2. Purpose & Scope
– The purpose of this presentation is provide a clear
guideline to follow during the audit and evaluation
process of the validation packages.
– The scope of this presentation is the qualification and
validation documentation located in the Facility.
– As part of the Remediation Project the contents of this
presentation can be used during the evaluation process of
any validation or qualification document.
3. Key activities & items
Validation
Worst case
scenario of the
current
manufacturing
process
Qualification
Critical
parameters
and limits
Calibration
Critical
parameters
and limits
4. Remediation Project List
Use the excel file during the evaluation process of
each binder.
Enter all the information requested by the excel
spreadsheet as possible.
If during the evaluation process easy or “low hanging
fruit” items are identified use the comment column to
document.
5. Process Validation List Summary Example
Product # Product Name PV Scope Facility Lot # Equipment Use Calibrated Equipment
Equip # Description Protocol #
Functional
Requirements
Design
Specifications
Design Qualification Parameters Executed Report Approval
Equipment Qualification List Summary Example
List Summary Example
7. General Guidelines to follows when planning validation process
• History
• Description
• Qualification/Validation
Status
• Risk Assessment
• References
• Impact of the changes
• How to handled thru the
entire process
• Critical Parameters and
Attributes
• Acceptance Criteria
• Changes versus
challenges (test cases)
• Evidence of the
• SOP
• Policy
• Protocol to execute
Training
Records
Validation
Strategy
Summary
Quality Risk
Management
8. Documentation Stages
Changes
• Changes in the
acceptance
criteria or
parameters
• Discrepancies
with scientifically
justification
Results
• Fail pre-define
and approved
acceptance
criteria
• Deviation and
follow local
investigation
process
Final Report
• Review of the
results vs.
acceptance
criteria
• Conclusion and
recommendation
Release
• Formal release
needs to be
approved
• Conditional
release needs to
be documented
thru deviation
9. Qualification Stages for the Equipment,
Facilities and Utilities
– URS needs to be created minimizing GMP risks
– Design Qualification can be the first document as
draft version
– Design review needs to be execute and compare
with the standards, requirements, specifications,
and changes
– SAT & FAT activities are recommended for
equipment novel or with complex technology
– IOPQ can be created either of the possible
combination. For example IQ, OQ, IOQ, IOPQ and
etc
– Also, Performance and Process Validation can be
created, executed and documented in one
qualification document as PPQ
10. Installation Qualification
IQ should be performed on equipment, facilities, utilities, or systems.
Major
Components
• Collect information of the suppliers
• Verification of the installation
Drawing
• Verification of material of construction
• Correct Installation of the equipment and instruments
• Correct installation of the pipe work and services (Utilities)
PM &
Calibrations
• Collect information to enter in the systems
• Verify the calibration certificates
11. Operational Qualification
Confirm upper and
lower operating limits
and/or “worst case”
conditions
Develop from knowledge
of the process ensuring
the systems operate as
designed
Operational System
Cleaning Procedures
Operators training
Preventive
Maintenance
12. Performance Qualification
Preparation
Use production materials, qualified substitutes or simulated product proven to
have equivalent behavior under normal operating conditions.
Worst case batch sizes
Cover the operating range of the intended process, unless documented evidence
form during the develop phase confirm the operational ranges available.
Sampling
Frequency of sampling used to confirm process control should be justified
13. Process Validation
– Types of process validation
– Traditional
– Batch size needs to be 10% of the maximum production scale or 100,000 units
whatever is the greater.
– In the protocol body needs to include the following aspects:
– product dossier
– manufacturing process
– Tests
– acceptance criteria
– description of any additional control
– justification
14. Process Validation
– Continuous (science and risk based real time approach)
– Relevant data of the Quality attributes of incoming material or components, In-process
material and finished product
– Verification of attributes, parameters, end points, assessment of CQA and CPP trends
– In the protocol body needs to include the following aspects:
– product dossier (support with laboratory data)
– description of a CPV strategy
– process parameters
– material attributes
– analytical methods
– stage that the process is considered under control
– Justification: number of batches and the variability
