IMPD Template Quality
IMPD Template Quality
IMPD Template Quality
FOR
PRODUCT NAME
Page
A. QUALITY DATA...........................................................................................1
2.1.S.2 Manufacture................................................................................................1
2.1.S.2.1 Manufacturer(s).......................................................................................1
2.1.S.2.2 Description of Manufacturing Process and Process Controls.................1
2.1.S.2.3 Control of Materials.................................................................................1
2.1.S.2.4 Control of Critical Steps and Intermediates.............................................1
2.1.S.2.5 Process Validation and/or Evaluation......................................................1
2.1.S.2.6 Manufacturing Process Development.....................................................1
2.1.S.3 Characterisation..........................................................................................1
2.1.S.3.1 Elucidation of Structure and Other Characterisation...............................1
2.1.S.3.2 Impurities.................................................................................................1
2.1.S.7 Stability........................................................................................................1
2.1.S.7.1 Stability Summary and Conclusions........................................................1
2.1.S.7.2 Post Approval Stability Protocol and Stability Commitment....................1
2.1.S.7.3 Stability Data............................................................................................1
2.1.P.3 Manufacture................................................................................................1
2.1.P.3.1 Manufacturer(s).......................................................................................1
2.1.P.3.2 Batch Formula.........................................................................................1
2.1.P.3.3 Description of Manufacturing Process and Controls...............................1
2.1.P.3.4 Controls of Critical Steps and Intermediates...........................................1
2.1.P.3.5 Process Validation and/ or Evaluation.....................................................1
2.1.P.8 Stability........................................................................................................1
2.1.P.8.1 Stability Summary and Conclusion..........................................................1
2.1.P.8.2 Post-Approval Stability Protocol and Stability Commitment....................1
2.1.P.8.3 Stability Data............................................................................................1
2.1.A APPENDICES.............................................................................................1
2
Product CONFIDENTIAL
A. QUALITY DATA
1
Product CONFIDENTIAL
2.1.S.1.1 Nomenclature
Compendial Name
Chemical Name(s)
Laboratory Code(s)
2.1.S.1.2 Structure
Structural Formula
Molecular Formula
2
Product CONFIDENTIAL
Chirality
Solubility
Physical Characteristics
Melting Point
Polymorphism
Hydroscopicity
pKa – values(s)
Partition coefficient
2.1.S.2 Manufacture
2.1.S.2.1 Manufacturer(s)
3
Product CONFIDENTIAL
Synthetic Route
Process Description
Any Other Methods Used to Prepare Batches Used in Preclinical Studies or Earlier
Clinical Trials
4
Product CONFIDENTIAL
2.1.S.3 Characterisation
Potential Isomerism
Physicochemical Characterisation
Analytical Validation
2.1.S.3.2 Impurities
2.1.S.4.1 Specification
Test Specification
Batches Tested
Results of Tests
6
Product CONFIDENTIAL
2.1.S.7 Stability
Batch(es) Tested
Assay
7
Product CONFIDENTIAL
Conclusions and how the Retest Period is established if not readily apparent
8
Product CONFIDENTIAL
Other ingredient(s):
2.1.P.2.1.2 Excipients
9
Product CONFIDENTIAL
2.1.P.2.2.2 Overages
2.1.P.2.6 Compatibility
2.1.P.3 Manufacture
2.1.P.3.1 Manufacturer(s)
Batch Size
Formula
10
Product CONFIDENTIAL
Ingredient Quantity
2.1.P.4.1 Specifications
11
Product CONFIDENTIAL
2.1.P.5.1 Specification(s)
Test Specification
12
Product CONFIDENTIAL
2.1.P.8 Stability
Test Specification
13
Product CONFIDENTIAL
Characteristics Studied
Physical Characteristics
Chemical Characteristics
Microbiological Characteristics
Chromatographic Characteristics
14
Product CONFIDENTIAL
15
Product CONFIDENTIAL
ND None Detected
NA Data not yet available
NP Not preformed per protocol
16
Product CONFIDENTIAL
2.1.A APPENDICES