(Check List Regarding CTD Submission For

Drug Registration Purposes)

Drug Name ,dosage form & Conc.:

Application Type: (check one)

Originator drug/ New drug (ND) Biological drug (BD) Generic drug(GD)

Herbal drug(HD)
Submission type : (check one)
Complete manufacturing Contract manufacturing Under License
Technology Transfer
Pack Size and Type:
Drug Manufacturer , Marketing Authorization Holder (MAH) & Country:

Applicant Name:

 This document is concerned with the data required to be presented in registration

applications of human drugs.
 The data requirements for each application will differ, depending on the drug submission
type. However, all the required data should be in accordance with the ICH CTD structure
as outlined in this guideline.
 In case of New drugs (Originators), Biological and Biosimilars ALL,
the CTD Modules are required.

 In case of Generic Products In preparing the dossier for generic

products, it is acknowledged that certain modules or sections of the
CTD would generally not be applicable and should be marked as such
(and not to be deleted).

1
 Section Requirements Company NMPB
(screening
Not unit)
Module 1 Regional Administrative Information Yes No applica
ble
1.0 Cover letter
 Company original paper (not a photocopy)
 Signature of authorized person
 Company official stamp
1.1 Comprehensive Table of content
 The table of content for the entire submission should list all documents included
in all Modules
1.2 Application Form
 The Last version available in the website
 Filled completely
 Singed and Stamped
1.3 Product Information
1.3.1 Summary of Product Characteristics (SPC)
1.3.1.1 Name of the medicinal product
1.3.1.2 Qualitative and quantitative composition
1.3.1.3 Pharmaceutical form
1.3.1.4 Clinical particulars
 Therapeutic indications
 Posology and method of administration
 Contraindications
 Special warnings and precautions for use
 Interactions with other medicinal products and other forms of interaction
 Pregnancy and lactation
 Effects on ability to drive and use machines
 Undesirable effects
 Overdose
1.3.1.5 Pharmacological properties
 Pharmacodynamic properties
 Pharmacokinetic
odynamic properties
properties
 Preclinical safety data
1.3.1.6 Pharmaceutical properties
 List of excipients
 Incompatibilities
 Shelf life
 Special precautions for storage
 Nature and contents of container
 Special precautions for disposal and other handling
o Marketing authorization holder
o Marketing authorization number(s)
o Date of first authorization/renewal of the authorization
o Date of revision of the text
o <Dosimetry>
o <Instructions for preparation of radiopharmaceuticals>
o Name of the medicinal product

1.3.2 o
Patient information leaflet (PIL)
2
1.3.2.1 Arabic leaflet
1.3.2.2 Arabic Or English leaflet
1.3.2.2.1 What {product name}is and what it is used for
 What type of medicine is it?
 What diseases or a medical condition is it approved to treat?
1.3.2.2.2 Before you <take> <use> {product name}
 Do not take or use
 Take special care
 Taking or using other medicines
 Taking or using your medicine with food and drink
 Pregnancy and breast-feeding
 Driving and using machines
 Important information about some of the ingredients in your medicine.
1.3.2.2.3 How to <take> <use> {product name}
 How to take or use the medicine.
 How often it should be used or taken.
 How long it should be used or taken for.
 What to do if you take or use more than you should.
 What to do if you forget a dose.

 What might happen if you stop taking or using the medicine.

1.3.2.2.4 Possible side effects
1.3.2.2.5 How to store {product name}
 How to check the expiry date of the medicine.
 How to store your medicine.
 How to dispose of your medicine.
1.3.2.2.6 Further information
 What {product name} contains- both the active and inactive ingredients
 What {product name} looks like and contents of the pack
 Name and address of Marketing Authorization Holder and Manufacturer
 This leaflet was last approved in {MM/YYYY}; version number { }
 To report any side effect(s):
 Box of Council of Arab Health Ministers - Union of Arab Pharmacists
1.3.3 Labeling
1.3.3.1 Particulars to appear on the <outer packaging> <and> <the immediate packaging>
 Name of the medicinal product
 Statement of active substance(s)
 List of excipients
 Pharmaceutical form and contents
 Method and route(s) of administration
 Special warning that the medicinal product must be stored out of the reach and
 sight of children
 Other special warning(s), if necessary
 Manufacturing and Expiry dates
 Special storage conditions
 Special precautions for disposal of unused medicinal products or waste materials
 derived from such medicinal products, if appropriate
 Name and address of the marketing authorization holder or manufacture
 Marketing authorization number(s)
 Batch number
 General classification for supply
 <Medicinal product subject to medical prescription.>
 <Medicinal product not subject to medical prescription.>

