SOP for New Product Startup Survey Proforma

Purpose

It is established for New Product Startup Survey Proforma.

Scope

This procedure is applicable to the R&D department.

Responsibilities

Manager R&D

R&D Pharmacist

Procedure

• This proforma is completed and planned by the Manager of R&D.
• This proforma shows all steps involved in the development of the product.
• Product design No. is given for each product being developed by the R&D department.
• Procurement of the equipment, raw material and trials of the raw material is documented and mentioned in this proforma.
• Samples of the raw material taken by QC are also documented.
• Test by QC of bulk and the finished product is mentioned on the proforma.
• Pre-formulation plus formula design is mentioned on the proforma.
• Product cost (MRP) is calculated and mentioned on the proforma.

• Design planning, design review with all interfaces, packaging material designing and design validation are also mentioned.
• Accelerated stability studies data is also mentioned.
• The following documents are also developed and documented.

1. Raw material specification
2. Product specification
3. Packing specification
4. Analytical Testing Method
5. Batch processing sheet Existing facilities are also mentioned.

• Difficulties and rectification periods are also mentioned.

Abbreviation

R&D: Research & Development

Annexure

Nil

Revision History

Nil

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