Quality Agreement Template

Note to the User of this Document

Please recognize that the goal of the Quality Agreement is for it to be a living document that is
used by both the client and the contracting organizations. Both organizations must determine the
business practices that are applicable to their relationship, and ensure that those are included in
the document with defined roles and responsibilities.

This document is a template that should be used to get you started on your journey, not a check
box exercise. A solid Quality Agreement is built with risk management practices employed. Each
relationship should be assessed to determine the proper amount of oversight and involvement
from the client organization.

Please contact us at Xavier University’s Med-XU if you feel you would benefit from consultation to
work with you through this process. We have a vairety of Quality Agreement templates for you to
use for free based on the services you are involved in (finished product manufacturing, API
manufacturing, packaging, etc.).

Best regards,

Marla A. Phillips, Ph.D.
Director of Med-XU
513-745-3073
Phillipsm4@xavier.edu

Page 1 of 17

Quality Agreement
Between

Contract Lab
Street address
City, State and Zip
USA

and

Client Company
Street address
City, State and Zip
USA

Director, Quality Assurance Client Company Date

Vice President Client Company Date

Director, Quality Assurance Contract Lab Date

President Contract Lab Date

Page 2 of 17

Contract Lab - CLIENT COMPANY Quality Agreement

Table of Contents

Section Description Page
Signature Page 1
1.0 Purpose 3
2.0 Scope 3
3.0 Policy Statements 3
4.0 Definitions 4
5.0 Regulatory Authorizations and Communications 4
6.0 Equipment and Testing Facilities 5
7.0 Documentation 6
8.0 Materials Receipt and Storage 7
9.0 Reference Standard Management 7
10.0 Analytical Methods and Testing 7
11.0 Deviations, Discrepancies, OOS, and Investigations 8
12.0 Change Control 9
13.0 Data Acceptance and Disposition 10
14.0 Sample and Record Retention 10
15.0 Complaints and Recalls 11
16.0 Inspections and Audits 12
17.0 Annual Product Review (commercial) 12
18.0 Subcontracting 13
19.0 Revision History 13
20.0 Communication Contacts 14
Attachment A: Events requiring Client Company notification 15
Attachment B: Documents requiring Client Company signature 16

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1.0 PURPOSE
The purpose of this document is to establish a Quality Agreement between the following two
companies who both are organized and exist under the laws of the United States of
America:
Registered Office: Contract Lab
Street address
City, State and Zip

and

Registered Office: Client Company Inc.
Street address
City, State and Zip

This Quality Agreement takes the form of a detailed checklist including the activities
associated with pharmaceutical analytical testing, release, and stability program
management of Client Company Product and Drug Substance. Responsibility for each
activity is assigned to either Contract Lab and/or Client Company (hereinafter, Client
Company) in the appropriate box in the Delegation Responsibility Checklist that follows. For
each responsibility listed, the respective party is required to put into effect all applicable
procedures and to take all necessary actions to effectuate that responsibility in accordance
with cGMPs, ICH guidelines and all applicable laws.
Nothing in this Quality Agreement shall affect in any way a party’s obligation to comply with
cGMPs, ICH guidelines and all applicable laws.

2.0 SCOPE
The scope of this agreement includes all activities related to the analytical methods
development, quality control testing, stability program management, and stability testing
required for innovator drug products, comparator drug products, and matching placebos.

This agreement is effective upon final approval by the designated individuals from both
Client Company and Contract Lab

3.0 POLICY STATEMENTS
The companies will treat this Quality Agreement as a binding document. Any changes to
this agreement shall require prior written approval from both parties.
Contract Lab agrees that all activities related to the testing and release of Product(s) and
Drug Substance will be conducted to the standards of cGMP (Code of Federal Regulations,
21 CFR §210 and §211), ICH guidelines, and according to guidelines outlined in this
agreement. This agreement may be amended with the written approval of both parties.
Both Contract Lab and Client Company are obligated to maintain, in confidence, the
information received during the term of this agreement regarding activities, scope, and
projects as well as products, tools, and production methods, beyond that which is publicly
available. The details of this obligation may be further specified in a separate Non-
Disclosure Agreement agreed to by Client Company and Contract Lab While on Contract
Lab's premises, or interfacing with Contract Lab employees, Client Company
representatives will honor and respect Contract Lab’s confidentiality agreements with their
other clients.
Contract Lab shall comply with all Federal, State, and local ordinances regarding hazardous
waste and environmental effects as a result of their procedures. Contract Lab shall avoid

Page 4 of 17


contributing to additional environmental stress during the handling and testing of the
Product and Drug Substance.

