Description
Unformatted Attachment Preview
CHEM53202 Prototype Development Assignment Part II
For part II of the prototype development, you will apply your knowledge of Chemistry, Manufacturing and Controls
principles to devise a strategy for obtaining approval to market this new drug in Canada by preparing selected sections
for submission to Health Canada.
The drug is Orserdu(Elacestrant)
Review information on the requirements and processes to submit a “New Drug Submission (NDS)” application as
described in the links below for the product type you selected which can be either a synthetic chemical drug substance
or a biologic drug substance: Synthetic Chemical Drug Substances:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugsreviewedcanada.html
Refer to the relevant attached Health Canada guidance documents to prepare a document where you summarize
selected information required for the new drug submission to Health Canada. Please refer to the table below for specific
sections you will need to review to prepare your document. The Health Canada guidance documents also provide
references to ICH M4Q guidelines which is in Guidance Document Quality Chemistry Manufacturing NDS ANDS pdf file
and you may also refer to the referenced ICH sections for additional information.
Synthetic Drug Substance
Section Name
Sections
S.1 General Information
S.1.1, S.1.2, S.1.3
S.3 Characterization
S.3.1, S.3.2
S.4 Control of Drug
S.4.2 Analytical
Substance
Procedures
If you are unable to find the exact information for your drug substance for a particular section for your submission, you
may provide your proposal and describe any assumptions you made in the absence of publicly available data or
information.
Please summarize the information for the sections listed in the table in a single document that is a maximum of 1000
words (no page limit to allow the inclusion of figures, graphs or tables as needed).
***Please ensure you review the rubric for guidance on how this assignment will be evaluated***
GUIDANCE DOCUMENT
Quality (Chemistry and Manufacturing) Guidance: New
Drug Submissions (NDSs) and Abbreviated New Drug
Submissions (ANDSs)
Published by authority of the
Minister of Health
Date Adopted
2017/10/30
Effective Date
2018/01/30
Health Products and Food Branch
Our mission is to help the people of Canada
maintain and improve their health.
Health Canada
The Health Products and Food Branch’s mandate is to take
an integrated approach to the management of the risks and
benefits to health related products and food by:
minimizing health risk factors to Canadians while
maximizing the safety provided by the regulatory
system for health products and food; and,
promoting conditions that enable Canadians to make
healthy choices and providing information so that they
can make informed decisions about their health.
Health Products and Food Branch
© Minister of Public Works and Government Services Canada 2017
Également disponible en français sous le titre : Ligne directrice : Qualité (chimie et
fabrication) : Présentations de drogue nouvelle (PDN) et présentations abrégées de drogue
nouvelle (PADN)
Health Canada
Guidance Document
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
FOREWORD
Guidance documents are meant to provide assistance to industry and health care professionals on
how to comply with governing statutes and regulations. Guidance documents also provide
assistance to staff on how Health Canada mandates and objectives should be implemented in a
manner that is fair, consistent and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow
for flexibility in approach. Alternate approaches to the principles and practices described in this
document may be acceptable provided they are supported by adequate justification. Alternate
approaches should be discussed in advance with the relevant program area to avoid the possible
finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right
to request information or material, or define conditions not specifically described in this
guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of
a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable
and that decisions are clearly documented.
This document should be read in conjunction with the accompanying notice and the relevant
sections of other applicable guidance documents.
Date adopted: 2017/10/30; Effective date: 2018/01/30
i
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Health Canada
Guidance Document
Document Change Log
Version Quality (Chemistry and
Replaces Quality (Chemistry and Manufacturing)
Manufacturing) Guidance
Guidance Document: NDSs and ANDSs
(draft, 2001, 2013 and 2016)
Document: NDSs and ANDSs
(2017)
Date
October 30, 2017
Change
Nature of and/or
Reason for Change
Change
Nature of and/or
Reason for Change
ii
Date
August 31, 2016
October 30, 2017
Guidance finalized
Changes in the content of this revision include
updates to:
1. Specify scope is drugs for Human use
2. Update the information on reworking
3. Update the information on the Regulatory
Operations and Regions Branch.
4. Move the information to the appropriate CTD
section.
