Transcript Validation - vishal Nakrani

VALIDATION & PERSONNEL
GUIDED BY:
DR.N.P. CHOTAI
PREPARED
&PRESENTED BY:
VISHAL B,NAKRANI
M.PHARM(Q.A.,2nd SEM.)
ID.NO:05PH912
DATE:31/05/06
1
Content:
•Validation definition
•Advantage of validation
•Protocol development
•GMP Inspector’s check list for validation
•Personnel
•Validation Working Groups
•Reference
2
Validation
WHO validation definition
The documented act of proving that
any procedure, process, equipment,
material, activity or system actually
leads to the expected results.
3
The WHO GMP Guidelines state:
Validation studies are an essential part of
good manufacturing practice and should
be conducted in accordance with
predefined protocols.
written report
process and procedures
processing
testing
cleaning procedures
4
Functionality, consistency and
repeatability
is confirmed by
validation
5
Validation as such
does not improve the process
but it
confirms and assures
that the process
Has been well developed
It is well maintained
It operates as it should
6
Advantages of validation:
 During the process the knowledge of process
increases
 Assures the repeatability of the process
 Assures the fluency of production
 Assures that the product is continuously
produce
according
to
the
marketing
authorisation
7
Decreases the risk of the manufacturing
problems
 Decreases the expenses caused by the
failures in production
Decreases the risks of failing in GMP
 Decreases the expenses of the every
day production even though the validation
itself will create expenses
8
Protocol development
Each stage in the validation of the overall
process should proceed in accordance with a
pre-established and formally approved
detailed, written protocol, or series of related
protocols.
Protocols should have a Title, Date and a
unique Identification or Reference Number.
They should be formally authorized/approved
by persons with the competence and
authority to do so.
9
It should specify the objectives and scope of
the study. Like, a clear and precise definition
of the process, equipment, system or subsystem which is to be the subject of the study,
with details of performance characteristics.
10
11
GMP Inspector’s
validation (1)
check
list
for
Check that the manufacturer has:
A VMP and
validation
multi-functional
team
for
Planned approach , defined requirements
Identified and described processes
Analyse the amount of validation work to
perform
12
GMP Inspector’s check list for validation
(2)
Check that the manufacturer has:
Selected methods and tools for validation
Created protocols
Performed DQ, IQ,
documented results
OQ,
PQ
and
Exerted change control, set revalidation
time
13
Validation - Logical
entity:
protocol +
procedure +
report
14
Personnel
• Personnel
actually
performing
any
validation studies, and in routine operation
can have so crucial an effect on the quality
of the end-product, it is appropriate and
necessary to consider both these aspects
of personnel involvement.
• Appropriately qualified personnel should
ensure that the protocol and the testing
methodology are properly evaluated and
certified.
15
• All personnel conducting tests should be
trained and experienced in the use of the
instruments, measuring devices and materials
used.
• Engineering/maintenance personnel should
be fully trained and competent in the
operation and maintenance of the machines,
equipment, and air control systems involved.
• Any operators involved in performing a
validation study should adopt the same
techniques, disciplines, and standards of
hygiene, clothing and behavior as in normal
routine manufacture.
16
• It is therefore vital that all personnel involved
in validation are trained, and fully
understand, the concepts and principles of
GMP, and validation.
• They must understand the importance of
personal hygiene and cleanliness, and be
made fully aware of the possible hazardous
consequences of product contamination.
• Operators should be provided with suitable
Clean Room clothing and trained in
appropriate gowning technique.
17
•The type of clothing to be worn, and
gowning process should be defined in written
procedures, available to the operators, and
preferably displayed in the changing room.
• The same clothing/gowning standards
should be observed during validation studies
as in routine production, and vice versa.
18
Validation Working Groups
The executive part of the validation work
should be delegated to dedicated personnel:
Director of validation
Manager or senior manager of validation
A representative from quality assurance
A representative from technical services
A representative
from
research
development
A representative from quality control
A representative from production
&
19
Director of validation
Primary responsibility:
• Directs company-wide process validation program.
• Directs company-wide cleaning validation program.
• Reviews and/or approves Master Batch Records for
development and Production, as required.
• support company-wide equipment qualification and
validation program.
20
• Supports company-wide computer system
validation program.
•Supports company-wide activities associated
with development of new technology,
improvement of existing technology and
utilizing newer, more automated equipment
and processes.
•Supports
company
management
in
evaluation of new products, technology and
equipment.
21
Essential functions:
Designs, implements and oversees company-wide
programs for process and cleaning validation.
Ensures that the system is in compliance with federal
and industry guidelines, and that each system is
documented and tracked in an orderly manner.
Designs, implements and oversees studies aimed to
determine whether process or systems meet or
exceed the specifications of its design, is suitable for
its intended application, conforms to cGMP
requirements, satisfies concerns of regulatory
agencies and meets company goals established for
quality.
22
Reviews and gives final approval for written
validation protocols and summaries.
Reviews and approves validation section of
change control notices to ensure that each
process continues to operate within its
designed parameters.
Reviews and approves procedures that
have been established to revalidate the
process in the event of a process or
equipment change.
23
Ensures validation protocols and studies are
properly documented, archived and stored for
timely retrieval.
