in this post Trials For New Products SOP is describe below with all detail.
Trials For New Products SOP Purpose:
To designed to provide a standard procedure for the formulation development of new products.
Scope:
It is applicable in Production Department.
Responsibility:
Production Manager
Production Pharmacist
Quality Assurance Manager
Procedure:
Trial for formulation development of a new product is carried out as follows:
Written or verbal instructions for launching of new products are received from C.E.O.
Dosage form of product to be formulated is checked in reference books.
One or two samples of same dosage form of leading manufacturers are collected from market to check the physical characteristics of the product.
Some reference books e.g. Pharma guide, PDR etc. is also consulted to gather the information regarding composition of formulation.
Some trials are carried out based upon tentative formulation.
Detail of tentative formulation and method of manufacturing is record in relevant Performa.
After the completion of trial the sample of each trial is given to Q.C.D. for analysis and stability studies purpose.
On the bases of analytical results and stability, suitable formulation is chosen for commercial manufacturing.