QUALIFICATION OF VENDORS AND

CONTRACTORS
SERVICE PROVIDER
A list of tests, references to analytical
procedures, and appropriate acceptance
criteria that are numerical limits,
ranges, or other criteria for the tests
described.
It establishes the set of criteria to which
a material should conform to be
considered acceptable for its intended
use.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
 Quality in collaboration with the appropriate
Subject Matter Experts (SMEs) are responsible
for the management of Contract Laboratories.
Contract Laboratories needs to be monitored
and evaluated to ensure that the contracted
testing services are performed in accordance
with the applicable procedures and cGMP
requirements established by the applicable
Regulatory Authorities.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES

The management of contracted testing

services needs to ensure compliance
with the provisions set forth in the
Quality Agreement between
Organization and the Contract
Laboratory.
QUALIFICATION OF VENDORS AND CONTRACTORS
CONTRACT LABORATORIES
A Quality Agreement needs to be prepared and made effective
prior to the commencement of contracted testing services from
a Contract Laboratory.
Contracted testing services provided on a one-time or
temporary must comply with the applicable quality requirements
and expectations.
 Typically,on-going monitoring of this type of Contract
Laboratory is limited to periodic audits and quality requirements
are included in specific service agreement or contracts.
QUALIFICATION OF VENDORS
AND CONTRACTORS
CONTRACT LABORATORIES

The Contract Laboratory can not sub-

contract testing services to another
contract laboratory without prior approval
from the organization.
A sub-contractor shall meet the same
quality requirements and expectations as
the Contract Laboratory and there must
be a Quality Agreement between the two
Parties.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
 The Quality Agreement
CONTRACT must ensure
LABORATORIES that the Parties clearly understand
their respective roles and responsibilities in relation to the contracted
testing services.
 These requirements may include, but are not limited to the following
 Regulatory and Compliance
 Communication Mechanisms and Contacts
 Laboratory Controls
 Deviations, Non-Conformances and Corrective and Preventive Actions (CAPAs)
 Change Control
 Qualification and Validation (IQ-Installation Verification, OQ-Operational
Qualification, PQ Performance
 QUALIFICATION OF VENDORS AND CONTRACTORS
CONTRACT LABORATORIES

Qualification and Validation (IQ-Installation Verification,

OQ- Operational Qualification, PQ Performance
Qualification, PV- Performance Verification) of instruments
and equipment
Right to audit the Contract Laboratory facility
Requirement the Contract Laboratory to notify of
Health Authority / Regulatory Agency inspections
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
 Right to review and approve Contract Laboratory responses to
Health Authority / Regulatory Agency inspection observations that
impact product
 Qualityshall assure that all the necessary information is provided to
the Contract Laboratory so that it is able to meet requirements.
 Allrecords relevant to assessing product quality shall be made
available according to the Quality Agreement provisions in the event
of Out-of- Specification (OOS) and Out-of-Trend (OOT) test results, or
any other issues related to product quality.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
• Incidents of non-compliance with the Quality Agreement shall be
escalated to appropriate management.
• Quality shall address non-compliance with the Quality
Agreement by a Contract Laboratory.
• Addressing such issues may include the evaluation of impact to
product, the implementation of additional oversight, a revision to the
Quality Agreement, and a discontinuation of the Service Agreement
with the Contract Laboratory.
QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
•  In-House legal counsel shall be sought in the event modifications
are required to the Quality Agreement.
•  Allmodifications to the Quality Agreement shall be approved by
the responsible management of the Parties prior to implementation.
•  Aspart of the management of contract testing services, the Quality
Agreement shall be reviewed periodically (at least once in 5 years) for
compliance to the quality requirements and standards.
• A risk analysis shall be performed to support the continued use of
a Contract Laboratory with an unacceptable audit rating.
QUALIFICATION OF VENDORS AND CONTRACTORS
CONTRACT LABORATORIES

• A Contract Laboratory shall be audited on a periodic basis, for

technical reasons, or "for cause".
• Quality shall establish the frequency and coordinate the
activities.
• The frequency of the audits shall take into account the performance
history of the Contract Laboratory, the risk profile and the criticality
assessment.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
A Contract Laboratory receiving an unacceptable audit
rating shall be required to present an action plan (CAPA)
for timely remediation of the observations.
An unacceptable audit rating shall require a notification
and escalation to Management.
A risk analysis shall be performed to support the continued
use of a Contract Laboratory with an unacceptable audit
rating.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
 Itshall be verified that all related contract testing records and
documentation are maintained and controlled by the Contract Laboratory
in a compliant manner and that the documentation can be made available
to upon request.
 The level of ongoing Quality oversight shall be based on the
Contract Laboratory performance and criticality to the business.
Highest risk Contract Laboratories shall be assessed on a more
frequent basis.
 Areas of assessment shall include review of the following
 Performance and Quality issues
 Investigations and CAPAs
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES

