Good Automated Manufacturing Practices

Good Automated Manufacturing Practices

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  Presented by –Prashant Tomar M.PHARM QAT 2nd SEM SGRRITS, DEHRADUN.
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   Good AutomatedManufacturing Practice (GAMP) is a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE), a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide Good Automated Manufacturing Practice (GAMP) guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality.  One of the interior principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product
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   ISPE haspublished a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice GAMP means is Good Automated Manufacturing Practice A Guide for Validation of Automated Systems in Pharmaceutical Manufacture
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   To helpUSERS understand the requirements for prospective validation of an automated system and the level to which the validation should be performed  To help SUPPLIERS ensure that systems are developed according to good practice, and to provide documentary evidence that their systems meet the agreed specification
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   GAMP4 December2001 Major revision and new content in line with regulatory and technological developments. Broadened scope to include regulated healthcare industries. Greater coverage of user responsibilities and detail on operational activities
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   The newGood automated manufacturing practices (GAMP)-5 guidelines were released February 2008 at the ISPE(International Society for Pharmaceutical Engineering) Manufacturing Excellence Conference in Tampa, Florida. These guidelines are the latest, up-to-date thinking in the approach to validation of GxP computerized systems. The purpose of the guidelines is to “provide a cost effective framework of good practice to ensure that computerized systems are fit for use and compliant with regulation.” There are five key concepts to GAMP 5:  Product and Process Understanding.  Lifecycle approach within QMS.  scalable Lifecycle Activities.  Science Based Quality Risk Management.  Leveraging Supplier Involvement.
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   GAMP5 guidanceaims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner
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  GAMP CLASS CATEGORY VALIDATION ACTION 1Operating systems Record version 2 Instruments and controllers. Record configuration & calibration 3 Configurable packages Audit supplier, validate any bespoke code. Apply full life cycle requirements. 4 System that the code or part of the code are configurable Audit supplier and code, validate any bespoke code. Configurations apply full life cycle requirements. 5 System utilizing custom or bespoke code which develop predicate rules information. Audit supplier, validate all code, apply full life cycle requirements
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  Hardware The majority ofthe hardware used by regulated companies will fall into this category. Standard hardware components should be documented including manufacturer or supplier details, and version numbers. Correct installation and connection of components should be verified. The model, version number and, where available, serial number, of preassembled hardware should be recorded These requirements are in addition to those of standard hardware components. Custom items of hardware should have a Design Specification (DS) and be subjected to acceptance testing. The approach to supplier assessment should be risk based and documented. In most cases a Supplier Audit should be performed for custom hardware development.
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  1. Product andProcess Understanding Understanding the product and process is critical in determining system requirements and for making science and risk-based decisions to ensure that the system is “fit for use.” In determining “fit for use,” attention should be focused on “those aspects that are critical to patient safety, product quality, and data integrity 2. Lifecycle Approach within a QMS Defining a lifecycle approach to a computerized system has been expanded from GAMP 4 to include all phases and activities from concept and implementation through operation and retirement. These activities should be defined within the quality management system (QMS). This allows for a consistent approach across all systems. There are four major phases defined for any system: 1. Concept 3. Operation 2. Project 4. Retirement
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  3. Scalable LifecycleActivities GAMP 5 guidelines GAMP outlines that lifecycle activities should be scaled according to: • System impact on patient safety, product quality, and data integrity (Risk Assessment) • System complexity and novelty • Outcome of supplier assessment There may be other factors that companies may want to consider when making assessments, but this process should be documented and follow established policies and procedures. By conducting this assessment companies can scale their validation effort and other lifecycle activities to the appropriate levels. Because of the use of a “scaled” approach, GAMP has reassessed their V-model and has “generalized” the model to account for other possible approaches. This model can be expanded or even reduced depending on the scale or scope of the system being validated. 4. Science Based Quality Risk Management Science Based Quality Risk Management allows companies to focus on critical aspects of the computerized system and develop controls to mitigate those risks. This is where a clear understanding of the product and process is critical to determine potential risks to patient safety, product quality, and data integrity. They acknowledge that this is not the only approach and that each company needs to decide what approach best works for its intended use. Risks that have been identified can be mitigated by: • Elimination by design • Reduction to suitable level• Verification to demonstrate that the risks are managed to an acceptable level. GAMP 5 describes and talks about a five step process for risk management based on ICH
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  V-model
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  Five step processfor risk management based on ICH Guidelines
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  5. Leveraging supplierinvolvement Regulated companies regularly involve suppliers throughout the system lifecycle. Suppliers the knowledge, experience, and documentation to assist companies throughout the system’s lifecycle. GAMP 5 suggests regulated companies need to maximize that involvement to determine how best to use supplier documentation, including existing test documentation, to avoid wasteful effort and duplication. Documentation should be assessed for suitability, accuracy, and completeness. There should be flexibility regarding acceptable format, structure and documentation practices. Suppliers can be used to assist companies with: 1. Gathering requirements 2. Creation of functional and other specifications 3. System configuration 4. Testing 5. Support 6. Maintenance 7. System retirement
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   GAMP 5sets the main requirements for the use of computerized systems in pharmaceutical applications: 1. Patient safety, product quality and data integrity. 2. Effective governance to achieve and maintain GMP compliance. 3. Quality by design (QBD). 4. Continuous improvement with in Quality management system (QMS). 5. Critical quality attributes (CQA). 6. Improving GMP compliance efficiency. 7. Configurable systems and development models. 8. Use of existing documentation and knowledge. 9. Effective supplier relationships. 10. Scalable approach to GMP compliance 11. Science based quality risk management system. 12. Life cycle approach within QMS.
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  The Specification, Design,and Verification Process
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  Monitoring manufacturing, productionand storage environments in the pharmaceutical industry Freeze drying in the pharmaceutical industry Monitoring the autoclaving process in the pharmaceutical industry Water purification in the pharmaceutical industry.
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   P. Lalasa& Vishal Gupta et.al., A Review on applications of GAMP – 5 in Pharmaceutical Industry, Jss university, July- September 2013, Vol. 5, Issue 3, ISSN 0975 – 9344.  GAMP®5: A Risk-Based Approach to Compliant GMP Computerized Systems. © Copyright ISPE 2008. All right reserved. [Cited 2012 Dec 26].Available from: www.ispe.org/publications/gamp4togamp5.pdf  ISPE GAMP-5 A Risk-Based Approach to Compliant GMP Computerized Systems, International society for pharmaceutical engineering (ISPE), Fifth edition, Febrauary-2008, – applying management based on the business process. [Cited 2012 Dec 26]. Available from: www.techstreet.com/products/preview/1559506 Application Description AD/Randi/005-EN.  Monitoring manufacturing, production and storage environments in the pharmaceutical Industry. [Cited 2012 Dec 26]. Available from: http://www05.abb.com/global/scot/scot203.nsf/veritydisplay/e1a32babfc8ddeb1
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  Any Questions ?