 Price

3
1.3.3.2 Minimum particulars to appear on blisters or strips
 Name of the medicinal product
 Name of the marketing authorization holder
 Manufacturing and Expiry dates
 Batch number
1.3.3.3 Minimum particulars to appear on small immediate packaging units
 Name of the medicinal product and route(s) of administration
 b. Method of administration
 Manufacturing and Expiry dates
 Batch number
 Contents by weight, by volume or by unit
 Special storage conditions
1.3.4 Artwork(Mock-ups)) (two copies)
 Artwork of outer Pack
 Artwork of inner Pack
 Artwork for the Shape of the inner Pack
 Artwork for the Shape of the Tablet or Capsule
 Artwork for the Shape of the blister by both side
1.4 Samples
 2 Samples
1.5 Information on the experts
1.5.1 Quality
1.5.2 Non-Clinical

1.5.3 Clinical

1.6 Summary of B.E

 The reference medicinal product identified and justified
 Demonstration :that the excipients in the multisource product are essentially the
same and in comparable concentrations as those in the reference product
 A signed statement confirming that the test product has the same quantitative
composition and is manufactured by the same process as the one submitted for
authorization.
 A confirmation whether the test product is already scaled-up for production
should be submitted
1.7 Environmental Risk Assessment
1.7.1 Non-Genetically Modified Organism (Non-GMO)
1.7.2 GMO
1.8 Pharmacovigilance
1.8.1 Pharmacovigilance system
1.8.2 Risk management plan
1.9 Certificates
1.9.1 CPP (or Free-sales when applicable)
 As WHO Format
 The Product Complete 3years after registration in country of origin
 Authenticated From Competent Health Authority
 Authenticated From Sudan MFA
 Authenticated From Embassy
 Not Expired
1.9.2 GMP
 A valid GMP Certificate for each finished product manufacturer inclusive
secondary packer(s)
 For biologics: GMP certification/proof of GMP compliance for each
drug substance manufacturer must be provided

4
 Copy of registration certificate of pharmaceutical company and production line in
1.9.3
Sudan
1.9.4 Certificate of analysis - Drug Substance (on a headed paper)
 Name of Drug- substance
 Name of Manufacturer of API
 Expiry date
 Batch number
 Date of Analysis
 Tests, Limits and Result
 Specification (Bp, USP, IP, In-House)
 Singed & Stamped from the Manufacturer
 Copy of Certificate (s) of Analysis of API From the Supplier
1.9.5 Certificate of analysis Finished Product (on a headed paper)
 Trade name
 Generic name
 Concentration & Dosage form
 Manufacturing & Expiry date
 Batch number
 Date of Analysis
 Tests, Limits and Result
 Specification (B.p, USP, IP, In-House)
 Original paper Singed & Stamped from the Manufacturer
1.9.6 Certificate of analysis - Excipients
 Name of Drug- substance
 Name of Manufacturer of API
 Expiry date
 Batch number
 Date of Analysis
 Tests, Limits and Result
 Specification (B.p, USP, IP, In-House)
 Singed & Stamped from the Manufacturer
 Copy of Certificate (s) of Analysis of Excipients From the Supplier
1.9.7 Alcohol-free declaration
 Company original paper (not a photocopy)
 Signature of authorized person
 Company official stamp
1.9.8 Pork-free declaration
 Company original paper (not a photocopy)
 Signature of authorized person
 Company official stamp
1.9.9 Patent Information
1.10 Pricing
1.10.1 Price Certificate documented by health authorities include
 Name and address of the factory in the country of origin.
 Product name, pharmaceutical shape and the concentration.
 Pack size and type.
 Factory price in the country of origin (Ex-Factory).
 Whole price in the country of origin.
 Retail price in the country of origin and the other countries where has been marked if
it found.
 Requested C&F price.

