Hello good people of the world! Today’s post covers ISPE’s release of the second edition of their commissioning and qualification guide. This is volume 5 of the baseline guides. The first edition was first released way back in March 2001, so we should expect this to be a significant revision. Please note this guide is not available for free.
One very nice thing about this second edition is that it not only updates the first edition of the volume 5 guide, but incorporates scope from two other now-outdated guides as well: “Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment” and “Applied Risk Management for Commissioning and Qualification.” So if you have these in your library, you can safely archive them.
It’s always important to note that industry guides such as this one do not constitute regulations and are not required to be followed. It is often the case however that best practices documented in guides become industry standard, and then set expectations for regulators. Per the guide, it is intended to comply with EU GMP Annex 15, FDA Guidance on Process Validation, and ICH Q9.
The table of contents shows the following sections:
- User Requirements Specification
- System Classification
- System Risk Assessment
- Design Review and Design Qualification
- C&Q Planning
- C&Q Testing and Documentation
- Acceptance and Release
- Periodic Review
- Vendor Assessment for C&Q Documentation Purposes
- Engineering Quality Process
- Change Management
- Good Documentation Practice for C&Q
- Strategies for Implementation of Science and Risk-Based C&Q Process
And the following appendices:
- Regulatory Basis
- User Requirements Specification Example
- System Classification Form Example
- Direct Impact System Examples
- System Risk Assessment Example
- Design Review/Design Qualification Examples
- Supporting Plans
- System Start-Up Examples
- Discrepancy Form Example
- Qualification Summary Report Examples
- Periodic Review Example
- Periodic Review for Controlled Temperature Chambers
- Vendor Assessment Tool Example
- Organizational Maturity Assessment Example
- Approach to Qualifying Legacy Systems or Systems with Inadequate Qualification
You’ll have to purchase the guide to get all the details, but below are some highlights that stuck out to me:
- This second edition introduces the term Critical Design Elements (CDEs). CDEs are defined as “design functions or features of an engineered system that are necessary to consistently manufacture products with the desired quality attributes.”
- Concepts that were removed from this edition of the guide include Component Criticality Assessment, Enhanced Commissioning, Enhanced Design Review, Enhanced Document, Indirect Impact (systems are either direct impact or not direct impact now), and the V-Model.
- A Direct Impact system is defined as a system that directly impacts product CQAs, or directly impacts the quality of the product delivered by a critical utility system. All other systems are considered to be not direct impact. An example included in section 3 demonstrates the previously categorized “indirect impact” systems would become not direct impact systems and would be commissioned only, although the commissioning for these system may be more robust than a purely “no impact” system. The guide provides an eight (8) question process for determining if a system is direct impact.
- System boundaries should be marked on design drawings.
- Inputs to the URS should include: CQAs, CPPs, regulatory, organization quality, business, data integrity and storage, alarm, automation, and health, safety, and environmental requirements, and engineering specifications and industry standards. The example URS template does include a classification of each requirement (e.g. business, safety, quality).
- A system risk assessment is performed to identify CDEs and controls required to mitigate risks. Standard off-the-shelf systems typically do not require a risk assessment. Risk levels are defined as low, medium, and high and the risk assessment approach is not a typical FMECA process. Instead each CQA at each step gets one entry on how the CQA can be impacted, what are the design controls around that CQA and any alarm or procedural controls to mitigate risk. The residual risk post-controls is includes as low, medium, or high.
- Design Qualification looks somewhat informal 0=- no DQ protocol, but a DQ report that summarizes other documents (URS, SIA) and design review meetings.
- A C&Q plan should include clear scope, the execution strategy, documentation expected for each system (URS, FAT, SAT, IOQ, SOPs, etc.), and roles and responsibilities (e.g. approval matrix).
- The discrepancy form has closure signatures only (no pre-implementation signatures)
- For legacy systems without adequate C&Q documentation, focus should be on identifying product and process user requirements including Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), and then the Critical Design Elements (CDEs) that affect them. It is necessary to confirm that accurate drawings exist, that maintenance files are up-to-date, and there is test evidence to support changes since commissioning. A risk-based approach can be used to qualify the system in the absence of typical C&Q documentation.
Do you use the ISPE guides for your C&Q approach? Comment below.
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