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APPENDIX 8 SINGAPORE QUALITY OVERALL SUMMARYNew Drug Applications and Generic Drug Applications (Chemicals)
The Quality Overall Summary (QOS) should be completed to summarize the Quality (i.e.,Chemistry, Manufacturing and Controls) portion of a New Drug Application (NDA) or a Generic Drug
Application (GDA) for a chemical drug product. Both hard copy and electronic copy of the SingaporeQOS shall be submitted for review.
The applicant is responsible for completing all sections and fields as much as possible. Sections andfields that are not applicable should be indicated with NA. An explanatory note must immediatelyfollow all NA entries.
INTRODUCTION
Proprietary Name of Drug Product
INN Common Name of DrugSubstance
Product Owner Name
Licence Holder Name
Dosage Form
Strength(s)
Route of Administration
Proposed Indication(s)
Other introductory information:
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S DRUG SUBSTANCE
S 1 GENERAL INFORMATION
Check appropriate box.
DMF (open) part is attached.
DMF (open and restricted) and Letter of Access to be submitted by DDMMYYYY (withinone month of PRISM submission),
OR
Letter of Access to the DMF filed with HSA (015:________) is provided.
* CEP (Certificate of Suitability from EDQM) for Drug Substance is attached.
CEP Number:
CEP (Certificate of Suitability from EDQM) for Raw materials and Excipients is attached.
Drug Substance meets the current USP/PhEur/BP/JP (delete as appropriate)requirements.
Drug Substance meets other pharmacopoeia standards.
Drug Substance meets in-house specifications.
Drug Substance meets other pharmacopoeia standards. Analytical methods andappropriate analytical method validation data are included in the dossier.
Drug Substance meets in-house specifications. Analytical methods and appropriateanalytical method validation data are included in the dossier.
* If CEP is provided and Ph.Eur standard is claimed for drug substance, please fill in S1, S2.1, S4.4 and #S7If CEP is provided and other standards are claimed for drug substance, please fill in S1, S2.1, S4.1 to S4.5 and#S7(#To be provided if re-test period/shelf life is not stated on CEP)
S 1.1 Nomenclature
Hard Copy Location/Pages:E-Copy Location/File Name:
Chemical Name:
Other names: (e.g. INN, BAN, USAN, common name)
Company or laboratory code:
Chemical Abstracts Service (CAS) registry number:
S 1.2 Structure
Hard Copy Location/Pages:E-Copy Location/File Name:
Structural formula (including stereochemistry): [insert structure]
Molecular formula:
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Molecular Mass:
S 1.3 General Properties
Hard Copy Location/Pages:E-Copy Location/File Name:
Physical description (e.g., appearance, colour, physical state):
Physical form (e.g., polymorphic form, solvate, hydrate):
Solubilities (e.g., in common solvents, aqueous/non-aqueoussolubility profile):
pH and pKa values:
Other (e.g., partition coefficients, melting or boiling points,optical rotation, refractive index (for a liquid), hygroscopicity,UV absorption maxima and molar absorptivity):
S 2 MANUFACTURE
S 2.1 Manufacturer(s)
Name, address, and activity of each manufacturer, including contractors, and each proposedproduction site or facility involved in manufacture and testing:
Activity Name and Address *GMP Compliance (Pleaseindicate Approving Agency)
Site of Manufacture
Site of Release testing
Site of Batch Release
* For information only.
