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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 sheetExisting 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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