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 /