency
– eg vancomycin
 Pharmacopoeial preservative efficacy test for all multidose presentations
– Closed shelf-life testing (developmental and at expiry)
– Open-shelf life testing to support in-use life if > 24 hours
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Parenteral products (SVP & LVP)
 Chemical tests
– Powders for reconstitution:
• Uniformity of mass for single dose preparation
• Moisture content (Karl Fischer or LOD) for antibiotics, etc
• Uniformity of content
– pH of solutions
– Particulate matter
– Preservative content assay
– Identity, assay and related substances
• HPLC
– Extractable volume for SVP
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Ophthalmic (eye) products

Supplied as
–
–
–
–
Sterile liquid, semi-solid, or solid preparations
Presented as eye drops and ointments
Usually aseptic manufacturing process
Quality of WFI?

Test for Sterility

Preservative efficacy if multidose
–
–

Closed shelf-life testing (developmental and at expiry)
Open-shelf life testing to support in-use life if > 24 hours
Microbiological bioassay
–
eg gentamicin eye drops

Particle size

Chemical tests
–
–
–
–
13 |
pH,
Identity
Assay and related substances by HPLC
Composition for antibiotics by HPLC
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Inhalation products
 Depends on presentation
–
–
–
–
Pressurised metered dose inhalers (MDI)
Dry powder inhalers
Products for nebulization
Non-pressurised metered dose inhalers (MDI)
 Sterile single dose presentations preferred
– Test for sterility for single dose products for nebulization
 Microbial attributes for all non-sterile products
 PET for multidose products for nebulization and non-pressurised MDIs
 Chemical tests
– Moisture content, mean delivered dose, uniformity of delivered dose, uniformity of
content (single dose), particle size distribution (twin impinger or impactor), leak rate
for pressurised MDI
– Assay of quantity of drug substance
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Nasal products
 Microbial attributes
– TAMC, presence/absence testing
 Preservative efficacy
– Closed shelf-life testing (developmental and at expiry)
 Chemical tests
– As for parenteral solutions
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Oral medicines - Liquids
 Microbial attributes
–
TAMC, absence/presence testing
 Test for Sterility
–
Eg sterile paediatric oral antibiotic products and some oral products for HIV/AIDS patients
 Preservative efficacy
–
Closed shelf-life testing (developmental and at expiry)
–
Open-shelf life testing to support in-use life if > 24 hours
 Bioassay
–
Potency of nystatin oral suspension
 Chemical tests
–
–
–
–
16 |
pH
Identity
Assay and related substances
Preservative content
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Oral Medicines - Tablets and capsules
 Hard, soft and modified release capsules
 Uncoated, coated and modified release tablets
– Modified release – extended or delayed?
• Micro-encapsulation process to modify rate of release in GI tract
 Microbial attributes
– Gelatin used in capsule shell
– Not usually necessary as tablets have low Aw
– TAMC, absence/presence testing
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Oral Medicines - Tablets and capsules
 Chemical tests
–
–
–
–
Uniformity of mass if active >5% of mass per IP
Uniformity of content if active is <5% of total formulation per IP
Disintegration test – not required if dissolution test is required
Dissolution test
• Enteric coated delayed release: dissolution testing at low gastric pH 2
and higher intestinal pH 6.8
• Modified release: dissolution test over intended period (eg 24 hours)
– Identity tests
– Related substances test
– Assay if uniformity of content does not apply
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Rectal preparations
 Suppositories
– Uniformity of mass for single-dose preparations
– Uniformity of content if active <2% of total mass (IP)
– Microbial attributes
• TAMC, presence/absence tests
– Chemical tests
• Disintegration
• Identification
• Assay and related substances
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Topical medicines – Creams & gels

Hydrophobic or hydrophilic preparations applied to skin or mucous membranes

Sterile or non-sterile

Test for sterility
–

Microbial attributes
–

Closed shelf-life testing (developmental and at expiry)
Open-shelf life testing to support in-use life if > 24 hours
Chemical tests
–
–
–
–
–
20 |
nystatin
Preservative efficacy
–
–