Discusses validation studies and plans with
customers and regulatory agencies as required
during reviews or inspections.
Develop and submit quarterly and monthly reports
as defined by Manager
Responsible for Master Validation Plans, SOP’s,
and Validation Guidelines. Reviews and approves
SOP’s in their related area.
Reviews and approves Master Batch Records.
24
Oversees and approves all documents pertaining to
company’s quality development program, such as
process development protocols and technology
assessment summaries.
Designs and evaluates all documents associated
with development and implementation of new
technology
and
improvement
of
existing
technologies, such as master batch records,
evaluation protocols, summary reports and change
control notices.
Participates in other activities, as may be requested,
relative to new products and/or new technology
transfers.
25
Performs employees performance reviews and
submits them for approval in a timely fashion.
Takes any corrective actions required up to and
including termination as appropriate and in
accordance with company policies and procedures.
Builds and maintains a staff of professional, highly
motivated and knowledgeable individuals.
Participates in selection of personnel and provides
effective training.
Establishes standards of performance in accordance
with company guidelines and evaluates performance
against those standards for all staff members.
26
Knowledge/Skills/Abilities
Thorough knowledge and understanding of
governmental
requirements
and
industry
standards, related to current Good Manufacturing
Practices and other appropriate government
regulations and requirements as related to
essential job
functions
Thorough knowledge of current validation
compliance,
standards, requirements for a
Pharmaceutical Industry, both domestic (FDA) and
international (ICH).
Ability to establish validation standards, SOP’s and
audits meeting current and future FDA
requirements
Experience working with and/or leading cross- 27
functional groups
Excellent written, verbal and interpersonal
communication skills, highly organized and
detail-oriented.
Ability to effectively and directly interface
with FDA and technical company personnel
at various levels
Ability to effectively communicate, directing,
guiding personnel who are not direct reports.
A strong
scientific
experience
and
knowledge
of
analytical,
research,
engineering, manufacturing, quality control
and quality assurance.
28
Good computer skills with knowledge of
Microsoft Office programs (Word, Excel,
Power point )
Ability to utilize statistical techniques and
approaches to reach scientifically sound
decisions regarding validation issues
Thorough knowledge and understanding of
product
formulations,
pharmaceutical
technology and equipment performance
relative to solid dosage forms, liquids and
semi-solids.
29
Education/Experience
B.S., M.S. or PhD in Industrial
Pharmacy, Pharmaceutics, Chemical
Engineering or related science area
30
Manager/Senior Manager, Validation
Responsibilities:
Responsible for the management of the
Validation Department personnel
Responsible for Validation Department budget
development and monitoring
Lead and coordinate the qualification and
validation efforts for new GMP facilities
31
Ensure that appropriate validation master
plans
addressing
facilities,
utilities,
equipment, cleaning, and process are
established and implemented according to
timelines
Manage and coordinate the activities of
contractors performing qualification and
validation work
Ensure that a validation/re-validation
program is established and implemented in
the new manufacturing facility and provide
program oversight
32
Review, approve, source and/or write validation
documents
Provide technical expertise and interpretation on
regulations and guidelines as they relate to
validation activities
Oversee the development and revision of validation
procedures and protocols to ensure that regulatory
compliance and company objectives are maintained
Ensure that the Validation Department personnel
are appropriately coached, trained and developed
for current and anticipated projects
Prepare and assist with the inspections from
regulatory agencies
33
Requirements:
Bachelor’s degree in Engineering, Science or related
technological field or equivalent combination of
education and experience
Seven to ten years experience of validation
experience in a cGMP environment with increasing
levels of responsibility for a wide range of validation
projects
Thorough knowledge of validation principles,
manufacturing
processes,
quality
systems,
engineering design fundamentals, regulatory agency
expectations and industrial trends
In-depth knowledge of validation requirements (GMP,
FDA, etc.) for pharmaceutical manufacturing facilities,
equipment and systems
34
Proven track record in managing a validation
department with multiple direct reports
Demonstrated ability in effectively managing multiple
validation projects simultaneously
Excellent leadership and organization skills to
effectively directing and managing validation
personnel and contractors in ensuring project
completion on time
Excellent verbal and written communication skills
including the ability to write, revise, and comment on
validation protocols and reports
35
SPECIFIC RESPONSIBITIES OF EACH PERSONNEL WITH THE
SCOPE OF VALIDATION
Engineering
Install; qualify & certify
equipment & support system.
plant,
facilities
Research & Design and optimize manufacturing process
design
limits
specification
&/or
development within
requirements in other words , the establishment
of process capability information
Production
Operate & maintain plant, facilities, equipment
support system & the specify manufacturing
process
within
its
design
limits,
specification&/or requirements
Qualityassurance
Establish approach validation protocol & conduct
process validation by monitoring, sampling,
testing, challenging, &/or auditing the specific
manufacturing process for compliance with
design limits, specification, &/or requirements36
Reference:
1.mednet3.who.int/prequal/pq_pres/
workshop_Russia/M08-Validation02f_U.ppt
2.siop.org/_Principles/principlesdefault.ht
m - 16k
3. www.genitope.com/text/G7605.htm - 8k
4. Pharmabiz, Sunday, april09, 2006
5.Validation standard operating procedure
37
38