Planning protocols

According to cGXP requirements, this plan should be reviewed and approved. Quality assurance involvement is recommended. It would be possible to generate a combined plan/protocol document that includes all information described in this chapter. The actual results generated during validation have to be added to complete the protocol. 

Preparing a master project plan is useful to achieve appropriate verification, qualification, and individual validation. According to the directions of the master project plan, protocol is generated, the study or test is performed, and the report is prepared. Of course, each protocol, performance record, and report must be reviewed and approved appropriately. The master project plan may... 

Instruction records (records that establish or define expectations, e.g., Validation Plans, Protocols, SOPs, specifications, recipe, method)... 

Beyond the list of 13 substances, a larger list of chemicals has been consolidated and is subject to reporting requirements under EPCRA and CAA (see footnote 1). Most are classified as extremely hazardous substances (EHSs) and are subject to limits on the quantities allowed on site (threshold planning quantities—TPQs). The use of EHSs requires that documentation, training, surveillance, and emergency planning protocols are created for dealing with everyday use and inadvertent release. 

No adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine. Therefore preclinical and toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/ vaccine combination [60], Evaluation in preclinical studies is important for identifying the optimum composition and formulation process and also for allowing development of tests for quality control [61]. Data from these studies also helps plan protocols for subsequent clinical trials from which safety and efficacy in humans can be evaluated. 

The primary focus of end-of-phase 2 meetings is to determine whether it is safe to begin phase 3 testing. This is also the time to plan protocols for phase 3 human studies and to discuss and identify any additional information that may be required to support the submission of an NDA. It is also intended to establish an agreement between the agency and the sponsor of the overall plan for phase 3 and the objectives and design of particular studies. These meetings avoid unnecessary expenditures of time and money because data requirements have been clarified. 

Failure to establish test plan/protocol for approved hardware ehanges. [FDA 483, reported... 

Testing Who develops test plans Are requirement specifications reviews and design inspections done periodically How is functional testing performed Who is testing (outside the development department) Are there test protocols Is there a test traceability matrix to ensure that all user requirements and product functions are tested Are there procedures for recording, storing and auditing test results Who approves test plans/protocols ... 

Planning, Protocol Development, Ethics Review and Regulatory Environment... 

Design verification test plan, protocols, and reports... 

Administrative processes Barriers Challenges Cost impacts Documentation Education Governance Implementation Improvement Leadership Learning pyramid Management Monitoring Philosophy Plan, Do, Act, Check (PDCA) cycle Planning Protocols Quality Self-improvement Time impacts. 

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