Validation

Action of proving and documenting that any process, procedure or method actually

and consistently leads to the expected results.

66 Industrial Pharmacy II

Validation master plan (VMP)

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

implementing the plan.

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—

for routine use.

Validation report (VR)

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

as well.

Responsibilities and principles to be followed by RU and SU under this section are

as follows:

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

resources, risk, communication, profit, procurement, etc.