The Scope of Cleaning Validation The Cleaning Validation Sequence Prerequisites Cleaning Validation Strategy, Plan, and Policy Sampling Recovery Studies Analytical Method Selection and Development Analytical Method Validation Acceptance Criteria Validation Master Plan Cleaning Validation Plan Cleaning Method Development 15 The Cleaning Validation Process An Easy to Understand Guide | Cleaning Validation
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The Cleaning Validation Process - Learnaboutgmp · PDF file16 Cleaning Process Standard Operating Procedures (SOPs) Cleaning Validation Protocols Protocol Execution Clean and Dirty
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The Scope of Cleaning Validation
The Cleaning Validation Sequence
Prerequisites
Cleaning Validation Strategy, Plan, and Policy
Sampling
Recovery Studies
Analytical Method Selection andDevelopment
Analytical Method Validation
Acceptance Criteria
Validation Master Plan
Cleaning Validation Plan
Cleaning Method Development
15
The Cleaning Validation Process
An Easy to Understand Guide | Cleaning Validation
16
Cleaning Process Standard Operating Procedures (SOPs)
Cleaning Validation Protocols
Protocol Execution
Clean and Dirty Hold Times
Validation Report
Post Validation Monitoring
Maintaining the Validated Status
Retrospective Cleaning Validation
Glossary
What You Learned
An Easy to Understand Guide | Cleaning Validation
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Normally, only cleaning procedures for surfaces of the equipment that
come into contact with product need to be validated.
To be more effective, however, programs for the elimination of cross-
contamination must also address non-product contact surfaces. When
establishing prerequisites for non-product contact surfaces, you must
review the probable interactions of those areas.
Cleaning validation is usually only needed for critical cleaning, e.g.
between manufacturing of one product and a different product and is not
normally necessarily for non-critical cleaning such as between batches of
the same product (or different lots of the same intermediate in a bulk
process).
In API manufacturing, it may be unnecessary to validate equipment
cleaning where residues are removed by subsequent purification steps.
Products that simulate the physiochemical properties of the substance to be
removed may be used instead of the substances themselves, where such
substances are toxic or hazardous.
The intervals between use and cleaning, as well as cleaning and reuse,
The Scope Of CleaningValidation
An Easy to Understand Guide | Cleaning Validation
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should also be validated. Cleaning intervals and methods should be
determined.
It is the responsibility of the manufacturer to demonstrate that the level
of cleaning and validation performed is adequate based on each individual
situation and on a justifiable scientific rational.
Microbiological aspects should be considered, although they should
consist largely of preventative measures rather than the removal of
contamination once it has occurred. (WHO)
An Easy to Understand Guide | Cleaning Validation
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The CleaningValidation Sequence
Cleaning ValidationStrategy
Process & ProductDevelopment
Validation MasterPlan
Cleaning Agents &Methods Identified
Cleaning MethodDeveloped
Sample techniqueand Methods of
Detection identified
Establishment ofAcceptable Levels
of Carry-over
Analytical MethodsIdentified /Developed
Analytical MethodsValidated
Recovery StudiedCompleted
RefiningAcceptable Levels
of carry-Over
Cleaning SOPsCreated
ValidationSummary Report
Revalidation
Execution ofProtocol
Cleaning ValidationProtocol
Cleaning VP
CLEANING VALIDATION PROCESS(Prospective)
An Easy to Understand Guide | Cleaning Validation
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Before beginning cleaning validation, the following should be available