TAMC, presence/absence tests
Microbial Bioassay
–

Sterile creams used on burns and open wounds
pH
Identity
Assay and related substances
Preservative content
Composition (including homogeneity) by HPLC
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Topical medicines – Transdermal patches
 Microbial attributes
– TAMC, presence/absence (patch and backing material)
 Chemical tests
– Release tested with a suitable dissolution test
– Active released per surface area per time unit
• Method: disc assembly, cell or rotating cylinder (drum) depending on
composition, dimensions and shape
• Ph Eur “Dissolution test for transdermal patches”
– Uniformity of content
– Identity
– Assay and related substances
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Topical medicines - Ointments
 Low Aw
 Bioassay
– Eg nystatin
 Preservative efficacy not required due to low Aw
 Chemical tests
– As for creams and gels
– Need to extract active by heating
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk Management Overview
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk-management?
 AS/NZS 4360:2004 – Risk management standard & HB 436
– Available from www.standards.com.au
– ISO/FDIS 31000:2009 – 1st draft based on AS/NZS 4360:2004
– ISO/IEC Guide 73 Risk Management – Vocabulary – Guidelines for use in
standards
“Although the concept of risk is often interpreted in terms of hazards or negative
impacts, this Standard is concerned with risk as exposure to the consequences
of uncertainty, or potential deviations from what is planned or expected. The
process described here applies to the management of both potential gains and
potential losses.”
“Organizations that manage risk effectively and efficiently are more likely to
achieve their objectives and do so at lower overall cost.”
“Risk management is aiming to make optimal decisions in the face of uncertainty”
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
What do we mean by risk?
 Risk can be defined as the combination of the
probability of an event and its consequence
 Risk assessment is the overall process of risk
analysis and risk evaluation
 In the health safety field consequences are
generally only negative and the management of
safety risk is focused on prevention and mitigation
of harm
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk Management Process – Overview
Analyse Risks
Evaluate Risks
Monitor and Review
Identify Risks
Risk Assessment
Communicate and Consult
Establish the Context
Treat Risks
Adapted from AS/NZS 4360 2004
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk Management Process – Overview
Analyse Risks
Evaluate Risks
Monitor and Review
Identify Risks
Risk Assessment
Communicate and Consult
Establish the Context
Treat Risks
Adapted from AS/NZS 4360 2004
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk Management Process – Detail
Communicate and Consult
Identify Risks
Analyse Risk
Evaluate Risks
Internal Context
What can happen?
Identify existing controls
Compare against
criteria
External Context
When and where?
Risk Management
Context
How and why?
Establish the
Context
Treat Risks
Identify options
Assess options
Determine
Consequences
Determine
Likelihood
Set priorities
Prepare and implement
treatment plans
Develop the Criteria
Define the Structure
Determine levels of risk
Treat
Risks
YES
Analyse and evaluate
residual risk
NO
Monitor and Review
Adapted from AS/NZS 4360 2004
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Establish the context
 Communication and consultation
– Consultation is a process not an outcome
• impacts on a decision through influence
• about inputs to decision-making
 With whom do you need to consult and communicate?
– List external organisations and individuals
– List internal individuals
 Formalise this process
– Document it!
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Medicine testing - Risk assessment team
 Clinical experts
 Pre-market assessors/evaluators
 GMP experts
 Adverse event reporting for the product
 Complaint and recall histories for the product
 Supply chain advisors
 Surveillance and counterfeit advisors
 Laboratory technical experts
 Consumers and community groups
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk assessment - Identify risks
If something happens, then it might lead to an outcome, which might have an impact
on public health due to the quality, safety or efficacy of a medicine
 Questions
–
–
–
–
–
What can happen?
Where can it happen?
When can it happen?
Why it can happen?
How can it happen?
 Tools and techniques depend upon the purpose of the risk management study
