NEW PRODUCT STARTUP SURVEY PROFORMA

Purpose:

It is established for New Product Startup Survey Proforma.

2. Scope:

This procedure is applicable to R&D department.

3. Responsibilities:

1. Manager R&D

2. R&D Pharmacist

4. Procedure:

1. This proforma is completed and planed by Manager R&D.
2. This proforma shows all steps involved in the development of the product.
3. Product design No. is given for each product being developed by R&D deparment.
4. Procurement of the equipment, raw material and trials of the raw material are documented and mentioned on this proforma.
5. Samples of the raw material taken by QC are also documented.
6. Test by QC of bulk and finish product are mentioned on the proforma.
7. Pre formulation plus formula design is mentioned on the proforma.
8. Product cost (MRP) is calculated and mentioned on the proforma.
9. Design planning, design review with all interfaces, packaging material designing and design validation are also mentioned.
10. Accelerated stability studies data is also mentioned.
11. Following documents are also developed and documented.

a) Raw material specification b) Product specification c) Packing specification

d) Analytical Testing Method e) Batch processing sheet

12. Existing facilities are also mentioned.

13. Difficulties and rectification period are also mentioned.