5
  The export price to all countries where the product has been marketed at the time of
registration.
 Price of the product in official pricing references if it found.
1.10.2 Other documents related – Pricing list
1.11 Response to question

Company
Section Requirements
NMPB
Module Not screening
Common Technical Document Summaries Yes No
2 Applicable
2.1 Table of Contents of Module 2-5
2.2 Introduction
2.3 Quality Overall Summary
Introduction
2.3.S Drug substance
2.3.S.1 General Information
2.3.S.2 Manufacture
2.3.S.3 Characterization
2.3.S.4 Control of Drug Substance
2.3.S.5 Reference Standards or Materials
2.3.S.6 Container/Closure System
2.3.S.7 Stability
2.3.P Drug Product
2.3.P.1 Description and Composition of the Drug Product
2.3.P.2 Pharmaceutical Development
2.3.P.3 Manufacture
2.3.P.4 Control of Excipients
2.3.P.5 Control of Drug Product
2.3.P.6 Reference Standards or Materials
2.3.P.7 Container/Closure System
2.3.P.8 Stability
2.3.A Appendices
2.3.A.1 Facilities and Equipment
2.3.A.2 Adventitious Agents Safety Evaluation
2.3.A.3 Novel Excipients
2.3.R Regional Information
2.4 Nonclinical Overview
2.5 Clinical Overview
2.5.1 Product Development Rationale
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety
2.5.6 Benefits and Risks Conclusions
2.5.7 References
2.6 Non-Clinical Written and Tabulated Summaries
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.2.1 Brief Summary
2.6.2.2 Primary Pharmacodynamics
2.6.2.3 Secondary Pharmacodynamics
6
2.6.2.4 Safety Pharmacology
2.6.2.5 Pharmacodynamic Drug Interactions
2.6.2.6 Discussion and Conclusions
2.6.2.7 Tables and Figures
2.6.3 Pharmacology Tabulated Summary
2.6.4 Pharmacokinetics Written Summary
2.6.4.1 Brief Summary
2.6.4.2 Methods of Analysis
2.6.4.3 Absorption
2.6.4.4 Distribution
2.6.4.5 Metabolism (interspecies comparison)
2.6.4.6 Excretion
2.6.4.7 Pharmacokinetic Drug Interactions
2.6.4.8 Other Pharmacokinetic Studies
2.6.4.9 Discussion and Conclusions
2.6.4.10 Tables and Figures
2.6.5 Pharmacokinetics Tabulated Summary
2.6.6 Toxicology Written Summary
2.6.6.1 Brief Summary
2.6.6.2 Single-Dose Toxicity
2.6.6.3 Repeat-Dose Toxicity
2.6.6.4 Genotoxicity
2.6.6.5 Carcinogenicity
2.6.6.6 Reproductive and Developmental Toxicity
2.6.6.7 Local Tolerance
2.6.6.8 Other Toxicity Studies (if available)
2.6.6.9 Discussion and Conclusions
2.6.6.10 References
2.6.7 Toxicology Tabulated Summary
2.7 Clinical Summary
2.7.1 Summary of Biopharmaceutic and Associated Analytical Methods
2.7.1.1 Background and Overview
2.7.1.2 Summary of Results of Individual Studies
2.7.1.3 Comparison and Analyses of Results Across Studies
2.7.1.4 Appendix
2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview
2.7.2.2 Summary of Results of Individual Studies
2.7.2.3 Comparison and Analyses of Results Across Studies
2.7.2.4 Special Studies
2.7.2.5 Appendix
2.7.3 Summary of Clinical Efficacy
2.7.3.1 Background and Overview of Clinical Efficacy
2.7.3.2 Summary of Results of Individual Studies
2.7.3.3 Comparison and Analyses of Results Across Studies
2.7.3.3.1 Study Populations
2.7.3.3.2 Comparison of Efficacy Results Across All Studies
2.7.3.3.3 Comparison of Results in Sub-Populations
2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
2.7.3.5 Persistence of Efficacy and/or Tolerance Effects
2.7.3.6 Appendix
2.7.4 Summary of Clinical Safety

