Validation Qualifications IQ OQ PQ...

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Installation Qualification (IQ)

The objective of the Installation Qualification is to see if the process or product is established (or set-up or installed) correctly.

Important IQ considerations are:

• Equipment design features (i.e. construction materials, cleanability, etc.)
• Installation conditions (wiring, utilities, functionality, etc.)
• Calibration, preventative maintenance, cleaning schedules
• Safety features
• Supplier documentation, prints, drawings and manuals
• Software documentation
• Spare parts list
• Environmental conditions (such as clean room requirements, temperature, humidity)


Operational Qualification (OQ)

In this phase the process parameters should be challenged to assure that they will result in a product that meets all defined requirements under all anticipated conditions of manufacturing, i.e., worst case testing. During routine production and process control, it is desirable to measure process parameters and/or product characteristics to allow for the adjustment of the manufacturing process at various action level(s) and maintain a state of control. These action levels should be evaluated, established and documented during process validation to determine the robustness of the process and ability to avoid approaching “worst case conditions.”

• Process control limits (time, temperature, pressure, line speed, setup conditions, etc.)
• Software parameters
• Raw material specifications
• Process operating procedures
• Material handling requirements
• Process change control
• Training
• Short term stability and capability of the process, (latitude studies or control charts)
• Potential failure modes, action levels and worst-case conditions (e.g. Failure Mode and Effects Analysis, Fault Tree Analysis)

• The use of statistically valid techniques such as screening experiments to establish key process parameters and statistically designed experiments to optimize the process can be used during this phase.

Validation Qualifications IQ OQ PQ

Product & Process Validation. Validation Qualifications IQ OQ PQ.
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Performance Qualification (PQ)

In this phase the key objective is to demonstrate the process will consistently produce acceptable product under normal operating conditions.

PQ considerations include:

• Actual product and process parameters and procedures established in OQ
• Acceptability of the product
• Assurance of process capability as established in OQ
• Process repeatability, long term process stability

Challenges to the process should simulate conditions that will be encountered during actual manufacturing. Challenges should include the range of conditions as defined by the various action levels allowed in written standard operating procedures as established in the OQ phase. The challenges should be repeated enough times to assure that the results are meaningful and consistent.

Process and product data should be analyzed to determine what the normal range of variation is for the process output. Knowing the normal variation of the output is crucial in determining whether a process is operating in a state of control and is capable of consistently producing the specified output.
One of the outputs of OQ and PQ is the development of attributes for continuous monitoring and maintenance. Process and product data should also be analyzed to identify any variation due to controllable causes. Depending on the nature of the process and its sensitivity, controllable causes of variation may include:

• Temperature
• Humidity
• Variations in electrical supply
• Vibration
• Environmental contaminants
• Purity of process water
• Light
• Human factors (training, ergonomic factors, stress, etc.)
Variability of materials
• Wear and tear of equipment


Validation Protocol Elements

When performing a validation it is important that the validation protocols are effectively developed. A validation protocol should contain the following elements:

• Identification of the process to be validated
• Identification of product(s) to be manufactured using this process
• Objective and measurable criteria for a successful validation
• Length and duration of the validation
• Shifts, operators, equipment to be used in the process
• Identification of utilities for the process equipment and quality of the utilities
• Identification of operators and required operator qualification
• Complete description of the process
• Relevant specifications that relate to the product, components, manufacturing materials, etc.
• Any special controls or conditions to be placed on preceding processes during the validation
• Process parameters to be monitored, and methods for controlling and monitoring
• Product characteristics to be monitored and method for monitoring
• Any subjective criteria used to evaluate the product
• Definition of what constitutes non-conformance for both measurable and subjective criteria
Statistical methods for data collection and analysis
• Consideration of maintenance and repairs of manufacturing equipment
• Criteria for revalidation


Final Validation Report

At the conclusion of validation activities, a final report should be prepared. This report should summarize and reference all protocols and results. It should derive conclusions regarding the validation status of the process. The final report should be reviewed and approved by the validation team and appropriate management.
Product and Process Validation Full Details

Product and Process Validation.

  • The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. … Etc.
  • Validation Qualifications IQ OQ PQ.
  • How to ensure Validation efforts are aligned with potential Risks.
  • How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
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