4.0 DEFINITIONS
cGMP: Current Good Manufacturing Practices and General Biologics Products Standards
as promulgated under each of the following, as in effect on the date of this agreement, and
as amended or revised after the date of this agreement, including:
• the U.S. Food, Drug & Cosmetics Act as published in 21 CFR (Parts 210, 211) and
other FDA regulations, policies or guidelines in effect at a particular time for the
manufacture, testing and quality control of investigational or commercial drugs, and
• any other non-U.S. jurisdiction's laws, regulations, policies, and guidelines applicable
to the testing of pharmaceutical materials, as may be requested by Client Company,
provided that Client Company provides Contract Lab with copies of all such applicable
laws and regulations, and that Contract Lab agrees to comply with the added
requirements. Such agreement shall not be unreasonably withheld by Contract Lab
Drug Substance and/or API: Active Pharmaceutical Ingredient, and for the purpose of this
agreement, shall mean any API being investigated by Client Company.
Manufacture: All steps in the manufacture of Product or Drug Substance, including but not
limited to filling, testing, labeling, packaging, and storage by the designated manufacturer.
Product: For the purposes of this agreement, Product(s) shall mean, singularly or
collectively, innovator drug products, over-encapsulated comparator drugs, and matching
placebos.
SOP: Standard Operating Procedure.
Specifications: A list of tests, references to analytical procedures, and appropriate
acceptance criteria that are numerical limits, ranges or other criteria for the test(s)
described. It establishes the set of criteria to which a material should conform to be
considered acceptable for its intended use. "Conformance to Specification" means that the
material, when tested according to the listed analytical procedures, will meet the listed
acceptance criteria as outlined in the IND/NDA.

RESPONSIBILITY DELEGATION CHECKLIST

Responsibilities Client Contract
Company Lab
5.0 Regulatory Authorization and Communications
5.1 Will maintain all registrations, licenses and authorizations X
as are required by applicable laws to operate cGMP
pharmaceutical testing and stability program management
sites for Product and Drug Substance.
5.2 Will act as liaison with FDA and other regulatory X
authorities for the approval, maintenance and updating of
specifications and C&M data in the IND/NDA.
5.3 Will provide Contract Lab with a copy of those portions of X
the IND/NDA that are applicable to the testing and stability
program management of Product and Drug Substance.
5.4 Will ensure that all specifications provided to Contract Lab X
comply with the IND/NDA.
5.5 Will ensure that all testing is conducted versus the most X
recent version of the specifications given to Contract Lab

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Company Lab
by Client Company.
5.6 Will prepare and submit post-marketing annual reports to X
the FDA or other regulatory authorities in accordance with
applicable laws.
5.7 Will prepare and provide all C&M data relating to the X
testing and stability program management of Product and
Drug Substance as necessary for Client Company to
perform its regulatory responsibilities.
5.8 Will make copies available, upon request, of any X X
documentation necessary for either party to respond to
inquiries by the FDA or other regulatory authorities
relating to Product or Drug Substance.
6.0 Equipment and Testing Facilities
6.1 Will provide all required qualified testing facilities, trained X
staff, and validated/qualified equipment necessary to
perform the testing of Product or Drug Substance in
accordance with the Specifications and instructions and in
compliance with cGMP regulations, ICH guidelines and
other applicable regulatory guidelines.
6.2 Will not perform any activities that may adversely affect X
Product or Drug Substance.
6.3 Will make no changes to the facilities or procedures used X
for the testing or stability program management of Product
or Drug Substance, either directly or indirectly, without the
written notification to Client Company.
6.4 Represents that the staff engaged in the testing and X
stability program management of Product and Drug
Substance has the education, training and experience, or
any combination thereof, to enable those persons to
perform their assigned functions. [Note: Training extends
to the particular operations that the employee performs
and to cGMPs as they relate to the employee’s functions].
6.5 Maintains all training records in such a way that they are X
readily available for the personnel working on Product and
Drug Substance.
6.6 Ensures that all training relative to a specific task will be X
completed prior to the initiation of the task, and that
training will be conducted with sufficient frequency to
assure familiarity with cGMP requirements applicable to
the position and function.
6.7 Certifies that it will not use the services of any person or X
organization debarred or suspended under 21 U.S.C.
§335(a) or (b), nor will it use the services of any person
who has been convicted of a felony under the laws of the
United States relating to the regulation of any drug
product under the Food, Drug and Cosmetic Act.
6.8 Shall have adequate written procedures for the prevention X
of Product or Drug Substance contamination and cross-
contamination.
6.9 The testing process and control procedures shall be X