7
2.7.4.1 Exposure to the Drug
2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies
2.7.4.1.2 Overall Extent of Exposure
2.7.4.1.3 Demographic and Other Characteristics of Study Population
2.7.4.2 Adverse Events
2.7.4.2.1 Analysis of Adverse Events by Organ System or Syndrome
2.7.4.2.2 Narratives
2.7.4.3 Clinical Laboratory Evaluations
2.7.4.4 Vital Signs, Physical Findings, Observations Related to Safety
2.7.4.5 Safety in Special Groups and Situations
2.7.4.5.1 Intrinsic Factors
2.7.4.5.2 Extrinsic Factors
2.7.4.5.3 Drug Interactions
2.7.4.5.4 Use in Pregnancy and Lactation
2.7.4.5.5 Overdose
2.7.4.5.6 Drug Abuse
2.7.4.5.7 Withdrawal and Rebound
2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of
MentalAbility
2.7.4.6 Post-Marketing Data
2.7.4.7 Appendix
2.7.5 References
2.7.6 Synopses of Individual Studies

8
 Module 3 Quality Company NMPB
Not (screening)
Section Requirements Yes No
applicable
3.1 Table of Contents of Module 3

3.2 Body of data

3.2.S Drug Substance
3.2.S.1 General Information
 Drug Substance meets the current USP/Ph.Eur/BP/JP
requirements
 Drug Substance meets other pharmacopoeia standards.
Analytical methods and appropriate analytical method
validation data are included in the dossier
 Drug Substance meets in-house specifications. Analytical
methods and appropriate analytical method validation data are
included in the dossier.
3.2.S.1.1 Nomenclature
 Recommended International Non-proprietary Name

 Compendial Name (if relevant):

 Chemical Name(s):
 Other non-proprietary name(s):
 Chemical Abstracts Service(CAS) registry number
3.2.S.1.2 Structure
 The structural formula including relative and absolute
stereochemistry
 Molecular Formula
 Molecular Mass
3.2.S.1.3 General Properties
 Physical description
 Solubility Characteristics
 Physical form (eg, polymorphic form, solvate, hydrate)
 PH and PKa

 Other (Hygroscopicity, Partition Coefficient ,Melting point

,Refractive Index UV max & molar absorptivity,)

3.2.S.2 Manufacture

3.2.S.2.1 Manufacturer( s )

 Responsibility (e.g. Manufacturing, packaging, labeling, and testing) of each manufacturer, including 
contractors and each proposed production site or facility involved in manufacturing and testing

 Name and Address

 Certificate Of GMP Compliance

3.2.S.2.2 Description of Manufacturing Process and Process Controls

 Flow diagram of the synthesis process

 Brief narrative description of the manufacturing process

 Alternate processes and explanation of their use

9
  Reprocessing steps and justification

3.2.S.2.3 Control of Materials

 For drug substances or drug substance manufactured with
reagents obtained from sources that are a risk of transmitting
agents of animal spongiform encephalopathies (BSE/TSE)
3.2.S.2.4 Control of Critical Steps and Intermediates
 Controls performed at critical steps of the manufacturing
process and on intermediates
3.2.S.2.5 Process Validation and/or Evaluation
 Process validation and/or evaluation studies for aseptic
processing and sterilization.
3.2.S.2.6 Manufacturing Process Development
 Description and discussion of the Manufacturing development
made to the manufacturing process and/or manufacturing site
of the drug substance
3.2.S.3 Characterization
3.2.S.3.1 Elucidation of Structure and Other Characteristics
 List of studies performed (e.g. IR, UV, NMR, MS, elemental
 analysis)
Discussion on the potential for isomerism and identification of
stereochemistry (e.g. geometric isomerism, number of chiral
centers and configurations)
 studies performed to identify potential polymorphic forms
(including solvates)
 Other characteristics

