Action of proving and documenting that any process, procedure or method actually
and consistently leads to the expected results.
A high-level document that establishes an umbrella validation plan for the entire project
and summarizes the manufacturers overall philosophy and approach, to be used for
establishing performance adequacy. It provides information on the manufacturer’s
validation work programme and defines details of and timescales for the validation
work to be performed, including a statement of the responsibilities of those
Validation protocol or plan (VP)
A document describing the activities to be performed in a validation, including the
acceptance criteria for the approval of a manufacturing process—or a part thereof—
A document in which the records, results and evaluation of a completed validation
programme are assembled and summarized. It may also contain proposals for the
improvement of processes and/or equipment.
5.5 ORGANISATION AND MANAGEMENT
The transfer of technology includes SU and RU, in some cases an additional unit (which
is responsible for directing, managing and approving the transfer).
The main objective of organisation and management in technology transfer is to
ensure that the main steps of TOT should have been properly executed and documented
Responsibilities and principles to be followed by RU and SU under this section are
i. There will be a formal agreement between RU and SU. This agreement specifies
the responsibilities of both the parties before, during and after TOT.
ii. There should be a project management plan whose main objective is to control
all the necessary activities identified at the start of the undertaking. The project
management plan is generally a document which specifies each phase of a project
like initiating, planning, executing, monitoring, controlling and closing. It can be
called a collection of sub-plans like management plan for scope, quality, human
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