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Company Lab
validated and qualified by Contract Lab in the facility they
intend to use for the testing of Product and Drug
Substance.
7.0 Documentation
7.1 Controlled Documents
7.1.1 All documents used to control Product or Drug Substance X
from the point of receiving Product or Drug Substance test
samples to releasing Product or Drug Substance test
data, are considered controlled documents. The following
list of documents to be controlled by Contract Lab
includes, but is not limited to:
• Product and Drug Substance Specifications
provided by Client Company
• SOPs related to the testing of Product and Drug
Substance, and stability program management
• Analytical Test Methods used for release and
stability testing of Product and Drug Substance
• Method Transfer Protocols and Reports
• Method Validation Protocols and Reports
• Stability Protocols
• Certificate(s) of Analysis
• Certificate(s) of Compliance
• OOS/OOT Investigations
• Laboratory Notebooks

7.1.2 The documents outlined in Section 7.1.1 above are X
controlled documents and shall be filed in such a manner
as to be traceable. Current SOPs and test methods shall
be readily accessible to QC chemists.
7.1.3 Shall have adequate SOPs for all cGMP operations X
performed.
7.2 Preparation, Review and Approval of Controlled Documents
7.2.1 Client Company Quality Assurance will review and X
approve all controlled documents related to Product and
Drug Substance that are created by Contract Lab
7.2.2 Shall sign and submit the controlled documents approved X
by Client Company to Contract Lab Inc.’s Document
Control for issuance and security.
7.2.3 Testing records for Product and Drug Substance will be X
reviewed and approved by Contract Lab Inc.’s Quality
Assurance to determine completeness and compliance
with all established, approved written procedures and
specifications. Client Company representatives may
review unapproved documents, if deemed appropriate.
7.3 Management of Controlled Documents

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Company Lab
7.3.1 Ensures that changes are not made to controlled X
documents in a manner inconsistent with the provisions in
Section 12.0 of this document entitled “Change Control”.
7.3.2 Ensures that only valid/current versions of the controlled X
documents are available for use.
7.3.3 Ensures that only valid/current versions of the controlled X
documents are used.
7.3.4 Ensures that outdated / non-valid versions of documents X
are archived according to documented procedures to
prevent unintended use.
8.0 Materials Receipt and Storage
8.1 Shall ensure that a sufficient volume from each lot of X
Product and Drug Substance is delivered to Contract Lab
for testing. Additional samples may be taken and shipped,
upon request from Contract Lab
8.2 Shall ensure that samples received contain labels with X
accurate sample identification.
8.3 Shall store sufficient numbers of Product and Drug X
Substance samples as necessary to perform the analytical
and stability testing according to approved protocols.
These samples shall be stored in a temperature/humidity
controlled storage area.
8.4 Product and Drug Substance stability samples shall be X
stored in appropriate stability chambers according to
associated stability protocols.
9.0 Reference Standard Management
9.1 Will be responsible for retaining and managing all X
necessary USP reference standards used for the testing
of Product and Drug Substance.
9.2 Will be responsible for supplying enough Product and X
Drug Substance to Contract Lab to be used as reference
standard material.
9.3 Will be responsible for establishing the purity values of X
Product-related reference standards.
9.4 Will be responsible for following approved procedures for X
managing the retest date requirements for all USP and
Product-related reference standards.
9.5 Will ensure that the most current reference standard X
material is available for the QC chemists to use during
analytical testing.
9.6 Will ensure that the most current purity value is available X
as a controlled document for the QC chemists to use
during analytical calculations.
10.0 Analytical Methods and Testing
10.1 Shall develop analytical methods for the testing of Product X
and Drug Substance.
10.2 Shall write method validation protocols. X

