Quality Agreement

Between

_________________________
and

_________________________

Effective Date : ___________________

Approvals:
CONTRACTOR

_______________________ ______________________ __________

Name Title Date

_______________________ ______________________ __________

Name Title Date

_______________________ ______________________ __________

Name Title Date

CONTRACTEE

_______________________ ______________________ __________

Name Title Date

_______________________ ______________________ __________

Name Title Date

_______________________ ______________________ __________

Name Title Date

Quality Agreement Template Page 1 of 10

Table of Contents

1.0 PREAMBLE .......................................................................................................................... 3

2.0 PURPOSE ............................................................................................................................ 3
3.0 SCOPE ................................................................................................................................. 3
4.0 POLICY STATEMENTS ....................................................................................................... 3
5.0 DEFINITIONS ....................................................................................................................... 3
6.0 TERM OF QUALITY AGREEMENT ..................................................................................... 4
7.0 SURVIVAL CLAUSE............................................................................................................. 4
8.0 REGULATORY AUTHORIZATION ...................................................................................... 5
9.0 EQUIPMENT, FACILITIES, AND PERSONNEL .................................................................. 5
10.0 DOCUMENTATION .............................................................................................................. 5
11.0 RECEIPT AND STORAGE OF EXCIPIENTS, COMPONENTS AND RAW MATERIALS. 6
12.0 PRODUCT RELATED MANUFACTURE.............................................................................. 6
13.0 TESTING AND ANALYSIS ................................................................................................... 6
14.0 STORAGE AND SHIPMENT ................................................................................................ 7
15.0 PRODUCT DISPOSITION .................................................................................................... 7
16.0 RECORDS ............................................................................................................................ 7
17.0 CHANGE CONTROL ............................................................................................................ 8
18.0 DEVIATIONS, INVESTIGATIONS AND CAPA .................................................................... 8
19.0 COMPLAINTS ...................................................................................................................... 8
20.0 RETRIEVAL OF PRODUCT ................................................................................................. 8
21.0 CONTRACTOR AND CONTRACTEE SITE AUDITS .......................................................... 8
22.0 REGULATORY AGENCY INSPECTIONS ........................................................................... 9
23.0 SUBCONTRACTING ............................................................................................................ 9
24.0 APPENDIXES ..................................................................................................................... 10

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 1.0 PREAMBLE
This document constitutes the Quality Agreement between the Contractor, ___________
located at ______________________________, and the contractee, ____________,
located at __________________________________________.

This agreement is intended to describe the responsibilities of both parties in the design,
manufacture, testing, packaging, control and delivery of the Product, and to ensure that
operations are in accordance with applicable United States Food and Drug Administration
(FDA) regulatory requirements. This agreement may be a supplement to an overarching
business agreement between the contractor and contractee.
This Quality Agreement is comprised of a detailed checklist of the activities associated
with manufacture of the Product. Responsibility for each activity is assigned to one or
both parties in the Responsibility Table.

2.0 PURPOSE
The purpose of this Quality Agreement is to define the responsibilities associated with the
manufacture of ______________, (hereinafter known as Product), between contractor and
contractee.

3.0 SCOPE
The scope of this agreement includes all quality/regulatory activities defined in the
Responsibility Table.

4.0 POLICY STATEMENTS

______________ and _____________ shall treat the Agreement as a binding document.
Any changes to this agreement shall require prior written approval from both parties.
For each responsibility listed, the respective party is required to implement all
corresponding documents and processes necessary to fufill the responsibility, which
ensure compliance with federal and local laws.

5.0 DEFINITIONS
Batch: A specific quantity of Product to be determined by the parties that is produced in a
process or series of processes that it is expected to be homogeneous within specified
requirements.
CAPA: Corrective and Preventive Action
CAPA System: A corrective and preventive action as defined in 21 CFR 210 and 211.
Certificate of Analysis (COA): A listing of all results for tests conducted on samples of
the lot of the Product compared to the specifications and listed in regulatory applications.
Certificate of Compliance (COC): A statement that the lot of Product was manufactured,
packaged and tested in accordance with cGMPs.
Contractee: The facility/organization responsible for defining expectations of the
contractor.

