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Quality aspects in

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

 The pharmaceutical industry remained stable up until the


early 1990’s
 For a long time, the pharmaceutical industry has been one of
the most profitable industries
 But, now this is changing rapidly….
 Generic market, health care policies and global economy –
key aspects driving profitability initiatives

 R&D productivity and/or Operational efficiency is the answer


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Supply Chain - Relevant and Critical
as never before in Pharma business

 Globalization

 Acquisitions and Divestitures

 Outsourcing

 Capability Constrains

 Ensuring Reliability

 Creating Flexibility

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Why Greater Coverage of Quality aspects in
SCM is needed?
 Cost driven sourcing

 Outsourcing from regions/country where quality


practices could be compromised by supplier

 Language barriers in understanding/emphasizing


Quality/ Regulatory aspects

 Under developed/less covered regulatory/GMP systems


prevailing certain large manufacturing countries

 Geographical distance – leading to reduced oversight


of goods/materials produced
 Long acquired mindset – Quality/GMP as part of
manufacture alone 4
GMP/Quality coverage

Materials Distributors

Patient
Materials Manufacturing Hospitals

Materials Retailers

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Classification of Materials

 Based on quality criticality to the process

 Non-critical raw materials

 Critical raw materials ( including Key starting


materials of API )

 Intermediates

 APIs

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Increasing Levels of GMP
APIs

Registered
intermediates

Critical Raw Materials

Non-Critical Raw Materials

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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

1. Supplier selection process

2. Due diligence process

3. Quality Assessment

4. Change control and production assessment

5. Supply chain security

6. Ongoing monitoring and evaluation


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Vendor management flow – 1 of 2

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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

 Mechanism for Review of Change


- Non Critical Raw Materials

- Critical Raw Materials and API Intermediates

 Execution of Change

 Evaluation of Change

 Closure of the Temporary Change Control


 Ongoing Monitoring – through review of key
performance indicators (delivery, audit observations,
customer complaints, and failures, etc.,)
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5. Supply Chain Security

FDA Counterfeit Drug Task Force

European Commission’s - legal proposal to


combat counterfeit medicines for human use

WHO Program “IMPACT“ (International Medical


Products Anti-Counterfeiting Taskforce)

“APIC Quick Guide for API Sourcing”

MHRA - Anti-counterfeiting Strategy 2007-2010

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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

samples are not


representative
Take new samples from
the batch

Analyze samples as per


release spec

Decision based on results


* Monitor the batch for stability of new samples
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Conclusion

Supply chain is a strategic enabler for


Pharmaceutical business performance

Coverage of quality and GMP to supply chain


aspects throughout the cycle of supply chain
management is essential to ensure product
quality

Integrating good practices and control


measures in supply chain management is the
key to success

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Thank you!
antonyrg@shasun.com
antonyrajgomes@rediffmail.com

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