From: Subject: Pharmaceutical Online: Sourcing Online, Archived Newsletter, Current Headlines, Supplier News, Download Library, Events Calendar Date: Wed, 5 Oct 2005 10:26:24 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C5C997.3C7D0C80" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.2180 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C5C997.3C7D0C80 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.pharmaceuticalonline.com/content/news/article.asp?docid={71f38050-7e78-4a61-a5e2-990d035cdf2f} Pharmaceutical Online: Sourcing Online, Archived = Newsletter, Current Headlines, Supplier News, Download Library, Events = Calendar
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Compliance = Shouldn=92t=20 Always Be Spoon-Fed
9/30/2005 =20

For too long, the pharmaceutical development and = manufacturing=20 industry has been hesitant to tweak approved processes. But, = to=20 foster quality enhancements, it=92s time to supplement = regulatory=20 hand-holding with cooperative hand-shaking.

=93Regulatory flexibility is not an oxymoron.=94 = For making=20 that statement in a session on quality systems, Zena = Kaufman, senior=20 director, QO, at Pfizer, received an appreciative chuckle = from the=20 audience at a recent event co-sponsored by the Parenteral = Drug=20 Association (PDA) and the FDA. Held in Washington, D.C., = September=20 12-14, 2005, the PDA/FDA Joint Regulatory Conference = provided a=20 useful barometer of industry and agency responses to process = improvement initiatives. Here=92s what I found to be most = encouraging:=20 Based on the presentations and conversations at the = conference, the=20 relationship between the industry and the regulatory bodies = clearly=20 seems to be in a transitional period. Stakeholders on either = side of=20 the regulatory fence are definitely attempting to pursue a = much more=20 open, trusting, and ultimately collaborative working = relationship.=20 If all parties aren=92t yet ready to embrace in outright = hugging, they=20 are at least prepared to extend cordial handshakes.=20

So, what=92s driving the love fest? (Make that = like fest for=20 now.) Well, Kaufman=92s juxtaposition of regulatory = with=20 flexibility served to do more than induce = good-natured=20 laughter at the expense of the regulators. Rather, it summed = up a=20 wishful impulse clearly permeating the presentations and=20 conversations at this conference. According to the consensus = opinion, regulatory standards, approval processes, and = guidances=20 have led to unforeseen and unintended consequences. Rather = than=20 fostering continuous improvement and guaranteeing quality,=20 regulations have tended to dissuade pharmaceutical companies = from=20 pursuing process enhancements. Instead, companies have = relied =97=20 nearly exclusively =97 on quality testing of finished = products, batch=20 after batch after potentially flawed and wasted batch. So, = to=20 promote and support innovation and quality, constraints must = be=20 loosened. That was definitely the will of this crowd.

Applied at the granular level of what happens in our labs = and=20 factories, an appropriate follow-up mandate could be stated = in this=20 way: Leverage the scientific expertise; leverage the = engineering=20 expertise; leverage the manufacturing expertise. In other = words,=20 make sure regulations don=92t prevent innovators from, well, = innovating. The jest about regulatory flexibility prefaced, = in fact,=20 Kaufman=92s observations about the need for the = pharmaceutical=20 development and manufacturing industry to undergo a = research-driven=20 transformation =97 in particular, to re-embrace = pharmaceutical=20 science. =93We need to move from being a compliance culture = to being a=20 quality culture,=94 she said. One key way of ensuring that=20 transformation, Kaufman suggested, is to operate from the = following=20 assumption: When it comes to influencing process change = decisions,=20 sound science should outweigh strictly literal = interpretations of=20 regulatory standards and guidances.

