ACTD for Generic drug
Part I: Administrative data and product information
1.Section A: Introduction (product name, therapeutic classification)
2.Section B: Table of contents
Certifications: Certificate of GMP, Certificate of Free Sale ,from the the FDA and certified by
Thai embassy in that manufacturer country.
3.Section C: Documents required for registration
3.1 Reference of Pharmacology of Product.
1.Pharmacodynamics/Pharmacokinetics.
2.Indications.
3.Recommended Do
摄像头怎么安装4.Mode of Administration.
5.Contraindication.
6.Warning and Precautions.
7.Interaction with other medicaments.
8.Pregnancy and lactation
9.Undesirable effects
10.Overdo and treatment
11. Storage Condition.
We must show the document in the Package inrt,and attached to FDA 3.2 Labeling
Unit carton: Product name, Dosage form, Name of active ingredient, Batch No.,
Manufacturing date, Expiration date, Route of administration,
Storage condition, Country’s registration number, Name and
address of marketing authorization holder (importer), Name and
address of manufacturer, Special labeling (local requirement),
Recommended daily allowance for vitamins and minerals, Warning
(local requirement), Pack sizes
Inner label: Product name, Dosage form*, Name of active ingredient, Batch No., Manufacturing date*, Expiration date, Route of administration, Storage condition*, Country’s registration number*, Name and address of marketing authorization holder (importer)*, Name and address of manufacturer*, Special labeling (local requirement)*, Recommended daily allowance for vitamins and minerals*, Warning (local requirement)*, Pack sizes
* exempt for small ampoule and vial (area is not more than 3 sq.
inches)
Blister/Strips: Product name, Name of active ingredient*, Strength of active ingredient*, Batch No., Expiration date* exempt for more than 3 active ingredients
-Product information (Package inrt, Reference to support the content on
package inrt):
Product name, Name and strength of active ingredient, product description,
Pharmacodynamic/Pharmacokinetic, Indication, Recommended do, Mode of
administration, Contraindication, Warning and precaution, Interactions with
other medicaments, Pregnancy and lactation, Undesirable effects, Overdo and
treatment, Storage condition, Dosage forms and packaging available, Name and
address of manufacturing / Marketing authorization holder, Date of revision of
package inrt
3.3 The picture of product with scale for tablet or capsule.
3.4 Sample for registration
Part II: Quality
表示看的词语4个字Section A: Table of contents
Section B: Quality overall summary (plea e the detail of required documents below) Section C: Body of data (plea e the detail of required documents below)
Section D: Key literature reference, if applicable
Section B: Quality overall summary
S. Drug substance:
S1.General information:
1.1Nomenclature
1.2Structure
1.3General properties
S2. Manufacture: Name and Address of Manufacturer
S3. Characterization:
3.1 Elucidation of structure and other characteristics
3.2 Impurities
S4. Control of drug substance:
4.1 Specification, Certificate of analysis
4.2 Analytical procedures
4.3 Validation of analytical procedures
S5. Reference standards or materials
S7. Stability
P. Drug product
P1. Description and composition
P2. Pharmaceutical development:
2.2 Component of drug product
2.3 Finished product
2.5 Container closure system
2.6 Microbiological attributes
2.7 Compatibility
P3. Manufacture:
3.1 Unit Formula and Batch formula
3.2 Manufacturing process and process control
3.3 Control of critical steps and intermediates
3.4 Process validation and/or evaluation
P4. Control of excipients:
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4.1 Specifications
4.2 Analytical procedures
4.3 Excipient of human or animal origin
P5. Control of finished product:
5.1 Specification, Certificate of analysis
5.2 Analytical procedures
5.3 Validation of analytical procedures
5.4 Batch analys
5.5 Characterization of impurities卡塔尔半岛
5.6 Justification of specification
P6. Reference standards or materials
P7. Closure container system
P8. Stability
P9. Product interchangeability equivalence evidence
Section C: Body of data
S. Drug substance:
紧张近义词S1.General information:
1.1Nomenclature
1.2Structure
1.3General properties
S2. Manufacture: Manufacturer
S3. Characterization:
3.1 Elucidation of structure and other characteristics
3.2 Impurities
S4. Control of drug substance:
4.1 Specification, Certificate of analysis
4.2 Analytical procedures
4.3 Validation of analytical procedures
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S5. Reference standards or materials
S7. Stability
P. Drug product
P1. Description and composition
P2. Pharmaceutical development:
2.2 Component of drug product
2.2.1 Active ingredient
2.2.2 Excipients
2.3 Finished product
2.3.1 Formulation development
2.3.2 Overages
2.3.3 Physicochemical and biological properties
2.5 Container closure system
2.6 Microbiological attributes
2.7 Compatibility
P3. Manufacture:
3.1 Batch formula
3.2 Manufacturing process and process control
3.3 Control of critical steps and intermediates
3.4 Process validation and/or evaluation
P4. Control of excipients:
4.1 Specifications
4.2 Analytical procedures
4.3 Excipient of human or animal origin
P5. Control of finished product:
5.1 Specification, Certificate of analysis
5.2 Analytical procedures
5.3 Validation of analytical procedures
5.4 Batch analys
5.5 Characterization of impurities
5.6 Justification of specification保安年终总结
P6. Reference standards or materials
P7. Closure container system
P8. Stability (Stability summary and conclusion, Post- approval stability protocol and stability commitment, Stability data)
P9. Product interchangeability equivalence evidence
-Bioequivalence study data in ca of AZT, sustained relea, as
requested),In vitro – In vivo correlation (IVIVC for sustained relea)
Detail of each part
S.Drug Substance
Active ingredient Official in Pharmacopia
1.Attached the monograph of Active ingredient and excipients from BP,or
USP,Eur.Ph,orJapan pharm.
2.From the monograph we must prepare the table of the specification
and control method.
Test Requirements Method
3.Attached the method of Identification and data of testing e.g TLC, UV-
Spectrum,IR-Spectrum, or retention time of sample and reference Standard ..
4.Attached the Method of Analytical and Analytical data e.g UV-Spectrum,IR-
Spectrum,HPLC Chromatogram of sample and reference Standard ,and certificate
of analysis.and raw data of analysis.
5.Attached the Chromatogram of testing impurity or related substance.
6.Attached the Certificate of Analysis from the manufacturer, of all
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substances.
P.Drug Product
A.Product Official in Pharmacopia
1.Attached the monograph of the dosage form from BP,or USP,Eur.Ph.
2.From the monograph we must prepare the table of the specification
and control method.
Test Requirements Method
3.Attached the method of Identification and data of testing e.g TLC, UV-
Spectrum,IR-Spectrum, or retention time of sample and reference Standard ..
4.Attached the Method of Analytical and Analytical data e.g UV-Spectrum,IR-
Spectrum,HPLC Chromatogram of sample and reference Standard ,and certificate
of analysis.and raw data of analysis..
5.Attached the Chromatogram of testing impurity or related substance.
B.Product Non Official in Pharmacopia
1.Attached the literature of the dosage form .
2.From the literature we must prepare the table of the specification
and control method.
Test Requirements Method
3.Attached the method of Identification and data of testing e.g TLC, UV-
Spectrum,IR-Spectrum, or retention time of sample and reference Standard ..
4.Attached theValidation Method of Analysis,:-Precision,Accuracy,Lineality
ect. and Analytical data e.g UV-Spectrum,IR-Spectrum,HPLC Chromatogram of
sample and reference Standard ,and certificate of analysis.and raw data of
analysis..
5.Attached the Chromatogram of testing impurity or related substance
