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Public opinion on the new ICH Q1 draft guidelines

When the ICH Q1 draft guidelines on Stability Testing of Drug Substances and Drug Products were first released in April 2025, they caused a stir across the pharmaceutical industry. With significant updates to storage justification, data interpretation, and risk-based planning, many teams were left wondering what it could mean for their ongoing and future stability studies. 

This comprehensive revision consolidates the previous ICH Q1A-F and Q5C guidelines into a single, unified document, bringing modern clarity to expectations for synthetic molecules, biologics, and advanced therapy medicinal products (ATMPs). 

At Q1 Scientific, we’ve been listening in at conferences, on webinars, and across social media. Think of this article as the equivalent of heading straight to the comments section on a trending story. Here’s what we’re hearing now that the industry has had time to process, digest, and debate the proposed changes. 

Key thoughts on the new ICH Q1 draft guideline 

Overall, the mood is cautiously optimistic. Now that some time has passed, and the initial reactions have been replaced by more in-depth analysis and expert commentary, the general sentiment is clearer and more balanced. These updates are seen as both a challenge and an opportunity, a shift towards more science- and risk-driven decisions that also ask more of companies when it comes to documenting and justifying their stability strategies.  

Many see the draft as a step in the right direction. The inclusion of risk-based approaches, clearer expectations around modelling, and more flexibility for certain study designs feels like progress. 

While the guidelines are still in draft form and clarity will be key when the final guideline is published, here are some of the areas drawing the most attention: 

Positive sentiments 

  1. Consolidation and clarity
    • Many industry professionals appreciate the consolidation of the previous Q1A–Q1F and Q5C guidelines into a single comprehensive document. This unification is seen as a major step forward in simplifying and harmonising stability testing requirements across different product types.
    • The streamlined structure, consisting of 18 main sections and 3 annexes, is praised for its holistic and modular approach to stability testing. 
  2. Appreciation for modernisation and innovation
    • The inclusion of specific guidance for advanced therapy medicinal products (ATMPs) and predictive stability modelling is widely welcomed. This addresses the unique stability needs of novel excipients and adjuvants, reflecting the latest scientific advances. 
  3. Enhanced compliance and quality management 
    • The guideline’s emphasis on transparency and documentation throughout the stability testing process is viewed positively. This is expected to benefit pharmaceutical manufacturers by reducing the risk of non-compliance and improving quality management practices. 
  4. Life cycle stability management 
    • Stability is no longer just a box-ticking exercise for regulatory submission. The draft encourages proactive, ongoing stability planning throughout the product lifecycle. There’s greater alignment with ICH Q8-12, encouraging a more science-based approach to stability, and encouraging continuity from development through to post-approval. 
  5. Reference standards guidance welcomed 
    • The introduction of clearer guidance on reference standards has received widespread approval from pharmaceutical and analytical professionals. The detailed instructions on stability testing and storage conditions are seen as a significant improvement, ensuring the reliability and consistency of reference standards. Experts believe these guidelines will lead to more accurate and reproducible results in analytical labs, marking a positive development for the industry. 
  6. New statistical model guidance praised 
    • The new ICH Q1 draft guidelines have introduced clearer instructions on using statistical models for stability testing, replacing the previous vague and complicated standards. This update is welcomed by industry professionals, who believe it will lead to more accurate and reliable stability predictions.   
  7. Embracing leaner stability study designs 
    • The draft ICH Q1 codifies what the industry has been practicing informally. Lean, risk-based, and model-driven stability programs are not only allowed, but they are also now formally guided. With the introduction of Annex 1, companies now have a clear framework for designing reduced stability studies using tools like bracketing, matrixing, and modeling. This aligns with modern Quality-by-Design and lifecycle management principles, offering greater flexibility while maintaining regulatory confidence, an evolution welcomed by industry stakeholders seeking efficiency without compromising compliance. 

