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Qualification and Validation - Coggle Diagram
Qualification and Validation
Qualification
Definition:
Means of providing documented evidence that a specific equipment, facility or system is fit for its intended use
Scope
Equipment
E.g. Milling machine, blender, tablet coater, oven, autoclave, filling and closing machine
Facilities
Software
Utilities
4 Phases
1) Design qualification
Verify that the facilities, systems and equipment are suitable for their intended purpose
Check if all parts of the equipment are according to the user specfications
Check completeness of items and documents delivered
Check safety features
Check design conformance to cGMP
2) Installation Qualification
Verify that the equipment comply to approved design as installed
Visual check of complete installation of all parts of the equipment
Check if materials used are within their specifications
Carry out calibration
3) Operational Qualification
Verify that the equipment performs as intended throughout the anticipated operating ranges (as installed)
Verify operability of equipment by testing individual parameters (using simulated product)
Includes critical variable studies of upper and lower processing, processing at the operating limits of the equipment
Finalise calibration, operating and cleaning procedures
Test safety interlocks
Permit a formal release of the equipment
4) Performance Qualification (Process validation)
Verify that the equipment, as an integrated system, can perform effectively and reproducibility to produce a product meeting specs
Tests to be carried out using production materials
Trials carried out for each product in the ranges to establish parameter settings for optimum productivity
Monitor product performance characteristics/attributes
Establish worst-case conditions
Samples (Where,when, how and how many?)
Generally, 3 consecutive batches/runs are considered acceptable
Worst-case conditions:
Account for possible large variability in the parameters during production
Process can be considered robust if the product can meet the specifications despite being produced under worst-case condition
E.g. If operating temp is 80, monitor product at 96 and 64 degrees (+- 16)
Risk Analysis
Purpose
identify critical and noncritical control parameters of processes and equipment
identify the activities necessary for qualification, validation, maintenance and calibration
Procedure
5 steps
List all parameters of the equipment
Classify the parameters (critical or noncritical)
Provide reason for classification in terms of impact on quality
Estimate failure probability of parameters
Identify measurements for parameters
Validation
Definition:
Means of providing documented evidence that a process, method, test or activity is capable of repeatedly producing the desired outcome
Scope
Analytical test methods
Manufacturing processes
Cleaning processes
Training programmes
Process Validation
/ process qualification
examines a process under normal operating conditions to prove that the process is in control
validate the reproducibility and consistency of a process
full defined process is carried out using qualified equipment, under the established procedure at least 3 times
process must be successfully and consistently meet all acceptance criteria each time
"Worst case" conditions are used to ensure that the process is acceptable in extreme case.
each process to be validated must be a specific process clearly described in an SOP
Cleaning Validation
documented evidence that an approved cleaning procedure will reproducibly remove the previous product/ cleaning agent
must be below the scientifically set maximum allowable carryover level
Validation of analytical methods
Types of validation
Prospective validation
validation carried out before routine production of products intended for sale
Concurrent validation
Validation carried out during production of products intended for sale
Retrospective validation
Validation of a process for a product which has been marketed based upon accumulated manufacturing, testing and control batch data
Purpose
1) Regulatory requirement (cGMP)
Qualification and validation should be completed prior to distribution or sale of pharmaceutical products
2) Ensure products are consistently manufactured to specifications
3) Increase efficiency of manufacturing processes
Documentation requirement
Must be documented evidence that equipment and processes are successfully qualified and validated
Hierarchy of documentation
Level 2 - Validation Master Plan
Level 3 - Protocols
Level 4- Validation Summary Reports
Validation Master Plan
Organizational structure of qualification and validation activities
List of facilities, systems equipment and processes to be qualified or validated
Outline test procedures and protocols
Documentation format (protocols & reports)
Planning and scheduling
Change control
Protocols
Describe how qualification and validation will be conducted
Critical steps
Acceptance criteria
Validation Summary Reports
Cross-reference to protocols
Summarize qualification and validation results (discussion, acceptance & conclusion)
Document any deviations with justication
Validation Lead Signature
Change control and re-qualification and re-validation
Any change made must be assessed for its impact on product quality
What is considered a change?
Change of:
raw materials
batch size
packaging material
process
equipment
method of testing
Transfer of processes to another site
Re-qualification/ Re-validation
Can also be used for periodic evaluation
confirm that systems remain valid
IF there is no significant changes
A review of evidence through the use of historical data is sufficient for re-qualifying or revalidating the system
Change control
Involves:
Seeking acceptance for the requested change
Evaluation of impact on product using Risk Analysis
Determining the extent of re-qualification and re-validation required