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Contractor: The facility/organization responsible for the manufactured Product and the
associated services.
Corrective Action: action taken to correct an immediate problem and prevent reoccurence
of an undesirable event or deviation.
Deviation: Unexpected, unplanned or unforeseeable event, departure from normal
processing or operation, or departure from normal or expected values (i.e. out of limits).
Investigational New Drug Application (IND): An application submitted to the FDA
relative to Investigational New Drug clinical trials.
Lot: A Batch, or a specific identified portion of a batch, having uniform composition and
quality according to specified requirements.
Product: The clinical material manufactured by ______. It may require further
processing or may be in it’s final format for patient use. It may be a solution, capsule,
tablet, etc., that contains an active drug ingredient generally, but not necessarily. The term
also includes a finished dosage that does not contain an active ingredient and is intended
to be used as a placebo.
Retention Sample: A sample representative of a clinical lot.
Reprocessing: Repeating of a step or insertion of other appropriate maniupulation into the
manufacturing process.
Subcontractor: A third party who performs manufacturing or testing of Product.

6.0 TERM OF QUALITY AGREEMENT

This Quality Agreement shall be effective on the Effective Date and shall remain in effect
for as long as ______ utilizes the services and facilities of _______ unless the Quality
Agreement is terminated earlier in accordance with the terms of a Business Agreement.

7.0 SURVIVAL CLAUSE

All regulatory obligations contained herein that are required of either entity by an
applicable regulatory authority shall survive termination of this Quality Agreement.

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 RESPONSIBILITY TABLE

RESPONSIBILITIES [Enter [Enter N/A (not

Name] Name] applicable)

8.0 REGULATORY AUTHORIZATION

8.1 Maintains facility registrations, licenses
and authorizations required by applicable
laws to operate a cGMP facility.

8.2 Prepares, maintains and updates the IND.

Submits to the FDA.
8.3 Maintains an independent quality unit who
establishes and maintains an effective
Quality System.
9.0 EQUIPMENT, FACILITIES, AND PERSONNEL
9.1 Provides equipment used in the
manufacture and analytics related to
Product.
9.2 Performs equipment maintenance and
calibration.
9.3 Performs equipment qualification.
9.4 Performs general facility maintenance and
sanitization.
9.5 Provides a qualified facility to perform the
manufacture of Product in accordance with
_____ (insert contractee name)
instructions, and in compliance with FDA
and local regulations.
9.6 Ensures that the staff engaged in the
manufacture of Product has the education,
training, and experience necessary to
perform their assigned functions.
10.0 DOCUMENTATION
10.1 Maintains a controlled document
management system to initiate, review,
revise, obsolete, and archive all documents
and records.
10.2 Ensures that specifications for the Product,
comply with applicable regulatory filings,
10.3 Develops the master batch production
record.
10.4 Approves master batch production record.

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 RESPONSIBILITIES [Enter [Enter N/A (not
Name] Name] applicable)

11.0 RECEIPT AND STORAGE OF EXCIPIENTS,

COMPONENTS AND RAW MATERIALS.
11.1 Ensures raw materials are USP/FDA
approved or cleared.
11.2 Release excipients, components and raw
materials according to specification.
11.3 Stores excipients, components and raw
materials according to required storage
conditions.
11.4 Provides segregation of released and
quarantined material.
11.5 Maintains an inventory control system for
clinical production materials.
12.0 PRODUCT RELATED MANUFACTURE
12.1 Stores Product according to defined
temperature conditions utilizing a system
with continuous monitoring capabilities.
12.2 If applicable: Qualifies the donors
according to FDA requirements.
12.3 Develops manufacture raw material
specifications.
12.4 Performs equipment cleaning and product
changeover processes.
12.5 Performs clean suite disinfection and
sanitization.
12.6 Develops procedures for the prevention of
Product contamination and Product mix-
ups.
12.7 Assigns lot number(s) for Product
12.8 Maintains retains and stability samples.
12.9 Performs processing, reprocessing and or
reworking.
12.10 Performs review of executed batch
production record.
12.11 Performs packaging and labeling of
Product.
13.0 TESTING AND ANALYSIS
13.1 Develop test methods and method for
verification/validation as appropriate.