S 2.2 Description of Manufacturing Process and Process Controls
Hard Copy Location/Pages:
E-Copy Location/File Name:
Typical production batch size:
Flow diagram of the synthetic process(es):
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S 2.3 Control of Materials
Hard Copy Location/Pages:E-Copy Location/File Name:
S 2.4 Controls of Critical Steps and Intermediates
Hard Copy Location/Pages:
E-Copy Location/File Name:
S 2.5 Process Validation and/or Evaluation
Hard Copy Location/Pages:E-Copy Location/File Name:
S 2.6 Manufacturing Process Development
Hard Copy Location/Pages:
E-Copy Location/File Name:
S 3 CHARACTERISATION
S 3.1 Elucidation of Structure and other Characteristics
Hard Copy Location/Pages:
E-Copy Location/File Name:
S 3.2 Impurities
Summary of potential and actual impurities arising from the synthesis, manufacture and/or degradation:
ChemicalName/Laboratory Code
Origin/Type of Impurity Structure
[insert structure]
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Process-related impurities (e.g., residual solvents):
Compound Name Step in Process
S 4 CONTROL OF THE DRUG SUBSTANCE
S 4.1 Specification
Standard Claimed for the Drug Substance (e.g., USP, BP,etc.):
Test Method(e.g., HPLC)
Source (e.g.,USP, in-house)
Acceptance Criteria
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S 4.2 Analytical Procedures
S 4.3 Validation of Analytical Procedures
For each test, please indicate yes or no as appropriate
Test Name Metho
dDescription
S
electivity
Linearity
Range
Accuracy
Precis
ion
-
Rep
eatability
-
Intermediate
Precis
ion
-
Rep
roducibility
LimitofDetection
LimitofQuantitation
Robustness
SystemSuitability
O
rOthers
(Ple
asespecify)
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S 4.4 Batch Analyses
Batch Number Batch SizeBatch Type
(production/pilot)Date of
ProductionSite of Production
S 4.5 Justification of Specification
Hard Copy Location/Pages:
E-Copy Location/File Name:
Test Justification of Specifications
S 5 REFERENCE STANDARDS OR MATERIALS
Hard Copy Location/Pages:
E-Copy Location/File Name:
Batch Number Source (e.g., USP, in-house)
Primary Reference Standard
Working Standard
S 6 CONTAINER CLOSURE SYSTEM
Description of the container closure system(s) for the storage of the drug substance:
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S 7 STABILITY
S 7.1 Stability Summary and Conclusions
Stability study details:
StorageConditions
(C, % RH, light)
BatchNumber
Batch Size Site of Manufacture
Completed Test Intervals(months)
Summary and discussion of all stability study results:
Hard Copy Location/Pages:E-Copy Location/File Name:
Proposed storage conditions and re-test period (or shelf life, as appropriate):
Container Closure
System
Storage Conditions Re-test Period (or Shelf Life, as
appropriate)
S 7.2 Post-approval Stability Protocol and Stability Commitment
Stability protocol for commitment batches (if applicable):
Protocol Parameter Description
Number of batches and batch sizes
Tests and acceptance criteria
Container closure system(s)
Testing frequency
Storage conditions (and tolerances) of samples
Other
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S 7.3 Stability Data
Hard Copy Location/Pages:E-Copy Location/File Name:
P DRUG PRODUCT
P 1 DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT
(1) Description of the dosage form:
(2) Composition, i.e., list of all components of the dosage form, and their amounts on a per unit basis(including overages, if any):
Strength (Label claim):
Components Quality Standard Quantity per unit % Function
Total
(3) Composition, i.e., qualitative list of all components of proprietary materials (e.g., capsule shells,colouring blends, imprinting inks, etc.):
Proprietary Material Qualitative Composition Quantitative Composition
(4) Description of accompanying reconstitution diluent(s), if applicable:
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P 2 PHARMACEUTICAL DEVELOPMENT
P 2.1 Components of the Drug Product
Hard Copy Location/Pages:E-Copy Location/File Name:
P 2.2 Drug Product
P 2.2.1 Formulation Development
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 2.2.2 Overages
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 2.2.3 Physicochemical and Biological Properties
Hard Copy Location/Pages:E-Copy Location/File Name:
P 2.3 Manufacturing Process Development
Discussion of the development of the manufacturing process of the drug product (e.g., optimizationof the process, selection of the method of sterilization, etc.):
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 2.4 Container Closure System
Discussion of the suitability of the container closure system (described in P 7) used for the storage,
transportation (shipping), and use of the drug product (e.g., physicochemical tests, biological reactivitytests, leaching, etc.):
Hard Copy Location/Pages:E-Copy Location/File Name:
P 2.5 Microbiological Attributes
