Advisory Services: Gain Insight. Save Time. Control Budget.
The traditional consulting model is based upon addressing the same issue for as many clients as possible. At CS Analytical, we handle things a bit differently.
CS Analytical’s Advisory Services sector routinely identifies regulatory challenges and trends facing our clients in the pharma, biotech, and med device industries, and builds solution-oriented packages to address them. Although a specific solution may be custom-tailored to a client’s organization, product-package system, or process, the root challenge tends to be industry-wide.
Rather than charging high hourly rates as part of open-ended consulting agreements, CS Analytical Advisory Service packages are designed to capture key elements of these common yet specific challenges life science companies continue to face in container closure system (package) development and validation, but in a defined scope of service and budget.
Determine what you need. Define the plan. Get it done.
Advisory services will be offered stand-alone, determining needs or building a strategy to address a specific challenge. However, a key value-add is integration of Advisory Service packages into broader test programs incorporating CSA’s Analytical Services; identifying needs and subsequently meeting them. Flexibility will be a key component of each package: each clients’ needs and mutual expectations are clearly defined and addressed through the consultative program, price schedule, and deliverables. Access to industry best practices in a communicable and efficient manner, with the unique ability to transition directly into analytical services highlights the new approach taken by the CS Analytical team to exceed client expectations.
Comprehensive Container Qualification Strategy Review (CCQSR)
Perhaps one of the most daunting and high-level challenges life-science clients continue to face is keeping up with the ever-changing regulatory requirements and test methods to generate appropriate data for a successful filing.
Objective of a CCQSR
Evaluate the product-package system to understand processes leading to its manufacture, distribution, storage, and use. The specific product-package use case largely dictates required testing and control strategies. Collect and interpret all currently available data on the container system, identifying gaps in the available data. Deliver a report to the client summarizing test data that has been generated to date, quality (risk) associated with currently generated data, and gaps in the current data package that need to be addressed through additional testing. The report would identify requirements on the package component level, as well as the package system level.
Maximum Allowable Leakage Limit (MALL) Determination
There tends to be much confusion around the MALL, though at its core, it is a fairly straightforward concept: What is the leak size / rate at which there is a risk to product quality or safety over its intended shelf-life and use? Demonstrating absence of leaks above MALL, (or, inversely, the ability of the package to meet the MALL) is a key aspect of demonstrating package suitability for its intended use.
Objective of a MALL Determination
Evaluate the product to gain a keen understanding of the product’s quality attribute requirements. This starts with understanding the sensitivities of the product to content loss, sterility, and reactive gases and moisture, as well as a general overview of processes leading to its manufacture, distribution, storage, and use by which the product may be exposed to such sensitivities. Use learnings to describes leaks of concern: those leaks that pose a risk to any relevant product physiochemical or microbiological quality attribute through expiry and use. Interface with relevant product development and regulatory teams to leverage existing product stability knowledge and data to characterize and describe leaks of concern and therefore, the Maximum Allowable Leakage limit in a written report. The report can be used to inform next steps, including selection and development of CCI methods to characterize the product lifecycle, or as part of justification for testing performed.
CCI Strategy Review (CCISR)
Historically, the classic “study goal” for CCI testing was to demonstrate sterility assurance of final product-packages for filing purposes. However, CCI of any product-package system is a function of its materials, design, and the processes that govern its creation, distribution, and use. For this reason, a modern consideration of CCI reaches much further back than the final product, encompassing every stage in a product’s lifecycle. This guidance is explicitly mentioned in USP <1207.1>, which establishes that CCI testing should be performed in package development and validation, product manufacturing, as well as stability and distribution. Where feasible, testing should occur to the MALL. A comprehensive control strategy will identify potential risks to CCI as part of each of these lifecycle stages and introduce test methods and control strategies to characterize and mitigate those risks to best practices.
Objective of a CCISR
Evaluate the product-package system to gain a high-level understanding of the product and package across the lifecycle. Identify key risks to CCI at each lifecycle stage. Understand existing control strategies used to mitigate these risks. Collect and interpret all currently available data with respect to CCI, identifying gaps in the available data. Deliver a report to the client summarizing current best practices with respect to CCI, relevant regulatory requirements and guidance, and a high-level plan on how to meet them, including assessment of gaps in the current data package that need to be addressed through additional testing or control strategies.
CCI Method Selection, Development, Validation, or Transfer
Choosing an appropriate CCI technology depends on limitations imposed by the product, the package, and the specific study goals to be addressed using methods developed. For example, evaluating an empty package system to verify assembly parameters may require a different method than testing the filled product-package system before and after distribution simulation. Development and validation of that method is critical to ensure it is suitable for its intended use. CSA’s years of experience and leadership in this field can be leveraged to accelerate this process and provide confidence in the choice. Furthermore, CSA can help develop, validate, and transfer methods for internal use at a client’s site (or across sites), or internally at CSA.
Objective of a CCI Method Selection, Development, Validation, or Transfer Package
Evaluate the specific reason a client is pursuing a CCI test. Gather and interpret all relevant information that could impact the applicability of a given test technology or a method developed on a specific technology. Understand the intended use of the method and evaluate whether or which method type is best suited to address the specific client concern or phase of implementation. Develop documents such as reports or protocols to facilitate this process, unique for each client.