5. Remove the prohibition of bovine vertebrae as
a source of gelatin.
6. Harmonization of guidance with CPID
guidance document
7. Make changes requested during the 2016
consultation. The consultation document is
available on request.
August 31, 2016
Some revisions throughout the document
Changes in the content of this draft revision
include updates to:
1. Add an addendum for Questions and Answers.
2. Update the guidance document as a result of
the 2014 consultation.
3. Include current guidance on existing
assessment practices.
4. Harmonize with the guidance document:
Biopharmaceutics Classification System Based
Biowaiver (2014)
Date adopted: 2017/10/30; Effective date: 2018/01/30
Health Canada
Guidance Document
Change
Nature of and/or
Reason for Change
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
September 19, 2013
Significantly updated in format and content
Changes in the content of the 2014 draft revision
included:
1. An update of the guidance document to
reference current ICH guidelines.
2. Current interpretation of the Food and Drug
Regulations as it pertains to New Drugs.
3. Clarification and expansion of the type of
information which should be provided in
Module 3 of the Common Technical
Document (CTD).
Date adopted: 2017/10/30; Effective date: 2018/01/30
iii
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Health Canada
Guidance Document
Table of Contents
G GENERAL………………………………………………………………………………………………………………… 1
G.1 PURPOSE ………………………………………………………………………………………………………………. 1
G.2 SCOPE …………………………………………………………………………………………………………………… 1
G.3 PREAMBLE …………………………………………………………………………………………………………… 2
Background ………………………………………………………………………………………………………………. 2
International Council for Harmonisations (ICH’s) Quality Overall Summary (QOS) and
Health Canada’s Quality Overall Summary – Chemical Entities (QOS-CE) Template ………… 3
MODULE 2.3: QUALITY OVERALL SUMMARY (QOS) ……………………………………………. 4
NOTES ON THE PREPARATION OF THE QUALITY OVERALL SUMMARY AND
THE QUALITY MODULE …………………………………………………………………………………………… 4
Health Canada’s Certified Product Information Document – Chemical Entities (CPID-CE) … 6
INTRODUCTION…………………………………………………………………………………………………………. 7
MODULE 3: INFORMATION TO BE PROVIDED IN MODULE 3 AND SUMMARIZED
IN THE QUALITY OVERALL SUMMARY (QOS) ………………………………………………………. 7
S DRUG SUBSTANCE………………………………………………………………………………………………….. 7
Master Files (MFs) …………………………………………………………………………………………………….. 8
Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) ………. 9
S.1 GENERAL INFORMATION …………………………………………………………………………………… 9
S.1.1 Nomenclature ……………………………………………………………………………………………………. 9
S.1.2 Structure …………………………………………………………………………………………………………. 10
S.1.3 General Properties ……………………………………………………………………………………………. 10
S.2 MANUFACTURE………………………………………………………………………………………………….. 11
S.2.1 Manufacturer(s)……………………………………………………………………………………………….. 11
S.2.2 Description of Manufacturing Process and Process Controls …………………………………. 12
S.2.3 Control of Materials …………………………………………………………………………………………. 16
S.2.4 Controls of Critical Steps and Intermediates ……………………………………………………….. 17
S.2.5 Process Validation and/or Evaluation …………………………………………………………………. 17
S.2.6 Manufacturing Process Development …………………………………………………………………. 18
S.3 CHARACTERISATION………………………………………………………………………………………… 19
iv
Date adopted: 2017/10/30; Effective date: 2018/01/30
Health Canada
Guidance Document
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
S.3.1 Elucidation of Structure and other Characteristics ……………………………………………….. 19
S.3.2 Impurities ……………………………………………………………………………………………………….. 21
S.4 CONTROL OF THE DRUG SUBSTANCE ……………………………………………………………. 26
S.4.1 Specification …………………………………………………………………………………………………… 26
S.4.2 Analytical Procedures ………………………………………………………………………………………. 28
S.4.3 Validation of Analytical Procedures …………………………………………………………………… 29
S.4.4 Batch Analyses………………………………………………………………………………………………… 31
S.4.5 Justification of Specification……………………………………………………………………………… 32
S.5 REFERENCE STANDARDS OR MATERIALS …………………………………………………….. 33
S.6 CONTAINER CLOSURE SYSTEM ………………………………………………………………………. 34
S.7 STABILITY…………………………………………………………………………………………………………… 34
S.7.1 Stability Summary and Conclusions …………………………………………………………………… 35
S.7.2 Post-approval Stability Protocol and Stability Commitment ………………………………….. 38
S.7.3 Stability Data ………………………………………………………………………………………………….. 39
