Design Qualification in Pharmaceutical Industry: 10 Tips

Equipment and machinery have an indispensable role in pharmaceutical manufacturing and quality control. Hence, they must pass the design qualification stage fulfilling predetermined user requirement specifications. Design qualification is the first step of the equipment qualification process. The equipment qualification process focuses on evaluating whether equipment being used in the facility meet regulatory and operational requirements. Design qualification in pharmaceutical industry ensures the design of the equipment aligns with its intended use and complies with regulatory requirements. Moreover, by identifying potential design flaws early on, design qualification (DQ) can prevent expenditure associated with equipment failure. In this blog, we have discussed what is DQ in pharma industry and its importance. Additionally, we have provided some tips for conducting effective design qualification in pharmaceutical industry.

What is design qualification in pharmaceutical industry?

Design qualification is a critical phase of the equipment and systems qualification process. Design qualification in pharmaceutical industry is the process of verifying and documenting whether the design of the equipment meets the required specifications and abides by regulatory and quality standards. Basically, design qualification (DQ) ensures the equipment design can achieve its intended purpose reliably and consistently. Moreover, the DQ process requires formal documentation and approval from the quality unit. It is focussed on critical aspects and critical design elements, which are vital for ensuring product quality and patient safety. Thus, the ultimate goal of DQ is to confirm the design is capable of fulfilling its intended purpose while maintaining compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines.

Practical examples of conducting DQ in pharma industry: For freeze-dryers, DQ ensures the design can handle required temperature ranges, chamber sizes, and pressure levels to meet production demands. In case of a tablet press machine, DQ reviews whether the design specifications can meet production requirements, such as tablet size and weight, as well as GMP guidelines.

Key objectives of DQ in pharma industry

DQ in pharma industry aims to ensure the equipment design aligns with the user requirements, operational needs, and regulatory standards. Design qualification is the first step of the equipment qualification process, which also includes installation qualification, operational qualification, and performance qualification. Basically, DQ ensures the design phase sets the stage for successful operation of the equipment being used in the facility.

• Meeting user specifications: DQ aims to verify that the equipment design fulfils the defined user requirement specifications (URS) and functional requirements.
• Risk mitigation: Design qualification identifies and addresses potential design flaws that could affect performance, reliability, or even regulatory compliance.
• Forms the basis for the next steps of the equipment qualification process: DQ establishes a solid foundation for the subsequent equipment qualification steps.
• Ensuring regulatory compliance: DQ ensures the equipment design adheres to relevant regulatory guidelines and industry standards.

Therefore, the purpose of design qualification in pharmaceutical industry is to confirm the equipment design is capable of fulfilling its intended purpose while maintaining compliance with GMP and regulatory standards. Hence, design qualification plays a vital role in ensuring consistent product quality and safety, thereby impacts patient safety.

Steps for conducting effective design qualification in pharmaceutical industry

We have provided an overview of the pharmaceutical industry design qualification steps.

1. Define user requirement specifications: Identify the user and functional requirements of the equipment to be used in the pharma manufacturing facility. Focus on key aspects, such as performance, safety, capacity, and compliance with applicable regulations.
2. Prepare equipment design documentations: Create detailed equipment design documentation, such as technical specifications, process flow diagrams, system architecture, and equipment layouts.

3. Perform risk assessment of the equipment design: Conduct a thorough risk assessment process to identify design flaws and potentials risks. It is important to evaluate critical parameters associated with the equipment design that might affect product quality or safety. Then, control measures have to be implemented to mitigate risks.
4. Conduct a thorough equipment design review: The equipment design has to be thoroughly reviewed. Feedback from engineering, quality assurance, production, and other relevant departments has to be taken into consideration.
5. Review and approve the prepared design documentation:  Check whether the design documentation aligns with the user and regulatory requirements as well as abides by industry standards.
6. Record the findings of the design review process: Findings and outcomes of the review process as well as any recommended changes or actions have to be properly recorded. A design qualification report has to be prepared.
7. Secure approval for the final design qualification report: The final design qualification report has to be vetted by stakeholders from relevant departments. After approval and validation, the report has to be maintained for audit and demonstrating regulatory compliance.

6 common pitfalls of an ineffective design qualification

A thorough and well-documented design qualification phase is of paramount importance for a successful pharmaceutical equipment qualification process. Hence, an in-effective design qualification phase will lead to serious regulatory consequences, thereby affecting product quality and patient safety. We have highlighted some of the common pitfalls of an ineffective design qualification in pharmaceutical industry.

1. Regulatory non-conformity: One of the most important consequences of an in-effective design qualification phase is regulatory non-compliance.  This will lead to suspension of operations by regulatory agencies, fines, and regulatory sanctions.
2. Compromised product quality: Equipment not designed properly might not function as intended, thereby leading to production of substandard products. Hence, an in-effective design qualification phase will translate to compromised product quality.
3. Threat to the entire equipment qualification process: Design qualification is the first and foundational phase of the equipment qualification process. Hence, an in-effective DQ will compromise the entire equipment qualification process, thereby affecting regulatory compliance and equipment reliability.
4. Reputational damage: If a substandard product reaches the market, it could result in lawsuits, thereby damaging the company’s reputation.
5. Operational inefficiencies: Equipment not aligned with user and functional requirements may lead to frequent breakdowns, thereby causing operational inefficiencies. Hence, an in-effective DQ will translate to increased maintenance costs as well as disrupt production schedules.
6. Financial losses: An in-effective DQ will lead to operational issues, regulatory non-compliance, and product quality issues. This will lead to recalls, rework, operational delays, regulatory sanctions, and fines that can lead to significant financial setbacks and losses.

Best practices for conducting effective design qualification in pharmaceutical industry

1. Collaborate with all relevant departments: Inputs from engineering, quality assurance, production, and other relevant departments have to be taken into consideration during the design qualification phase.
2. Vendor selection: Choose reliable vendors and suppliers. Also, clearly communicate the user and regulatory requirements to ensure the equipment design aligns with them.
3. Clearly define the user requirement specifications: Clearly define the user requirement specifications for the equipment. It should state the intended use, performance criteria, and operational conditions for the equipment to be used in the manufacturing facility.
4. Conduct thorough risk assessments: Thoroughly conduct risk assessments. Identify potential risks associated with the equipment design. Furthermore, implement mitigation strategies to address design flaws.
5. Secure equipment design approval: The equipment design should be reviewed and approved by qualified personnel. Involve stakeholders from all departments, including the quality assurance team.
6. Train personnel involved: Ensure all personnel involved in the DQ process are adequately trained. Furthermore, they should be made aware of their roles and responsibilities.
7. Plan for any deviations: Develop a process for addressing any deviations from the design specifications. Furthermore, these deviations should be documented.
8. Audits: Conduct regular internal audits to ensure the DQ process remains robust and compliant with industry standards and regulatory guidelines.
9. Perform regular verification: Verify whether the equipment design meets the specified requirements throughout the development process.
10. Thorough documentation and record keeping: Extensive documentation of the DQ phase outlining design specifications, risk assessments, and approval records should be maintained. Thorough documentation is vital for conducting an effective design qualification as well as regulatory compliance.

Pharmadocx Consultants: Your trusted regulatory support

Design qualification in pharmaceutical industry has a vital role in regulatory compliance and ensuring product quality. DQ is the first foundational step of the equipment qualification process. Hence, it has to be conducted effectively and thoroughly. For any regulatory support, feel free to drop an email at [email protected] or call/Whatsapp on 9996859227.