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Company Lab
10.3 Shall review and approve the method validation protocols. X X
10.4 Shall execute all validation-related activities for Product X
and Drug Substance.
10.5 Shall notify Client Company via email or telephone within X
2 business days of identification of failures encountered
during validation-related activities. These failures must be
investigated and properly documented.
10.6 Shall create all validation summary reports related to X
validation-related activities for Product and Drug
Substance.
10.7 Shall approve all validation summary reports for Product X X
and Drug Substance.
10.8 Will retain a copy of the approved protocol and final report X
for all validation-related activities for Product and Drug
Substance.
10.9 Shall write stability and release testing protocols. X
10.10 Shall perform stability studies and release testing, X
according to the protocols provided by Client Company, in
order to support all regulatory submissions.
10.11 Shall provide stability summary reports to Client Company X
of data for all stability testing conducted on Product and
Drug Substance.
11.0 Deviations, Discrepancies, OOS, and Investigations
11.1 Planned Deviations
11.1.1 Shall follow Contract Lab Inc.’s change control procedure X
to address all planned deviations as a revision of the
approved test methods.
11.1.2 Shall sign and approve the change control documentation X X
addressing planned deviations, prior to implementation.
Consent by a facsimile message is also adequate.
11.2 Unplanned Deviations, Discrepancies, and OOS Results
11.2.1 Contract Lab will communicate to Client Company Quality X
Assurance via telephone or by email (as a second choice)
any unplanned deviation within two (2) working days of
discovery.
11.2.2 Shall place the lot(s) in question on HOLD pending the X
resolution/final approval of all deviations.
11.2.3 Shall follow the applicable SOP for investigating X
unplanned deviations in order to determine the root cause,
impact, and data disposition.
11.2.4 Shall forward a copy of the proposed retest plan, if X
applicable, to Client Company Quality Assurance for
review and approval prior to implementation.
11.2.5 Shall communicate if in agreement with the proposed X
retest plan within two (2) working days of receipt from
Contract Lab If in agreement, the retest plan will be
approved by Client Company.

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Company Lab
11.2.6 Investigations shall be approved within thirty (30) calendar X
days of the date of discovery.
11.2.7 If an extension is required for the investigation, a written X
request for extension shall be submitted to Client
Company for approval prior to the due date.
11.2.8 Shall approve (or deny) due date extension requests X
within one (1) working day of receipt.
11.2.9 Shall submit a written interim report to Client Company X
within three (3) working days of the end of the 30 day
timeframe.
11.2.10 Shall ensure that all corrective actions are closed within X
the assigned due date.
11.2.11 If an extension is required for corrective actions, a written X
request for extension shall be submitted to Client
Company for approval prior to the due date.
11.2.12 Shall approve (or deny) due date extension requests X
within one (1) working day of receipt.
11.2.13 Shall approve all investigations. X
11.2.14 Contract Lab will furnish Client Company a copy of all X
approved investigation reports.
12.0 Change Control
12.1 Shall have established procedures for managing control of X
changes to facility, equipment, critical computer systems,
Product and Drug Substance specifications, and test
methods.
12.2 May propose change requests related to Product and X X
Drug Substance for review, which shall be managed
through the Contract Lab Inc.’s change control process.
12.3 Changes proposed by Client Company will be forwarded X
to the Regulatory/Quality Assurance unit at Contract Lab
12.4 Changes proposed by Contract Lab will be forwarded to X
Client Company’s Regulatory/Quality Assurance unit for
approval.
12.5 Shall obtain all necessary and appropriate regulatory and X
quality approvals, as required, prior to authorizing any
changes.
12.6 Upon approval from Client Company, Contract Lab will X
initiate the changes, as defined by internal Contract Lab
SOPs.
12.7 Ensures that only valid/current versions of the documents X
are available for use.
12.8 Ensures that only valid/current versions of the documents X
are used.
12.9 Ensures that outdated/non-valid versions of documents X
are archived according to documented procedures, to
prevent unintended use.

