Lean Validation

Keith Powell Evans,Senior Consultant
De Valck Consultants
pharma@devalckconsultants.com

Lean approaches in validation are nothing new in our industry, methods in ‘streamlining (as it used to be termed)’ have been around since the early ‘90s and conceptualised in trade publications as early as the late ‘80s.

However, the subject has come a lot since those early pioneering days, or rather our understanding of the subject and its wider implications have, whilst the fundamentals of validation remain largely un-changed. Experienced practitioners now talk in terms of modular and configured approaches and apply their craft in several specialist areas: Facilities, Utilities, Equipment, Cleaning, Methods/Assays, Analytical, most are subject to elements of Computer systems (CSV), and collectively, most provide a ‘State of Control’ better known to you and I as; Process Validation.

The thrust of this short critique emphasises a growing need for manufacturers to implement lean approaches in validation, not least because of the growing diversity of the subject matter, rather, the information, materials, data, documentation and array of support needed to service regulatory inspections, continues to grow exponentially.

If validation supports the notion of proving that the company is doing things right, lean approaches extend still further to ensure that the company is; ‘doing the right things.’ A simple cost analogy would have the company giving birth to a validation monster and having to feed and maintain the monster for the duration of the life cycle.

Lean approaches help diminish this undesirable significantly; less cost, more control and an overall reduction in the compliance risk and less chance that the ‘monster’ might one day bite the very hand that feeds it! In more prosaic terms, in the absence of lean validation methods, the entire operating parameters of the business maybe elevated to a level it cannot afford, is ill equipped to service and incapable of sustaining.

As the intensity of a project builds and the scramble to validate begins, the pressure on those in key positions contorts the perception of compliance away from one of substantive inconvenience towards a general state of upheaval, temperatures rise and tempers fray.

Add to this the barbed comments between colleagues in the fall out from the monthly project budget reviews, where the disparity between project outlay (finance) and progress becomes all too apparent, validation then becomes even more controversial. Make no mistake, management has every right to feel prickly, the cost and business risks is enormous, get it wrong and you can compromise more than just product quality, or the health of patients…you can quite literally cost the company!

So what are some of the more widely used ‘lean’ methods in validation?

The following top ten bullets - point the way, they’re in no pre-defined order of importance, but they provide an outline to a more enlightened and lean approach to validation and compliance. Savings which collectively WILL off-set the capital outlay ion validation, if not immediately, then certainly in a realistic pay-back period.

1. It’s all in the planning as they say, plan the work and work the plan, validation and the uniform state of compliance are no exceptions to this rule. Break the project down to the basics and marry these to the existing business model.

2. Perform a gap analysis against each business units to find out, ‘in real time’ how robust the infrastructure is (compliance with the regulations) and use the findings (the gaps) as the outline scope of a remedial plan. Apply impact assessment in order to rationalized and differentiate between business and regulatory risks.

3. A remedial plan is a rather recent concept in the area of compliance, but a non the less essential one, for, if a company does not plan to remediate the infrastructure (address the compliance gap across the departments), problems will manifest later in validation along with countless administrative issued evoked by having to deal with numerous change controls/deviations and OOS results.

4. Simplify the validation suite of documents with innovative lean approaches that rationalize procedures, guidelines and macro-driven templates. Use these as the basis in the formation of validation plans. The prior development of a compliance and validation ‘Policy and Strategy’ document will provide a hub of information that will facilitate lightweight (abstract) documents elsewhere.

5. Commit resource and funding to optimizing manufacture as there is little difference between process development (PD) and process validation (PV), therefore the commitment to lean PD calls in to play the very mechanics found in PV, resulting in greater efficiency and visibility in manufacture and the control thereof: Less scrap; more yield…increased margin . Essentially, a full commitment to PD should provide PV…for free! One of the primary functions in PD is the characterization of the process steps, the system of documenting the capabilities of these process steps all the way to the edge of failure.

6. Simplification of the review and approvals process: Whilst it may not take that long…initially to develop a working procedure; a protocol, the real time constraints are often found in the facilitation of the document through the review and approvals process.

A problem exacerbated where electronic approval is used. A reluctance to let go of hard copy means that the old and new way of document approvals currently live along side each other. The difficulties are further complicated with the routing of documents for ‘unofficial’ pre-approval to smooth their eventual passage through the electronic system. A route that seems to have invited far more reviewers and approvers than is required to achieve actual compliance; remember what they say about ‘too many cooks?’.

7. Rationalisation of procedures and the document system. Each business unit will have a plethora of dedicated SOPs that have evolved to a greater and lesser extent autonomously with little or no regard to how they configure with others. Ostensibly, the coverage of procedures carries overlaps; conflicts; misalignments; gaps and a degree of duplication of effort. A commitment here should be towards a reduction in the number of procedures, through rationalization, retirement, amalgamation and re-designation. Remembering, we should never have a procedure when a guideline, work instruction or routine of some description will do. Lots of room for improvement here too.

8. Cultural resistance is perhaps the most difficult hurdles to overcome in the run up to a regulatory inspection. In engineering circles for example, such issues as validation has never part of the culture engineers have grown up with; ‘why try and fix something that in a commercial sense, not broken’ this is the kind of question I have been asked on many occasions, the stock answer is this: ‘Engineering has evolved primarily to satisfy commercial terms and conditions; however, there are certain elements of engineering by way of associated risks that have regulatory significance. The ISPE C&Q baseline guide addresses this very issue with an impact assessment tool; a very simple and effective way separating commercial risk from regulatory risks.

It should always be remembered that validation is not there to police the business, or to find fault with the personnel, it is not a witch-hunt; rather, validation it is a great business tool and one that should not only services the required compliance demands, but also, used as a robust diagnostic tool.

Done properly, and always with the greater compliance needs in mind, validation not only safeguards the products, and the people who use them, it will be seen inn so many respects to safeguards ‘the company.’

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