3.2.S.3.2 Impurities
1. potential and actual impurities arising from the synthesis,
manufacture and/or degradation

 Chemical Name

 Type of Impurity

 Structure

2. Process-related impurities (e.g., residual solvents)

 Compound Name
 Step in Process
3.2.S.4 Control of the Drug Substance
3.2.S.4.I Specifications
 Standard claimed (e.g. Ph.Int., Ph.Eur., BP, USP, House)
 Justification of specification
 Specification reference number and /or version
 Test
 Acceptance criteria(Release specification, shelf life
specification, If applicable)
 Analytical procedure(Type/Source/Version)

10
3.2.S.4.2 Analytical Procedures (Include but not limited to:
 Reference stander preparation
 Sample preparation
 Use of the Apparatus
 Generation of the calibration curve
 Use of formula for the calculation
3.2.S.4.3 Validation of Analytical Procedures
 Test name
 Method description
 Parameters according to type of Test
o System Suitability
o Robustness
o Limit of quantitation
o Limit of detection
o Precision (repeatability- intermediate)
o Precision (reproducibility)
o Accuracy
o Range
o Linearity
o Selectivity
o Method description
3.2.S.4.4 Batch Analyses
 Batch number
 Batch size
 Batch type (pilot/production)
 Date of production
 Site of production
3.2.S.4.5 Justification of Specification
 Justification of Specification for each test
3.2.S.5 Reference Standards or Materials
1. Drug substance
 Type of reference standard used (primary reference Or
working reference)
o Batch NO.
o Source (e.g. USP, In-house)
2. Impurities
 Type of impurities standard used (primary reference Or
working reference)
o Batch NO.

o Source (e.g. USP, In-house)

3.2.S.6 Container/Closure Systems

 Description of the container closure system include (Identity

of material of construction of each primary packaging)

 Specification
o Description

11
 o Identification
o Critical dimension with drawing, where appropriate
 The suitability should be discussed
3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions

 Batch Number

 Batch Size

 Batch Type

 Date of manufacture

 Site of manufacture

 Container closure system

 Storage conditions (°C, %RH, Light)

 Completed Test Intervals (e.g.; 0,3,6,9,12,18,24,36 months)

 Summary and discussion of all stability study results

o Specification and Results for stability Indicating
Tests
o Summary and discussion

 Proposed storage conditions and re-test period (or shelf life ,

as appropriate):

o Container closure system

o Storage conditions

o Re-test period, If applicable

o Shelf life, If applicable

3.2.S.7.2 Post-approval Stability Protocol and Commitment
 Stability protocol for commitment batches(If applicable)
 Protocol parameter
o Number of batches and batch size
o Tests and acceptance criteria
o Container closure system
o Testing frequency
o Storage condition( and tolerances) of samples
o Other
3.2.S.7.3 Stability Data
o Results of stability study (e.g.: force degradation studies and
stress conditions )
o Information on the Analytical procedure used to generate the
data
o Validation of these procedure, If any.
3.2.P Drug Product

3.2.P.1 Description and Composition of the Drug Product

1. Description of the dosage form

12
 2. Composition formula
 List of all components of the dosage form including
component of mixture (e.g. colorants, coating, capsule
shells),If any
 Amount on per unit basis (including overages , if any)
 The function of the components

 A reference to components quality standards

3. Description of accompanying reconstitution diluents(s)
4. Type of container and closure used for the dosage form and
accompanying reconstitution diluents
3.2.P.2 Pharmaceutical Development
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug substance
 The compatibility of drug substance with excipients
(discussed)
 The compatibility of drug substances with each other (for
combination products) (discussed)
 Physicochemical characteristics of the drug substances
(discussed )
3.2.P.2.1.2 Excipients
 The choice of excipients (discussed)
 Their concentration (discussed)
 Their characteristics that can influence the drug product
(discussed)
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development
 Description Of the development of the drug product should
be provided, taking into consideration the proposed route of
administration and usage

 The differences between clinical formulations and the

composition (discussed)