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Company Lab
12.10 Shall ensure that all change control documentation will be X
available to Client Company, upon request, for audit.
13.0 Data Acceptance and Disposition
13.1 Shall complete a review of all testing and control X
documents within thirty (30) calendar days of the testing of
Product(s) and Drug Substance. Both parties
acknowledge that not all of the corrective actions and/or
investigations may be completed within this timeframe, in
which case Contract Lab will provide a written notification,
with acceptable justification, for the time extension as
specified in Section 11.2 of this Quality Agreement.
13.2 Shall certify for each batch of Product and Drug X
Substance, that it was tested in accordance with cGMPs,
internal procedures, ICH guidelines, and this Quality
Agreement, by providing a Certificate of Analysis for
release testing, and SLIM reports for stability testing, to
Client Company.
13.3 Shall provide copies of the completed test records to X
Client Company for each lot, which may include, but are
not limited to, the following documents:
• Completed testing records, including data analysis
reports
• Deviation, Discrepancy, and Out-of-Specification
(OOS) investigations, including corrective and
preventive actions taken
• Certificate of Analysis, lab work request form, analysis
report or SLIM report
13.4 Is responsible for final quality control release of Product to X
the market.
14.0 Sample and Record Retention
14.1 Any portion of stability samples remaining after testing X
shall be stored by Contract Lab in a temperature/humidity
controlled storage area for sixty (60) days, unless
otherwise requested by Client Company.
14.2 All documentation related to Product(s) and Drug X
Substance, including reference standards, shall be kept in
a manner to protect and secure the documentation
against damage, destruction, unintended changes or
disposal during the required time of storage.
14.3 The documentation shall be kept for a minimum of five (5) X
years and subsequently must be made available for
transfer to Client Company Quality Assurance at the end
of the 5-year storage period.
14.4 For the archiving of data, media, diskettes, etc., the X
original media and back-up copies shall be kept in a
separate location protected against damage, destruction,
and/or disposal during the required time of storage.
14.5 Data media shall be readable for the entire period that the X
documentation is retained, and must be compliant with 21
CFR §11, as applicable.

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Company Lab
15.0 Complaints and Recalls
15.1 In cases where Contract Lab is notified of any complaint, X
Contract Lab will forward the complaint information to
Client Company immediately (within one (1) working day)
of such an event and will assist Client Company in taking
prompt corrective actions.
15.2 Upon request by Client Company, shall investigate the X
complaints, as required, and provide a written report on
the results of the investigation to Client Company in not
more than thirty (30) working days, or sooner, if agreed to,
by both parties.
15.3 Shall communicate with the customers and/or regulatory X
authorities the results of the complaint investigations, if
necessary.
15.4 Shall provide complaint files to Client Company onsite, or X
via facsimile within one (1) working day, if they are
required during a FDA or other regulatory body inspection.
15.5 Recalls will be performed by Client Company according to X
Client Company’s standard operating procedures.
Contract Lab agrees to support these proceedings, if
necessary.
16.0 Inspections and Audits
16.1 Visits
16.1.1 Shall permit Client Company to have manufacturing X
and/or quality representatives present during Client
Company's Product(s) and Drug Substance testing.
16.1.2 Client Company will provide at least three (3) working X
days’ prior notification of their intention to witness
scheduled testing.
16.1.3 Client Company representatives will be permitted to be X
present in the testing area.
16.1.4 Client Company representatives in the plant will adhere to X
Contract Lab’s quality and safety procedures and, for the
purpose of regulatory compliance, will train on any of
Contract Lab’s SOPs, policies or procedures, as deemed
necessary by Contract Lab
16.1.5 Contract Lab shall also provide a key contact person, at X
their facility, to communicate the Product(s) and Drug
Substance quality-related issues during the testing.
16.2 Site Audits
16.2.1 Contract Lab agrees that Client Company, as well as any X
other independent authority which Client Company and
Contract Lab approve as a contract auditor, shall be
entitled to audit the quality systems of Contract Lab,
during mutually agreeable and reasonable times.
16.2.2 Contract Lab will provide a written response to the audit, X
itemized by each observation, within thirty (30) calendar
days after receipt of the written audit report.

