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Training Program on
Vendor Qualification
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Vendor Qualification
Background :
Manufacture of medicinal products and the active Pharmaceutical
Ingredients (APIs) is subject to strict good manufacturing practice regulations
that are designed to ensure their quality, safety and efficacy.
This ensures that patients worldwide and at any time can have confidence in
quality, safety and efficacy of medicines
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Vendor Qualification
Background :
In some cases business pressures to reduce costs results in sourcing the raw
materials used in their manufacturing at the lowest cost.
While this practice, in and of itself, does not create non compliance, it does
create opportunity for substandard material.
This situation also highlight the need for clarity regarding expectation and
requirements for supplier quality and assurance of the fully supply chain.
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Vendor Qualification
Vendor Qualification : Applicable Guidelines
ICH HARMONISED TRIPARTITE GUIDELINE
GOOD MANUFACTURING PRACTICE GUIDE FOR
ACTIVE PHARMACEUTICAL INGREDIENTS
Q7
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Vendor Qualification
Vendor Qualification: Applicable Guidelines / Procedure
• ICH Q7- Section 7 : Material Management
• APIC (Active Pharmaceutical ingredients committee) guidelines on Supplier
Qualification and Management
• SOP for Vendor Qualification# CDPL/SOP/QA/042
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Vendor Qualification
Scope: Vendor Qualification
Scope of this training session is to address the supply chain management through vendor
qualification.
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Vendor Qualification
Objective: Vendor Qualification
Vendor qualification are performed to adequately mange the suppliers, through the
complete life cycle of the product and to ensure that raw materials received are suitable
and approved by the quality unit prior to use.
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Vendor Qualification
ICH Q7
A
t Coral Drugs Pvt Ltd
Section 7.11
Manufacturers of intermediates and/or APIs should
have a system for evaluating the suppliers of critical
materials.
Section 7.12
Materials should be purchased against an agreed
specification, from a supplier or suppliers approved
by the quality unit(s).
Coral Drugs evaluate all its vendors (manufacturer)
of critical and non critical raw materials .
Section 6.2 & 6.3
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
The supplier is selected and approved for purchase
against the required specification.
Section 6.1
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
ICH Q7
A
t Coral Drugs Pvt Ltd
Section 7.14
Changing the source of supply of critical raw
materials should be treated according to Section 13,
Change Control.
Qualification of vendor and up
-dation of approved
vendor is carried out through formal change control
for critical raw material.
Section 6.4
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 1 Supplier Selection
The user requirement specifications provided to
purchasing should contain as a minimum the
following information .
• Name of the Product (including formulae and CAS
number when available)
•
Material specifications
•
Quantity required.
The supplier selection starts with the user
requirement specification provided by coral drugs
for concerned material. Specifications contain as a
minimum; Name of product (including formulae and
CAS number when available), Material
specifications, quantity required.
Section 6.1.1
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 1 Supplier Selection
The materials within scope of this guideline have be
classified as follows:
Non
-critical materials
Critical raw materials (including API Starting
materials); Registered intermediates and API
Coral drugs have classified the materials as followed
Critical raw materials (including API Starting
materials, intermediates and API)
Non
-Critical raw materials
Section 5.1.1 & 5.1.2
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 1 Supplier Selection
The following information from the supplier should
be requested as part of supplier questionnaire:
Specifications; Manufacturing, packing and labelling,
MSDS, certificate regarding quality system, TSE /BSE
etc.
Based on criticality of the material, supplier is
requested to provide information such as
specification, Manufacturing, packing and labelling,
MSDS, certificate regarding quality system, TSE /BSE
etc.
Section 6.2.3
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 2 Due Diligence
For Critical Raw materials including API starting
materials the necessity to perform a due diligence
can be based on risk assessment.
For critical raw materials the necessity to perform
due diligence (Format# CDPL/FR/QA/006, Section
-
4)
shall be based on the risk assessment.
Section 6.2.5
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 2 Due Diligence
Documented evidence will be assembled to support
the Go / No Go decision process.
Documented evidence will be assembled to support
the Go / No Go decision process.
Section 6.2.6
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 2 Due Diligence
The implemented system and existing facility of
manufacturer will be assessed and challenged in
order to evaluate his capability to comply with the
customer’s requirement.