 Results from comparative in vitro studies (e.g., dissolution) or

comparative in vivo studies (e.g., bioequivalence) should be
discussed (when appropriate)

3.2.P.2.2.2 Overages

 Any overages in the formulation(s) should be justified

3.2.P.2.2.3 Physiochemical and Biological Properties

 Parameters relevant to the performance of the drug product
should be addressed
3.2.P.2.3 Manufacturing Process Development
 Discussion of the development of the manufacturing process
of the drug product (e.g. optimization of the process, selection
of the method of sterilization)

 Discussion of the differences in the manufacturing process(es)

3.2.P.2.4 Container Closure System

13
  Discussion of the suitability of the container closure system
(describe in P7) used for storage, transportation (shipping),
and use of drug product (e.g.: physiochemical tests, biological
reactivity tests…etc)
3.2.P.2.5 Microbiological Attributes
 Discussion of microbiological attribute of the dosage form
(e.g. : the rationale for not performing microbial limits testing
for non-sterile products and the selection and effectiveness of
preservative systems in products containing antimicrobial
preservatives )
 Address the integrity of the container closure system to
prevent microbial contamination, for sterile products

3.2.P.2.6 Compatibility
 The compatibility of the drug product with reconstitution
diluents(s) or dosage devices should be addressed
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer( s )
 Responsibility (e.g. Manufacturing, packaging, labeling and
testing) of each manufacturer, including contractors and each
proposed production site or facility involved in manufacturing
and testing
 Name and Address
 Certificate Of GMP Compliance
3.2.P.3.2 Batch Formula
 List of all components of the dosage form
 Amount on a per batch basis (including overages , if any)
 A reference to components quality standards
3.2.P.3.3 Description of Manufacturing Process and Process Controls
 Flow diagram of the synthesis process
 Narrative description of the manufacturing process including
packaging, equipment type and working capacity, process
 parameters
Justification of reprocessing of materials if used
3.2.P.3.4 Controls of Critical Steps and Intermediates
 Controls performed at critical steps of the manufacturing
process and on intermediates
3.2.P.3.5 Process Validation and/or Evaluation
 Description, documentation, and results of the validation
and/or evaluation studies should be provided for critical steps or
critical assays used in the manufacturing process
o Validation scheme

o Type of validation (e.g.: Retrospective, prospective,

concurrent, ….ect)

o Batch number, Batch size, Batch type

o Manufacture site at which the validation is carried
out
o Date of production

o Specification and results

 Product formula for validation batches, If not provide

justification

14
 o List of all components of the dosage form
o Amount on a per batch basis (including overages , if
any)
o A reference to components quality standards
3.2.P.4 Control of Excipients
3.2.P.4.l Specifications
 Standard claimed (e.g. Ph.Int., Ph.Eur., BP, USP, House)

 Justification of specification
 Specification reference number and /or version
 Test
 Acceptance criteria(Release specification, shelf life
specification, If applicable)
 Analytical procedure(Type/Source/Version)

3.2.P.4.2 Analytical Procedures, include but not limited to:

 Reference stander preparation
 Sample preparation
 Use of the Apparatus
 Generation of the calibration curve
 Use of formula for the calculation
3.2.P.4.3 Validation of Analytical Procedures
 Test name
 Method description
 Parameters according to type of Test
o System Suitability
o Robustness
o Limit of quantitation
o Limit of detection
o Precision (repeatability- intermediate)
o Precision (reproducibility)
o Accuracy
o Range
o Linearity
o Selectivity
o Method description
3.2.P.4.4 Justification of Specifications
 Justification of the specification (e.g., evolution of tests,
analytical procedures, acceptance criteria, exclusion of certain
tests, differences from compendia standard, ,ect)
3.2.P.4.5 Excipients of Human or Animal Origin
 List of excipients that are of human or animal origin (including
country of origin)
 Information (e.g., sources, specifications, description of the
testing performed, viral safety data) regarding adventitious
agents for excipients of human or animal origin

