Adequate documents

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. 

For those waste streams that can impact public health or the environment (if mismanaged), provide a summary of the treatment and disposal methods (for example, solvents are incinerated or recycled, lab wastes are incinerated) used to manage them and identify the on-site or off-site facilities used. Is the disposal of the waste adequately documented (for example, retention of manifests, bills of lading or transfer notes) ... 

An adequately documented requirement would be a written contract, schedule of work, and/or specification. However simple the requirement, it is wise to have it documented in case of a dispute later. The document needs to carry an identity and if subject to change, an issue status. In the simple case this is the serial numbered invoice and in more complicated transactions, it will be a multi-page contract with official contract number, date, and signatures of both parties. 

How do you ensure that requirements are adequately documented before they are accepted ... 

Systems documentation and control. For any system to be auditable there must be adequate documentation covering procedures, actions taken and results obtained. Ideally most of this documentation should be included in an Environmental Manual which each employee has access to. 

FieldNotes user verification can be conducted by following the SOP written by Astrix, which can be downloaded from the Astrix Web site. The SOP contains a script that is typed into the computer system. If the printout matches the SOP script, then verification is complete. A record of this must be placed in the facility archive. This verification process takes 1 h or less. For FieldNotes, calculations are not verified at the field site since the manufacturer feels that the software developer and the sponsors have performed adequate validation of these calculations previously. This may, therefore, require a visit to the sponsor or to the manufacturer to confirm that this important step of the validation process has been completed and is adequately documented. By following the Astrix SOP, the user is simply ensuring that the program operates on their system(s). The SOP script must be typed in exactly as written in order to confirm the printout accuracy. QA must ensure that the verification documentation is properly archived. Just as with any other SOP, this SOP must be approved in writing by field site management to comply with GLP. 

For /-Advantage, more extensive field site verification is conducted. A field site notebook is used which verifies every step in the data entry process. Following this procedure, a form is completed and returned to American Agricultural Services, Inc. (AASI), where the form is checked to ensure that verification was properly conducted and documented. This verification takes approximately 2 h to perform. Documentation and verification may require a visit to AASI to confirm that the validation process has been completed and is adequately documented. 

The need for adequate documentation of laboratory operations is established not only by good science but also by regulatory requirements [137],... 

Studies with susceptible and selectively bred carbofuran-resistant houseflies (Musca domestica) indicated that LD50 values for susceptible and resistant strains were 0.1 and 1.3 pg/insect, respectively (Dorough 1973). Resistant flies contained up to 34% more cholinesterase than susceptible strains and could excrete carbofuran almost twice as fast (Dorough 1973). Carbofuran resistance among pestiferous insects is not yet widely known or adequately documented. 

Active IPL or human action (active IPLs) and adequate documentation, training, and testing procedures (human action)] PFDs from industry1 PFDs from CCPS1... 

Snapshots show only an example of a particular occurrence of an action in a particular situation. They are therefore used only for illustration, and are not adequate documentation by themselves. 

No human studies with adequate documentation of air levels of -hexane were found for intermediate-duration inhalation exposure. The animal data were insufficient to derive an MRL for this duration. No NOAELs which were below the LOAELs in the intermediate duration database could be identified for neurological effects, which are the most sensitive. 

This statement suggests that provided the manufacturer has performed and adequately documented the functions mentioned in the Analytical Instrument Qualification chapter no further qualification activities that are specific to the software is required by the user of the instrument. 

Discussion This was first adequately documented study of the exposure of military volunteers to BZ. More extended baselines were used, as well as scheduled observations at 1, 2, 3, 4, 5, 6, 10, 24, 48 and 72 hours after administration of the drug. Vital signs and neurological status were recorded at approximately the same intervals. The examining physician recorded mental status changes whenever they occurred. The data were less than optimal due to the infrequency of observations after 10 hours, as well as the brevity of written records of behavioral changes. 