Discussion of microbiological attributes of the dosage form (e.g., preservative effectiveness studies):
Hard Copy Location/Pages:
E-Copy Location/File Name:
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P 2.6 Compatibility
Discussion of the compatibility of the drug product with reconstitution diluent(s) or dosage devices(e.g., precipitation of drug substance in solution, sorption on injection vessels, etc.):
Hard Copy Location/Pages:E-Copy Location/File Name:
P 3 MANUFACTURE
P 3.1 Manufacturer(s)
Name, address, and activity of each manufacturer, including contractors, and each proposed
production site or facility involved in manufacture and testing of product intended for Singapore:
Activity Name and Address
Site of Fabrication, Manufacturing
Site of Primary Packaging
Site of Secondary Packaging
Site of Release Testing
Site of Batch Release
P 3.2 Batch Formula
List of all components of the dosage form to be used in the manufacturing process, and their amountson a per batch basis (including overages, if any):
Strength (Label claim):
Batch Size (Number of dosage units):
Component and Quality Standard (and Grade, if applicable) Quantity per batch
Total
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P 3.3 Description of Manufacturing Process and Process Controls
Hard Copy Location/Pages:
E-Copy Location/File Name:
Flow diagram of the manufacturing process(es):
P 3.4 Controls of Critical Steps and Intermediates
Hard Copy Location/Pages:E-Copy Location/File Name:
P 3.5 Process Validation and/or Evaluation
Hard Copy Location/Pages:
E-Copy Location/File Name:
Please check appropriate boxes.
Development Pharmaceutics Report Starting page #:Ending page#:
Validation Scheme Starting page #:Ending page#:
____ (e.g. 2) Pilot batches were used in the
validation study
Starting page #:
Ending page#:
____ (e.g. 3) full production batches were used inthe validation study
Starting page #:Ending page#:
Type of Validation
Retrospective
Prospective
Concurrent*
Others; please specify:
* Prior consultation with HSA is required.
Manufacturing site at which the validation is carried out:
Batch Number (Batches must beconsecutive)
Batch SizeBatch Type
(production/pilot/experimental)
Post-Approval Commitment
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(1)Validation protocol for commitment batches:
Protocol Parameter Description
Number of batches per strength
Batch Size
P 4 CONTROL OF EXCIPIENTS
P 4.1 Specifications
Specifications for non-compendial excipients and for compendial excipients which includesupplementary tests not required by the monograph(s) may be found in:
Hard Copy Location/Pages:E-Copy Location/File Name:
P 4.2 Analytical Procedures
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 4.3 Validation of Analytical Procedures
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 4.4 Justification of Specifications
Justification of the specifications (e.g., evolution of tests, analytical procedures, and acceptancecriteria, exclusion of certain tests, differences from compendial standard, etc.):
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 4.5 Excipients of Human or Animal Origin
Hard Copy Location/Pages:E-Copy Location/File Name:
P 4.6 Novel Excipients
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Hard Copy Location/Pages:
E-Copy Location/File Name:
P 5 CONTROL OF DRUG PRODUCT
P 5.1 Specification(s)
Standard Claimed for the Drug Product(e.g., USP, Ph.Eur, BP, JP etc.):
Test Method (e.g.,HPLC)
Source (e.g.,USP, In-house)
ReleaseSpecification
Shelf LifeSpecification
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P 5.2 Analytical Procedures
P 5.3 Validation of Analytical Procedures
For each test, please indicate yes or no as appropriate
Test Name Metho
dDescription
S
electivity
Linearity
Range
Accuracy
Precis
ion
-
Rep
eatability
-
Intermediate
Precis
ion
-
Rep
roducibility
LimitofDetection
LimitofQuantitation
Robustness
SystemSuitability
O
rOthers
(Ple
asespecify)
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P 5.4 Batch Analyses
Batch Number Batch SizeBatch Type
(production/pilot)Date of
ProductionSite of
ProductionSite of Batch
Release
P 5.5 Characterisation of Impurities
Information on the characterization of impurities, not previously provided in S 3.2 (e.g., summary ofactual and potential degradation products, basis for setting the acceptance criteria, etc):
Chemical Name/LaboratoryCode
Origin/Type of Impurity
P 5.6 Justification of Specification(s)
Hard Copy Location/Pages:E-Copy Location/File Name:
Test Justification of Specifications
P 6 REFERENCE STANDARDS OR MATERIALS
If the reference standard is a secondary standard (in house /working standard), evidence that thesecondary standard has been standardised against an official standard should be provided Data ofstudies performed on working standard against primary standard should be included, together withappropriate Certificate of Analysis.