 Change Control
 Management Reviews
 Quality shall define performance criteria of a Contract Laboratory, taking
into consideration the following occurrences:
 GMP critical event created by the Contract Laboratory requiring
Management Notification.
 Critical audit observations and failure to implement effective CAPAs to
correct critical or major gaps.
 Recurring failures to meet specifications and suspected testing errors.
 Lack of effective Change Control (i.e. changes to process or procedure without
prior notification and approval from Quality)
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
 Contract Laboratory shall be re-assessed, using a risk-based approach, under the
following circumstances:
A different category or type of Product is to be tested
A new testing facility is added and/or changes to an existing testing facility are
made
A Contract Laboratory that has been inactive for an extended period of time shall
be evaluated to determine if services are still required and if audits of the supplier
should continue. Re-assessment to determine the need for re-qualification prior to
resuming contract testing services may be required.
 Ifthe intended service is meant to be on a periodic basis then re-assessment is not
required as long as periodic audits or reviews have been maintained.
 QUALIFICATION OF VENDORS
AND CONTRACTORS
CONTRACT LABORATORIES

 The Contract Laboratory shall have an effective process in

place to assure regulatory compliance for any changes to the
Test Methods that require reporting or filing or pre-approval by
the applicable Regulatory Agency.
 Qualityshall assure that the documentation and controls
supporting the stability program at Contract Laboratory are
consistent with:
 The applicable cGMP requirements for the product.
 The Marketing Authorization or intended market.
 The agreed upon stability protocols.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
CONTRACT LABORATORIES
 Quality shall address the requirements for the review and approval of
qualification / validation protocols and final reports for the analytical procedures,
equipment, and facilities at the Contract Laboratory, as applicable.
 Quality shall assure that there is an effective notification process with the
Contract Laboratory to report investigations of product testing deviations / non-
conformances that could impact unreleased, released or distributed product as
defined and agreed upon in the Quality Agreement.
 Quality shall ensure that unfavorable reviewed results at the Contract Laboratory,
or any data or information that comes to the attention that may adversely impact,
are notified to Management.
 QUALIFICATION OF VENDORS AND CONTRACTORS
CONTRACT LABORATORIES

Qualityshall monitor Regulatory

Agency inspection results at the
Contract Laboratory that have
impact on product or procedures,
equipment and facilities used to test
product.
 QUALIFICATION OF VENDORS AND CONTRACTORS
CONTRACT LABORATORIES
 Quality shall continually monitor and evaluate change control notifications from
the Contract Laboratory and perform an impact assessment of those changes,
individually and collectively when applicable.
 Examples of significant changes that require prior notification and approval
include, but are not limited to the following
 Changes to the Testing Methods
 Changes to the testing site
 Sub-contracting of testing services
 Organization shall communicate applicable changes to the Contract Laboratory
to ensure that Testing Methods, Specifications etc. are in alignment with current
internal and regulatory requirements
 QUALIFICATION OF VENDORS AND CONTRACTORS
CONTRACT LABORATORIES

 Quality Performance
 The Contract Laboratory status
will be based, at minimum, on
the following quality
performance criteria.
 Inspection Outcomes
 Compliance to
Quality Agreement
 QUALIFICATION OF VENDORS AND
CONTRACTORS
DISENGAGEMENT OF CONTRACT LABORATORY
 The Contract Laboratory disengagement
process shall meet the requirements of
internal change control procedures and
process.
 Activitiesof the change control shall
consider a separation strategy, a phase
out plan containing all activities required
to end the relationship, a justification for
the separation and the approval of
Management.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
DISENGAGEMENT OF CONTRACT LABORATORY

• An analysis of the Contract Laboratory controls shall be performed

to adequately address and mitigate any risks associated with the
disengagement and the impact to organization, affiliates and
regulatory filings.
• The need to replace the Contract Laboratory and a subsequent
identification and selection for a new Contract Laboratory shall be
determined.
 QUALIFICATION OF VENDORS AND
CONTRACTORS
DISENGAGEMENT OF CONTRACT LABORATORY
The Quality Agreement shall remain in effect for as
long as deemed necessary for investigations etc for
products tested that are within shelf life.
At the conclusion of the disengagement the Contract
Laboratory phase out plan shall be reviewed and shall
include documented evidence that the closure
activities outlined the strategy and plan are complete
 CONSEQUENCES OF
CONTAMINATIONS
 Deterioration of Product
 Loss of Potency
 Pyrogenic Reaction
 Infection/Risk of Secondary
Spread
 Inadequate Drug Delivery
 Alteration of Pharmacological
Activity
 Regulatory Issues