P DRUG PRODUCT……………………………………………………………………………………………………. 39
P.1 DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT ……………………… 39
P.2 PHARMACEUTICAL DEVELOPMENT………………………………………………………………. 41
P.2.1 Components of the Drug Product ………………………………………………………………………. 42
P.2.2 Drug Product …………………………………………………………………………………………………… 45
P.2.3 Manufacturing Process Development …………………………………………………………………. 47
P 2.4 Container Closure System…………………………………………………………………………………. 51
P.2.5 Microbiological Attributes ………………………………………………………………………………… 53
P.2.6 Compatibility ………………………………………………………………………………………………….. 54
P.3 MANUFACTURE …………………………………………………………………………………………………. 54
P.3.1 Manufacturer(s)……………………………………………………………………………………………….. 55
P.3.2 Batch Formula …………………………………………………………………………………………………. 55
P.3.3 Description of Manufacturing Process and Process Controls …………………………………. 56
P.3.4 Controls of Critical Steps and Intermediates ……………………………………………………….. 58
P.3.5 Process Validation and/or Evaluation …………………………………………………………………. 61
P.4 CONTROL OF EXCIPIENTS ……………………………………………………………………………….. 63
P.4.1 Specifications ………………………………………………………………………………………………….. 63
P.4.2 Analytical Procedures ………………………………………………………………………………………. 64
P.4.3 Validation of Analytical Procedures …………………………………………………………………… 64
P.4.4 Justification of Specifications ……………………………………………………………………………. 64
Date adopted: 2017/10/30; Effective date: 2018/01/30
v
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Health Canada
Guidance Document
P.4.5 Excipients of Human or Animal Origin ………………………………………………………………. 65
P.4.6 Novel Excipients ……………………………………………………………………………………………… 65
P.5 CONTROL OF DRUG PRODUCT ………………………………………………………………………… 66
P.5.1 Specification(s) ……………………………………………………………………………………………….. 66
P.5.2 Analytical Procedures ………………………………………………………………………………………. 68
P.5.3 Validation of Analytical Procedures …………………………………………………………………… 69
P.5.4 Batch Analyses………………………………………………………………………………………………… 70
P.5.5 Characterisation of Impurities……………………………………………………………………………. 71
P.5.6 Justification of Specification(s) …………………………………………………………………………. 72
P.6 REFERENCE STANDARDS OR MATERIALS …………………………………………………….. 74
P.7 CONTAINER CLOSURE SYSTEM ………………………………………………………………………. 74
P.8 STABILITY ………………………………………………………………………………………………………….. 76
P.8.1 Stability Summary and Conclusions …………………………………………………………………… 76
P.8.2 Post-approval Stability Protocol and Stability Commitment ………………………………….. 80
P.8.3 Stability Data ………………………………………………………………………………………………….. 80
A APPENDICES …………………………………………………………………………………………………………. 81
A.1 FACILITIES AND EQUIPMENT …………………………………………………………………………. 81
A.2 ADVENTITIOUS AGENTS SAFETY EVALUATION ………………………………………….. 81
A.3 EXCIPIENTS ……………………………………………………………………………………………………….. 82
R REGIONAL INFORMATION …………………………………………………………………………………. 82
R.1 PRODUCTION DOCUMENTATION …………………………………………………………………… 82
R.1.1 Executed Production Documents ………………………………………………………………………. 82
R.1.2 Master Production Documents (MPDs) ……………………………………………………………… 83
R. 2 MEDICAL DEVICES…………………………………………………………………………………………… 84
R. 3 ACCEPTABLE COMPENDIAL MONOGRAPHS ……………………………………………….. 84
vi
Date adopted: 2017/10/30; Effective date: 2018/01/30
Health Canada
Guidance Document
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
G GENERAL
G.1 Purpose
As required by Section C.08.002 of the Food and Drug Regulations, a New Drug Submission
(NDS) or an Abbreviated New Drug Submission (ANDS) must contain sufficient information
and material to allow an assessment of the safety and effectiveness of the new drug. This
document is intended to provide guidance with regard to the Quality [that is (i.e.), Chemistry and
Manufacturing] portion of NDSs and ANDSs for drug substances of synthetic or semi-synthetic
origin and their corresponding drug products that are filed with Health Canada pursuant to
Division C.08 of the Food and Drug Regulations. The purpose of the guidance document is to
outline the Quality technical requirements and to assist submission sponsors in preparing the
NDS or ANDS to ensure an effective and efficient assessment process. It can also be used as
guidance on the requirements for related drug submissions [for example (e.g.), Supplemental
New Drug Submissions (SNDSs), Supplemental Abbreviated New Drug Submissions (SANDSs),
Post-Notice of Compliance (NOC) Changes].