and include:
–
–
–
–
–
–
33 |
Checklists
Judgements based on experience and records
Flow charts
Brainstorming
Systems analysis
Scenario analysis and systems engineering techniques (eg fault analysis)
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Identify risks
 A source of risk or hazard
 An event or incident
 A consequence, outcome or impact
 A cause (what and why)
 When and where could the risk occur
 Controls and effectiveness
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Analyse risks
 Develop and understand the risk
 Consider the source of risk
 Consider both positive and negative consequences
 Consider the likelihood that consequences might occur
 Identify factors that affect consequences and likelihood
 Analyse risk by combining consequences and likelihood
 Take into account existing controls
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Evaluate risks
 Compare against your defined criteria
 Consider balance between potential benefits and adverse
outcomes
 Set priorities
– In terms of the extent and nature of treatments required
– What tests can your laboratory target to increase the likelihood
of detecting a substandard medicine in order to prevent an
adverse event occurring?
Performing a risk assessment is an iterative process
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Types of risk analysis
 Qualitative analysis
– Words describes the magnitude of potential consequences and the
likelihood that they will occur – eg high, medium, low risk
– Informed by factual information and data where available
 Semi-quantitative analysis
– Descriptive words are given values (1= low, 10 = high)
 Quantitative analysis
– Numerical values
“Particular care must be taken with quantitative analysis when examining
consequences that are intangible or difficult to quantify such as
environmental or safety effects or reputation” (AS/NZS 4360:2004)
Check sensitivity of the method
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Treat risks
 Identify options
 Assess options
 Prepare and implement treatment plans
 Analyse and evaluate residual risk
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Monitor and review
 Monitor effectiveness of risk management process
 Ensure priorities have not changed
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
TGA
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
TGA’s targeted testing approach
 Service Level Agreements (SLA) define annual lab testing program
– Prescription Medicines Regulator
• Includes drugs, plasma products, vaccines, biologicals, blood and tissues
– Over-the-Counter (OTC) Medicines Regulator
– Complementary Medicines Regulator
– Medical Devices Regulator
 Non-discretionary sample testing (urgent or priority)
– Usually unplanned from an operational viewpoint
 Discretionary sample testing (routine)
– Amenable to operational planning
– Based on an agreed risked-based sampling program
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
TGA’s testing priorities
 Non-discretionary testing
–
–
–
–
–
–
–
Problem and complaint investigations
Adverse reactions
GMP alert samples
International alerts
Referral as a result of surveillance seizures
Suspect counterfeits
Urgent or high priority according to set performance timeframes
 Discretionary testing
–
–
–
–
–
42 |
Compliance monitoring of products on the market
Selection of marketed products according to risk assessment
Usually includes a random selection of a small percentage of products
Product surveys conducted to maximise resources
Routine testing according to a monitored performance timeframe
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Targeted testing
 Level of risk associated with medicine itself
– Intrinsic toxicity of the medicine
– Likelihood of treatment failure if the medicine is ineffective
– Medicine failure due to likelihood of deficiencies in quality
• eg if product is difficult to make, or often poorly made
 Other concerns about quality, safety, efficacy
–
–
–
–
43 |
Surveillance activity
Reports of adverse consumer reactions
Quality problems identified during manufacturer audits
Literature reports and international concerns
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Factors that might affect the level of risk
– The quality of the manufacturing process
– The history of the manufacturer or sponsor
– The potential for product to be contaminated with adventitious
agents such as viruses and prions
– Whether the product is intended to be sterile
– Whether the product is an antibiotic, where potency may give
rise to antibiotic-resistant strains
