Beruflich Dokumente
Kultur Dokumente
Pharmaceutical
Supply Chain Management
Antony Raj Gomes
Head- Quality Management & Regulatory
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Pharmaceutical Business – Challenging and
testing times
“Man has moved up the therapeutic hierarchy, through
magic, voodoo, faith healing, to modern, orthodox medicine
and surgery” (Peter and Hill, 1969).
The pharmaceutical industry is thus, as old as mankind
Globalization
Outsourcing
Capability Constrains
Ensuring Reliability
Creating Flexibility
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Why Greater Coverage of Quality aspects in
SCM is needed?
Cost driven sourcing
Materials Distributors
Patient
Materials Manufacturing Hospitals
Materials Retailers
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Classification of Materials
Intermediates
APIs
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Increasing Levels of GMP
APIs
Registered
intermediates
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Further Classifications and Definitions
Raw Materials – classified in to 3 sub categories
1. Widely commercially available (acids, bases, solvents,
etc,.)
2. Commercially available for use in API industries (catalysts,
enzymes, etc,.)
3. API starting materials – generally available or custom
synthesis before becoming industrial scale
Registered intermediates
custom synthesis or process development by the supplier
APIs
manufactured under custom synthesis or contract
manufacture
Will be generally manufacture of off-patent medicinal
products
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Critical steps in managing suppliers
3. Quality Assessment
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Vendor management flow – 2 of 2
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1. Supplier selection process
Start by defining requirements
Name of the product (including formulae/ CAS no.)
Material specifications
Quantity required
And Classification
Criteria to be considered
Assurance of Supply
Quality & Regulatory Compliance
Procurement/Cost
Innovation/Technical
Responsiveness & Communication
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2. Due diligence process
Not applicable for non-critical raw materials
Critical Raw Materials/KSM - based on Risk
analysis
Cross functional team - covering critical functions
Areas to be covered
General Material Information Analytics & Stability
Quality Systems Regulatory
Plant Tour / Organization Economics
Documentation / Organization Intellectual Property
Safety, Environment & Health Process
Conclusion/Outcome
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3. Quality Assessment
Summary of Quality Assessment procedure
Requirement Non Critical Critical Raw Registered
Raw material material Intermediate/ API
TSE/BSE Assessment
Tanker Cleaning Assessment
Supplier/Manufactures
Questionnaire
Manufacturer Audit - **
Historical Performance* **
cGMP Compliance History - **
3rd party certification* **
Contract Agreement
Quality Agreement - **
* If applicable
Required
** Based on risk assessment performed on material being purchased 16
4. Change control and production assessment
Aspects to be evaluated
Initiation of Change
Execution of Change
Evaluation of Change
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6. Ongoing monitoring and evaluation
Responsibility – Quality unit
Elements of monitoring and rating
Ongoing monitoring (own results vs CoA, labeling, and
packaging, etc.,)
Periodic evaluation (full testing, PQR, change assessment,
audit and compliance, etc)
Rating (classification of supplier)
Review with supplier (sharing of periodic evaluation
report with supplier as a tool of improvement)
Re-audit - Frequency depends on rating
- Completely satisfactory – 5years
- Mainly satisfactory – 3 years
- Partially satisfactory – 1 year
Re-Evaluation
Reduced testing - Outcome of rating and performance
over a period of time
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Practical issues/controls
Own material code - linking with suppliers
Tracking of supplier manufacturing site
Certificate of analysis?
Label?
Any other means?
Control of raw material source of manufacturing of KSM
Control of raw material source by supplier for advanced
key intermediates
Tamper-resistant packaging
Getting the maximum from Quality Agreement
Labeling
Change management
Info on complaints
Regulatory audit compliance and status
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Transportation/Distribution – Medicinal products
Shipping & storing the drug products - outside of their
recommended storage conditions potentially impact the safety
and effectiveness of the drug product
Basic principles of Good distribution Practices
Quality should be maintained throughout distribution network
Tracking system to find any faulty product
Effective recall procedure
Available guidance
USFDA
USP <1079>
EU Guidelines on Good Distribution Practice of Medicinal Products for
Human Use (94/C 63/03)
WHO guidance on Good Distribution Practices For Pharmaceutical
Products
Health Canada Guidelines for Temperature Control of Drug Products
during Storage and Transportation
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Typical Transport Worthiness Study of
Medicinal Goods
Key aspects
- Protocol driven study
- Covering possible ways of shipment (road, sea, air freight)
- Sampling and transportation of samples
- Defined responsibilities (sender, transport provider and
receiver)
- Selection of data logger
- Positioning of data logger (viz stacking of goods)
- Labeling of containers and samples (identification of loose
containers, container having samples, and container having data
loggers etc.,)
- Monitoring of shipping conditions
- Retrieval and interpretation of information from data
loggers
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Typical Transport Worthiness Study of
Medicinal Goods
Approach for fixing tolerances
- ICH guideline Q1A, 2.1.7 storage conditions
“Data from the accelerated storage conditions and, if appropriate,
from the intermediate storage condition can be used to evaluate
the effect of short term excursions outside the label storage
conditions (such as might occur during shipping)”
- Derive maximum tested temperature (MTT) from stability
studies (e.g; Product is stable for 3 months at ACC stability the
MTT is 40°C)
- Define allowed tolerances
Target range Accepted rage Critical range
8°C to 25°C 0°C to MTT MKT is less than 0°C and
MKT is more than MTT
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Typical Transport Worthiness Study of
Medicinal Goods
- If the MKT is within tolerance, but shows extreme data for a short
time (e.g: *40 to 50°C for 6 hours, or more than 50°C for 2 hours)
samples are
representative Check if samples for
Decision based on results analysis are shipped
with batch
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Thank you!
antonyrg@shasun.com
antonyrajgomes@rediffmail.com
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