Hard Copy Location/Pages:E-Copy Location/File Name:
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Batch Number Source (e.g., USP, in-house)
Primary Reference StandardWorking Standard
P 7 CONTAINER CLOSURE SYSTEM
Description of the container closure systems:
Description of Container Closure Quantity Per Container Pack Size
P 8 STABILITY
P 8.1 Stability Summary and Conclusions
Hard Copy Location/Pages:
E-Copy Location/File Name:
Proposed Commercial Batch Size (kg):
BatchNumber
Batch Size Date of Manufacture
Site ofManufacture
Source of ActiveIngredient andBatch Number
ContainerClosureSystem
Storage Conditions (C, % RH,light)
Completed Test Intervals
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In-use stability testing (where applicable):
In-use Storage Conditions(C, % RH, light)
Length of Storage prior to Startof In-use Stability Testing
Completed In-use Test Intervals(e.g. minutes/ hours/ days)
Proposed storage conditions and shelf life:
Container ClosureSystem
Storage Conditions (and In-useStorage Conditions, if
applicable)
Shelf Life (and In-use Period, ifapplicable)
P 8.2 Post-Approval Stability Protocol and Stability Commitment
(1)Stability protocol for commitment batches:
Protocol Parameter Description
Number of batches per strength and batchsizes
Tests and acceptance criteria
Container closure system(s)
Testing frequency
Storage conditions (and tolerances) of samples
Other
(2)Stability protocol for continuing (i.e., ongoing) batches:
Protocol Parameter Description
Number of batches per strength per year andbatch sizes
Tests and acceptance criteria
Container closure system(s)
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(2)Stability protocol for continuing (i.e., ongoing) batches:
Protocol Parameter Description
Testing frequency
Storage conditions (and tolerances) of samples
Other
P 8.3 Stability Data
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 9 PRODUCT INTERCHANGEABILITY
P 9.1 Bioavailability / Bioequivalence Study
Details of the batches usedfor BA/BE study
Generic Product Submitted toHSA for Registration
Current RegisteredSingapore Reference
Product
Product Name
Strength of Dosage Form
Site of ManufactureSite of Batch Release N/A
Batch No.
Batch size N/A
Product formula Same as section P.3.2
Yes
No, please providejustification
N/A
Study Report NumberBA/BE Study Site (Name & Address)
Date of Inspection of Study
Name of Inspecting Agency/Authority
Availability of Inspection Report (Yes/No)
Generic Product Usedin BA/BE Study
Reference Product Usedin BA/BE Study
Product Name
Strength of Dosage FormSite of Manufacture
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Study Report Number
BA/BE Study Site (Name & Address)
Site of Batch Release
Country where the supply is
sourced for this study:
P 9.2 Comparative Dissolution Profile
Product 1: =
Product 2: =
Study Report Number:
Profile of Product 1 Profile of Product 2
Product Name
Strength of Dosage Form
Site of Manufacture
Site of Batch Release
Dissolution Method Used
Country where the supply issourced for this study:
Dissolution Test Results Profile of Product 1 Profile of Product 2
Medium 1
Range
Mean of 12 tablets
RSD
F2 Calculation
Medium 2
Range
Mean of 12 tablets
RSD
F2 Calculation
Medium 3
Range
Mean of 12 tablets
RSD
F2 Calculation
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Graphical Presentation Presented in Pages ..
Statistical Analysis
Hard Copy Location/Pages:
E-Copy Location/File Name:
Other Relevant Information:
A APPENDICES
A 1 FACILITIES AND EQUIPMENT (NAME, MANUFACTURER)
Hard Copy Location/Pages:
E-Copy Location/File Name:
A 2 ADVENTITIOUS AGENTS SAFETY EVALUATION (NAME, DOSAGE FORM, MANUFACTURER)
Hard Copy Location/Pages:E-Copy Location/File Name:
A 3 NOVEL EXCIPIENTS
Hard Copy Location/Pages:
E-Copy Location/File Name:
Applicants Name: Date:
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