Gap analysis

Identification of critical elements of a process which are available at the SU but are

missing from the RU.

Good manufacturing practices (GMP)

That part of quality assurance which ensures that pharmaceutical products are

consistently produced and controlled to the quality standards appropriate to their

intended use and as required by the marketing authorization.

In-process control (IPC)

Checks performed during production in order to monitor and, if necessary, to adjust

the process to ensure that the product conforms to its specifications. The control of the

environment or equipment may also be regarded as a part of in-process control.

Installation qualification (IQ)

The performance of tests to ensure that the installations (such as machines, measuring

devices, utilities and manufacturing areas) used in a manufacturing process are

appropriately selected and correctly installed and operate in accordance with

established specifications.

Intercompany transfer

A transfer of technology between sites of different companies.

Intracompany transfer

A transfer of technology between sites of the same group of companies.

Operational qualification (OQ)

Documented verification that the system or subsystem performs as intended overall

anticipated operating ranges.

Performance qualification (PQ)

Documented verification that the equipment or system operates consistently and gives

reproducibility within defined specifications and parameters for prolonged periods

(in the context of systems, the term "process validation"may also be used.)

Process validation

Documented evidence which provides a high degree of assurance that a specific process

will consistently result in a product that meets its predetermined specifications and

quality characteristics.

Qualification

Action of proving and documenting that any premises, systems and equipment are

properly installed, and/or work correctly and lead to the expected results. Qualification

is often a part (the initial stage) of validation, but the individual qualification steps

alone do not constitute process validation.

WHO Guidelines for Transfer of Technology 65

Qualification batches

Those batches produced by the RU to demonstrate its ability to reproduce the product.

Quality assurance (QA)