Handling and Documentation

The logistics of test and reference item receipt, handling and storage have to provide for the possibility of tracing, in retrospect, the complete life cycle of any test or reference item. Thus, appropriate procedures have to be defined, adequate records have to be maintained, and proper identification of test and reference items has to be assured. 

The first of these two points deals with an important consideration in the whole area of test item documentation, namely the accountability of test item and its usage. The GLP Principles are not only concerned about the possibility for checking back the identity of the test item, i.e. that the correct test item had been applied to the test system, but also that it should be possible to reconstruct the probability that the test item had been applied in the correct amounts, concentrations and/or doses at all times. Since with its application the test item disappears in the test system, there is no immediate and direct means of ascertaining in retrospect that the correct amount had been applied. Obviously, it would provide for the highest degree of confidence in the assertion that indeed the target doses had been applied to the test system, if each and every preparation were to be analysed. It is, however, as obvious that such an effort would be stretching the analytical (and financial ) resources to the unbearable, and therefore some compromise will have to be reached. On the whole, it is considered sufficient, if periodic analyses are performed which, in connection with the full documentation of the actual preparation activities, 

With this train of information available, it may be possible to exclude calculation and weighing errors at least to a certain extent, if the records of the test item logistics, compared to the application records, would show no discrepancies between these two data sets. The side-by-side comparison of the progressive diminution of test item remaining, with the records for the amounts weighed out for the application, will enable the reconstruction of the day-to-day procedures of test item preparation. 

Test item name Batch number Container number Gross weight received  

Net weight Date of receipt Storage conditions Re-Analysis date  

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A online query management system that allows sites to receive queries within minutes of data submission and resolution to be handled and documented immediately (Fig. 23.3)... 

Sample Preservation, Storage, Handling and Documentation, http //denr.sd.gov/des/gw/spills/ Handbook/SOP7.pdf 04/26/2011. 

QA requires the efficient analysis of many samples to support routine production release and stability programs. Methods are typically established in the analytical development group. Efficiency and convenience issues, including the speed of media preparation and the relative convenience of data handling and documentation, are important here. While compliance is important in all aspects of the pharmaceutical industry, QA functions must approach compliance perfection. Depending upon the facility, the automated apparatus may be tailored to specific methods with fixed configurations. Dissolution methods may be routine enough that a custom system, optimized for productivity, may be justified. Compliance of USP and use of industry standard apparatus is important to maintain compatibility with other company laboratories or in the case contract laboratory services are required. 

The change control SOP warrants particular attention. This procedure should clearly spell out how any deviations in instrument operation/per-formance, and hardware/firmware/software updates are to be handled and documented. It should also make clear what distinguishes routine maintenance, minor vs. major changes and what the procedural differences should be. The change control procedure may be a specific SOP, as part of an HPLC system s validation plan, or as part of the corporate validation master plan (VMP) that is established within each company. 

The SHE staff inspects each plant department at regular intervals concerning such conditions as machine guarding, handling and documentation of chemical substances, waste handling. 

The EPA publishes Series Methods that describe the exact procedures to be followed with respect to sample receipt and handling, analytical methods, data reporting, and document control. These guidelines must be followed closely to ensure accuracy, reproducibility, and reliability within and among the contract laboratories. 

Personal computers have introduced new ways to handle pdvate biblographic and text files. The most important factors to consider to achieve satisfactory results in building a bibhographic or text database are the type of information to be stored and the needs of the user. Types of information include correspondence, research results and documentation, meeting notes, and bibliographic references. Needs of the user to be considered should include the potential number of users of the database, restrictions for the access and display of the information because of privacy or proprietary reasons, and the retrieval mechanisms (eg, by keyword, authority list, controUed vocabulary, author, tide, date, or other document or information attributes). In addition, criteria for selecting and encoding information for the database need to be established. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

Like decontamination, directions for proper waste disposal should be indicated in the initial technology package. In some cases, the client company should be very involved in how certain wastes are handled and disposed of, and may even maintain control over this part of the toll. Both parties have vested interest in assuring waste disposal is properly completed and adequately documented prior to termination of contract. 

The individual responsible for completing the data input forms needs formalized training in data collection procedures, with written instructions on form completion, on data handling, and on documentation procedures. Other material needed to encode raw data properly must be available. In addition, these individuals need access to a consultant within the organization to help resolve questions that may arise. 

A well-developed records management program that defines rules by which records and documents are handled from creation to retirement is necessary for a successful electronic data archiving process. In a GLP-compliant system, records are classified by type, such as study-specific raw data, reports, personnel records, etc. Each record type has a defined retention time. 

As shown in Figure 1.5 and described in Section 1.4, the design and engineering of a chemical process requires the co-operation of many specialist groups. Effective cooperation depends on effective communications, and all design organisations have formal procedures for handling project information and documentation. The project documentation will include ... 

This compilation has been prepared and revised to give access to a wide and up-to-date selection of documented information to research students, practising chemists, safety officers and others concerned with the safe handling and use of reactive chemicals. This will allow ready assessment of the likely potential for reaction hazards which may be associated with an existing or proposed chemical compound or reaction system. 

Methods and procedures, including sampling, sample handling, analysis and the estimated uncertainty of the final result, must be appropriate for the work carried out. All of the methods used, standard and non-standard, must be fully validated and documented. The extent of validation has to be considered on a case-by-case basis. The integrity of all analytical data must be protected at all times so that raw data can be inspected at a later date if required. 

Despite the diverse range of documented enzyme-catalyzed reactions, there are only certain types of transformations that have thus far emerged as synthetically useful. These reactions are the hydrolysis of esters, reduction/oxidation reactions, and the formation of carbon-carbon bonds. The first part of this chapter gives a brief overview by describing some examples of various biotransformations that can easily be handled and accessed by synthetic organic chemists. These processes are now attracting more and more attention from nonspecialists of enzymes. 

By all means, employ defensive specification at appropriate interfaces in your system but make sure that the checking and exception handling are specified and documented as part of the interfaces and not just in the code. 

The protection of the public in the safety of food, drinks, and drugs is entrusted to agencies such as the FDA and the ERA. They also issue many documents on what is not safe and the suggested procedures on how to handle and to dispose of them. 

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