Equipment, systems, and components used throughout the pharmaceutical manufacturing process are essential to ensuring the safety, quality and regulatory compliance of products manufactured. Before installation and qualification of any equipment, it must be demonstrated that it is designed for its designated purpose and is compliant with regulations of GMP.
The process of verifying that an equipment meets design requirements through review of its drawings, specifications and documentation is referred to as Design Qualification (DQ).
Design Qualification is the initial phase of the qualification lifecycle and serves as the basis for the validation of any manufacturing equipment or systems. As part of this process, the manufacturer shall be satisfied that the equipment or system has been manufactured according to user specifications including regulatory requirements.
DQ is normally performed after the URS and the functional design specification (FDS) have been completed but before any equipment is purchased. DQ demonstrates that the design, materials and functions selected will provide consistent and reliable performance for the application for which they were designed.
In other words DQ answers the question - “Is this design appropriate for the intended use within a GMP environment?”
EU GMP Annex 15: Qualification and Validation "Design qualification means that the proposed design for a facility, system or equipment will meet the intended use of that facility, system or equipment."
WHO Technical Report Series 937, Annex 4: "DQ demonstrates that the design of a facility or equipment will meet the intended use of that facility or equipment."
ISPE Baseline Guide Volume 5: Commissioning and Qualification
FDA 21 CFR Part 211.63: All equipment, including design, size, and location, must enable cleaning and maintenance.
These references interpret that DQ is a regulatory requirement for all equipment and systems that are critical to Good Manufacturing Practices (GMP).
In the case of purified water system, URS would provide specification for quality of water, flow rate, temperature, conductivity and microbial limits.
- Functional design specification (FDS)
- Piping and instrumentation diagrams (P&ID)
- General arrangement drawings (GAD)
- Equipment specifications
- Control Logic & Software Description
These documents are reviewed to determine if they meet URS and GMP compliance. The reviewing party is an independent team who will compare the document criteria to the original user requirements and good manufacturing practices.
Risk evaluation is based upon:
- Material compatibility
- Cleanability
- Cross-contamination potential
- System redundancy
- Alarm and control systems
After assessing each risk, a strategy for reducing the risks is developed and documented.
- System layout and accessibility
- Safety and ergonomically designed work areas
- Utility connections and maintenance check points
- Data integrity and automation controls
- GMP compliance & engineering standards
Discrepancies or opportunities for improvement are documented as an action plan.
- Objective & scope
- Reference documents (URS, FDS & P&ID)
- Acceptance criteria
- Responsibilities
- Verification checklist
- Summary & conclusion section
Download Design Qualification Sample Protocol
- Scope and objective
- Documents reviewed
- Observation and resolution
- Summary of deviations
- Final recommendations and approval
The report indicates if the design is appropriate for procurement and installation.
Quality Assurance - Ensures DQ documentation complies with good manufacturing practices (GMP) and approves DQ documentation.
Validation Team - Create DQ protocol and ensure the design meets the requirements of the user requirement specifications (URS).
User Department - Review design to ensure it is suitable for operation.
Supplier - Provide the technical drawings and specifications for DQ.
- Approved user requirement specification (URS)
- Functional design specifications (FDS)
- Piping and instrumentation drawings (P&ID) and drawings
- Specifications for components
- Reports of risk assessments
- Protocols and reports for design qualification
- Vendor information and qualification certificates
Together these documents provide assurance that the design of the system is scientifically and regulatory acceptable.
2. Inadequate Risk Assessment – Failure to recognize early on which risks are the most critical.
3. Poor Documentation – There may be missing information related to drawings etc.
4. No Cross-Function Reviews – Engineering, QA and all departments have not participated in a cross functional review.
5. Rushed Execution – Skipping the DQ for the sake of saving time that ultimately leads to a delay in validation efforts down the road.
Preventing these issues can create a better qualified and compliant qualification process.
2. Traceability must be maintained between URS → FDS → DQ → IQ → OQ.
3. Your design verification process must have a risk-based approach to find the risks associated with design.
4. Vendor documentation must meet 21 CFR Part 11 and good manufacturing practice requirements.
5. Computerized systems must be designed to ensure data integrity and compliance with Automated Process Control System (APCS) requirements as per 21 CFR Part 11.
6. Change controlled documents require formal approval before being archived.
The connection between the URS and DQ allows for a smooth transition to validating the requirements of a user for a specific system.
- Before installation, DQ assures compliance with good manufacturing practices (GMP) regarding design.
- DQ helps to eliminate design-related non-conformance events.
- DQ helps to reduce rework and project costs due to error.
- DQ increases the reliability and maintainability of a system.
- DQ provides an increased level of preparedness for future audits by improving documentation quality.
A properly executed DQ establishes the basis for the continued success of future qualifications and supports long-term operational performance within an organization.
