The successful delivery of manufacturing facilities , including small, large, new, expansion, or renovation type projects regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. These facilities are required to meet all applicable GxP regulations, and to comply with all other relevant local and international governing codes, laws, and regulations. This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high-quality products and consistently operate to meet product and process requirements. Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory. Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach to Quality Risk Management. This course will be of interest to those following the latest industry and regulatory initiatives, including application product and process understanding within qualification and the science- and risk-based approach with emphasis on commissioning and qualification of equipment and systems.
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Recent developments, e. Adjustments to the state of the art were made in the past by means of " bridges ". The new document is very extensive with a total of pages. The Baseline itself contains "only" pages, though. The remaining pages contain 17 appendices with references to the regulations, sample documents, references and a glossary. Appendix 15 describes the handling of legacy systems or systems with inadequate qualification.
The Baseline itself is divided into 14 chapters:. Introduction 2. User Requirements Specification 3. System Classification 4. System Risk Assessment 5. Design Review and Design Qualification 6.
Acceptance and Release 9. Periodic Review Engineering Quality Process Change Management The aim and purpose of the Baseline are to present an integrated commissioning and qualification approach that is "compliant" with the regulations and enables the qualification process to be carried out efficiently and cost-effectively.
The chapters 2 to 9 describe this process. The CDEs are system functions or properties that influence product quality and thus patient safety. The Baseline is applicable to human and veterinary medicinal products and to the content of medicinal products in combination products.
Medical devices, on the other hand, are outside the scope of the Baseline. User Requirements SpecificationThe integrated commissioning and qualification approach starts with the development of user requirements. They are based on product risks, critical quality attributes CQAs and critical process parameters CPPs as well as on regulatory and internal company requirements. If necessary, health and safety aspects can also be included.
These user requirements must be met in order for the system to be suitable for its intended purpose. System ClassificationIn a second step, the system is classified. Depending on its influence on product quality, the system can have a direct impact direct impact system or no direct impact not direct impact system on product quality. Direct impact systems will be commissioned and qualified.
Not direct impact systems will only be commissioned. In the baseline, commissioning is not only related to initial operation, but may also be extended to the design of the systems e.
FAT, see below. Subject matter experts SMEs who understand the "science" behind the manufacturing process that is to run on the system should be involved in this risk assessment. Unacceptable risks must be reduced within the framework of risk management, including CDEs.
The next step is the planning of commissioning and qualification, which can take place parallel to the design process. However, sufficient design information must be available.
As an iterative process in the design phase, a design review is then carried out to ensure that all user requirements and CDEs are mapped in the design. Design aspects that influence product quality are confirmed in the Design Qualification DQ for direct impact systems. The quality unit releases the design qualification. After completion of the design review and the DQ, the commissioning and qualification plan can also be finalised.
Commissioning and qualification tests should start at the earliest possible stage. Of course, the prerequisites must be in place and the tests must be meaningful at such an early stage. This means that it can be started even before the design has been completed. The tests also include checking documents. In the commissioning and qualification planning, tests are also addressed which are used within the scope of qualification. Once the tests have been completed, they have to be accepted and released.
The release then confirms that the system is suitable for the intended purpose. Afterwards, the process validation or routine production can begin. The maintenance of the commissioning and qualification status after release and also during routine operation is carried out by various systems such as change management, calibration and maintenance.
In addition, a periodic review of the system is required. Supporting processes of the actual, integrated commissioning and qualification process are described in the chapters 10 to The sample examples in the appendices also serve as illustrative material for a possible implementation. Due to the revision, the first version of Baseline No.
The various roles involved in releasing the various documents are also explicitly discussed. Especially the quality unit should have an "oversight". It should be integrated in the release of test plans and documents for "direct impact systems" and in the acceptance and release documentation.
The SMEs play an important role in the baseline. As an example, a document approval matrix in Chapter 6 gives suggestions regarding the signatures to be provided on various commissioning and qualification documents. The revised Baseline No. The feedback on this guide is currently being incorporated into further development of the original guide.
Baseline Guide Volume 5: Commissioning and Qualification (Second Edition)
Recent developments, e. Adjustments to the state of the art were made in the past by means of " bridges ". The new document is very extensive with a total of pages. The Baseline itself contains "only" pages, though.
Commissioning and Qualification
By Steve Wisniewski , July 16, The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment. This guide defined a better understanding of baseline cGMP requirements through coordination with ISPE, industry, and global regulatory bodies. The guide defined a flexible and innovative lifecycle approach to facility, systems and equipment design, construction, commissioning, and qualification supported by the definition of key terms for consistent interpretation and application. Beginning in industry began recognizing the importance of a science and risk-based qualification approach with a focus on Quality by Design that was built around risks to product quality and patient safety.
ISPE publishes revised Guideline on Commissioning and Qualification
The guide was first issued in and reflective of that time. With emerging markets, changes in the regulatory This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and Baseline Guides. Good Practice Guides. Published: July Pages: Table of Contents Special Pricing for Emerging Economies Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations. This online course provides an overview of success factors for Commissioning and Qualification projects.