G.2 Scope
This guidance document applies to NDSs and ANDSs for drug substances of synthetic or
semi-synthetic origin and their corresponding drug products for human drug use, excluding
Biotechnological/Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs, that are
filed with Health Canada pursuant to Division C.08 of the Food and Drug Regulations. It can
also be used as guidance on the requirements for related drug submissions (e.g. S(A)NDSs1,
Post-NOC Changes).
Alternate approaches to the principles and practices described in this document can be acceptable
provided they are supported by adequate scientific justification. Sponsors are advised to discuss,
in advance, alternate approaches in their drug submission to avoid rejection or withdrawal of the
drug submission.
This guidance document applies to new active pharmaceutical ingredients (APIs), existing APIs
and their corresponding drug products. An existing drug substance or product is one that is not or
does not contain a new medicinal ingredient, but requires the filing of a New Drug Submission
(NDS), an Abbreviated New Drug Submission (ANDS) (e.g. an application for a generic
product) or a Supplement. This would include, for example, submissions for new dosage forms,
new strengths, and other changes to authorized products which require the filing of an S(A)NDS.
When an S(A)NDS is submitted for a post-NOC change, data should be provided in accordance
with the sections of the guidance which apply to the proposed change.
1
The abbreviation S(A)NDS refers to either an SNDS or an SANDS.
Date adopted: 2017/10/30; Effective date: 2018/01/30
1
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Health Canada
Guidance Document
The Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and
Abbreviated New Drug Submissions (ANDSs) should be consulted to determine the extent of data
generation which is necessary to support NDSs, ANDSs or S(A)NDSs. The Post-Notice of
Compliance (NOC) Changes: Quality Document should be consulted for drug products that have
received an NOC and have considerable commercial scale manufacturing experience for the drug
substance or drug product (e.g. validation of scale-up is completed). If significant knowledge of
the drug substance or drug product is not available at the time that a S(A)NDS for a post-NOC
change is submitted, the application should reflect the requirements listed in this Quality (C&M)
Guidance: NDSs and ANDSs guidance document.
The scientific and risk-assessment principles outlined in this document are also applicable to
other types of applications (e.g. for Applications for Drug Identification Number Submissions
(DINAs)).
G.3 Preamble
Background
The Common Technical Document – Quality (CTD-Q) (Module 3) outlines the format of the
Quality portion of applications within the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD).
Also, as part of the CTD guideline, the ICH process has produced recommendations for a
Quality Overall Summary (QOS) (Module 2) which is a summary that follows the scope and the
outline of the Quality Module (Module 3).
This Health Canada guidance document follows the format recommended in ICH’s CTD-Q
guideline. The text following each section title is taken directly from the ICH CTD-Q guideline.
This guidance provides information on data which should be provided in Module 3 of the
CTD-Q. Where relevant, guidance has been provided on how to summarize the information in
the QOS.
Terminology used in this guidance document is defined in one or more of the references listed,
unless the term is specifically defined in the text of this document or in the companion Glossary
of Quality Terms that accompanies this guidance document.
