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Module 5 Validation

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Module 5 Validation

Uploaded by

m.monir.sa
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Module 5 -Validation

1. Validation

1.1 Module 5 Validation

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1.2 About this module

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1.3 Objectives

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1.4 Validation/qualification

1.5 What is validation?

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1.6 Validation vs. qualification

1.7 Validation vs. qualification (continued)

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1.8 Validation vs. qualification (continued)

1.9 Overview of validation/qualification documents

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1.10 Validation Master Plan (VMP)

1.11 Critical elements

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1.12 Critical elements (continued)

1.13 Critical elements (continued)

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Change Control
The manufacturer must have a “change control”
procedure. Failure to properly document changes to the
system means invalidation.

Change control is an important element in any Quality


Assurance system. Written procedures should be in place
to describe the actions to be taken if a change is
proposed to a product component, process equipment,
process environment (or site), method of production or
testing or any other change that may affect product
quality or support system operation. All changes should
be formally requested, documented and accepted by
representatives of Production, QC/QA, R&D, Engineering
and Regulatory Affairs as appropriate. The likely impact
(risk assessment) of the change on the product should be
evaluated and the need for, and the extent of revalidation
discussed. The change control system should ensure that
all notified or requested changes are satisfactorily
investigated, documented and authorised.

Products made by processes subjected to changes should


not be released for sale without full awareness and
consideration of the change by responsible staff,
including (where appropriate) the Qualified Person.

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1.14 Validation Protocol

1.15 Protocol for Validation of Manufacturing Process

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1.16 Protocol for validation of manufacturing process (continued)

1.17 Life Cycle Approach

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1.18 Validation Report

1.19 Validation summary

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1.20 What is process validation?

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1.21 The goals of process validation

1.22 Types and Stages of Process validation

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Types of Process Validation:-
1. Prospective Validation: It is establishment of documented evidence of
what a system does or what it purports to do based upon a plan. This
validation is conducted prior to the distribution of new product.
2. Retrospective Validation: It is the establishment of documented evidence
of what a system does or what it purports to do based upon the review and
analysis of the existing information. This is conducted in a product already
distributed based on accumulated data of production, testing and control.
3. Concurrent Validation: It is establishment of documented evidence of
what a system does or what it purports to do information generated during
implemented of the system.
4. Revalidation: Whenever there are changes in packaging, formulation,
equipment or processes which could have impact on product effectiveness
or product characteristics, there should be revalidation of the validated
process.
• Conditions that require revalidation studies are:
• Changes in critical component
• Change in facility or plant
• Increase or decrease in batch size
• Sequential batches that fail to conform product and process specifications

Stage:

Process Design: The commercial process is defined during this stage based
on knowledge gained through process development activities.

2.Process Qualification: During this stage, the process design is confirmed as


being capable of reproducible commercial manufacturing. Including
qualification of the facility, utilities and equipment.

3.Continued Process Verification: Maintenance, continuous verification, and


process improvement. On-going assurance that routine production process

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remains in a state of control. Assessed by collecting and monitoring
information during commercialisation.

1.23 Types of process validation

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1.24 Types of process validation (continued)

1.25 Stages of process validation

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1.26 Summary of process validation

1.27 Success of process validation depends on…

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1.28 Process validation documents

Notes:

• Validation Master Plan :

• All validation activities must be described in a validation master


plan which must provide a framework for thorough and
consistent validation of product. Key element of validation are:
Requirements, Design Control ,Testing, Change Control,
Traceability and Monitoring.
• Process Validation master plans must include:
A.Introduction with a scope of the plan, e.g., sites, systems,
processes ,,Responsibilities by function.

B.Related documents, e.g., risk management plans ,


Products/processes to be validated and/or qualified.

• Validation Protocol and Report :


• The validation protocol must be numbered, signed and dated , and must

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contain as a minimum the following information’s:
• Objectives , Scope of coverage of the validation study ,
• Validation team , their qualifications and responsibilities
• Justification for validation’
• Risk Assessment ,
• Type of validation: Prospective , concurrent , Retrospective , revalidation,
• A list of all equipment to be used with calibration, qualification,
requalification and preventive maintenance details.
• Outcome of IQ , OQ for critical parameter,
• Critical parameters and their respective tolerance;
• Description of the processing steps : Challenges
• of sampling and sampling plans;
• Statistical tools to be used in the analysis of data ,
• Forms and chart to be used for documenting results ,
• Non-conference ( Out of Specification /Out of Trend/Deviation )
• Change control
• Conclusion
• Summary
• Approval of study

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1.29 Process validation life cycle

1.30 Process validation documents

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1.31 Cleaning validation: Protocols

1.32 Protocols (continued)

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1.33 Protocols (continued)

1.34 Protocols (continued)

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1.35 Protocols (continued)

1.36 Protocols (continued)

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1.37 Reports

1.38 Equipment

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1.39 Equipment (continued)

1.40 Detergents

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1.41 Bioburden

1.42 Sampling – general

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1.43 Sampling – general (continued)

1.44 Direct surface sampling – direct method

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1.45 Direct surface sampling – direct method (continued)

1.46 Rinse samples – indirect method

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1.47 Recovery validation

1.48 Establishing acceptable limits

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1.49 Establishing acceptable limits (continued)

1.50 Establishing acceptable limits (continued)

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1.51 Establishing acceptable limits (continued)

1.52 Establishing acceptable limits (continued)

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1.53 Analytical method validation - Introduction

1.54 Analytical performance characteristics

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1.55 Specificity

1.56 Methodology

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1.57 Linearity and range

1.58 Accuracy

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1.59 Precision

1.60 Limit of detection/limit of quantitation

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1.61 Limit of detection/limit of quantitation (continued)

1.62 Robustness

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1.63 Analytical procedures and characteristics evaluated in validation (ICH
Q2 (R1))

1.64 Final assessment

Notes:

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