Scribd
Upload
195 views18 pages

Process Validation: Victor Dorman-Smith Abbott Ireland

This document discusses process validation requirements and guidelines. It defines validation, verification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It provides examples of processes that should be validated, may be verified, or may need validation. The document recommends establishing a validation team and plan, identifying processes, and using statistical methods to demonstrate a process will consistently produce acceptable products. Maintaining validation records is important for auditing.

Uploaded by

Babboo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
195 views18 pages

Process Validation: Victor Dorman-Smith Abbott Ireland

This document discusses process validation requirements and guidelines. It defines validation, verification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It provides examples of processes that should be validated, may be verified, or may need validation. The document recommends establishing a validation team and plan, identifying processes, and using statistical methods to demonstrate a process will consistently produce acceptable products. Maintaining validation records is important for auditing.

Uploaded by

Babboo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 18

PROCESS VALIDATION

VICTOR DORMAN-SMITH
ABBOTT IRELAND

Singapore 2002/05/17
DEFINITIONS

n From ISO 9000:2000


n Verification - confirmation, through the
provision of objective evidence, that specified
requirements have been fulfilled
n Validation - confirmation, through the provision
of objective evidence, that the requirements for
a specific intended use or application have
been fulfilled
VALIDATION
REQUIREMENTS
n ISO 9001:2000 & DIS 13485(2002)Clause 7.5.2
n The organization shall validate any processes
for production and service provision where the
resulting output cannot be verified by
subsequent monitoring or measurement. This
includes any processes where deficiencies
become apparent only after the product is in
use or the service has been delivered.
Validation shall demonstrate the ability of these
processes to achieve planned results.
VALIDATION
REQUIREMENTS 2
n ISO 9001:2000 & DIS 13485(2002) Clause
7.5.2 continued
n The organisation shall establish arrangements
for these processes including, as applicable
>defined criteria for review and approval of the
processes
>approval of equipment and qualification of
personnel
>use of specific methods and procedures
>requirements for records, and
>revalidation
DIS 13485 >> ISO13485:2003
n Clause 7.5.2.2.1
n The organization shall establish documented
procedures for the validation of the application of
computer software (and changes to such software
and/or its application) for production and service
operations and measuring and monitoring operations
that affect the ability of the product to conform to
specified requirements. Such software applications
shall be validated prior to initial use.
The results of validation shall be recorded.
DIS 13485 CONTINUED

n Clause 7.5.2.2.2 – for sterile medical devices


n The organization shall establish documented
procedures for the validation of sterilization
processes. Sterilization processes shall be
validated prior to initial use.
The results of sterilization process validation(s)
shall be recorded, and shall identify the process
parameters of the sterilization process
necessary to demonstrate control.
GHTF GUIDANCE
n Available on GHTF website (www.ghtf.org)
n Document GHTF.SG3.N99-10
Dated June 29,1999
Written by GHTF SG 3 – Kim Trautman (US
FDA) Convenor

n Active participation from regulators and industry


from USA, Europe, Japan, Canada, Australia
GHTF GUIDANCE

n Examples of processes which should be


validated
>Sterilization processes
>Clean room ambient conditions
>Aseptic filling processes
>Sterile packaging sealing processes
>Lyophilization processes
>Heat treating processes
>Plating processes
>Plastic injection moulding processes
GHTF GUIDANCE
n Processes which may be satisfactorily covered by
verification
>manual cutting processes
>Testing for colour, turbidity,total pH of solutions
>Visual inspection of printed circuit boards
>Manufacturing and testing of wiring harnesses
n Processes which may need to be validated
>Cleaning processes
>Certain human assembly processes
>Numerical control cutting processes
>Filling processes
GETTING STARTED
n Form multi-functional team for validation
n Plan the approach and define the requirements
n Identify and describe the processes
n Specify process parameters and desired output
n Create a master validation plan
n Select methods and tools for validation
n Create validation protocols
n Perform IQ,OQ,PQ and document results
n Determine continuous process controls
MORE DEFINITIONS
n Installation qualification (IQ): establishing by
objective evidence that all key aspects of the
process equipment and ancillary system
installation adhere to the manufacturers
approved specification and that the
recommendations of the supplier of the
equipment are suitably considered.
n Operational qualification (OQ): establishing by
objective evidence process control limits and
action levels which result in product that meets
all predetermined requirements.
MORE DEFINITIONS 2

n Performance qualification (PQ): establishing by


objective evidence that the process, under
anticipated conditions, consistently produces a
product which meets all predetermined
requirements.
INSTALLATION
QUALIFICATION IQ
n Is the equipment installed correctly ?
>Equipment design features
>Installation conditions
>Calibration, preventative maintenance, cleaning
>Safety
>Supplier documentation – drawings,manuals etc
>Software documentation
>Spare parts
>Environmental conditions
OPERATIONAL
QUALIFICATION OQ
n Process control limits
>Software parameters
>Raw material Specifications
>Process operating procedures
>Material handling requirements
>Process change control
>Training
>Short term stability and capability
>Potential failure modes, action levels and worse case
conditions
>Statistically valid techniques
PERFORMANCE
QUALIFICATION PQ
n Demonstrate that the process will consistently
produce acceptable product under normal
operating conditions
>Produce actual product under process
parameters established in OQ
>Check acceptability of product
>Assure process capability
>Check process repeatability and long term
process stability
GHTF GUIDANCE

n Statistical methods
n Stable / Unstable processes
n Process capability
n Transmission of variation
n Control charts
n Useful tools
n Example validation of a Heat Sealer machine
SUMMARY
n This guidance provides general suggestions on ways
manufacturers may prepare for and carry out process
validations
n Some regulatory requirements state that every
process that cannot be fully verified by subsequent
inspection or test must be validated
n Records of every step in the process are most
important for reference and audit
n Frequency of revalidation is the responsibility of the
manufacturer and should be carefully defined

You might also like