This guidance document supersedes Health Canada’s guideline entitled Chemistry and
Manufacturing: New Drugs (1990) and the draft Quality (Chemistry and Manufacturing)
Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
(2001, 2013 and 2016).
2
Date adopted: 2017/10/30; Effective date: 2018/01/30
Health Canada
Guidance Document
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
International Council for Harmonisations (ICH’s) Quality Overall Summary (QOS)
and Health Canada’s Quality Overall Summary – Chemical Entities (QOS-CE)
Template
Subsection C.08.005.1 (1) (c) of the Food and Drug Regulations stipulates that new drug
submissions (NDSs), abbreviated new drug submissions (ANDSs), supplemental new drug
submissions (SNDSs), and supplemental abbreviated new drug submissions (SANDSs) should
include a comprehensive summary of each human, animal and in vitro study referred to or
included in the submission or supplement. The intent of this requirement is to facilitate the
assessment of the extensive experimental data and hence contribute toward a more effective and
timely processing of drug submissions.
As previously mentioned, ICH has integrated a Quality Overall Summary (QOS) within its CTD
guideline. The QOS is considered a comprehensive summary that follows the scope and the
outline of the Body of Data in Module 3. The QOS should not include information, data, or
justification that was not already included in Module 3 or in other parts of the drug submission.
A template entitled Quality Overall Summary – Chemical Entities (New Drug
Submissions/Abbreviated New Drug Submissions) (QOS-CE (NDS/ANDS) is available on the
Health Canada website to facilitate preparation of a summary of the Quality data submitted to
Health Canada. The QOS-CE (NDS/ANDS) template is consistent with the directives in ICH
guidelines, principles of applying sound science and risk management to the systematic
development of drugs, and current Quality standards and terminologies.
ICH’s QOS and Health Canada’s QOS-CE (NDS/ANDS) are collectively referred to as the Quality
Overall Summary or QOS throughout the remainder of this document. The guidance refers to
what should be submitted, regardless of the template used.
Use of Health Canada’s QOS-CE (NDS/ANDS) template is optional, although its use may
facilitate the preparation of the Quality Overall Summary and may contribute to review
efficiencies. It is recommended that the QOS be limited to the minimum number of pages
required to summarize key information (e.g. 40-100 pages).
Health Canada considers that the QOS is a summary created specifically for each regulatory
submission and the QOS does not need to be managed over the life cycle of a product.
Date adopted: 2017/10/30; Effective date: 2018/01/30
3
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Health Canada
Guidance Document
MODULE 2.3: QUALITY OVERALL SUMMARY (QOS)
Notes on the Preparation of the Quality Overall Summary and the Quality
Module
Sponsors are encouraged to devote sufficient time to prepare an accurate, consistent, and concise
QOS based on the detailed information included in the Quality Module. The filing of an
inaccurate or incomplete QOS will result in greater expenditure of an assessor’s time in
retrieving, assessing and summarizing data.
Essential elements of the minimal approach and the enhanced, Quality by Design (QbD)
approach (as described in ICH’s Q8 guideline) and QbD terminologies should be used to
facilitate an efficient assessment process.
It is recognized that the tables included in the QOS-CE (NDS/ANDS) template may need to be
modified (e.g. with data cells being split or joined, as necessary). In order to best summarize the
data tabular structure should be used whenever possible. All headings listed in the default
sections of the CTD should nonetheless be retained or addressed, regardless of their perceived
relevance, unless the subject matter of the entire section or table is irrelevant to the drug
substance or drug product in question.
If portions of the QOS (e.g. sections, tables) are clearly not relevant for the drug submission due
to the nature of the drug substance or drug product, this should be indicated by the designation
“Not Applicable” (e.g. under the heading of Module 2.3.P.4.5, if no excipient of human or
animal origin is used in the manufacture of the drug product). Portions that are “Not Applicable”
should be accompanied by an explanatory note or justification describing their inapplicability.
