Life-cycle management

The availability of a new class of efficient separations technology for chiral drugs can have an impact on other business issues now at the forefront of the pharmaceutical industry. For example, the strategy of better drug life cycle management can be... 

A first obvious consequence of such considerations is that we should not only look at the costs of the product from an economic point of view, but that we must consider the costs of the production process in a broader sense. We must take into account the raw materials used, the amount of energy invested and the possibility to design alternatives, more environmentally friendly processes. In other words, we should not only look at the desired product, but we must consider the total life cycle of the product The design of a production process taking into account these aspects is often referred to as integral life cycle management. 

Simulations may also be used to inform understanding of market dynamics and life cycle management and to aid in understanding the ways in which reference pricing and parallel trading may influence the best sequence of drug... 

A physical component of IT life cycle management is storage media management. Tapes, disks, and other electronic media degrade over time. Optimally, they are refreshed every 10 years. Ideally, this is part of the SOPs for the data centers and archive facilities. 

Labuschagne, C., and Brent, A., 2004. Sustainable project life cycle management The need to integrate life cycles in the manufacturing sector, International Journal of Project Management, 23 (2), 159-168. 

Life cycle management (LCM), 14 828 Life cycles, reliability and, 26 992-993 Life preservers, kapok-stuffed, 11 297 Life span, 2 811... 

Contractors, contract manufacturers, transporters, warehouses, and end users of reactive chemicals should be informed not only of chemical reactivity hazards, but provided information or training on how to control them. This should be done as part of product life-cycle management and Responsible Care/Product Stewardship. Specific issues needing to be addressed may include but probably are not limited to those that are highlighted during the hazard/risk analyses (Section 4.5), including ... 

Integrated Drug Product Development — From Lead Candidate Selection to Life-Cycle Management... 

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

Life-cycle management, including risk management. 

Life Cycle Management Strategies of Brand Firms... 

Arguably, the most effective life cycle management strategy is the introduction of a new class of therapies. Competition evolves in pharmaceuticals by the introduction of new classes of entities with superior therapeutic properties to prior generations of products. Firms that have a commercially... 

Risk-based orientation Regulatory scrutiny based on the level of scientific understanding Mechanistic basis for understanding failure modes and variability Sources of variability and risk to quality Drive out fear Continuous improvement— Change control and life cycle management... 

As discussed in section Continuous Improvement—Change Control and Life Cycle Management. Change towards continuous improvement should be encouraged. Quality by design and process understanding can... 

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

Guidances recommend an integration of software life-cycle management and risk management activities. Software validation and verification activities must be conducted throughout the software life cycle [12,14]. Software verification and validation are terms frequently confused. Software verification is defined as the process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase... 

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