The basis of validation for drug manufacturing in the pharmaceutical industry is the design qualification. DQ guarantees that the design of a piece of equipment or system is optimal and allows for the user's expectations and GMP requirements to be met correctly.
Pharmaceutical manufacturers benefit from following a structured approach to DQ, using a documented and risk-based methodology to conduct the design qualification process. By doing so, a company will maintain compliance with regulatory agencies while minimizing the potential risks associated with a project and protect the quality of their product.
The process of verifying that an equipment meets design requirements through review of its drawings, specifications and documentation is referred to as Design Qualification (DQ).
What is Design Qualification (DQ)?
Design qualification (DQ) is a documented procedure verifying that the design of facilities, utilities, systems, or equipment is compliant with the User Requirement Specification (URS) as well as all regulatory requirements.DQ is normally performed after the URS and the functional design specification (FDS) have been completed but before any equipment is purchased. DQ demonstrates that the design, materials and functions selected will provide consistent and reliable performance for the application for which they were designed.
In other words DQ answers the question - “Is this design appropriate for the intended use within a GMP environment?”
Purpose of Design Qualification
- The design qualification (DQ) determines whether the following conditions are satisfied:
- The design meets all user needs and requirements.
- The design complies with GMP, safety and regulatory requirements.
- The design is developed based upon good engineering practices.
- The design provides for adequate controls over critical operations.
- The design can be operated, cleaned and maintained as intended.
- The design includes appropriate documentation and vendor support.
Regulatory References for Design Qualification
All pharmaceutical manufacturers must have an established structure to follow during the qualification and validation process from regulatory agencies worldwide. Key references include:EU GMP Annex 15: Qualification and Validation "Design qualification means that the proposed design for a facility, system or equipment will meet the intended use of that facility, system or equipment."
WHO Technical Report Series 937, Annex 4: "DQ demonstrates that the design of a facility or equipment will meet the intended use of that facility or equipment."
ISPE Baseline Guide Volume 5: Commissioning and Qualification
FDA 21 CFR Part 211.63: All equipment, including design, size, and location, must enable cleaning and maintenance.
These references interpret that DQ is a regulatory requirement for all equipment and systems that are critical to Good Manufacturing Practices (GMP).
Design Qualification Process
The DQ process consists of several clearly outlined stages and each section has a specific set of documentation and approval requirements associated with it.Step 1: Creating the User Requirement Specifications (URS)
Process starts with URS, where URS describes the expectations of the system or equipment to be designed and built. URS define performance criteria, capacity, control systems, safety and regulatory compliance.In the case of purified water system, URS would provide specification for quality of water, flow rate, temperature, conductivity and microbial limits.
Step 2: Review of Design Documents
Design documents are prepared by either vendors or engineering teams with the following descriptions:- Functional design specification (FDS)
- Piping and instrumentation diagrams (P&ID)
- General arrangement drawings (GAD)
- Equipment specifications
- Control Logic & Software Description
These documents are reviewed to determine if they meet URS and GMP compliance. The reviewing party is an independent team who will compare the document criteria to the original user requirements and good manufacturing practices.
Step 3: Risk Assessment
The use of a risk-based strategy in accordance with ICH Q9 identifies possible design risks that may impact product quality or safety.Risk evaluation is based upon:
- Material compatibility
- Cleanability
- Cross-contamination potential
- System redundancy
- Alarm and control systems
After assessing each risk, a strategy for reducing the risks is developed and documented.
Step 4: Design Review Meeting
The cross functional team reviews the design of the system, which includes the following aspects:- System layout and accessibility
- Safety and ergonomically designed work areas
- Utility connections and maintenance check points
- Data integrity and automation controls
- GMP compliance & engineering standards
Discrepancies or opportunities for improvement are documented as an action plan.
Step 5: Design Qualification Protocol Preparation
The design qualification protocol provides documentation of the evaluation process of the equipment being qualified. The design qualification protocol consists of:- Objective & scope
- Reference documents (URS, FDS & P&ID)
- Acceptance criteria
- Responsibilities
- Verification checklist
- Summary & conclusion section
Download Design Qualification Sample Protocol
Step 6: Execution of the Design Qualification
During the DQ implementation phase, the design components are evaluated against previously defined approval qualifications. Each URS section will be checked to ensure its design is compliant to each section of the URS. Fill the required information given in the design qualification protocol.Step 7: Compilation of Design Qualification Report
The DQ reports are put together once all the testing has been performed. Each DQ report will contain a summary of the following information:- Scope and objective
- Documents reviewed
- Observation and resolution
- Summary of deviations
- Final recommendations and approval
The report indicates if the design is appropriate for procurement and installation.
