QAS-001 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 131

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

c . Concurrent: A combination of retrospective and prospective validation performed
against an approved protocol but the product is released on a lot by lot basis. Used
on existing product that has not been previously validated or insufficiently
validated.

d . Installation qualification: When new equipment is installed it should be confirmed

that it operates in accordance with design specification or “equipment installed vs
design specification.” It includes checking the electrical and mechanical input and out-
put flow, directions of valves, operational speed, calibration of control features, and
operation of automatic control devices.

e . Operational qualification: The purpose of the study is to verify that the equipment is

capable of processing at established parameters which will confirm respective specifi-
cation requirements.

f . Performance qualification: To ensure that the system will operate and produce

expected product quality results.

g . Validation master plan preparation: The purpose of the plan is to

i. Define all the plant activities, for example, facility, equipment, processes, HVAC
system, water system, utilities, cGMP requirements, and products requiring
validation.

ii. Refer all the plans, procedures, and time table intended for accomplishing the
validation.

The QA manager shall prepare the validation master plan. The following validation requirements
must be considered during the preparation of the validation master plan.

• Deinitionsoftheterm“validation”
• What is validation master plan
• Validation team member
• Validation team responsibility
• Concept of qualiication/validation
• Facility description
• Equipment description
• HVAC description
• Utilities description
• Validation program overview
− Validation project management

− Validation responsibilities

− Design and validability review

− Enhanced turn-over package

− Installation qualification protocols

− OQ protocols

− PQ protocols

− Process validation (PV) protocols

− Change control initiation

− Cycle development

− Validation final reports

− Validation package

− Certificate for use in manufacturing

− Required protocols and procedures