Quality by Design (QbD)
Build quality into products and processes instead of testing it in at the end.
Quality by Design (QbD) turns development and manufacturing into a science- and risk-based discipline. Instead of hoping a validated batch will behave, you define a Quality Target Product Profile (QTPP), link critical material attributes (CMAs) and critical process parameters (CPPs) to critical quality attributes (CQAs), and design experiments and controls around that understanding.
Amalia Technologies helps you implement QbD in a practical way – from early development through tech transfer and commercial lifecycle – integrating DoE, PAT and validation so your teams can explain why a process works, not just that it passed.
Quality is not systematically built into the process, leading to risk and inefficiency
Quality still verified through end-product testing rather than built into the process
Weak linkage between QTPP, CQAs, CPPs and material attributes
Late-stage surprises during scale-up and validation
Advanced tools (PAT, models) used in isolation without a coherent framework
Difficulty demonstrating control and flexibility to regulators
Why QbD matters
Define clear QTPP, CQAs and their link to process and materials
Use DoE and PAT to generate true process understanding
Establish design space and robust control strategies
Integrate advanced tools into a coherent QbD framework
Enable lifecycle control and continuous improvement
Embed QbD into daily development and manufacturing practice
What we do under Quality by Design (QbD)
We structure QbD engagements as a sequence of practical phases that can be applied to a single product, a shared platform, or an entire portfolio.
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Define or refine the Quality Target Product Profile (QTPP) – route of administration, dose, performance, stability, patient and market needs and intended clinical use
Clarify regulatory context and target markets (and therefore which guidelines and pharmacopeias matter most)
Agree scope: new product, major process change, site transfer or lifecycle optimisation
A shared, documented QTPP and objective set that anchors the rest of the QbD work
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Identify CQAs for the product (for example potency, purity, dissolution, particle size, aggregation)
Map CMAs and CPPs that could influence those CQAs, using process maps and prior knowledge
Run structured quality risk assessments to rank risks and focus development on what matters most
Define what needs to be understood through experimentation, modelling or PAT
A living CQA/CMA/CPP map and risk register that guides experimental work and control-strategy design.
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Design DoE programmes for key unit operations or process trains, using right-sized designs that fit material, equipment and plant constraints
Decide where PAT instrumentation (for example Raman or NIR spectroscopy) and data tools (e.g. multivariate models and soft sensors) will add value in development and – later – in routine use
Plan how knowledge will be captured and reused, not left in isolated notebooks, spreadsheets or models
An integrated process characterisation plan and data strategy that link DoE, PAT and classical analytics to the QbD objectives.
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Analyse DoE and PAT data to understand main effects, interactions and robustness margins
Propose design space(s) or proven acceptable ranges where CQAs remain within specification
Define an overall control strategy spanning raw materials, in-process controls, PAT measurements, release testing and Continued Process Verification (CPV)
Assess options for Real-Time Release Testing (RTRT) where justified by data and risk
.A design-space and control-strategy package that supports internal governance and regulatory dialogue.
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Align QbD outputs with your validation strategy (for example process validation, cleaning validation, analytical QbD) and documentation structure
Integrate QbD deliverables into tech-transfer packages between R&D, pilot and commercial sites
Define life-cycle management and continued process verification (CPV) plans, including how you will monitor signals of drift and update models or controls
Provide training and coaching for development, QA, manufacturing and regulatory teams so QbD becomes a shared way of working
QbD that is embedded in your SOPs, validation, and governance, not just a one-off initiative.
Deliverables
A typical QbD engagement includes a tailored selection of:
Translating patient, clinical, and market needs into clear quality goals.
Including FMEA or similar, with prioritised risks and mitigation actions.
An integrated view of DoE, PAT, analytical methods and sampling strategies.
Content that can flow into Common Technical Document (CTD) sections.
How data will be trended, and how changes will be justified.
So teams can reuse the approach across products and sites.
Day-to-day project management, stakeholder co-ordination and facilitation are included; we take full ownership of delivery, not just the slideware.
Customer Stories & Insights
Outcomes you can expect by working with Amalia
By working with Amalia Technologies on QbD you can expect:
Risks are surfaced and explored early, backed by structured experimentation and modelling.
Submissions and inspections are supported by a coherent QbD story anchored in ICH Q8/Q9/Q10 expectations.
Clearer design spaces and control strategies allow you to manage variability, introduce improvements and adopt continuous or hybrid manufacturing with confidence.
Development, manufacturing, QA, regulatory and supply chain work from a shared map of what matters and why.
QbD becomes part of how you design and improve processes, not an exception reserved for a few flagship products.
When to consider Quality by Design (QbD)
You are developing a new product or major line extension and want a modern, regulator-aligned development approach from the start
You are facing a significant process change – new site, new equipment, new scale or new supplier – and want to reduce transfer risk
You are planning continuous manufacturing or advanced PAT deployments and need a solid QbD foundation to support design and validation
You have been asked by regulators or partners to strengthen your QbD narrative in submissions or inspections
You want to harmonise varied development practices across sites into a consistent QbD framework.
As more organisations adopt advanced PAT tools and multivariate models, QbD provides the structure to ensure these technologies are tied back to CQAs, CPPs and a coherent control strategy rather than remaining isolated pilots.
Why Amalia
We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.
We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.
A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.
We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.
Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.
We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.
Senior leaders stay involved from start to finish on every engagement. Each programme is treated as a long-term partnership, not a one-off project.
Want to simplify complex work without losing control?
Work with a team that can join up governance, assurance, platforms and technical depth from start to finish.