Audits combining

Community case management for acute respiratory infection (ARI) and diarrhoea were clearly successful in reducing mortality their overall effects on the appropriateness of drugs choices, especially in the case of ARI, have however not been well studied. Other approaches that may yield moderate to large improvements were audit and feedback (or group processes), and audit combined with supervision. As in the industrialised world, the simple dissemination of printed educational material (clinical guidelines, prescribing information) had no impact. Experience in Zimbabwe underlines the relevance of... 

Now you can reconsider the material balance equations by adding those additional factors identified in the previous step. If necessary, estimates of unaccountable losses will have to be calculated. Note that, in the case of a relatively simple manufacturing plant, preparation of a preliminary material-balance system and its refinement (Steps 14 and 15) can usefully be combined. For more-complex P2 assessments, however, two separate steps are likely to be more appropriate. An important rule to remember is that the inputs should ideally equal the outputs - but in practice this will rarely be the case. Some judgment will be required to determine what level of accuracy is acceptable, and we should have an idea as to what the unlikely sources of errors are (e.g., evaporative losses from outside holding ponds may be a materials loss we cannot accurately account for). In the case of high concentrations of hazardous wastes, accurate measurements are needed to develop cost-effective waste-reduction options. It is possible that the material balance for a number of unit operations will need to be repeated. Again, continue to review, refine, and, where necessary, expand your database. The compilation of accurate and comprehensive data is essential for a successful P2 audit and subsequent waste-reduction action plan. Remember - you can t reduce what you don t know is therel... 

Whether you use an audit, a survey, or a combination of both, remember that your results provide a picture of your PSM activities as of a fixed point in time. This creates a useful point of departure for detailed planning, pointing the way toward implementation and establishing a benchmark for future measurement. 

Most facilities are designed around layers of protection commonly referred to as Independent Layers of Protection (ILP). A protection layer or combination of combination of protection layers qualifies as a ILP when one of the following conditions are met (1) the protection provided reduces the risk of a serious event by 100 times, (2) the protective function is provided with a high degree of availability (i.e., greater than 0.99) or (3) it has the following characteristics - specificity, independence, dependability, and auditability. 

The fire protection audit element can be conducted with the scope of the audit focused only on fire protection. However, many companies in the process industries audit fire prevention as an integral part of the overall loss prevention effort and combine it into audits with other programs. 

With a combined throughput of around 250 000 samples and over 1.75 M determinations a year, quality assurance is of paramount importance. This is ensured by a continuous process of introspection and audit, both internal and external. 

Procedures are in place to restrict access to data and records to appropriately authorized persons. Confidential patient records, of course, dictate their own security standards. This form of confidentiality is largely an issue in chnical research, but may impact upon some laboratory environments. Of greater concern here are issues of access related to the potential to modify or delete laboratory records, either through accident or fraudulent intent. A combination of protected audit trails (see below) and read-only electronic controls can assure appropriate restriction. 

A combination approach may also be used that employs elements of top-down and bottom-up audits. This allows some level of assessment of the effectiveness of the overall quality system while evaluating the cause of specific quality problems. 

Auditors should select the audit method most appropriate for their intended audit purpose. Initial quality system audits or regularly scheduled audits are likely candidates for the top-down approach, while audits conducted as part of a root cause analysis, for example, may best employ a bottom-up approach. The FDA employs a similar approach to inspections. Regular scheduled biennial inspections are more likely to employ a top-down methodology. For cause inspections conducted in response to a specific product issue such as a recall are more likely to employ a bottom-up approach. FDA investigators may employ a combination approach during biennial inspections if investigators are aware of specific quality problems that they wish to include in the inspection. 

Once the baseline data for heat distribution are established, the combination of in-process moisture analysis (of the load being dried) and heat or airflow distribution (for a loaded oven) will help the technologist understand the drying process for a product. In addition, other information learned will include the moisture level in the dried granulation can be reached without exposing the material to excess heat. This relationship will help QA evaluate the process during validation as well as audit the process if process deviations should be encountered. 

Another item of concern regarding Standard Software Packages is that the package by itself may not be Part 11 compliant. An example of this is a package that does not have Part 11-compliant audit trails functionality. In this case, the Standard Software package may need to be combined with third-party applications and/or plug-ins, in order to make it compliant with Part 11. 

One of the key controls for audit trails is the linking of the electronic record with the audit trail. It must not be possible to modify audit trails access rights to audit trial information must be limited to print and/or read only. The combination of authentication, digital certificates, encryption and ACLs, provides the technical mechanisms needed to control the access to audit trail files. 

From a perspective of the data user, a combination of audits and PE samples may be a cost-effective approach to laboratory quality assessment. Single-blind and double-blind PE samples are typically used on long-term, large sample volume projects. Because of the additional costs, they are not sent to the laboratory with every shipment of field samples. PE samples for the project contaminants of concern analyzed at the start of project activities will enable the data user to establish the laboratory s performance. Depending on the project duration and on the volume and importance of the collected samples, additional PE samples may be analyzed on a quarterly or semiannual basis. 

The corporation must have an SOP that combines the method development and validation activities. Also, SOPs for the preparation of analytical method and validation protocols must stress change control and procedural deviations. The SOPs must allow the analytical chemist to revise methods and protocols to reflect changes encountered during the drug development process. Additionally, an accurate audit trail of changes must exist to track all changes and modifications. 

An inspection by a regulatory body will probably be one that receives the most attention and preparation activities. These audits can be focused [such as a preapproval inspection (PAI)] on a specific product general (an overall evaluation of processes, products, and procedures), or a combination of both. These points are some general areas of inspection and should be considered a good basis of preparation, but are not all-inclusive of the questions routinely asked by auditors. 

For colored plastics producers, a combined audit for ISO 9001 or ISO 9002 with laboratory assessment for ISO 17025 may be the preferred method of operation. For supplying the automotive industry, regardless of whether it is as a tier 1, 2, or 3 supplier, QS 9000 is a necessity. The good news is that interest and acceptance of ISO certification has virtually eliminated supplier audits. 

The combination of clozapine and lithium has been examined in 44 patients (298). Medical records were retrospectively audited and a subsample of 23 patients was reassessed. The mean total duration of combination treatment was 23 months, and the combination was rated as effective in 84% however, there were adverse effects in 64%, most often fatigue (32%), hypersalivation (14%), and, in 7% of patients, orthostatic dysregulation, muscle fatigue, weight gain, and oral dyskinesias. 

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