For serious incidents, the investigation team should document the truncation of branches and alternate cause scenarios that were disproved by the team. For major consequence occurrences or for occurrences where litigation is expected, the investigation team may have to defend its decision to reject certain potential cause scenarios. This defense may occur many months after the conclusion of the investigation team activities, so adequate documentation is critical. 

ISO 78-2 1999 defines the layout needed for adequate documentation of chemical methods. The standard indicates a logical order for material with recommended headings and advice on the kind of information that should appear under each heading. Documented methods should be subject to an appropriate document control. 

Adequate documentation forms an essential part of good manufacturing practice. For this reason, every aspect of pharmaceutical manufacture is characterized by the existence of extensive associated documentation. This is essential in order to ... 

The wording cited above from the Guidance Document is selected very carefully and there is not too much to add. Generally, historical control data should be collected and adequately documented in each laboratory, and their usefulness is selftevident. For exceptional cases like very rare malformations even the use of historical control data from other laboratories may be appropriate (these are most unlikely to be caused by specific housing conditions). However, a clear and unequivocal study will always be one which exclusively refers to current control data. If this is not the case, then the use of historical control data may help clarifying open questions, but the study will normally be classified as grey zone. ... 

Having chosen the analytical instrument or system, Installation Qualification, IQ, should be carried out to ensure that the equipment works the way the vendor or manufacturer specifies it should. IQ should be performed in accordance with a written test protocol with acceptance criteria with certification from the installation engineer, who is suitably qualified. Full written records of all testing carried out should be maintained as well as ensuring that adequate documentation and manuals have been supplied. The latter should include any Health Safety information from vendor or manufacturer. 

An adequate documentation level is established to ensure compliance to this international standard. The documentation includes ... 

A major problem encountered in field studies of nuclear craters at long periods after shot time lies in separating the depositional variations from those which have taken place since shot time. The ability to separate depositional variations from those caused by environmental influences will depend upon an adequate documentation of the spatial and... 

What if a company has done a good job planning for validation, has put in place adequate documentation, has sufficient time, but does not have funding to support validation It should be obvious that validation probably will not occur— until funding has been provided. 

Recovery of reactants, intermediates, or APIs from mother liquors or filtrates is acceptable as long as the procedures used meet in-process product/ process specifications. Solvents can be recovered and reused as long as the procedures employed are adequately documented. 

Make a brief description of the plant, process, and product or reference to adequate documents. 

Does the system provide adequate documentation of the application With this in mind and to achieve and maintain validated computer systems, pharmaceutical manufacturers need to include the following as part of their compliance policy ... 

For new applications or projects a prospective validation based on a recognized life cycle is the most effective and efficient approach. The life-cycle methodology can also be adapted for existing systems that do not have adequate documented records to support a retrospective validation. 

Support documentation Documentation that provides background information about the computer system application, but that is not essential to the execution of the IQ protocol or required to adequately document the system... 

The OQ final report is intended to summarize all relevant data that are collected during the validation run. The report gives a short description of all test functions and a discussion of the overall validation. This compilation is adequate documentation of assurance of the acceptability and validity of the packaging equipment. The basis for this assurance is the result of the data, test functions, and supporting documentation. A dossier in sections is provided in Table 5. 

Candidates may freely utilise modem computational aids. However, when these aids are employed, the candidate should clearly indicate the extent of his own contribution, and the extent of the assistance obtained from other sources. For computer programs which have been prepared by the candidate himself, a specimen print-out should be appended to the report. Programs from other sources should only be used by the candidate provided adequate documentation of the program is freely available in recognised technical publications. The candidate must demonstrate clearly that he fully understands the derivation of the program, and the significance and limitation of the predictions. 

Some chemistry units support the biologists by preparing the test solutions. Whoever prepares the aliquots of test material and/or makes the stock solutions should adequately document the removal of the appropriate amounts of test material from the bulk container. 

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