Pre-Action Protocols

Change legislation to give hse the authority to direct all local authority health and safety inspection and enforcement activity, in order to ensure that it is consistent and targeted towards the most risky workplaces. Clarify and restate the original intention of the pre-action protocol standard disclosure list and review regulatory provisions that impose strict liability by June 2013 and either qualify them as reasonably practicable where strict liability is not absolutely necessary or amend them to prevent civil liability from attaching to a breach of those provisions. 

As mentioned earlier the legal system in England and Wales changed dramatically with the introduction of the Woolf reforms in 1999. These reforms apply to injury claims. This date was feared by many because of the uncertainty and the fact that the pre-action protocols were very demanding. 

Pre-action protocol directed towards co-operation between litigants before proceedings. 

Perhaps the most fundamental difference for personal injury practitioners was the introduction of the Pre-Action Protocol for personal injury claims which, for the first time, laid down rules and recommended practice governing behaviour of the parties prior to the commencement of proceedings. 

Administer medication according to pre-established protocol when requested by physicians Identify and take specific corrective action for drug-induced problems... 

Although some laboratories do not use any article/carrier mixture until satisfactory analytical results are obtained from a concentration assay of the mixture, this is not a GLP requirement. The concentration assays provide periodic assurance that test systems are being exposed to the amounts and types of test and control articles that are specified in the protocol, therefore the results of the periodic concentration assays must be reviewed critically and promptly. Analytical results outside a pre-established acceptable range (as defined by laboratory SOPs) will require follow-up. Followup should attempt to determine the cause of poor analytical results (e.g., improper pereparation of the article/carrier mixture, sample mix-up, poor analytical technique, equipment malfunction). Corrective action should then be provided as necessary. Usually analytical results in excess of 10% above or below expected values will require follow-up. 

Ideally, validation criteria should be compiled at different stages in the analytical procedure development, but to a different extent. It is a misconception to believe that development of an analytical procedure and validation are independent processes they are interdependent. The actions required to ensure that valid and reliable analytical measurements are being made are not trivial. Development of a procedure and validation is an iterative process. The procedure s suitability must be studied in initial validation experiments. Pre-study validation is a formal validation protocol designed to characterise the method before analysis of real samples. Prerequisite is a detailed description of the method. Acceptance criteria should be established a priori. In the validation stage, it is necessary to demonstrate that the method works with samples of the given analyte, at the expected concentration in the anticipated... 

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