Roles and Responsibilities in Design Qualification
Engineering - Prepare DQ design document and facilitate the review of DQ design document.Quality Assurance - Ensures DQ documentation complies with good manufacturing practices (GMP) and approves DQ documentation.
Validation Team - Create DQ protocol and ensure the design meets the requirements of the user requirement specifications (URS).
User Department - Review design to ensure it is suitable for operation.
Supplier - Provide the technical drawings and specifications for DQ.
Key Deliverables of Design Qualification
A complete design qualification package may include:- Approved user requirement specification (URS)
- Functional design specifications (FDS)
- Piping and instrumentation drawings (P&ID) and drawings
- Specifications for components
- Reports of risk assessments
- Protocols and reports for design qualification
- Vendor information and qualification certificates
Together these documents provide assurance that the design of the system is scientifically and regulatory acceptable.
Common Challenges in Design Qualification
1. Incomplete URS – Regarding unclear expectations for designs due to a lack of detail on the user requirements specification (URS).2. Inadequate Risk Assessment – Failure to recognize early on which risks are the most critical.
3. Poor Documentation – There may be missing information related to drawings etc.
4. No Cross-Function Reviews – Engineering, QA and all departments have not participated in a cross functional review.
5. Rushed Execution – Skipping the DQ for the sake of saving time that ultimately leads to a delay in validation efforts down the road.
Preventing these issues can create a better qualified and compliant qualification process.
Best Practices for Effective Design Qualification
1. Involve all concerned departments during the initial design stages.2. Traceability must be maintained between URS → FDS → DQ → IQ → OQ.
3. Your design verification process must have a risk-based approach to find the risks associated with design.
4. Vendor documentation must meet 21 CFR Part 11 and good manufacturing practice requirements.
5. Computerized systems must be designed to ensure data integrity and compliance with Automated Process Control System (APCS) requirements as per 21 CFR Part 11.
6. Change controlled documents require formal approval before being archived.
Relationship Between URS and DQ
The URS states what the user needs, while the DQ confirms how the user's requirements have been met by the design. In other words, the URS defines expectations for the user's needs and the DQ confirms that the design under consideration has met those expectations.The connection between the URS and DQ allows for a smooth transition to validating the requirements of a user for a specific system.
Benefits of Design Qualification
There are many tangible benefits to committing to proper design qualification (DQ):- Before installation, DQ assures compliance with good manufacturing practices (GMP) regarding design.
- DQ helps to eliminate design-related non-conformance events.
- DQ helps to reduce rework and project costs due to error.
- DQ increases the reliability and maintainability of a system.
- DQ provides an increased level of preparedness for future audits by improving documentation quality.
A properly executed DQ establishes the basis for the continued success of future qualifications and supports long-term operational performance within an organization.
The basis of validation for drug manufacturing in the pharmaceutical industry is the design qualification. DQ guarantees that the design of a piece of equipment or system is optimal and allows for the user's expectations and GMP requirements to be met correctly.
Pharmaceutical manufacturers benefit from following a structured approach to DQ, using a documented and risk-based methodology to conduct the design qualification process. By doing so, a company will maintain compliance with regulatory agencies while minimizing the potential risks associated with a project and protect the quality of their product.
Frequently Asked Questions (FAQs) on Design Qualification
Q1. What is the purpose of a Design Qualification?
Answer: The purpose of DQ is to establish expectations for a given system or equipment's design based upon user and GMP requirements prior to the construction phase.Q2. When is DQ done?
Answer: DQ is completed prior to the installation or fabrication of a new system or piece of equipment in order to ensure that the design meets the User Requirements Specification (URS) as well as any applicable regulatory requirements.Q3. What documents are needed during DQ?
Answer: To perform design qualification the following documents will be needed: URS, Functional Design Specification (FDS), P&ID, Risk Assessments, DQ protocol and vendor data sheets.Q4. Who is responsible for completing design qualification?
Answer: The validation or engineering department will complete DQ and the Quality Assurance (QA) department will review and approve the completed DQ document and the user department will also provide their approval of DQ.Q5. What is the purpose of design qualification?
Answer: The purpose of DQ include confirming that the proposed design will be appropriate and effective for the intended use of the system or equipment and satisfying the requirements of GMP compliance and safety.Q6. What are examples of common mistakes happened during DQ?
Answer: Common mistakes identified during DQ include incomplete URS documentation, missing risk assessments and a lack of review from multiple functions.Q7. What comes after design qualification approval?
Answer: After the approval of design qualification document the next step will be to start installation qualification (IQ) for the new system or equipment. It will verify that the system or equipment is installed according to the installation specifications for that system or equipment.Q8. Why is design qualification important for ensuring compliance with GMP regulations?
Answer: The performance of the design qualification process shows the ability to build systems or equipment correctly the first time and then minimize regulatory risks and ensure product quality.
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