Process Analytical Technologies. February 2002 FDA Subcommittee Meeting. Process and Method Validation. Leon Lachman, Ph.D. President Lachman Consultant Services, Inc. Validation.
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FDA Subcommittee Meeting
Process and Method
Leon Lachman, Ph.D.
Lachman Consultant Services, Inc.
“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”
IQ and OQ and Calibrations need to be performed prior to use of equipment for process validation.
Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug products.
System Suitability TestingMethod Characteristics to Be Considered for Validation
The Analytical procedures in the USP 25/NF 20 are legally recognized under section 501(b) of the Federal Food, Drug and Cosmetic Act as the regulatory analytical procedures for the compendial items. The suitability of these procedures must be verified under actual conditions of use. When using USP 25/NF 20 analytical procedures, the guidance recommends that information be provided for the following characteristics:
Increase knowledge of process
Improve monitoring, control and decisions
Improve process and product consistency
Improve documentation & reporting capabilities
Reduce costsAppropriate Automation Can….
e.g., individuals; mean; range; control limits
Process assurance and adjustments based on inadequate information
Product quality problems
rejection of in-process and finished product
eroded goodwillConsequences of Inadequate Automation