GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APPENDIX 8
APRIL 2011
SINGAPORE QUALITY OVERALL SUMMARY
New 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 Singapore
QOS shall be submitted for review.
The applicant is responsible for completing all sections and fields. Sections and fields that are not
applicable should be indicated with “NA”. An explanatory note must immediately follow all “NA”
entries.
INTRODUCTION
Proprietary Name of Drug Product
INN Common Name of Drug
Substance
Product Owner Name
Licence Holder Name
Dosage Form
Strength(s)
Route of Administration
Proposed Indication(s)
Application Type
E.g. NDA-1, NDA-2, NDA-3, GDA-1, GDA-2 etc
Other introductory information:
Description of the dosage form: E.g. white, scored, round tablet
Container Closure System:
Shelf Life:
Storage Condition:
Others:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Appendix 8 - Page 1 of 22
GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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 (within
one 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. 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.
* If CEP is provided and Ph.Eur standard is claimed for drug substance, please fill in S1, S2.1, S4.1, S4.4, S6 # and S7#
If CEP is provided and other standards are claimed for drug substance, please fill in S1, S2.1, S4.1 to S4.5, S6 # 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:
Molecular Mass:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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-aqueous
solubility 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 proposed
production site or facility involved in manufacture and testing:
Activity
Name and Address
*GMP Compliance (Please
indicate Approving Agency)
Site of Manufacture
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:
Flow diagram of the synthetic process(es):
[insert diagram]
S 2.3 Control of Materials
Hard Copy Location/Pages:
E-Copy Location/File Name:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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:
Chemical
Name/Laboratory Code
Origin/Type of Impurity
Structure
[insert structure]
Process-related impurities (e.g., residual solvents):
Compound Name
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Step in Process
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Process-related impurities (e.g., residual solvents):
Compound Name
Step in Process
S 4 CONTROL OF THE DRUG SUBSTANCE
S 4.1 Drug Product Manufacturer’s Specification
Standard Claimed for the Drug Substance (e.g., USP, BP,
etc.):
Test
Method
(e.g., HPLC)
Source (e.g.,
USP, inhouse)
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Release
Specification
Shelf Life
Specification (if
applicable)
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
S 4.1 Drug Substance Manufacturer’s Specification (if different from above)
Standard Claimed for the Drug Substance (e.g., USP,
BP, etc.):
Test
Method
(e.g., HPLC)
Source (e.g.,
USP, inhouse)
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Release
Specification
Shelf Life
Specification (if
applicable)
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
S 4.2 Analytical Procedures (Drug Product Manufacturer)
S 4.3 Validation of Analytical Procedures (Drug Product Manufacturer)
For each test, please indicate “yes” or “no” as appropriate
System Suitability
Or Others
(Please specify)
Robustness
Limit of Quantitation
Limit of Detection
Precision
- Repeatability
- Intermediate
Precision
- Reproducibility
Accuracy
Range
Linearity
Selectivity
Method Description
Test Name
(as per S4.1)
S 4.2 Analytical Procedures (Drug Substance Manufacturer, if different from above)
S 4.3 Validation of Analytical Procedures (Drug Substance Manufacturer, if different from
above)
For each test, please indicate “yes” or “no” as appropriate
System Suitability
Or Others
(Please specify)
Robustness
Limit of Quantitation
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Limit of Detection
Precision
- Repeatability
- Intermediate
Precision
- Reproducibility
Accuracy
Range
Linearity
Selectivity
Method Description
Test Name
(as per S4.1)
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
S 4.4 Batch Analyses
Typical production batch size:
Batch Number
Batch Size
Batch Type
(pilot/production)
Date of
Production
Site 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:
Drug Substance
Batch Number
Source (e.g., USP, in-house)
Batch Number
Source (e.g., USP, in-house)
Primary Reference Standard
Working Standard
Impurities
Primary Reference Standard
Working Standard
S 6 CONTAINER CLOSURE SYSTEM
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Description of the container closure system(s) for the storage of the drug substance:
S 7 STABILITY
S 7.1 Stability Summary and Conclusions
Summary and discussion of all stability study results:
Hard Copy Location/Pages:
E-Copy Location/File Name:
Proposed Production Batch Size (kg):
Batch Number
Batch Size
Storage Conditions
(°C, % RH, light)
Date of
Manufacture
Site of Manufacture
Batch Number
Container Closure
System
Completed Test Intervals
E.g. 0, 3, 6, 9, 12, 18, 24, 36 months
Proposed storage conditions and re-test period (or shelf life, as appropriate):
Container Closure System
Storage Conditions
Re-test Period
Shelf Life
If applicable
If applicable
S 7.2 Post-approval Stability Protocol and Stability Commitment
Hard Copy Location/Pages:
E-Copy Location/File Name:
Stability protocol for commitment batches (if applicable):
Protocol Parameter
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Description
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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
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:
Presence of Score Line: Yes / No (delete as appropriate)
(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
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
(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:
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., optimization of
the process, selection of the method of sterilization, etc.):
Hard Copy Location/Pages:
E-Copy Location/File Name:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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 reactivity
tests, 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:
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 Batch Release
P 3.2 Batch Formula
List of all components of the dosage form to be used in the manufacturing process, and their amounts
on a per batch basis (including overages, if any):
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Strength (Label claim):
Batch Size (Number of dosage units):
Please provide batch formula for all proposed production batch sizes. If
a batch range is proposed, the minimum and maximum batch formula
should be provided.