– The natural propensity of the active constituent to instability,
both molecular structure and pharmaceutic form (formulation)
– The degree of exposure of the population to the product
– The availability of counterfeit products in the market place, and
– The outcome of other post-market activities
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Formulating a risk-based testing plan
 Consult Regulators, adverse reactions, surveillance, recalls, and
GMP areas
 Products prioritised for testing after determining risk level
 Example outcomes
– High end of risk spectrum
• Every batch of product tested
• Comprehensive selection of tests applied to each batch
– Medium risk range
• Might be subjected to physical testing periodically
• Narrower range of relevant tests applied
– Lower end of risk spectrum
• Might undergo review of every batch documentation without physical
testing
• Periodic review of batch documentation only
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
The risk assessment
(Introduction to hands-on exercise)
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Product: (Proprietary name, generic name)
Presentation
Dosage Forms
Registration numbers
(1) Event Consequence Table
(1=insignificant, 2=minor, 3=moderate, 4=major, 5=catastrophic)
Rank
Adverse
Reactions
Clinical
Issues
Parameter
Manufacturing Recalls
Aspects
Score
Testing/other
Total
Rank
(2) Event Likelihood:
Event Likelhood
Outcome
Risk Rating
Risk Action
Comments:
Assessed by:
Date
Approved:
(eg rare, unlikely, moderate, likely, almost certain)
Event consequence Table 1 (example)
Rank
Description
1
Insignificant
2
Minor
Parameter
Adverse Reactions
Clinical
Issues
Manufacturing
aspects
Recalls
Testing/other
No or few reports of adverse events
associated with product
Quality failures
not of clinical
significance
Current GMP licence with A1
rating. No reported problems.
No evaluation issues.
Product never recalled
No substantiated
complaint. No
counterfeiting or illegal
supply known. No
testing failures.
Product of minor concern to ADRU with
few serious reactions
Quality failures of
low clinical
significance
A2 rating for last GMP audit.
Medium risk manufacturer.
Class II or III
Wholesale.
Counterfeiting or illegal
supply of low concern.
Failed low concern
quality issues (eg label)
Class III Hospital or
Retail level
3
Moderate
Product of moderate concern to ADRU with
a number of serious reactions
Quality failures of
moderate clinical
significance
A3 rating for last GMP audit.
High risk manufacturer
Class I Wholesale
Class II Hospital
Class III Consumer
4
Major
5
Catastrophic
48 |
Product of major concern to ADRU and
has been associated with a relatively small
number of patient deaths or a significant
number of adverse reactions
ADRU has recommended regulatory action
because of significant number of deaths or
a large number of serious adverse
reactions.
Quality failures of
severe clinical
significance
Unacceptable risk assigned
by GMP auditors
Class I Hospital or
Retail
Class II Retail or
Consumer
Manufacturer’s licence
revoked or suspended due to
critical deficiencies
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Class 1 Retail or
Consumer
Class 1 Hospital for
Highly Specialised
Drugs
Counterfeiting or illegal
supply of mod.
concern. Failed mod.
quality parameters (eg
borderline potency)
High frequency
counterfeiting, including
overseas. Failed critical
quality issues (eg
dissolution)
Product failed critical
quality parameters (eg
sterility, wrong active)
Applied example for Capsule Product X
from Table 1
Capsule Product X:
Rank
Total
Parameter
Score
?
49 |
8
Adverse
Reactions
Clinical
Issues
Manufacturing
aspects
Recalls
Testing/other
Product of minor
concern to TGA’s
Office of
Medicines Safety
Monitoring
(OMSM) with few
serious adverse
reactions
Quality
failures of
low clinical
significance
A1 rating for
last GMP audit.
Current licence.
No previous
reported
problems or
pre-market
evaluation
issues
identified.
Product has
never been
recalled.
Counterfeiting
or illegal
supply is of
low concern.
Failed low
concern
quality issues
(eg minor
label issues)
2 (Minor)
2 (Minor)
1 (Insignificant)
1 (Insignificant)
2 (Minor)
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Table 1(a) Risk category rank
Use score from Table 1
50 |
Risk consequence score
Risk Category Rank
5-10
Insignificant
11-15
Minor
15-19
Moderate
20-23
Major
23-25
Catastrophic
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Event likelihood Table 2 (example)
Rank
Description
I
Rare
Event Likelihood (examples only)
