Mon, 20 Nov 2017

Analytical Method Transfer for Solid Dosage Forms

Pradnya M. Mardolkar1*, Krishnananda K. Kamath1

1.Department of Quality Assurance, Srinivas College of Pharmacy, Mangalore, Karnataka,  India


ABSTRACT

The transfer of analytical procedure (TAP), also referred to as method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended. Method Transfer enables to adapt method to new facility or instrument and to meet new facility validation requirements and also helps to maintain validated state of method. It gives documented guidance in principle and provides general recommendations on the necessary activities that should be addressed to conduct a successful intra- or inter- site transfer. It applies to all dosage forms such as sterile products, metered-dose aerosols and clinical trial supplies. There are many approaches to Method Transfer such as Comparative Testing, Co-validation between two laboratories, Revalidation, Transfer waiver.

Keywords: Method Transfer, transferring unit, receiving unit, validation.

 


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