Areas of concern 

  1. Interpretation and implementation consistency 
    • There’s some uncertainty about how national regulatory authorities will interpret and enforce leaner protocols, especially in more conservative jurisdictions. 
  2. Complexity, length, training and change management 
    • Some stakeholders have noted that the new guideline is significantly longer and more complex, which can make it challenging for manufacturers to navigate and implement the new requirements effectively. 
    • The expanded content may require additional training and resources for proper implementation. 
    • Companies anticipate a learning curve for internal teams and inspectors, requiring investment in training and updates to quality systems. 
  3. Impact on study design 
    • The industry is actively exploring how the new guidance could change how stability studies are designed, and how this will affect cost, timelines, and resource allocation. Some companies are optimistic that smarter, risk-based design will allow them to streamline their protocols and reduce the volume of samples stored. Others worry that without clear regulatory consensus, they’ll still have to take the “belt and braces” approach to satisfy global authorities. 
  4. Scientific justification burden 
    • While welcomed in principle, the level of data and documentation needed to justify lean protocols may be resource intensive, particularly for smaller companies. 
  5. Gaps in specific areas
    • Critics have pointed out gaps in the guideline, such as insufficient detail on short-term storage, processing holds, and in-use stability. These areas are critical for understanding the stability of drug substances and products during manufacturing and transportation. 
    • There is also a call for more explicit guidance on stability modelling and extrapolation strategies, as well as detailed protocols for thermal cycling and freeze-thaw studies. 
  6. Advanced Therapy Medicinal Products (ATMPs)
    • While the guideline includes provisions for ATMPs, it does not fully address the unique stability challenges associated with these products, including cell and gene therapies, which have distinct storage and handling requirements. 
    • More detailed guidance on stability testing for ATMPs would support manufacturers in ensuring the quality and safety of these innovative therapies. 
  7. Digital tools and predictive modelling 
    • Another topic gaining traction is how these guidelines may encourage broader adoption of digital modelling tools. Software vendors and big pharma are engaging in discussions about: 
      • Validation requirements for modelling software 
      • Acceptability of simulations for expiry dating under accelerated conditions 
      • How to communicate and defend modelling assumptions during inspections 
    • The general consensus is that modelling is on the rise, but confidence varies depending on company maturity, regulatory experience, and therapeutic area. 

Preparing for changes in the new draft ICH Q1 guideline 

Companies are hesitant to change internal SOPs or study designs until final guidance is released, and regulator positions are clearer. 

Although the Step 2 document is not final, companies can take proactive steps to prepare for the upcoming changes. Here are some key actions to consider: 

  1. Conduct a gap analysis 
    • Perform a thorough gap analysis to compare current stability testing practices with the new requirements outlined in the draft guideline. This will help identify areas where changes are needed. 
    • Focus on key areas such as data evaluation, shelf-life extrapolation, and specific requirements for advanced therapy medicinal products (ATMPs). 
  2. Review stability testing protocols 
    • Review existing stability testing protocols to align with the new guidelines. This includes incorporating new scientific advances and methodologies, such as predictive stability modelling and risk-based approaches. 
    • Ensure that protocols for thermal cycling, freeze-thaw studies, and in-use stability are detailed and comprehensive. 
  3. Plan for training sessions 
    • Plan training sessions for relevant personnel to familiarise them with the new guidelines and updated protocols. This includes laboratory staff, quality assurance teams, and regulatory affairs professionals. 
    • Emphasise the importance of transparency, documentation, and adherence to the new stability testing requirements. 
  4. Engage with Regulatory Authorities and seek clarifications 
    • Engage with regulatory authorities to seek clarifications on any ambiguous areas of the guideline. This can help ensure that stability testing practices are fully compliant with the new requirements. 
    • Participate in public consultations and provide feedback on the draft guideline to influence its finalisation. 
  5. Develop an implementation plan 
    • Develop a detailed implementation plan that outlines the steps needed to transition to the new guidelines. This includes timelines, resource allocation, and milestones. 
    • Monitor progress regularly and adjust the plan as needed to address any challenges that arise during implementation.

