This document discusses managing risks related to cross contamination and contamination in the pharmaceutical manufacturing process. It provides an overview of how regulators are concerned with cross contamination between drugs and outlines the science and risk-based approach taken in ISPE's Risk MaPP Baseline Guide. The document then describes how risk assessment involves identifying, analyzing, and evaluating risks, and how risk control involves accepting, reducing, or removing risks. It also discusses communicating risks via a quality risk management plan. Finally, it offers pharmaceutical manufacturing services and tools for assessing cross contamination risks.

1. Cross Contamination and Contamination
Analysis and Control

2. Managing the Risks
• Regulators around the world have a concern
with cross contamination of one drug by
another
• ISPE’s Risk MaPP Baseline Guide® sets
out to demonstrate a science and risk-based
approach
• Stephanie and Julian Wilkins of
PharmaConsult Us were part of an
international core team who wrote the guide
• The guide follows the ICH Q9 approach
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3. How We Can Help
Risk Assessment
•Risk Identification (setting limits)
•Risk Analysis (qualitative and quantitative tools)
•Risk Evaluation (comparing limits with results of analysis)
Risk Control
•Risk Acceptance (the risk is managed to acceptable levels)
•Risk Reduction (reduce risk either by modifying the process to
remove exposure points, close or contain the process, etc)
Risk Communication via a Quality Risk Management Plan
(QRMP)
Risk Review
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4. Copyright © PharmaConsult Us 2010

5. Our specialty is working with:
• Hormones
• Beta Lactams and
Penicillin’s
• Cytotoxics
• Sensitizers
• ‘Gens
• We can help you
manufacture these
products in an efficient
and cost effective
manner
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5

6. What is a Plausible Pathway?
A route by which cross contamination by one
API may be transferred by various
mechanisms into another products
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7. Our Tools
• Customized FMEAs
that assist you in
focusing on the issues
of cross contamination
and contamination
• Master Matrix that
Russell Finex Sieve
Suspension Filling
records all
Nanomill-10 Train
Nanomill-2 Train
20cuft V Blender
42" Coating pan
Dispensary unit
IKA Mill Bld 15
GKF 2000/2500
Bottling Line**
Powder Addition
Vector Coater
CF Granulator
Accela Coater
Glatt GC 1500
Casburt oven
Fitzmill D6A
Sweco Sieve
Blister line**
IBC Blender
Fette P2100
Zanasi Z85
Autoclave
Weighing
Glatt 120
Gral 300
Sample
Total
relevant data and SAP
3001312
3000057
3000057
1
2
2
1 15
10
10
5
17
1 5
10
10
10 10
10
1 24
47
49
3000011 2 10 20 17 5 12 10 15 5 96
becomes a living 3000018
3000018
3001271
3000014
8001472
2
2
2
2
10
10
10
10
20
20
20
20
17
17
17
17 12
1 5 5
30
30
35
60
20
20
25
45 10
12
12
12
12
10
10
10
10
5
5
5
126
126
131
198
16
document that 3001460
Risk 17
2 10
81 115
5
10 102 12 2 5 5 5 155 0 115
10 10
10 40 60 10 30 10 10
10
30 15 15 0 1
47
identifies areas of
concern
Copyright © PharmaConsult Us 2010