The document is a quality agreement template between a contract laboratory and client company. It outlines responsibilities for regulatory communications, equipment and facilities, documentation, materials receipt and storage, reference standard management, analytical methods and testing, and other quality-related activities. The goal is for both parties to work together to ensure testing and stability management are conducted according to cGMP and meet all applicable regulations and specifications. Responsibilities for each activity are assigned to either the contract laboratory or client company.
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
The presentation herein, on Basics of Specification Drafting, was delivered by Mr. Somashekar Ramakrishna at the National Law School of India University, Bangalore, for Senior Officials of the Ministry of MSME, Government of India. Starting with specification contents, the presentation covers drafting guidelines, claim drafting basics and examples. For more information about the presentation or the event, you may contact the Sinapse team at sinapse@bananaip.com.
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Our Product catalogue2 - Standard & Partners LtdEmesure Mark
Looking for an international company that has the financial capacity & integrity to do business with in the area of agric commodity, fmcg, food products?
Standard and Partners Ltd is your best partner for international trade.
We source and deliver products from around the globe.
From factory to supermarket shelf or refrigerator, we can
provide the supply, marketing and packaging solution for our clients
Please go through our product catalogue presentation. And visit our website.. www.standardandpartnersltd.com
Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
CONTRACT MANUFACTURING is defined as the manufacture (or partial manufacture) of a product to the order of one person or organization (the contract giver or customer) by another independent person or organization (the contract acceptor or principal manufacturer).
What Is An Assistant Drug Controller (Adc) Noc In India And Why Is It Importa...PranshuCorpseed
The pharmaceutical industry plays a pivotal role in public health by manufacturing and distributing drugs and medical products. To ensure the safety, quality, and efficacy of pharmaceuticals, governments around the world have established stringent regulatory frameworks. In India, the Assistant Drug Controller (ADC) assumes a crucial role in this regulatory process. This article delves into the significance of an Assistant Drug Controller (ADC) No Objection Certificate (NOC) in India and its pivotal role in the pharmaceutical sector.
Cavitation Technologies, Inc develops, manufactures, and
commercializes disruptive patented nano technology fluid
dynamics systems geared at reducing the environmental
impact of industry. The Company aims to embody a global
role as an ESG technology leader.
Procurement Management Template
Procurement Management Plan
(Project Name)
(Company Name)
(Street Address)
(City, State Zip Code)
(Date)
Here's YourProcurement Management Plan Template
This Procurement Management Plan template has been written to include instruction for creating the final document along with actual verbiage for each section. You are free to edit and use this template and its contents; however, we do ask that you don't distribute this template as a template on the web without explicit permission from us.
Revision History
Name
Date
Reason For Changes
Version
Table of Contents
2
1.0 Purpose
2
2.0 Procurement Roles and Responsibilities
3
3.0 Procurement Requirements
3
4.0 Vendor Identification and Selection
4
5.0 Vendor Management
4
6.0 Contract Requirements
4
7.0 Approvals1.0 Purpose
Many projects require items or services that cannot be provided from within the organization. In these cases it is necessary for the project team to procure the necessary items or services required to successfully complete the project. This section should provide a high-level explanation of purpose of the Procurement Management Plan. Generally, the purpose of the Procurement Management Plan is to define what items will be procured for the project and how vendors will be identified, selected, and managed. Additionally, the plan should outline roles and responsibilities relating to procurement as well as any contract requirements which must be met.
The purpose of the Procurement Management Plan is to define procurement parameters for the Software Upgrade Project in order to ensure its successful completion. Procurement is a deliberate process which involves many internal departments as well as external vendors. This Procurement Management Plan has been created to provide a framework in which all procurement actions will be managed across all of the organizations involved.
2.0 Procurement Roles and Responsibilities
This section describes the roles and responsibilities of all key project personnel as they relate to procurement actions. These roles must be clear to prevent any gaps or overlap in project procurement actions. Additionally, roles and responsibilities help establish accountability throughout the project’s lifecycle.
To facilitate effective procurement management, the following roles and responsibilities have been established for all procurement actions for the Software Upgrade Program:
Role
Responsibilities
Project Sponsor
Approve Procurement Management Plan
Approve vendor selection
Approve all contracts prior to award
Approve any procurement action in excess of $50,000
Project manager
Provide oversight for all procurement actions
Approve procurement actions under $50,000
Develop procurement requirements
Manage vendor selection process
Measure vendor performance
Closing out vendor contracts
Contracting Department Director
Assist procurement actions by submitting requests for proposal (RFPs) to i.
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement.
The three-day course, "Introduction to CMMI", introduces participants to the fundamental concepts of the CMMI model. The course assists companies in integrating best practices from proven discipline-specific process improvement models, including systems engineering, software engineering, integrated product and process development and supplier sourcing.
The course is composed of lectures and class exercises with ample opportunity for participant questions and discussions. After attending the course, participants will be able to describe the components of CMMI, discuss the process areas in CMMI, and locate relevant information in the model.
The workshop will help the participants to:
Understand the CMMI framework
Understand the detailed requirements of the process areas in the CMMI V1.3
Make valid judgments regarding the organization's implementation of process areas
Identify issues that should be addressed in performing process improvements using the CMMI V1.3
This lecture include introduction to software contracts. Before starting development companies prepare agreement document to deal with conflicts afterwards.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
Similar to Analytical Quality Agreement Template (20)
1. 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
2. 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
3. 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
Page 3 of 17
4. Contract Lab - CLIENT COMPANY Quality Agreement
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
5. Contract Lab - CLIENT COMPANY Quality Agreement
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
Page 5 of 17
6. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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
Page 6 of 17
7. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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
Page 7 of 17
8. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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
Page 8 of 17
9. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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.
Page 9 of 17
10. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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.
Page 10 of 17
11. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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.
Page 11 of 17
12. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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.
Page 12 of 17
13. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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.
Page 13 of 17
14. Contract Lab - CLIENT COMPANY Quality Agreement
Responsibilities Client Contract
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
Page 14 of 17
15. Contract Lab - CLIENT COMPANY Quality Agreement
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
16. Contract Lab - CLIENT COMPANY Quality Agreement
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
17. Contract Lab - CLIENT COMPANY Quality Agreement
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