15
  For excipients obtained from sources that are at risk of
transmitting Bovine Spongiform Encephalopathy
(BSE)/Transmissible Spongiform Encephalopathy (TSE)
agents (e.g., ruminant origin), a letter of attestation (with
supporting documentation) should be provided.
3.2.P.4.6 Novel Excipients
 details on the manufacture, characterization, and controls, with
cross references to supporting safety data (nonclinical and/or
clinical) on novel excipients
3.2.P.5 Control of Drug Product
3.2.P.5.1 Specifications
 Standard claimed (e.g. Ph.Int., Ph.Eur., BP, USP, House)
 Justification of specification
 Specification reference number and /or version
 Test
 Acceptance criteria(Release specification, shelf life
specification, If applicable)
 Analytical procedure(Type/Source/Version)
3.2.P.5.2 Analytical Procedures (Include but not limited to:
 Reference stander preparation
 Sample preparation
 Use of the Apparatus
 Generation of the calibration curve
 Use of formula for the calculation
3.2.P.5.3 Validation of Analytical Procedures
 Test name
 Method description
 Parameters according to type of Test
o System Suitability
o Robustness
o Limit of quantitation
o Limit of detection
o Precision (repeatability- intermediate)
o Precision (reproducibility)
o Accuracy
o Range
o Linearity
o Selectivity
o Method description
3.2.P.5.4 Batch Analyses
 Batch number
 Batch size
 Batch type (describe purpose of batch- e.g. developmental,
pilot, production, clinical, validation, commercial)
 Date of production
 Site of production
3.2.P.5.5 Characterization of Impurities

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  Information on the characterization of impurities, not
previously provided in S 3.2 (e.g., summary of actual and
potential degradation products, basis for setting the acceptance
criteria, etc):
o Chemical Name/Laboratory Code
o Origin/Type of Impurity
3.2.P.5.6 Justification of Specifications
 Justification of Specification for each test
3.2.P.6 Reference Standards or Materials
1. Drug substance
 Type of reference standard used (primary reference Or
working reference)
o Batch NO.
o Source (e.g. USP, In-house)
2. Impurities
 Type of impurities standard used (primary reference Or
working reference)
o Batch NO.
o Source (e.g. USP, In-house)
3.2.P.7 Container/Closure System
 Description of the container closure system include (Identity
of material of construction of each primary packaging)
 Specification
o Description
o Identification
o Critical dimension with drawing, where appropriate
 The suitability should be discussed
 Certificate of Analysis (Contains all Tests related to Its
quality)
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusions
 Trade Name
 Generic Name , Dosage Form and Strength
 Batch Number
 Batch Size
 Batch Type
 Date of manufacture
 Site of manufacture
 Source of Active Ingredient and Batch Number

 Container closure system
 Storage conditions (°C, %RH, Light)
 Completed Test Intervals (e.g.; 0,3,6,9,12,18,24,36 months)
 In-use stability testing (where applicable):
o In-use Storage Conditions (°C, % RH, light)
o
Length of Storage prior to Start of In-use Stability
Testing
o Completed In-use Test Intervals (e.g. minutes/ hours/
days)
 Summary and discussion of all stability study results

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 o Specification and Results for stability Indicating
Tests
o Summary and discussion

 Proposed storage conditions and shelf life:

o Container closure system

o Storage conditions (with In-use Storage Conditions,
if applicable )
o
o Shelf Life (with In-use Period, if applicable)

3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitments

 Stability protocol for commitment batches(If applicable)
 Protocol parameter
o Number of batches and batch size
o Tests and acceptance criteria
o Container closure system
o Testing frequency
o Storage condition( and tolerances) of samples
o Other
 Stability protocol for continuing (i.e., ongoing) batches:
 Protocol parameter
o Number of batches and batch size
o Tests and acceptance criteria
o Container closure system
o Testing frequency
o Storage condition( and tolerances) of samples
o Other
3.2.P.8.3 Stability Data

o actual stability results

o Results of stability study (e.g.: force degradation
studies and stress conditions )
o Information on the Analytical procedure used to
generate the data
o Validation of these procedures, if any.
3.2.A Appendices
3.2.4.A.l Facilities and Equipment
3.2.4.A.2 Adventitious Agents Safety Evaluation
3.2.4.A.3 Excipients
3.2.R Regional Information
3.2.R.l Alcohol Content Declaration
3.2.R.2 Porcine/Pork - content/origin
3.2.R.3 The diluents and coloring agents in the product formula
3.3 Literature References

