QAS-001 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 133

SOP No. QAS-001.00 Effective date: mm/dd/yyyy
Approved by:

The departmental managers are responsible for checking and reviewing the plan. Directors of R&D,
QC, maintenance, and production departments are responsible for the plan approvals. The QA
director will sign the plan to give authorization.

20.5.2 P rotocolS d eveloPment
The QA manager or designate will be responsible for the development of a protocol with the consent
of validation team members. Selected tests are carried out according to the designed protocol to
accumulate data that are subjected to evaluation.
New equipment to be identified in the plan and IQ, OQ, and PQ shall be carried out. Existing
equipments revalidation will be carried out as per SOP QAS-000.

20.5.2.1 installation Qualification
Validation establishes confidence in the process/equipment and ancillary system that they consis-
tently operate within established limits and tolerance and that they are installed properly.
This phase of validation will include the following or as appropriate:

i. Document description

ii. System description

iii. General characteristics

iv. Installation requirements

v. Documentation

For the detailed procedure refer to the corresponding SOP.

20.5.2.2 operational Qualification
The following elements of the process are to be analyzed at the initiation of the OQ program or as
appropriate:

i. Document description

ii. Operational checks

iii. Draft SOPs

iv. Identification of the personnel for training

v. Software/hardware structural testing

For the detailed procedure refer to the corresponding SOP.

20.5.2.3 Performance Qualification
The following elements of the process are to be analyzed at the initiation of the PQ program or as
appropriate:

i. Document description

ii. Approved SOPs

iii. Training record for identified personnel

iv. System recovery SOPs

v. PQ test

For the detailed procedure refer to the corresponding SOP.