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Supplier Qualification Program
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1.
PURPOSE
1.1.
To provide a consistent procedure for qualifying approved suppliers in order to establish a
reduced testing program for components, containers, and closures in accordance with 21
CFR 211.84.
2.
SCOPE
2.1.
This SOP is followed when establishing a component, container, or closure supplier as an
approved supplier.
Note: The FDA cGMP regulations under 21 CFR 211.84 states “each lot of components,
drug product containers, and closures shall be withheld from use until the lot has been
sampled, tested, or examined, as appropriate, and released for use by the QC unit.” This
section of the regulations goes on to define the specifics of such testing or examination.
However, the regulations do allow for relief of full testing under CFR 211.84(d)(2) and (3)
by stating that in lieu of such testing by the manufacturer, a report of analysis or certificate
of testing may be accepted from the suppliers of these materials, provided that at least
some identification test is performed by the manufacturer, and the manufacturer establishes
the reliability of the supplier’s analyses through appropriate validation of the supplier’s test
results at appropriate intervals. In addition, compliance to cGMP regulations needs to be
established with the vendor by the manufacturer’s Quality Assurance (QA) department. All
of these activities constitute the approved vendor certification program.
3.
RESPONSIBILITY
3.1.
Quality Control (QC) determines reliability of component, container, or closure supplier test results.
3.2.
Quality or compliance department conducts cGMP audits of component, container, or closure
supplier, and determines the acceptability of the supplier as qualifying as an approved supplier.
4.
DEFINITIONS
4.1.
Container: That entity which holds the article and is, or may be, in direct contact with the article.
4.2.
Closure: That part of the container system that is intended to contribute to the preservation of the quality, purity, strength, and identity of the article housed in the container.
4.3.
Component: Any ingredient (active or inactive) intended for use in the manufacture of a
drug product that may appear in such a drug product.
4.4.
Supplier: The manufacturer of the purchased item. Also known as the vendor.
4.5.
Approved Supplier: A supplier that has satisfied the minimum qualification criteria of the
supplier qualification program, and has been approved to supply a required raw material.
Requirements to meet a status of approved supplier include undergoing a successful initial quality audit, and/or completion of a quality audit questionnaire. Full release testing is
required for all materials sourced from approved suppliers.
4.6.
Preferred Supplier: An approved supplier that is actively participating in the supplier qualification process. Requirements to meet the status of a preferred supplier include an established acceptable quality audit history, and demonstration that all received material lots to
date, consisting of at least three (3) consecutive lots, have been confirmed as meeting
specifications based on supplier verification testing by the manufacturer’s QC department.
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4.7.
5.
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Supplier Qualification Program
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Full release testing is required from all materials received from preferred suppliers.
Certified Supplier: A preferred supplier that has satisfied all requirements of the supplier
qualification program. Requirements to meet the status of certified supplier include an established acceptable quality audit history, and demonstration that all received material lots to
date, consisting of at least an additional two (2) consecutive lots, have been confirmed as
meeting specification based on verification testing by the manufacturer’s QC department.
Reduced testing, consisting of at least one (1) specific identification test, and receipt and review of the supplier report of analysis may be used to release the material for use.
PROCEDURE
5.1.
Determine the need to establish the component, container, or closure supplier in the Supplier Qualification Program (Production QC).
5.2.
Notify QA/compliance to determine approved supplier qualification requirements (Production, QC).
5.3.
QA/compliance schedules and conducts an initial cGMP compliance audit of the selected
supplier. This audit may also include or be substituted by the use of a supplier completed
quality audit questionnaire, depending on the criticality (e.g., early versus late clinical
phase use) of the component, container, or closure usage.
5.4.
If the supplier is determined to meet cGMP requirements as established by QA/compliance, an initial status of approved supplier is granted by QA/compliance.
5.5.
Based on the frequency of material use from the approved supplier, the status of the supplier
may be upgraded to preferred supplier by establishing a verification testing agreement between
the supplier and manufacturer for each material type and grade being sourced from that supplier. This agreement outlines a specified number of lots to be jointly tested by the QC department and supplier, where the number is required to be a minimum of three (3) consecutive lots.
Note: If an agreement to a verification testing protocol is not feasible due to the supplier’s
unwillingness to enter into such an agreement based on the manufacturer’s infrequent use
of the vendor, or for any other business reasons as communicated by the vendor, the manufacturer reserves the right to establish the reliability of the supplier’s test results on three (3)
designated incoming lots of the material, and tested against the supplier’s tests, and/or manufacturer established quality standards.
5.6.
If the test results generated by the QC department are determined to be satisfactory, QA/compliance reviews the supplier’s audit status and the release results, and compares to the QC
department's test results. This comparison determines if the supplier qualifies for a preferred vendor status.
5.7.
If a vendor is determined to be eligible for certified supplier status, an additional two (2)
consecutive lots are tested by the QC department for verification testing.