Product not distributed in your country. No previous testing failures. Product has never been recalled
No recent changed to manufacturing process, specifications or test procedures. Recent self-assessable change
by manufacturer. Current manufacturing licence. No previous reported problems. No issues identified during premarket evaluation stage.
II
Unlikely
Product used infrequently (eg vaccines used by travellers, antivenoms). Testing failures more than 5 years ago.
Product has been subjected to a Level 1 Recall more than 3 years ago. Product subjected to a Level 3 Recall
only in the last 5 years.
Recent minor change to manufacturing process, specifications, test procedures. Recent change of manufacturing
site for excipients. Manufacturing problems more than 3 years ago.
III
Moderate
Product failed significant quality parameters in the last 2-5 years. (eg potency, impurities). Failed moderate quality
parameters within last 2 years. Recent moderate change to manufacturing process. Specifications, test
procedures. Recent change of manufacturing site for API. Manufacturing problems in last 3 years.
IV
Likely
Product failed significant quality parameters in last 2 years (potency, impurities, incorrect active present). Subject
to a Level 1 or 2 Recall in the last 3 years.
Recent moderate change to manufacturing process, specifications, test procedures. Recent change of
manufacturing site for API.
V
(Almost)
Certain
51 |
Product administered to large proportion of population (eg National Childhood Immunization Program). Product
subject of a Level 1 or 2 Recall in past 12 months. Significant adverse events reported in last 3 years. Stability
studies indicate low thermal stability. Recent major change to manufacturing process, specifications, test
procedures. Recent change of manufacturing site for API and previous problems notes with manufacturing
process. Manufacturing audit is overdue or license has expired.
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk ranking Table 3
Use the risk consequence score from Table 1(a) and the likelihood from Table 2
Remember the score from Consequence Table 1(a) is ‘Insignificant’
Remember the score from Likelihood Table 2 is ‘V (Almost certain)’
Risk Category (from Table 1(a))
52 |
Likelihood
(From Table 2)
Insignificant
Minor
Moderate
Major
Catastrophic
I (Rare)
1
3
6
10
15
II (Unlikely)
2
5
9
14
19
III (Moderate)
4
8
13
18
22
IV (Likely)
7
12
17
21
24
V (Almost certain)
11
16
20
23
25
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Risk action Table 4 (example)
Example of level of Post-market compliance testing required.
Remember score from Risk ranking Table 3 is ’11’
Risk Ranking
Risk Rating
Action Required (TGA’s test groupings)
Over 23
Severe
17 to 22
High
Product(s) placed in Test Group 3: products requiring the highest level of postmarket assessment.
(Batch release protocols examined for every batch and samples of every batch
required, but not every batch is tested).
11 to 16
Moderate
Product(s) placed in Test Group 4: products requiring a moderate level of postmarket assessment.
(Batch release protocols examined for every batch and samples requested
periodically for testing).
New products placed in Test Group 2 until acceptable consistency established.
(Protocols and samples required for first 5 batches. 3/5 batches tested and if
results satisfactory, then move to Test group 4).
0 to 10
Low
Urgent laboratory testing/ investigation
Product(s) placed in Test Group 5: products requiring a lower level of postmarket assessment.
(Protocols and samples might be requested occasionally.
Annual requirement for a report of batches manufactured.
Status reviewed ever 5 years).
Note: Test Group 1 - Pre-Registration testing to facilitate method development and validation in quality control testing laboratory.
53 |
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Product X
Capsule
Oral
2009001234
2
2
1
1
2
8
Insignificant
V (almost certain)
11
Moderate. Samples of first five batches tested (Group 2), then tested periodically (Group 4)
Target tests: visual, LOD, degradation products (related substances) by HPLC or TLC,
and dissolution profile.
V. Christ
1/0/2009
Summary
 Pharmacopoeial tests
– General, microbiological and chemical tests
– Tests for various dosage forms
 Risk assessment (analysis)
 TGA’s approach to targeted sample testing
 Worked example of a risk-based analysis to target
samples and testing to assist with the hands-on exercise
55 |
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Questions???
56 |
Sampling and testing for Quality Control Laboratories, Nairobi, September 2009