1.0 OBJECTIVE
1.1 To lay down a standard procedure for technology transfer to Production department from R & D.
2.0 SCOPE
2.1 This SOP is applicable for manufacturing technology transfer at company Name.
3.0 RESPONSIBILITY
3.1 Chemist– Research and Development.
4.0 ACCOUNTABILITY
4.1 Manager– R&D
5.0 PROCEDURE
5.1 A formal approval by the appropriate authority for technology transfer has to be submitted to R&D.
5.2 The Manufacturing description and process flow diagram (Annexure II or MPCR (Annexure I) as per the requirement has to be given to Head-QA.
5.3 In a review meeting, Head-R & D, Head-Production and Head-QA shall look into the details of operations, equipment's, instrument and utilities required for production and analysis of the product.
5.4 The availability of all the facilities for taking a pilot batch has to be ensured and confirmed by heads of production, R & D and QA/QC departments.
5.5 R & D department has to give a list of raw materials and packaging materials along with specifications for a pilot batch, to the Head-Production.
5.6 The purchase of packing and raw materials has to be arranged.
5.7 Pilot scale batches of the product, as per the regulatory requirement of different countries, are manufactured by production, supervised by R&D and QA.
5.8 Final MPCR is transferred to production and the BPCR is prepared by production in coordination with R&D.
6.0 ABBREVIATIONS
6.1 MPCR Master Production & control records.
6.2 BPCR Batch Production & control records
.JPG)
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