Procedures and Protocols

Validation should always proceed according to a validation plan. A well-defined validation strategy saves time and effort on the part of the 

A second approach is to prepare validation protocols for each method prior to the commencement of validation activities. This has the advantage of performing method-appropriate experiments while eliminating those portions of validation work that do not apply. It also allows the analysts to set more specific acceptance criteria based on the performance of the individual method instead. A drawback is that the protocol adds to the workload of the analyst since it must be prepared for each validation. This approach also allows for the possibility of greater variance in the approach to validation within the company. 

Injecting solutions of known process impurities, degradation products, intermediates, homologues, dimers, etc. further challenges the specificity of a method. Identification of these compounds may require an extensive search in order to identify all possible species that may be 

FIGURE I Example chromatogram demonstrating the absence of interference from piacebo at the retention time (t of the active component. 

If reference materials are not available, the challenge study lives np to its name. Specificity may still be demonstrated by a comparison of test results containing the impurities of interest to a second, well-characterized procedure (e.g., USP method). If a secondary method is unavailable, peak purity evaluation may be used to further demonstrate specificity of the method. 

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Suppose you are asked to develop a way to determine the concentration of lead in drinking water. How would you approach this problem To answer this question it helps to distinguish among four levels of analytical methodology techniques, methods, procedures, and protocols. ... 

Chart showing hierarchical relationship among a technique, methods using that technique, and procedures and protocols for one method. (Abbreviations APHA = American Public Health Association, ASTM = American Society for Testing Materials, EPA = Environmental Protection Agency)... 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

Looking at the downstream processing of recombinant pharmaceutical proteins from different sources as a whole, there are more common steps than operations addressing expression system-specific problems or requirements. One of the most important common features is that a given end product must meet the same standards and specifications in terms of safety, quality, potency and efficacy, regardless of the production host. Furthermore, the physicochemical properties of such end products should be identical, so that the intrinsic features used for purification (affinity, hy-drophobicity etc.) are the same. Well-established procedures and protocols should therefore be utilized, and should be adapted to the special requirements of the source material only when absolutely necessary. This is particularly true in the case of pharmaceuticals, since the tendency in this field is to stick to established methods... 

Pressure design of straight-threaded joints shall be based on calculations consistent with design requirements of this Code. These calculations shall be substantiated by testing in accordance with to-be-determined procedures and protocols. The testing shall consider such factors as assembly and disassembly, cyclic loading, vibration, shock, hydrogen embrittlement, thermal expansion and contraction, and other factors to be determined. 

Considering the variety of analytical methods, it becomes obvious that different test methods require different validation schemes. ICH distinguishes mainly four different cases shown in Table 3. It is the responsibility of the applicants to choose the validation procedure and protocol most suitable for their method because different performance characteristics will require different validation criteria. 

Modern medical research expects the proposed procedures and protocols of clinical trials to be submitted for peer review and that the human study subjects involved are provided with trial information before freely consenting to participate in that clinical trial. 

As mentioned earlier, the immunoassay can be done with a number of procedural modifications and in this instance one must substitute the isotope with another molecule (fluorescent dye, magnetic particle, enzyme) which can be measured and therefore serve as the source of tracer. For our initial studies we have chosen to use the enzyme immunoassay (EIA) system. At the present time the EIA is still in its infancy and although a number of successful EIA s have been developed the method cannot be considered a panacea (34). The future of this assay appears to be very bright and exciting, and there is considerable interest in the application of the EIA to problems in both microbiology and clinical medicine (34). Many of the procedures and protocols are derived from RIA procedures and the EIA, like the RIA, has the potential to be performed in a multitude of procedural variations but, for the purpose of this manuscript we will describe only the system we have chosen for our use. 

What procedures and protocols will be put in place for the delivery of the services How will the system function that delivers the service How will outcomes versus level of inputs be measured How will quality be measured and reliability maintained How fast can the service be delivered, the system improved ... 

A. Supervises the preparation and distribution of medications from the pharmacy according to established policies, procedures, and protocols. 

The methodology used here for structure proof of phosphatidylethanolamine (and its analogs) is very similar to that described in Chapter 4 for phosphatidylcholine (and its analogs). Consequently a more limited discussion of the procedures and protocols for phosphatidylethanolamine will be undertaken... 

Planning is an ongoing feature of all Red Cross disaster activities. The Red Cross disaster response plan documents what it will take to respond to each type of disaster, what resources will be needed, how the resources will be coordinated and used, and contains policies, procedures, and protocols to ensure a systematic management of each facet of response, including those related to health (see Appendix I). The role of the Red Cross in disaster relief is that the Red Cross supplements the resources and services of the local, state, and federal government and does not override or substitute for the local, state, and federal governments responsihilities in times of disasters. The American Red Cross is not a first responder—all disasters are local—hut its services can be activated when the local need exceeds the availahle resources. 

Some of the more interesting systems studied in inorganic and bioinorganic spectroscopy may be unstable as well as air, heat, light, moisture or temperature sensitive. Procedures and protocols are required to acconunodate for... 

Reviewed the types of rubber used in the food industry. Five mbber compounds were prepared and used to develop a range of analytical procedures and protocols. Migration data obtained using food simulants. 

All of those activities are regulated by complex internal procedures and protocols, such as ... 

The ICH was very valuable in harmonizing terms and definitions as well as basic requirements for analytical validation. Of course, due to the nature of the harmonization process, there are some compromises and inconsistencies, but the importance of a proper validation is currently widely known and accepted. In Table 1, the required validation characteristics for the various types of analytical procedures are shown. In the following, the main ICH requirements for the validation characteristics are summarized. However, the ICH guidelines must not be regarded as a checklist. It is the responsibility of the applicant to choose the validation procedure and protocol most suitable for their product. ... 

The pharmacist must also take an active role in the development, implementation, and review of an organization s policies, procedures, and protocols. The pharmacist should ensure that all aspects of care are addressed, including patient care, drug preparation and dispensing, quality control, infection control, and equipment maintenance. Involvement in such activities can have far-reaching effects on efficiency and financial outcomes. 

It should define the nature and extent of testing and the test procedures and protocols to be followed. 

Validation should be performed in a structured way according to the documented procedures and protocols. 

According to the cGMP, compliance investigation reports must be documented for process, procedure, and protocol. The quality and authenticity of the document must be reviewed by management and retained for reference. 

The authors felt that since these guidelines seem almost trivial to some analysts, but to others (perhaps the less successful ones) they are unknown, we believed that It would be helpful to state a few of them explicitly. Our purpose here Is to begin assembling shared knowledge so that we can develop more formalized procedures and protocols with hope to construct an esqiert system for solving process related problems In microcircuit manufacturing. 

The past few years have seen an increase in research into procedures and protocols for patient decontamination and the development of a range of equipment to facilitate that process at the scene and in hospitals. A detailed account of recent developments in this field is provided below. Depending on the type of agent released, speedy decontamination can be a critical part of preventing or limiting harm and controlling the spread of contamination. 

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