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 Module 4 Non-Clinical Study Reports
NMPB
Not screening
Section Requirements Yes No
applicable
4.1 Table of Contents of Module 4
4.2 Study Reports
4.2.1 Pharmacology
4.2.1.1 Primary Pharmacodynamics
4.2.1.2 Secondary Pharmacodynamics
4.2.1.3 Safety Pharmacology
4.2.1.4 Pharmacodynamic Drug Interactions
4.2.2 Pharmacokinetics
4.2.2.1 Analytical Methods and Validation Reports
4.2.2.2 Absorption
4.2.2.3 Distribution
4.2.2.4 Metabolism
4.2.2.5 Excretion
4.2.2.6 Pharmacokinetic Drug Interactions
4.2.2.7 Other Pharmacokinetic Studies
4.2.3 Toxicology
4.2.3.1 Single-Dose Toxicity
4.2.3.2 Repeat-Dose Toxicity
4.2.3.3 Genotoxicity
4.2.3.3.1 In vitro Studies
4.2.3.3.2 In vivo Studies
4.2.3.4 Carcinogenicity
4.2.3.4.1 Long Term Studies
4.2.3.4.2 Short or medium term studies
4.2.3.4.3 Other studies
4.2.3.5 Reproductive and Development Toxicity
4.2.3.5.1 Fertility and Embryonic Development
4.2.3.5.2 Embryo-Fetal Development
4.2.3.5.3 Pre- and Post-natal Development & Maternal Function
4.2.3.5.4 Offspring, Juvenile, Second & Third-Generation Studies
4.2.3.6 Local Tolerance
4.2.3.7 Other Toxicity Studies
4.2.3.7.1 Antigenicity
4.2.3.7.2 Immunogenicity
4.2.3.7.3 Mechanistic Studies (not included elsewhere)
4.2.3.7.4 Dependence
4.2.3.7.5 Metabolites
4.2.3.7.6 Impurities
4.2.3.7.7 Other
4.3 Literature References

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 Clinical Study Reports
Module 5 NMPB
Not screening
Section Requirements Yes NO applicable
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutic Studies
5.3.1.1 Bioavailability (BA) Study Reports
5.3.1.2 Comparative BA & BE Study Reports
5.3.1.3 In vitro in vivo Correlation (IVIIVC) study reports
5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human studies
5.3.2 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports
5.3.2.2 Reports of Hepatic Metabolism and Drug Interactions studies
5.3.2.3 Reports of Studies Using other Human Biomaterials
5.3.3 Reports of Human Pharmacokinetic Studies
5.3.3.1 Healthy Subject PK and Tolerability
5.3.3.2 Patient PK and Initial Tolerability
5.3.3.3 Intrinsic Factor PK Study Reports
5.3.3.4 Extrinsic Factor PK Study Reports
5.3.3.5 Population PK Study Reports
5.3.4 Reports of Human Pharmacodynamic (PD) Studies
5.3.4.1 Healthy Subject PD and PK/PD Study Reports
5.3.4.2 Patient PD and PKlPD Study Reports
5.3.5 Reports of Efficacy and Safety Studies
Study reports of Controlled Clinical Studies pertinent to the claimed
5.3.5.1
Indication
5.3.5.2 Study reports of Uncontrolled Clinical Studies
5.3.5.3 Reports of Analyses of Data from More than One Study
5.3.5.4 Other Study Reports
5.3.6 Reports of Post-Marketing Experience
5.3.7 Case Report Forms and Individual Patient Listings
5.4 Literature References

I declare that all the documents which refer to in this check list are attached & number of files
Submitted for this application…………………………………
Name & Sign of responsible Pharmacist: …………………………… Date: ………………… STAMP

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