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 RESPONSIBILITIES [Enter [Enter N/A (not
Name] Name] applicable)

13.2 Responsible for the management of in-

process and final testing of Product.
13.3 Manages analytical method transfer for
those methods to be performed by a third
party.
13.4 Performs in-process and final testing of
Product.
14.0 STORAGE AND SHIPMENT
14.1 Stores Product in accordance with storage
specifications utilizing a continuous
storage condition monitoring system.
14.2 Ships Product to approved consignee.
14.3 Documents unfulfilled specifications in the
case of Product shipment to another
manufacturing facility prior to final
release. Document with an approved “Ship
at Risk” for further manufacture.
14.4 Performs final Product release.
15.0 PRODUCT DISPOSITION
15.1 Provides a Product Certificate of Analysis
(COA).
15.2 Provides a Product Certificate of
Compliance
15.3 Performs a batch release of Product
manufactured at ______.
16.0 RECORDS
16.1 Generates new documents/procedures
related to Product manufacture.
16.2 Revises/updates documents related to the
Product manufacture.
16.3 Retains all documentation (records) related
to Product in a manner to protect and
secure it against damage, destruction,
unintended changes or disposal during the
required time of storage.
16.4 Archives electronic data in a separate
location protected against damage,
destruction, and/or disposal during the
required time of storage.
16.5 Notifies ______ in writing at the end of
the document retention, of either transfer

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 RESPONSIBILITIES [Enter [Enter N/A (not
Name] Name] applicable)

or destruction, based on the direction of

____.
17.0 CHANGE CONTROL
17.1 Maintains established procedures for
managing control of changes to quality
systems, facility, equipment, critical
computer systems, and Product specific
documents.
17.2 Notifies ______ within ______of changes
related to facility, utilities or equipment
that could impact Product.
18.0 DEVIATIONS, INVESTIGATIONS AND CAPA
18.1 Ensures closure of deviations,
investigations and/or CAPAs.
19.0 COMPLAINTS
19.1 Notifies manufacturer/contractee of any
complaint or adverse event(s) related to
Product within ___ business days of
receipt of the information.
19.2 Investigates Product complaints/adverse
events as it related to manufacture by
______. Provides a response to the
appropriate parties within ___ working
days.
19.3 Communicates the results of the
complaint/ investigation, as necessary,
with; investigator; patient MD; contractee
and/or regulatory authorities.
19.4 Reports Product and adverse events to the
FDA according to FDA requirements.
20.0 RETRIEVAL OF PRODUCT
20.1 Manages Product recall.
20.2 Notifies ______ within ___ business days
of any incident, investigation or deviation
that may result in recall of Product.
20.3 Notifies appropriate regulatory agencies of
recall or product withdrawal.
21.0 CONTRACTOR AND CONTRACTEE SITE AUDITS
21.1 May perform routine audits of the quality
systems of _____ at mutually agreed upon
dates

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 RESPONSIBILITIES [Enter [Enter N/A (not
Name] Name] applicable)

21.2 Performs a written response related to the

audit finding performed by contractee,
within ____ business days after receipt of
the written audit report.
21.3 Implements corrective actions based on a
mutually agreed upon time-frame.
21.4 May perform a “for-cause” audit in
addition to routine audits in response to
significant product related quality or
compliance issues.
21.5 Performs periodic internal audits in
accordance with standard operating
procedures.
22.0 REGULATORY AGENCY INSPECTIONS
22.1 Informs _____ within ____ business days
of any communication received from
regulatory agencies regarding an
inspection directly related to Product.
22.2 Permits representatives from _____ to be
on-site for consultation during the portions
of a FDA inspection directly related to
Product.
22.3 Cooperates in the development and review
of FDA 483 responses required by
regulatory authorities relating directly to
Product.
22.4 Provides an unredacted copy of the FDA
report to _____ of the written inspection
observations, report, and response as they
relate directly to Product.
23.0 SUBCONTRACTING
23.1 May not delegate or subcontract to a third
party any part of the services to be
performed unless _____ has agreed in
writing to such delegation or
subcontracting.

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24.0 APPENDIXES

APPENDIX 1: List of Contractor Approved Subcontractors

The following subcontractors have been approved by and may be engaged for the
activities as specified under this Agreement:

Subcontractor Activities (as applicable)

[Insert Names] [Insert Activities]

APPENDIX 2: Contractor and Contractee Communication Contacts

Functional Area [Insert Contractor Name] [Insert Contractee Name]

Quality Name:
Assurance Title:
Phone:
email:
Operations Name:
Director Title:
Phone:
email:
Principal Name:
Investigator Title:
Phone:
email:

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