To facilitate the assessment, when the information in a section has been included in a prior drug
submission in its entirety (e.g. in a Supplement for a new dosage form filed after the NDS/ANDS
is authorised or while the NDS/ANDS assessment is in progress) and the information has not
changed subsequent to that filing, the relevant section should be cross referenced, and so noted in
section 1.0.7, General Note to the reviewer, the Introduction to the QOS and Quality Module (e.g.
under section (b) Other Introductory Information). The Introduction should include the names of
the cross-referenced drug product and sponsor, date of the Notice of Compliance (if applicable),
and dossier identification and control numbers. If there are changes to any sections that have
been cross-referenced, these should be summarized appropriately. Submission of information
which is cross-referenced should be in accordance with the Management of Drug Submissions
Guidance Document (e.g. Section 5.2, 5.5 and 5.7).
4
Date adopted: 2017/10/30; Effective date: 2018/01/30
Health Canada
Guidance Document
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Following is additional guidance to assist sponsors in preparing the QOS and the Quality
Module:
a) Examples of applicable guidance documents are identified under the various sections.
Those developed by ICH are identified by their code names only (e.g. Q1A, Q2). When a
guidance document or pharmacopeia is referred to, the most recent (current) version
should be consulted.
b) Abbreviations should not be used in the QOS and Quality Module unless initially defined
and consistently used (e.g. N/A = Not applicable), or unless they represent
well-established scientific abbreviations (e.g. HPLC, UV).
c) Copies of original documents (e.g. certificates of analysis) are preferred as transcription
of documents leads to frequent errors and their availability allows for verification of
analytical data.
d) For new drug submissions (e.g. NDSs, ANDSs, Supplements) regarding drug substances
that are no longer considered new drugs according to Part C, Division 8 of the Food and
Drug Regulations, consult Health Canada’s Quality Guidance: Applications for Drug
Identification Number Submissions (DINAs) for Pharmaceuticals for the information that
should be provided on the drug substance. If the drug substance is not covered by a
compendial monograph (e.g. USP or Ph.Eur.) then additional information on the route of
synthesis and impurities (e.g. mutagenic impurities) may be necessary to justify the
specifications. The information that should be provided on the drug product should be as
described in this document Quality Guidance: NDSs and ANDSs.
e) When filing a response to a request for additional information from Health Canada (e.g.
Request for Clarification (Clarifax), Notice of Non-compliance (NON), Notice of
Deficiency (NOD)), sponsors should summarize new or updated data (e.g. specifications,
analytical procedures, stability results) in the response in a question and answer format,
with additional documentation being provided in Module 3 of the CTD. Generally, an
updated QOS should not be submitted as Health Canada uses the first QOS submitted as
the basis of preparing the original Quality Assessment Report (QAR). However, in the
case of an NOD or an extensive NON where the magnitude of deficiency comments
warrants the filing of extensive changes to the information contained in the original drug
submission, a refiled/updated QOS can be necessary. If updated documents are submitted,
annotated and non-annotated versions should be submitted to expedite assessment (e.g.
the Certified Product Information Document (CPID)).
References:
ICH M4 (Common Technical Document)
ICH M4Q (Common Technical Document – Quality)
Date adopted: 2017/10/30; Effective date: 2018/01/30
5
Quality (Chemistry and Manufacturing):
NDSs and ANDSs
Health Canada
Guidance Document
Preparation of Drug Regulatory Activities in the CTD Format
Management of Drug Submissions
Health Canada’s Certified Product Information Document – Chemical Entities
(CPID-CE)
The CPID-CE constitutes part of the Notice of Compliance (NOC) package and provides a
condensed summary of the key Quality information for NDSs and ANDSs. The CPID-CE
provides an accurate record of information on the Quality of the drug substance and drug product
at the time the NOC is issued. The CPID-CE is a condensed version of the QOS and represents
the final, agreed upon key data from the drug submission (e.g. list of manufacturer(s),
manufacturing procedure and control strategy, specifications, container closure system including
delivery devices, storage conditions, retest period or shelf life, and commitments). Most
importantly, it serves as a valuable knowledge management tool and a reference document to
track the changes in the Quality information for the drug substance and drug product during its
lifecycle. It is a useful document for both the sponsor and the regulator as an official reference
document during the course of post-authorization activities. The CPID-CE template is structured
to permit the rapid assembly of the CPID-CE by copying requisite information from the
corresponding portions of the QOS filed with the original drug submission.
For NDSs and ANDSs, the proposed CPID-CE should be