By taking these steps, you can ensure a smooth transition to the new stability testing requirements and maintain compliance with the updated ICH Q1 guidelines when they are finalised. 

What the ICH Q1 draft guidelines mean for customers storing with Q1 Scientific 

So, what does that mean for your storage programs, and how is Q1 Scientific helping customers navigate the changes ahead? 

For our customers, the new draft guidelines reinforce the importance of partnering with a storage provider that’s compliant, responsive, and adaptable.  

If you’re already storing samples with Q1 Scientific in Belgium, Ireland, or the US, there’s nothing you need to change right now. But it’s a great time to start thinking ahead: 

  • Could protocol design shift under the final guidance? 
  • Will you need to adapt how you justify your storage conditions? 
  • How might risk-based approaches be applied or questioned during audits? 

Here’s how we’re helping

  1. Support for evolving study needs 
    • Our flexible storage model allows customers to scale up or modify storage conditions as their stability strategy evolves, whether that’s adjusting conditions or extending studies across product life cycle phases 
  2. Sample tracking and reporting 
    • Our custom-built Electronic Sample Tracking System (ESTS) provides real time visibility of your samples and full historical tracking, supporting traceability and aiding in OOS investigations or trend reviews 
  3. GMP-compliant stability storage 
    • With GMP-compliant stability storage facilities in Belgium, Ireland and the US, we offer a fully compliant, audit-ready environment giving you confidence in data integrity 

Access the ICH Q1 draft guidelines 

For those who haven’t yet explored the full draft, the ICH Q1 Stability Testing of Drug Substances and Drug Products document outlines the proposed updates in detail. It’s available on the ICH website under the quality guidelines section. Stakeholders can also review the explanatory notes and background materials accompanying the draft to better understand the intent behind the revisions. 

Feedback submission strategies 

For anyone impacted by the changes, particularly those responsible for designing and managing stability programs, or storing with Q1 Scientific, the coming month is a critical window. The draft is still open to consultation until 30 July 2025, after which the ICH Expert Working Group will review responses and work toward finalising the guideline. 

Many companies are: 

  • Collaborating through trade groups (e.g. PDA, ISPE, EFPIA) to submit cohesive industry feedback 
  • Preparing internal regulatory assessments to identify gaps between current practice and the proposed guidance 
  • Watching to see what major regulators (FDA, EMA, HPRA) say in their comment submissions, which may hint at future enforcement direction 

Helping you stay ahead of the ICH Q1 draft guidelines 

The draft ICH Q1 guidelines mark a significant step forward in aligning stability testing practices with today’s evolving regulatory and scientific landscape. From the increased emphasis on science- and risk-based approaches to the clearer guidance on bracketing, matrixing, and alternative storage conditions, the proposed updates reflect how far the industry has come since Q1A was adopted over two decades ago. 

Overall, the new draft ICH Q1 guideline is viewed as a significant advancement in stability testing standards, with both positive reception and constructive feedback from the industry. The general sentiment is optimistic, with stakeholders recognising the potential for improved harmonisation and modernisation of stability testing practices, while also acknowledging areas that need further clarification and detail. 

At Q1 Scientific, we’re keeping a close eye on developments and preparing to support customers through any required adjustments. We know that change can be disruptive, especially when regulations shift mid-study. That’s why we will work closely with customers to: 

  • Review current storage protocols and identify areas where the new guidelines may apply 
  • Offer guidance on condition justification and documentation 
  • Maintain open communication with QA teams to ensure alignment with compliance expectations 

Whether the final guidance results in subtle refinements or more substantial changes, our priority remains the same: to provide compliant, reliable and future-ready stability storage services across Belgium, Ireland, and the US. 

As the draft continues toward finalisation, we’ll keep tracking updates and sharing practical advice through our website, webinars, and emails. 

Have questions? We’re here to help 

Whether you’re planning new studies or reviewing your current protocols in light of the draft guidelines, we’re here to support you. Reach out to your Q1 Scientific contact or contact us directly for expert guidance. 

As the process unfolds, we also welcome your questions and feedback along with way.