The document contains essential information about a drug product to ensure its safe and effective use, including a scientific account of its benefits and limitations as supported by data. It provides an objective presentation devoid of promotional content. The product information must include details about the class, dosage form, primary packaging, manufacturing area/equipment availability, materials, and stability to support product launch.

1. PRODUCT
INFORMATION

2. It is a document which contains
information sufficient to ensure safe and
effective use of the drug under nearly all
circumstances.
It is to present a scientific, objective account
of the drug's usefulness and limitations as
shown by the data supporting the application.
It is to be devoid of promotional material.

3.  Product classes
 Dosage form of Product
 Primary Packing
 Market survey / Availability of competitor’s sample
 Product Manufacturing area /Equipments availability
 Material Details
 Product stability
 Product launching
PRODUCT INFORMATION MUST BE COMPRISED OF
FOLLOWING:

4.  Nutraceutical Products
 Herbal Products
 Allopathetic Products

5.  Solid Dosage form
 Semisolid Dosage form
 Liquid Dosage Form
 Parental Dosage form

6. Primary packaging includes the materials that directly
come in contact with drug products, it includes:
Blister
Bottles
Tubes
Sachet
Jar
Dropper
S
p
r
a
y

7.  Collect Bench mark
 Screening of Bench mark

8. Area availability Includes;
 Dispensing
 Granulating
 Drying
 compression
 coating
 Filling
 Blistering
 storage

9. Availability of Equipments
 Punches and dyes
 coating machine
 capsule filling machine
 suspension /syrup/gel / cream filling machine
 blistering machine .

10.  In product detail complete information of
material included.
 It comprises complete information of label
claim and dosage as well.

11.  Prepare product on lab scale
 Evaluate necessary parameter
 After satisfactory results product placed on
stability

12.  Prepare Pilot batch
 Then prepare commercial batch