ISO/GMP/FDA Training Topic: Date: Facility: Trainer: Validation 2/23/2012 SS White India Hollie Johnson

Validation

documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practices and other regulatory requirements. Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification

The activity of qualifying systems and equipment is divided into the following: qualification (DQ) Component qualification (CQ) Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ)
Design

WHY DO WE VALIDATE?

FDA(21 CFR 820.75) and ISO 13485 require it High probability that product will pass specs Reduces in-process/finished goods testing Reduces scrap/rework, saving money Consistent products have fewer complaints Validation generates ideas for improvement Build quality in, not try to inspect it in

History

Introduced by FDA in mid 1970s to improve the quality of pharmaceuticals Started as a focus on improving manufacturing processes Quickly spread to other areas (next slide) All regulations are a direct result of some catastrophic event that occurred in real life Validation is no exception Therac-25 incident

What CAN We Validate?

Systems Passivation, compressed air New Processes, prospective cannot inspect 100% Existing processes Retrospective Test Equipment Comparators Equipment CNC Software CNC Programs, Databases Security Electronic Signature People Repeatability and ability to follow procedures Product CNC, winding, assembly Facility Design, construction, materials, layout Utilities Air, water, HVAC

Cleaning ultrasonic, hand cleaning Analytical Methods - titration Packaging, shipping Sterilization Design Manufacturing SOPs and Methods Technology Transfer Suppliers Automated Systems passivation, CNC Anything that affects product quality Endless

What WILL We Validate?

Equipment

CNC IOQ Test Equipment Comparators Systems Passivation, compressed air Cleaning ultrasonic, hand cleaning

WHEN DO WE VALIDATE
When

product testing isnt sensitive enough to verify product safety & effectiveness. When testing would destroy the product to prove the result. Destructive testing (UTS). When we cannot inspect 100%

HOW DO WE VALIDATE?

Start with a Plan Validation Master Plan (VMP)(process, equipment and cleaning VMP) Write protocol Specified equipment, methods, SOPs, Training, calibration 3 successive runs (process qualification) Statistically valid sampling plan Measurable, predetermined acceptance criteria (specifications)

INSTALLATION /OPERATION QUALIFICATION (IQ/OQ)

Verifies

correct equipment installation Assures that measuring and monitoring equipment is calibrated, and personnel are trained verifies that equipment operates correctly at process settings. Process settings include worst case (high and low) conditions and most common.

PROCESS PERFORMANCE QUALIFICATION (PQ)

This

is what we usually call Process validation. Demonstrates the process is reproducible and effective at normal and extreme operating limits. Includes worst case (low), worst case (high) and average case.

WHAT TRIGGERS REVALIDATION

Preventive

Maintenance Change in raw material and/or supplier Change in process or equipment According to schedule ECO form or change control has a place to identify need for validation Unanticipated event/incident. Move equipment

DESIGN OF EXPERIMENTS (DOE)

Using

this technique, a few experiments tell us quickly what parameters control the process. We can find and test the limits easily. Used to develop acceptance criteria Statistically valid means of designing your qualification protocols

SS White India Validation Requirements

Required to do equipment Validation

IOQ Protocol template will be provided to you You are required to update protocol and submit to NJ for approval execute the protocol Manage training, documentation and calibration Write an executive summary report of the data and include al relevant attachments Manage deviations and justifications Submit report to NJ for final approval

SN Validation Requirements Cont

Promptly report all deviations and discrepancies to Hollie Need to hire local talent if resources spread too thin All data pages are reviewed and signed/dated by Quality manager in SN All Validation documents are controlled documents with an individual FCD number All data requires a second person to look at the data and verify accuracy in addition to the final review of the entire data page Scan the final approved protocol, report and attachments

QUESTIONS???

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