E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.
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Strategies for Raw Material Variability
Very little information is currently available describing systematic approaches that could be applied in the development stage to characterize raw material variability. Such knowledge is needed to develop an appropriate process to manage this variability. More. ( 208 KB)
What Process Validation Approaches Have Worked for You?
Read ISPE’s latest discussion papers on Process Validation and give us your feedback. Let the authors know about process validation approaches that have worked for you and your company and lessons learned from proposed approaches. Your industry examples and direction could be used to create an ISPE Good Practice Guide. More.
EMA Draft Guideline on Process Validation Available for Comment
The EMA draft Guideline on Process Validation deadline for comments is 31 October 2012. This guideline replaces the previous guideline on process validation. The guideline is brought into line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q8, Q9 and Q10 documents. The possibility to use continuous process verification in addition to, or instead of, traditional process verification described in the previous guideline has been added. More.
Process Validation: Practical Application of the Lifecyle Approach
Because of a recent shift in Process Validation expectations, ISPE is offering this topic-specific Conference on how to implement these changes into your business and be compliant with the FDA Process Validation Guidance, as a tool to achieve improved quality and reliability of supply.
The conference, to be held 17-18 October 2012 in Silver Spring, Maryland, USA, will provide a unique opportunity to compare and contrast the European proposed approach to process validation with the FDA’s approach in a direct discussion featuring an EU regulator and the US FDA’s Grace McNally. You’ll have an opportunity to hear the European perspective, join with US industry colleagues and regulators in discussion, and provide more insightful commentary to the EU proposals prior to the comment deadline at the end of October. More.
New Good Practice Guides Focus on Quality by Design Principles and Practices
ISPE has released Parts 1 and 2 of a new series of Good Practice Guides on Product Quality Lifecycle Implementation (PQLI®). The Guides collectively address product and process development through a Quality by Design (QbD) approach that covers the entire product lifecycle. The series uses ICH guidelines Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System as a basis, together with other relevant ICH guidelines. More.
Message from the 2012 PPD COP Committee Chair
Avril Vermunt, 2012 PPD COP Steering Committee Chair, shares her thoughts on last year’s accomplishments and a look ahead to activities planned for the new year. More. ( 15 KB)
Special Track on Process Validation at ISPE Conference
The ISPE Conference: Lessons from 483s: Enhancing Efficiency, Quality and cGMP Compliance (27-28 February 2012, Tampa, Florida, USA) will feature a Process Validation track. Presentations, practical application examples, small group exercises, and discussion forums will bridge the gap between conceptual contemporary expectations for the lifecycle approach to Process Validation and implementation. More.
Updated ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
In December 2011, ICH released a revised version of its ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation. Not intended to be new guidelines, the Guide supplements the existing Q & A and workshop training materials of the ICH Quality Implementation Working Group. The Guide is intended to provide clarity to industry and regulators and facilitate the preparations, assessment, and inspection related to applications filed for marketing authorizations. More. ( 227 KB)
Overview of ICH Q11 Draft Guideline
The Product/Process Development (PPD) Community of Practice (COP) gives a summary and perspective on the draft ICH Q11 Guideline on the Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities). More. ( 70 KB)
Sneak Preview of New PQLI Guide Series Offered to ISPE Members Registered for Annual Meeting
ISPE is pleased to announce the release of a new two-part Product Quality Lifecycle Implementation (PQLI) Guide Series intended to assist in the development and implementation of practical “how to” approaches using the enhanced, quality by design approach supported by sound scientific, engineering, and business principles. At this time, the Guide Series is available only to ISPE Members who register for Annual Meeting and at a special rate. More.
ICH Endorsed Guide for ICH Q8/Q9/Q10
The ICH Quality Implementation Working Group published the document, “Points to Consider – ICH-Endorsed Guide for ICH Q8/Q9/Q10.” The document is “based on questions raised during ICH Q_IWG training workshop sessions in the three regions” and “intended to provide clarity to both industry and regulators …” The main points covered are the criticality of quality attributes and process parameters, the life cycle of the control strategy, and the required documentation to support the system (i.e., design of experiments). More.
FDA’s Grace McNally Discusses Process Validation Guide with Pharmaceutical Engineering
In an exclusive interview with Pharmaceutical Engineering magazine (July/August 2011 issue), FDA’s Grace McNally – a visible player in the development of FDA’s 2011 Final Guidance on Process Validation – shares her experience on the effort it takes to shape such policy and her perspective on the Guide’s key recommendations. More. ( 328 KB)