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Company Lab
16.2.3 A time schedule for follow-up and corrective actions will X X
be mutually agreed upon between the parties.
16.2.4 Audits by Client Company’s partner may be conducted, X
but only if scheduled through, and accompanied by, Client
Company QA.
16.2.5 Notwithstanding the foregoing, Client Company, either X X
directly, or in conjunction with its partner, may perform a
for-cause audit (in addition to the annual audit, described
previously) in cases where Contract Lab has quality
systems issues or failures, resulting from or related to,
FDA or other regulatory agency inspections, batch
failure(s) related directly to handling, storage or testing of
Product and Drug Substance by Contract Lab, or other
quality issues which reflect the need for an audit in order
to determine the continued compliance of Contract Lab
with cGMPs, ICH guidelines and/or the requirements of
this agreement.
16.3 Site Inspections
16.3.1 Contract Lab shall inform Client Company about any X
communication received from regulatory agencies
regarding Pre-Approval Inspections (PAIs) directly related
to Client Company’s Product(s) within two (2) working
days.
16.3.2 Representatives from Client Company may be present X
during those portions of the PAI directly related to Client
Company’s Product(s). The Client Company partner may
be present as an observer, but is limited to two (2)
representatives, and may not participate in the actual PAl.
16.3.3 Will cooperate in the development and review of X X
responses required by the FDA or other regulatory
authorities relating to Product and Drug Substance prior to
submission. Nothing contained within this Quality
Agreement shall restrict the right of either party to make a
timely report of such matter to the FDA, or other
regulatory authorities, or take other action that it deems to
be appropriate or required by applicable law, rule or
regulation.
17.0 Annual Product Review (commercial)
17.1 Shall be responsible for submitting Annual Product X
Reviews to the FDA for Product.
17.2 Shall notify Contract Lab at least sixty (60) calendar days X
prior to the close of the Annual Product Review reporting
period, to ensure that Contract Lab is aware of the data
submission deadline for Product.
17.3 Shall, upon request, provide Client Company with any X
requested Product-related documentation updates for the
purpose of annual regulatory report submission.
17.4 Any data prepared in support of an Annual Product X
Review will be prepared and reviewed according to
Contract Lab Inc.'s policies and procedures for
commercial Product.

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Company Lab
17.5 The Annual Product Review documentation completed by X
Contract Lab will be provided to Client Company within
thirty (30) days of the close of the Annual Product Review
reporting period, as mutually agreed to by both parties.
18.0 Subcontracting
18.1 Contract Lab may not delegate or subcontract to a third X
party(ies) any part of the services to be performed by it
under this agreement unless Client Company, or a Client
Company affiliate, has expressly agreed, in writing, to
such delegation or subcontracting.
18.2 No delegation or subcontracting on the part of Contract X
Lab shall act to relieve Contract Lab from its obligations,
duties or liability to Client Company, or a Client Company
affiliate, hereunder.
18.3 Shall be liable to Client Company for the performance of X
any delegate or subcontractor of its duties and obligations.
18.4 In the event that Contract Lab subcontracts or delegates X
to a third party any obligations or responsibilities for the
performance of services under this agreement, Contract
Lab shall enter into a written contract with such third party.
Such contract shall require the third party to comply with
the terms and conditions of this agreement in the same
manner as Contract Lab
18.5 Shall be responsible for any audits necessary to monitor X
and assure such compliance related to Section18.4.

19.0 REVISION HISTORY

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20.0 COMMUNICATION CONTACTS

Functional Area Contract Lab Contact Client Company Contact
Main Switchboard
Facsimile (FAX)

Mailing Address

Quality
Assurance/
Qualified Person

Regulatory Affairs

Project
Management

Pharmaceutical
Development

Quality Control

Page 15 of 17


Attachment A
Events Requiring Client Company Notification

1. Deviations, Discrepancies, OOS, OOT, and Investigations

2. Stability failure or trend that could result in a failure

3. Contract Lab is contacted by a regulatory agent wanting to conduct an inspection

4. Contract Lab is contacted by a consumer, physician, pharmacist or regulatory agency of a
Product complaint

5. Planned or unplanned changes to the facility that may impact Product performance (such
as stability chambers, storage conditions, laboratory)

6. Planned or unplanned changes to the testing methods for Product and Drug Substance

7. Changes to controlled documents related to Product and Drug Substance

8. Inability to meet established timelines for completion of investigations and Corrective
Action/Preventative Actions.

Page 16 of 17


Attachment B
Documents Requiring Client Company Signature

1. All Change Control requests related to Product and Drug Substance

2. All Method Validation protocols and final reports related to Product and Drug Substance

3. Memos requesting due date extensions for investigations or Corrective
Action/Preventative Actions related to Product and Drug Substance

4. Product and Drug Substance Specifications

5. SOPs related to the testing of Product and Drug Substance, and stability program
management for Product and Drug Substance

6. Analytical test methods used for release and stability testing of Product and Drug
Substance

7. Method transfer protocols and reports

8. Stability protocols

Page 17 of 17

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