5.8.
If the test results generated by the QC department are determined to be satisfactory, QA/compliance reviews the supplier’s audit status, and the supplier release results, and compares to the
QC test results. This comparison determines if the supplier qualifies for a certified vendor status.
5.9.
For approved, preferred, or certified suppliers, regulatory documentation establishes a
vendor file for the supplier that contains results of the supplier and QC verification testing,
and a copy of audit report(s) of the supplier conducted by QA/compliance.
5.10. The current approved, preferred, or certified supplier rating is entered into the QA/compliance approved supplier list. Refer to Figure 1.
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5.11.
5.12.
5.13.
5.14.
5.15.
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Supplier Qualification Program
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Classification status of an approved supplier is maintained by continued demonstrated
ability of the supplier to meet required quality standards as determined by the QA/compliance audit program. Classification status for preferred or certified suppliers is granted by
QA/Compliance for a period not to exceed two (2) years with exceptions to exceed the two
(2) year cycle for re-certification status listed under 7.12 - 7.13.
QC determines the selection of the appropriate tests required to accept material from the
supplier under the reduced testing program. Selection is based on test criteria that can
detect potential quality changes of material during handling and transportation from the
supplier to the manufacturer, and that includes, at a minimum, a suitable identity test.
If one (1) or more lots are rejected by QC during the reduced testing program period established with a preferred or certified supplier within the granted certification period, an investigation is conducted to determine cause and to establish corrective action.
Following the successful investigation by QC and corrective action by the supplier, a successful re-audit of the supplier and verification of supplier test results as described above
is required to re-establish the supplier as a preferred or certified supplier by QA/compliance.
Biennial (every 2 years) re-certification of a preferred or certified supplier is required in
order to maintain the supplier on the approved vendor list.
Biennial (every 2 years) re-certification (surveillance of a current approved supplier) occurs by successful completion of an annual QA/compliance cGMP audit, full testing, and
verification to vendor results by QC on a minimum of one (1) lot.
6.
RECORDS
6.1.
Exhibit A: QA/compliance approved supplier list. Regulatory documentation assigns Supplier File (SF) numbers. SF numbers are assigned sequentially as SF-# beginning with
SF-1 and continuing indefinitely.
7.
RECORD DISTRIBUTION
7.1.
Supplier files are maintained by regulatory documentation.
7.2.
QA/compliance approved supplier list is maintained by regulatory documentation.
8.
REVISION LOG
Revision Number
00
9.
Revision Date
Section(s)
NA
Description
Original Issue
APPROVALS
Written By:
__________________________________ Date: _______________________________
Reviewed By: __________________________________ Date: _______________________________
Approved By: __________________________________ Date: _______________________________
Quality Unit
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Supplier Qualification Program
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EXHIBIT A
APPROVED SUPPLIER LIST
Quality Assurance (QA) Approved Vendor List
Material
Supplier Name/
Location
Status
Date Classification
Granted
Supplier File
Number
Poloxamer,
NF
ABC Excipients
Anywhere, USA
Approved
01-Apr-2002
SF-1
Section Four:
Supplier Quality Auditing
A quality audit determines whether a new or
existing supplier is suitable for supplying components to the specification required by the customer, or whether an existing supplier is continuing to meet the specification required. Oversights
at this stage can have serious implications, both
from a quality and financial standpoint. It is therefore essential that continuous quality audits be
performed as part of the supplier qualification
program.
Quality Auditor
Since there is considerable complexity in quality
auditing, various types of industry involved, and a
limited time period for performing the audit, the
quality auditor must have the appropriate requirements, training background, and experience to perform the audit. Some required attributes include:
■ The auditor must be a realistic, practical person capable of quickly understanding process
details, and practical problems encountered
by the supplier. This will ensure that unrealistic
demands are not placed upon the supplier by
the auditor.
■ The auditor must be capable of communicating with staff at all levels, from the production
supervisor to the laboratory personnel. This
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ability is necessary for the auditor to fully access the quality system of the supplier.
■ The auditor must be very observant, and be
prepared to ask questions that provide background information efficiently, and be able to
look behind areas and bypassed equipment
during the plant tour.
■ The auditor should have extensive experience
with the intended use of the components or
packaging materials, and in particular, potential quality problems and standards that may
be encountered during use.
■ The auditor should have full awareness of
the GMP requirements for component manufacture and usage. The auditor should also
be aware of the regulatory requirements and
the particular country requirements in which
the final product will be sold using the
sourced component or packaging material.
■ The auditor should have experience of the
component or packaging material manufacturing process prior to conducting the supplier
quality audit.
■ The auditor can usually acquire knowledge of
component and packaging material processing and quality requirements by touring companies involved in manufacturing similar materials. By doing this, the auditor obtains experience for the required GMP standard for
that industry. Not having this experience can
often result in an unrealistic standard being
requested of the supplier.