How to Create a Dossier for ASEAN Countries.


ASEAN common dossier is a format for dossier approved for following countries.
  • Brunei
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Laos and Burma
  • Cambodia
I have created a point to point illustration to create and understand the dossier for ASEAN Countries.
First of all Create a nice Looking Cover Page mentioning …ASEAN COMMON TECHNICAL DOSSIER for Products…with Label Claim and your company Name and rest is as below.
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  1. APPLICATION FORM :- Enclose  A Copy of Application from provided by your overseas agent who will submit the dossier to another countries FDA Department.
  2. LETTER OF AUTHORISATION Enclose   as provided by your overseas agent.
  3. CERTIFICATION :- This Part Includes Product License, WHO-COPP and GMP Certificate.
      3.3 For imported products
  • License of pharmaceutical industries/importer/wholesaler(country specific)
  • Certificate of Pharmaceutical Product issued by the competent authority in the country of origin according to the current WHO format.
  • GMP CERTIFICATE
  • Site master file of manufacturer (unless previously submitted within the last 2 years) (Country specific)  Enclose a copy of your Site Master File if not shared earlier

4. LABELLING  :- Mention the Product Labeling i.e. Carton/Label/Bottle etc…
5. PRODUCT INFORMATION
5.1 Package insert (package insert is required for generic products ) Make a Package Insert as below.
  • Description: Product Description..name and label claim.
  • Indications: for which dieses it will be helpful.
  • Contraindications: Mention Contra-Indications if any with the Product
  • Precautions:  to be taken care while using the product by customer.
  • Adverse reactions:  Mentioned this point if any..
  • Laboratory interference:
  • Dosage and administration: How to take the preparation…
  • Presentation: How the Finished Product looks like..
5.2 Summary of Product Characteristic ( Product Data Sheet )(required for NCE & Biotechnology products)
5.2.1 Name of the Medicinal Product
  • (a) Product Name :- Mentioned Finished Product Name
  • (b) Strength :- I.e. 100 ml… or 500 mg tablets.
  • (c) Pharmaceutical Dosage Form  : Tablet/Capsules/Liquid/Syrup etc.
5.2.2 Quality and Quantitative Composition : Mentioned All the items of your product i.e. Active/excipients in each 5 ml or per tablet.
5.2.3 Pharmaceutical Form Visual description of the appearance of the product (color, markings.etc)
  • Appearance:  How it will look…
  • Packing details: Like 100 ml PET Amber bottle or Strip of
5.2.4 Clinical Particulars
  • (a) THERAPEUTIC INDICATIONS :- Mention the Indications of Finished Product why and when it should be used.
  • ( b) Posology and method of administration:- How Much time it will take to cure the disease
  • ( c) Contraindications:- Mentioned if any.
  • ( d) Special warnings and precautions for use :- Mentioned if any.
  • ( e) Interaction with other medicinal products and other forms of interaction
  • ( f) Pregnancy and lactation
  • (g) Effects on ability to drive and use machines
  • (h) Undesirable effects
  • (i) Overdose
5.2.5 PHARMACOLOGICAL PROPERTIES. Mentioned Pharmacological Properties of Active Raw Material used.
5.2.6 PHARMACEUTICAL PARTICULARS
  • (a) List of Excipients : Mentioned the List of Excipients being used in your Product.
  • (b) Incompatibilities : Mentioned if any.
  • (c) Shelf life : Mentioned as per the Stability of Finished Product.
  • (d) Special precautions for storage:- Storage Conditions.
  • (e) Nature and contents of container:  Packaging Style of Finished Product.
5.2.7 Marketing Authorization Holder:- Mentioned who will hold the marketing for the product.
5.2.8 Marketing Authorization Numbers:-  Mentioned if any.
5.2.9 Date of first authorization/ renewal of the authorization First Authorization (As per your Agent)
5.2.10 Date of revision of the text (Mentioned if any)
5.3 Patient Information Leaflet (PIL)  Insert a soft copy of Packaging Insert having all the points as mentioned earlier.
S-DRUG SUBSTANCES
S1 I. General Information – API-2
  1. Name of Active Product Ingredient
  2. Molecular Formula Active Product Ingredient
    1. Molecular mass Active Product Ingredient
    2. Chemical Name Active Product Ingredient
  3. Description of Active Product Ingredient
S1 I. General Information –  API-2
  1. Name of Active Product Ingredient
  2. Molecular Formula Active Product Ingredient
    1. Molecular mass Active Product Ingredient
    2. Chemical Name Active Product Ingredient
  3. Description of Active Product Ingredient
And so on…
S2 MANUFACTURE
S2.1 Manufacturer (s) of API  (Mentioned the Name and Address of Manufacturers from whom you are getting the API (Active Product Ingredients )
P - DRUG PRODUCT (Finished Product)
P1 Description and Composition: -
  • Dosage Form & Characteristics :
  • Type of Container & Closer :
  • Components of the Drug Product (Label Claim)
  • Active ingredient
P2.1 Information on development Studies:
P2.2 Components of the Drug Product  (Mention as per below Table)
Sr. No. Name of Raw Material Category Pharmacopoeial Specification

P2.2.1 Active Ingredients
P2.2.2 Excipients :-
P2.3 Finished Product : (Mention Finished Product Name)
P2.4 Manufacturing Process Development : Enclosed Copy of Master Formula or Batch Manufacturing Record
P2.5 Container Closure System : Packing Style of Finished Product. Also Enclosed Specifications/Certificate of analysis of Packing Material.
P2.6 Microbiological Attributes:-
P2.7 Compatibility: Not Applicable
P3 MANUFACTURING DETAILS
P3.1 Batch Formula :
  • Product Name:
  • Dosage form :
  • Strength:
  • Product Description and Appearance:.
  • Formula:  (As per Below Table)
Sr. No. Name of Raw Material Category Pharmacopoeial Specification Quantity per tablet/Bottle
(mg/ml)
1

P3.3 Control of Critical Steps and Intermediates
- Tests and acceptance criteria as per the reference Pharmacopeia.
(A) RAW MATERIAL DISPENSING : (Process for RM Issue)
(B) PACKING MATERIAL DISPENSING : (Process for PM Issue)
(C) MANUFACTURING : (Please Mentioned Complete Process as per BMR)
P3.4 Process Validation and/or Evaluation
P4 CONTROL OF EXCIPIENTS (RM Specifications/COA
P4.1 - Specifications for Excipients. *
- Compendia requirement or appropriate information from the manufacturer
P4.2 Analytical Procedures used for testing Excipients where appropriate.
P4.3 Excipient of Human or Animal Origin Information regarding sources and or adventious agents.*
P4.4 Novel Excipients : Not Applicable.
P5. CONTROL OF FINISHED PRODUCT
P5.1 Specification

P5.2 ANALYTICAL PROCEDURE Method of Analysis
P5.3 VALIDATION OF ANALYTICAL PROCEDURES
P5.4 BATCH ANALYSES (COA of Finished Product)
P5.6 JUSTIFICATION OF SPECIFICATION(S)  (From where you have taken the specifications)
P6 CONTAINER CLOSURE SYSTEM – PACKING STYLE  (We have already mentioned it 3-4 times in this dossier so you can use the same.)
P8 STABILITY STUDY PROTOCOL 3 Batches of Stability.
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That all However providing all the details make at least 150-200 pages file. Just copy above in a word file and start filling the data..
Hope this is helpful to you..

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