Component
Quality Standard (or Grade)
Quantity per batch
Total
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):
[insert diagram]
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#:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Please check appropriate boxes.
____ (e.g. 3) full production batches were used in
the 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:
Product formula of validation batches:
Batch Number
Date of Production
Same as section P.3.2
Yes
No, please provide justification
Batch Size
Batch Type
(production/pilot/experimental)
Post-Approval Commitment
(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 include
supplementary 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
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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 acceptance criteria,
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
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., Source (e.g.,
HPLC)
USP, In-house)
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Release
Specification
Shelf Life
Specification
Appendix 8 - Page 15 of 22
GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Standard Claimed for the Drug Product
(e.g., USP, Ph.Eur, BP, JP etc.):
Test
Method (e.g., Source (e.g.,
HPLC)
USP, In-house)
Release
Specification
Shelf Life
Specification
P 5.2 Analytical Procedures
P 5.3 Validation of Analytical Procedures
For each test, please indicate “yes” or “no” as appropriate
System Suitability
Or Others
(Please specify)
Robustness
Limit of Quantitation
Limit of Detection
Precision
- Repeatability
- Intermediate
Precision
- Reproducibility
Accuracy
Range
Linearity
Selectivity
Method Description
Test Name
(as per P5.1)
P 5.4 Batch Analyses
Batch Number
Batch Size
Batch Type*
Date of
Production
Site of
Production
Site of Batch
Release
* describe purpose of batch – e.g. developmental, pilot, production, clinical, validation, commercial
P 5.5 Characterisation of Impurities
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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):
Chemical Name/Laboratory
Code
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 the
secondary standard has been standardised against an official standard should be provided. Data of
studies performed on working standard against primary standard should be included, together with
appropriate Certificate of Analysis.
Hard Copy Location/Pages:
E-Copy Location/File Name:
Drug Substance
Batch Number
Source (e.g., USP, in-house)
Batch Number
Source (e.g., USP, in-house)
Primary Reference Standard
Working Standard
Impurities
Primary Reference Standard
Working Standard
P 7 CONTAINER CLOSURE SYSTEM
Description of the container closure systems:
Description of Container Closure
Quantity Per Container
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Pack Size
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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):
Same as section P.3.2
Yes
No, please provide justification
Product formula of Stability Batches
Batch
Number
Batch Size
Storage Conditions
(°C, % RH, light)
Date of
Manufacture
Site of
Manufacture
Batch Number
Source of Active
Ingredient and
Batch Number
Container
Closure
System
Completed Test Intervals
E.g. 0, 3, 6, 9, 12, 18, 24, 36 months
In-use stability testing (where applicable):
In-use Storage Conditions
(°C, % RH, light)
Length of Storage prior to Start
of In-use Stability Testing
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Completed In-use Test Intervals
(e.g. minutes/ hours/ days)
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GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE
– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Proposed storage conditions and shelf life:
Container Closure System
Storage Conditions (with In-use Shelf Life (with In-use Period,
Storage Conditions, if applicable)
if applicable)
P 8.2 Post-Approval Stability Protocol and Stability Commitment
Hard Copy Location/Pages:
E-Copy Location/File Name:
(1) Stability protocol for commitment batches:
Protocol Parameter
Description
Number of batches per strength and batch
sizes
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 and
batch sizes
Tests and acceptance criteria
Container closure system(s)
Testing frequency
Storage conditions (and tolerances) of samples
Other
P 8.3 Stability Data
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
Hard Copy Location/Pages:
E-Copy Location/File Name:
P 9 PRODUCT INTERCHANGEABILITY
P 9.1 Bioavailability / Bioequivalence Study
Generic Product Submitted to
HSA for Registration
Current Registered
Singapore Reference
Product
Product Name
Strength of Dosage Form
Site of Manufacture
Site of Batch Release
N/A
Details of BA/BE Study:
Study Report Number
BA/BE Study Site (Name & Address)
Date of Inspection of Study
Name of Inspecting Agency/Authority
Availability of Inspection Report (Yes/No)
Generic Product Used
in BA/BE Study
Reference Product Used
in BA/BE Study
Product Name
Strength of Dosage Form
Site of Manufacture
Site of Batch Release
N/A
Country where the supply is
sourced for this study:
Batch No.
Batch size
Product formula
N/A
Same as section P.3.2
Yes
No, please provide justification
N/A
P 9.2 Comparative Dissolution Profile
Hard Copy Location/Pages:
E-Copy Location/File Name:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
State the Product Name & strength, batch number and either BE/SIN reference product or generic
product.
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
Country where the supply is
sourced for this study:
Description of Dissolution
Method Used
Dissolution Test
Results
e.g. USP paddle 1, 900mL, 50rpm
Profile of Product 1
*0min
15min
30min
45min
Profile of Product 2
60min
0min
15min
30min
45min
60min
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
Location of
Dissolution Graphs
*Please revise the table accordingly to suit the number of testing time intervals used.
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
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– SINGAPORE QUALITY OVERALL SUMMARY FOR CHEMICAL DRUGS
APRIL 2011
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:
Applicant’s Name:
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP
Date:
Appendix 8 - Page 22 of 22