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Dossier Checklist Topical-Plasters

The document provides a checklist of information needed to submit a product dossier for a topical plaster, including sections on product information, particulars, formula and quality, packaging, supplementary documents, and a stability test checklist. The checklist includes details on active and inactive ingredients, manufacturing processes, quality control tests, batch records, stability study protocols and results, packaging specifications, and required supporting documents like GMP and CFS certificates.

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Arif Amin
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319 views2 pages

Dossier Checklist Topical-Plasters

The document provides a checklist of information needed to submit a product dossier for a topical plaster, including sections on product information, particulars, formula and quality, packaging, supplementary documents, and a stability test checklist. The checklist includes details on active and inactive ingredients, manufacturing processes, quality control tests, batch records, stability study protocols and results, packaging specifications, and required supporting documents like GMP and CFS certificates.

Uploaded by

Arif Amin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Dossier Checklist

PRODUCT INFORMATION
1 Product Name
2 Dosage Form:
3 Active ingredients (strength, source)
4 List of Excipients (quantity, function)
PRODUCT PARTICULARS
Product Description – Colour, shape, and dimension
1
Example : Brown color self-adhesive patch, with a hint of spicy scent, sized 10 cm* 7cm.
2 Indication/Usage
3 Recommended dose
4 Route of administration - Topical
5 Contraindication
6 Warning & precaution
7 Drug interaction
8 Pregnancy & lactation
9 Side effects
10 Symptoms & treatment of over-dosage
11 Storage condition - Include range or exact temperature.
12 Shelf-life
PRODUCT FORMULA / QUALITY
1 Batch Manufacturing Formula (BMF) - *Refer to Document Template Topical -Plasters.doc pg.2
In-Process Quality Control (IPQC) -specifications for each stage, type of tests, test reference,
2 frequency of sampling, quantity of samples taken. *Refer to Document Template Topical -Plasters
.doc pg.4
3 Description of Manufacturing Processes *Refer to Document Template Topical -Plasters.doc pg.2
Manufacturing Process Flowchart - Include all the IPQC in the flowchart. *Refer to Document
4
Template Topical -Plasters .doc pg. 3
5 Finish Product Specifications(FPS) - *Refer to Document Template Topical -Plasters .doc pg. 5

Certificate of Analysis
i. Finished product (2 batches)
ii. Excipients ( Please provide clear original COA from supplier)
6
iii. Active ingredients (1 batch; please provide clear original COA from supplier)
iv. Packaging
Protocol of Analysis (POA) -Every method used for all specification mentioned in Finished Product
7
Specification (FPS) need to be included.

Stability Study Data (According to Zone IVb)


- Accelerated (40 ˚C/RH 75%)
8
- Real time (30˚C/RH 75%)
*Refer to Document Template Topical -Plasters pg. 6

PRODUCT PACKAGING
1 Pack Size
2 Type of packaging materials used
3 Immediate/primary Label (artwork)
4 Outer/Secondary label (artwork)
SUPPLEMENTARY DOCUMENTS
1 Letter of Appointment/Authorization as Product Registration Holder
2 GMP Certificate
3 CFS Certificate
4 Manufacturer’s address

Stability Test Checklist

Stability Test Plaster/Patch Tablet Soft Capsule Hard Capsule


Appearance/ organoleptic (odor, color, taste) * / / / /
Assay – At least one of the active ingredients in product / / / /
Hardness/ friability /(Uncoated) /
Disintegration or dissolution rate / / /
Moisture content /
Microbial content / / / /
Adhesiveness /

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