The ISTA Pharma Committee aims to synchronize the industry on its practices for implementing reusable shippers in the distribution of temperature-controlled pharmaceutical/biotech products.
The group released their best practice guideline last March at ISTA’s TempPack conference (co-located with TransPack) in 2019 and immediately jumped into developing their next document: an operational qualification (OQ) best practice.
The upcoming document, to be released at TempPack (Mar 16-19, 2020 in Orlando) covers considerations for:
- Equipment
- Test plan/methodology
- Documentation required
- Implementation
We spoke with ISTA Pharma Committee Chair Anthony (TJ) Rizzo from Cold Chain Technologies, LLC and a couple of committee members from end user pharmaceutical companies about their efforts, the challenges and how you can benefit as a member of the pharmaceutical logistics community.
HCP: What makes it so important to come to an industry agreement on an OQ standard?
Anthony Rizzo (AR): Our goal is to drive industry standardization to minimize the complexities that the end users have with evaluating “like” pre-qualified thermal packaging solutions from industry suppliers. It can be difficult to compare solutions from supplier A, B, and C to assess which one best fits your needs unless they're all developed and tested to the same set of standards.
A key driving factor for both end users and suppliers is expediting and streamlining the process of developing, evaluating and implementing off-the-shelf solutions. We want to improve speed to market, and minimize qualification costs and the labor effort for both the end user companies and suppliers.
As a supplier it’s definitely a benefit for us to have a general target we're trying to reach and to reduce the amount of customization we're doing.
Voice of the End User: There are opportunities to streamline supplemental testing that each pharmaceutical company may have to do in order to get that pre-qualified container up to a company specific standard. And it enforces or requires the suppliers to all test according to the same criteria. Right now, some vendors go above and beyond, while some do the minimum requirement, and then everybody calls it ‘prequalified.’
There are benefits for everyone including our customers: wholesalers, pharmacies, their affiliates globally. If there’s more standardization on the systems they use, everybody in the supply chain will benefit.
HCP: What are the most challenging areas to come to a consensus on?
AR: The team is composed of representatives from both supplier and pharma companies—small, medium and large—that contributed to the best practice guidance paper based on end user experiences and different business needs. But that also posed a bit of a challenge. We recognized that each pharma company has different requirements or approaches so we wanted to leave room for companies to have some flexibility in the application of the guidelines based on internal risk assessments.
Voice of the End User: When you get down to the detail of the OQs, we always seem to have some consternation as to what ambient temperature profile the pre-qualified solutions are going to be tested to. What kind of product load are you going to use? Do people want to be conservative or not? Getting into the weeds is a challenge. At 30,000 feet everybody would like to standardize the process. We had to make sure these are going to apply to your business goals or your product quality goals.
The team had to “agree on what we could agree on” to standardize and what would be left for company evaluation. Much of this is addressed within the document in terms of the risk assessment, where the company has the ability to make sure that it meets the specific company needs.
HCP: For people who are just learning about the ISTA Pharma Committee, what’s the first action you hope they take?
AR: The first step is increasing awareness of the ISTA Pharma Committee. Once people are aware of it, then they can determine how involved they want to be. Do they want to be part of the process either participating in content development or peer review? At a minimum we hope they download these best practices.
The main reason we created this group was to develop and publish technical guidance that addresses relevant needs of the industry driving standardization. Sometimes terminology and company practices can be a little bit different here and there, so we want more people to join the effort and comment because ultimately, we want industry acceptance. We can complete and publish the guidance but unless it's actually adopted by the masses, it will not be successful.
Voice of the End User: I think that there should be some solace in knowing that the people who are actually developing and using shippers are creating the standards they’re following.
People can reach out to the ISTA Pharma Committee if they have challenges or potential new topics to address. We want them to read it and follow it, and know that if there are optimization opportunities later on, that the pharma committee can be there to work through that.
HCP: Have the documents already been put to work?
AR: From the supplier's standpoint, a lot of the suppliers have really endorsed this new standard. Many are working to make sure that their reusable products, processes, and service offerings align with what is in the paper.
End users have said that, in a good way, it helps to expose the challenges that they’ve all gone through in creating and/or implementing reusable solutions. This will allow them to potentially mitigate those common issues from happening to others.
Voice of the End User: From a high level, first document is already working. In the past, there was a lot of emphasis on single-use solutions. And I think now there's more of an opportunity and it's more accepted to use a reusable solution. Based on the best practices document, I think companies are starting to evaluate their use much more. The success stories will probably come after the OQ document gets completed, approved and presented.”
Having this industry standard strengthens our internal case that reuse is a good option in some scenarios. We have some reuse opportunities that we've implemented, and we expanded upon the initial implementation driven by cost savings and improved environmental impacts.
HCP: Do you have other goals for after this is published?
AR: In preparation for finishing the OQ paper, we compiled a list of over a dozen different topics to tackle. During the development process of both papers, we tabled certain topics and said, “That's out of scope for this document but that is a great thing to work on next.”
We’ve been working with a relatively small group, but now with ISTA’s backing, our goal is to expand it, work on multiple topics at once and start to create more standardization in the industry by developing more best practices.
It's been a wonderful opportunity… in the past I think it's been difficult to get pharma companies to talk to other pharma companies, or suppliers to talk to other suppliers, and now we have examples within this group of how that collaboration and that communication is benefiting the industry.
