Beruflich Dokumente
Kultur Dokumente
to
Pharmaceutical
Validation
www.parasshah.weebly.com
1
Contents
• What is Validation?
• Approaches to validation
• Scope of validation
• Advantages of validation
1. Prospective validation
1. Concurrent validation
2. Retrospective validation
3. Revalidation
• Prerequisites for process validation
• Qualification
1. Design qualification
2. Installation qualification
3. Operational qualification
4. Performance qualification
• References
What is Validation?
Definition :
ISO definition :
validation is to:
a. Production
b. Engineering
c. Calibration laboratory
e. Maintenance
f. HVAC
g. Product development
Department interaction :
• Once the validation team has been constituted and mission
have been formalized, the team will interact with different
departments which are :
I. Research and development department
II. Engineering department,
III.Production department,
IV.Maintenance department,
V. Quality control department,
VI.Quality assurance department.
Types of Documentation
• Protocol consists of :
– Objectives of the validation and qualification study
– Site of the study
– Responsible personnel
– Description of the equipment
– SOPs
– Standards
– Criteria for the relevant products and processes
Report
• Report consists of :
– Title
– Objective of the study
– Refer to the protocol
– Details of material
– Equipment
– Programmes and cycles use
– Details of procedure and test methods
Validation Master Plan
Principle
Multidisciplinary approach:
Time constraint:
Generally validation work is submitted to rigorous time schedules. These studies are
always the last stage prior to taking new processes, facilities into routine operation.
Costs:
Validation studies are costly as they require time of highly specialized personnel and
expensive technology.
Purpose
Introduction
• Firm's validation policy, general description of the scope of
those operations covered by the VMP, location and schedule
(including priorities).
contain:
All items covered by the VMP that are subject to validation describing the
Documentation Format
• The format to be used for protocols and reports should be
described or referred to.
Required SOP's
• List of relevant SOP’s should be presented.
Planning & Scheduling
• An estimate of staffing (including training needs), equipment and
other specific requirements to complete the validation effort should
be described in the VMP. A time plan of the project with detailed
planning of subprojects. This time plan could be included in the
above mentioned matrix A VMP requires regular updating.
Change Control
• A statement of the company's commitment to controlling critical
changes to materials, facilities, equipment or processes (including
analytical techniques), should be included.
Types of Process Validation
• Experimental approach
– Prospective validation
– Concurrent validation
– Retrospective validation
• Revalidation
– Periodic revalidation
a review of historical data, i.e. data generated during in-process and finished
product testing after the latest validation, aimed at verifying that the process is
under control. During the review of such historical data, any trend in the data
of a scheduled revalidation:
• Have any changes in master formula and methods, batch size, etc.,
updated?