The implemented system and existing facility of
manufacturer can be assessed and challenged in
order to evaluate his capability to comply with the
coral drugs requirement.
Section 6.2.7
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 2 Due Diligence
Depending on a criticality evaluation a cross
functional team will be formed.
Depending on a criticality evaluation a cross
functional team will be formed
Section 6.2.8
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 2 Due Diligence
If Critical issues (Quality, Safety, Health, Environment,
Regulatory)are identified and do not have clearly
defined actions for remediation, this information
must be escalated to Senior Management.
If critical issue (Quality, Safety, Health, Environment,
Regulatory) observed an do not have a clearly
defined actions for remediation; shall be informed to
higher management.
Section 6.2.9
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 3 Quality Assessment
The level of quality assessment is based on risk
assessment which will take into account the level of
in house analysis the customer intends to perform.
Quality assessment is dependent on the criticality of
the raw material being purchased and the outcome
of risk assessment being performed on the material.
Section 6.3.3
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 3 Quality Assessment
In some circumstances, depending on the supply
relationship, the customer can use the suppliers
evaluation procedures for the manufacturer, as long
as this is documented as part of their (the
customers) supplier evaluation procedure.
In some circumstances, depending on the supply
relationship, coral drugs can use the
suppliers/manufacturers evaluation procedure.
Section 6.3.4
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
APIC (SQ&MG)
A
t Coral Drugs Pvt Ltd
Chapter 6 Ongoing monitoring and Evaluation
After the approval of a new supplier, a periodic
evaluation should be performed.
Periodic evaluation of critical raw material suppliers
is carried out at the interval of 3 years.
Section 6.7
SOP#CDPL/SOP/QA/042 (Procedure for Vendor
selection and Approval)
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Vendor Qualification
Critical Materials, Intermediates and APIs
A raw material, intermediate or an API that is used in the production of an API and that is
incorporated as a significant structural fragment into the structure of API. The material
that could affect the quality of the API and / or the material having direct link with API to
form the final drug molecule.
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Vendor Qualification
Non critical raw materials
A raw material which is essential for the production of the API but not related to the main
chemical structure or side chain of the main structure of API or final product. These are
widely commercially available and are used in multiple industries. i.e. acid, bases,
solvents, filter aids, packing materials, water system or utilities in contact with APIs such
as Nitrogen or compressed air.
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Vendor Qualification
Supplier Identification and selection:
• Supplier Identification and selection process starts with the user requirement
specification and Sample evaluation.
• The specification should contain as a minimum Name of the product (including
formulae and CAS number when available), Material specifications and quantity
required.
• Samples from two or three batches (depending upon availability) should be organized
from vendor along with the Certificate of analysis (COA).
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Vendor Qualification
Supplier Evaluation, Due Diligence and Quality Assessment
• QC compare the vendor COA, specification and analytical results with the in-house methods.
• If sample meet the specifications and supplier qualifies in the initial assessment, a supplier
questionnaire (Format No. CDPL/FR/QA/006) Section-1 for critical raw materials and Format No.
CDPL/FR/QA/006 Section-2 for Non-critical raw material are sent to supplier.
• Based on the criticality of the material, the supplier are requested to provide detailed information such
as Route of synthesis, Manufacturing, Packaging, labeling details, analytical test method, solubility &
impurity profile, material safety data sheet, Certificates regarding quality system, declaration such as
TSE/BSE, Residual solvents, GMO/Allergen, Metal catalyst, GMP, No change in process and willingness to
inspected etc.
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Vendor Qualification
Supplier Evaluation, Due Diligence and Quality Assessment
• The quality assessment is under the complete control of quality unit.
• Quality assessment / due diligence report is prepared for critical raw material on Format No.
CDPL/FR/QA/006 Section-4.
• The quality unit is responsible for taking the Go/No Go decision based on the quality assessment
independently.
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Vendor Qualification
Vendor Approval and ongoing monitoring
• Vendor list is updated for vendors of critical and non critical material.
• Quality / Contract agreement is executed with the critical vendor.
• Change in source of critical raw material is treated with change control.
• User trail/production & validation assessment may require.
• Periodic evaluation of critical raw material supplier is carried out at the interval of 3 years
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Vendor Qualification
Flow Chart for supplier qualification
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Vendor Qualification
