Product analysis - Pharmaceutical Biotechnology: Concepts and Aapplications - page 202

core principle of GMP as applied to (bio)pharmaceutical manufacture, as such studies help assure
the overall safety of the fi nished product (Box 7.2).
All validation procedures must be carefully designed and fully documented in written format
(Box 7.2). The results of all validation studies undertaken must also be documented, and retained
in the plant fi les. As part of their routine inspection of manufacturing facilities, regulatory person-
nel will usually inspect a sample of these records, to ensure conformance to GMP.
Validation studies encompass all aspects of (bio)pharmaceutical manufacture. All new items
of equipment must be validated before being routinely used. Initial validation studies should be

Box 7.2

Validation studies: a glossary of some important terms

Validation master plan Document that serves as an overall guide for a facility's vali-

dation progra m me. It identifi es all items/procedures, etc., that
must be subjected to validation studies, describes the nature
of testing in each instance and defi nes the responsibilities of
those engaged in validation activities

Validation protocol Document describing the specifi c item to be validated, the

specifi c validation protocol to be carried out and acceptable
results, as per acceptance criteria

Prospective validation Validation undertaken prior to commencement of routine

product manufacture

Concurrent validation Validation undertaken while routine manufacture of product

is also taking place

Retrospective validation Validation carried out by review of historical records

Qualifi cation How an individual element of an overall validation pro-

gramme performs. When validation of that specifi c element
is complete, it is 'qualifi ed'. When all elements are (satisfac-
torily) completed the system is validated

Design qualifi cation Auditing the design of a facility (or element of a facility, such

as a cleanroom) to ensure that it is compliant with the specifi -
cations laid down and that it is, therefore, capable of meeting
GMP requirements

Installation qualifi cation Auditing/testing to ensure that specifi c items of equipment

have been correctly installed in accordance with the design
specifi cations laid down

Operational qualifi cation Auditing/testing process that evaluates the system being

tested to make sure that it is fully operational and will per-
form within operating specifi cations

Performance qualifi cation Demonstration that equipment/processes operate satisfac-

torily and consistently during the manufacture of actual
product