Kaufman's take echoed an observation made by a conference = attendee during the Q&A portion of an earlier session on = development and technical transfer. =93Once the FDA and the=20 manufacturer have reached agreement on what constitutes = batch record=20 compliance for a particular product, science becomes = irrelevant in a=20 way because the company just wants to keep the product on = the=20 market,=94 said this attendee. =93Even if a scientist or = engineer within=20 the company suggests a process improvement, the interface = with the=20 FDA can make it difficult to move forward with any changes. = That=20 person may have to interface with various FDA entities, deal = with=20 multiple supplemental approvals, and so on.=94

Over the course of the conference, I heard no dissenting = opinions=20 uttered by spokespeople from the regulatory agencies, the = FDA=20 included. On the contrary, agency officials were quite vocal = about=20 their intention to allow some process change decisions to be = made=20 under the radar of formal review and approval. In the = aforementioned=20 session on development and technical transfer, presenter Jon = Clark,=20 associate director for policy development, Office of = Pharmaceutical=20 Science, CDER, FDA, stated that the FDA wants to help the = industry=20 =93take control of process improvements.=94 Clark reminded = the audience=20 that the existing regulations don=92t actually preclude = scientists and=20 engineers from applying newly gained process understanding = or from=20 striving for continuous improvement. Nevertheless, Clark = admitted,=20 the agency could do more to encourage new approaches. = =93Instead of=20 reviewing new strategies case-by-case, the FDA could review = and=20 approve broad-based types of solutions,=94 Clark offered. = =93The goal=20 would be to eliminate requirements for re-review when a = process=20 change is of little consequence.=94

Clark also acknowledged that the FDA has a relatively = static=20 number of reviewers but an increasing amount of work for = those=20 reviewers. To more efficiently identify processes = necessitating=20 re-examination versus those in which risk is minimal, = applications=20 could, Clark said, "be formatted along the lines of = risk-based=20 questions.=94 Clark encouraged the audience to be hopeful = yet patient=20 regarding any rollout of revised guidances or revamped=20 review/approval procedures. =93This is the direction the FDA = is trying=20 to go,=94 Clark said. =93But, it will take time.=94=20

The conference also demonstrated that it=92s not just at = the FDA=20 where signs of a new regulatory climate are emerging. = Several=20 sessions focused, for instance, on the various = quality-by-design=20 activities currently underway at the International = Conference on=20 Harmonization (ICH), including ICH Q8 on pharmaceutical = development,=20 Q9 on pharmaceutical risk management, and Q10 on quality = systems. In=20 addition, one session offered insight into the relationship = between=20 process improvement and the United States Pharmacopeia = (USP). The=20 discussion centered on USP=92s role in the evolution and = possible=20 standardization (official or de facto) of PAT (process = analytical=20 technology) principles, practices, and solutions. Gary = Ritchie,=20 scientific fellow for the Department of Standards = Development at the=20 USP, reminded the audience that USP standards already allow = for=20 alternate testing procedures. In that sense, PAT is simply = the=20 latest step in the industry=92s pursuit of innovative = approaches to=20 quality control. And, USP recognizes it as such. =93PAT is = compatible=20 with USP philosophy,=94 Ritchie asserted. =93If the industry = moves=20 toward PAT, then USP standards must change to accommodate = that=20 shift.=94

You may be wondering what the warm and fuzzy vibes at the = PDA/FDA=20 Joint Regulatory Conference mean in terms of real action? A = lot,=20 actually. In truth, real action is already at hand. The = steady=20 progress of various ICH-sponsored projects is sure to have a = positive impact on risk management and quality initiatives. = The FDA=20 is revisiting and, in some cases, revising the language in = several=20 existing guidances, including descriptions of process = validation=20 originally crafted in 1987. For its part, the USP is = currently=20 revising the General Chapter on NIR (near-infrared)=20 spectrophotometry to reflect its use and applicability in = terms of=20 PAT. The USP has also proposed general chapters focusing on = several=20 additional technologies.=20

So, there seems to be motivation and commitment to change = the=20 nature of compliance as it pertains to developing and = refining=20 quality products and processes. The PDA/FDA event showed = solid=20 promise that pharmaceutical companies and the agencies will = generate=20 the mutual trust and collaborative energy required for = blasting=20 through decades of industry inertia.=20

Tom von Gunden, PhD, is editor in chief = of=20 Pharmaceutical Online, the industry=92s leading = manufacturing Web=20 site.

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