Working Definitions for V&V - Why Needed?

From several of my V&V webinar slides

 

ISO and CGMP definitions generally can’t be easily followed without some additional explanation.  Hence, the need for “working definitions”, workable explanations.

Note:  The information  presented here has also specifically been field tested with the FDA and various N-Bs over several decades; it is not theoretical or derivative of other consultants work.  

These definitions are also in basic agreement with several guidance documents, ISO standards, and similar.

Verification:  Inspection, testing or checking; includes most “qualifications”; Decommissioning; Product: Design Output = Design Input. Usually verify one "Requirement"

Validation (includes a series of verifications, many involving destructive testing); may include “commissioning”, Usually validate a series of "Requirements / Qualifications":

Product: Customer Needs (+ standards, guidance documents, etc.) = Resulting product

FAT, SAT (may need supplemental V&Vs)

Commissioning

Process / Equipment / Facility:  DQ, IQ, OQ, PQ

Software:  In-product, As-product, Process / Equipment; 11 elements (U.S. FDA guidance “model”)

Software:  QMS; 21 CFR Part 11 ER / ES

Master Validation Plan

Site “qualification”.

Product Verification / Testing Examples:

Biocompatibility:  Cytotoxicity, Hemolysis, Sensitization / Irritation, Carcinogenicity ...

Functional and In-process functional testing / QC

Software / firmware testing if appropriate

Accelerated aging, and start of concurrent real-time aging

Shake / drop, shipping

Product bioburden, LAL (bacterial endotoxin test), particulate

Sterilization (and residuals if EO)

Other testing as appropriate per product, standards, guidance documents

Each of the above tests is a verification.  Put them all together and you've validated a product.  Compile all verification documentation into the product validation  package.

DQ, IQ, OQ, PQ “Working” Definitions  

DQ (Design Qualification):  Insure requirements are ID’d =  Requirements Spec(s) are complete (include applicable Guidances and Standards)

IQ (Installation Qualification): Verification that item is installed per vendor’s / company’s / legal & regulatory requirements

OQ (Operational Qualification):  Optimize settings / parameters and tolerance ranges; DOE; ensure all Requirements are functional

PQs (Performance Qualification):  Prove system reproducibility / repeatability over extended time periods with expected company “allowable worst case” inputs (shifts, times, personnel, RM, et al) – 3 or more, the exact number of PQs determined by the number of different inputs, e.g., 24/7 work shifts:  1-3 PQs for the1st shift, 1 for Swing, 1 for Night, 1 for weekend/Sunday, 1 for holiday (next one coming up) = 5-7 PQs just to address a 24/7 production schedule.

Determine / Draft  Test  Cases: 

For IQs (usually a checklist, with each verified requirement signed by a qualified individual, e.g., plumber, electrician, rigger, etc.), OQs, PQs (test cases for OQ and PQs, signed by the one running the test case / operator, and verified by an impartial party, e.g., QC, and dated):

 List all requirements; group under installation requirements under the IQ; and all other requirements under the OQ (to prove they do what they should and don't do what they shouldn't); any OQ requirements that are subject to a company's "allowable worst case inputs" would also be challenged by 3 or more PQ's, with each test case expanded by samples, e.g., n=10, n=3-, n=125, etc., with justification for the sample sizes chosen.

Expand requirements to specific elements that support each requirement (rephrase each element into a question to assist);

Consider how each element can be verified;

Develop a test case for each element;

State the element, the expected observation / outcome / output;

Provide check boxes, fill in the blank, or area for actual observations / outcomes / outputs; and

Include provision for Tester’s signature / initials and date, and a Verifier’s signature / initials and date  (Initials require a “log” …).

Review / refine with team.

-- jel@jelincoln.com