Records Must Be Kept

This point is very important. As I mentioned in Chapter 7, Training, you can never have too much communication. Similarly, allow me to make another very important point You can never have too much documentation. When reports are filed, the person accepting the reports must have an eye for detail. Incomplete reports cannot be accepted. The numbers that one uses to analyze trends are usually already so minimal that to not consider one case file because it is incomplete can significantly skew your results. 

The time of day seemed to have some significance regarding vehicle accident occurrences. For this study it appeared that more than half of the accidents occurred between 0600 and 1200 hours. This time-of-occurrence statistic was more closely examined, and it was found that more than half of the morning accidents occurred between 0700 and 0930. Unfortunately, not enough information was available to determine why this would occur. Some people theorized that more driving is done during those hours than at any other time. But the truth be known, we just do not know. And probably we will never know. Here are some of the questions these issues raised  

The questions kept coming, but the answers for most of our questions were We do not know. It is truly difficult to come up with the answer for why an accident occurred at a certain time when lots of information is not available to the person performing the analysis. Those persons performing analysis need to be careful with statistics. Sometimes analysts can give numbers a meaning and significance that is not warranted. 

Example Statistics Aren t Always What They Seem 

As an example, I was a young driver when the National Safety Council seemed to blitz the media about safe driving. Much of the media blitz seemed to focus on near-peak holiday travel season or summer holiday and vacation season. The significant statistic that seemed to be a motto and that has been embedded in my memory for more than 30 years is that More than 80 percent of accidents occur within 50 miles of the driver s residence.  

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Careful records must be kept to enable verification of compHance. Each lot of wine must be traceable back to the grapes and vineyard. Tanks must be carefully gauged and the capacities recorded on them. If the wine is to be labeled "estate botded," not only must the wine be fermented, processed, and bottled by the state winery at thein Hsted address, but the vineyard must also be owned or controlled by that winery. Other label terrninology, subject to some further intricacies, are "produced," ie, fermented 75% or made into a different class of wine "prepared," "vinted," or "cellared," ie, subjected to ceUar processing or aging without changing the class of wine "blended," ie, combined at the stated address, wines (probably purchased) of the same class and type and "botded" or "packed" by the stated winery. 

The primary thmst of GMP is that it is not enough merely to make chemicals to meet USP or other apphcable specifications. The chemicals must be made under clean and sanitary conditions, procedures and processes must be vahdated and documented, and processing and packaging must be carried out under conditions that preclude mixup and mislabeling. Records must be kept of complaints, and the manufacturer must know enough about the storage properties of the products to specify storage conditions and, if necessary, expiration dates on the label. 

Records must be kept of any aHegations a company receives about such risks. TSCA noncompliance could result in fines of up to 25, 000/d per violation... 

Health records must be kept of the health surveillance caiTied out for at least 40 years after the last entry. Appropriate action should be taken based upon the results, i.e. it should be established how and when workers should be referred for further examination and how the results will be used to improve the management of health risks. 

You must keep a copy of each report. In addition, you must keep the supporting materials used to develop the Information contained in the report. These records must be kept at the facility for a period of three years from the date of the submission and must be readily available for Inspection by EPA. 

The increasing use of computers has made record keeping less of a chore than it once was. Even in laboratories with computerized records, however, there is still need for some written record keeping. The same kinds of records must be kept regardless of the method used. 

A system of documentation should exist such that the history of each batch of the product, including details of starting materials, packaging materials, and intermediate, bulk and finished products, may be determined. Distribution records must be kept. This information is of paramount importance should a defective batch need to be recalled. 

Approved batch records must be kept for registering all relevant information during the manufacturing process. 

Cell Line One needs to know the origin, source, and history of the cells. Records must be kept for the cultivation of cells, medium used, genetic manipulation, selection criteria, isolation methods, identification, characteristics, and tests for endogenous and adventitious agents. 

Cell Bank Records must be kept of the cell banking method and procedure. 

SAIES OF 24c OH UNDER FOR WHICH DETAILED SEGREGATED RECORDS MUST BE KEPT... 

The FDA IND regulations contain requirements for various types of records and reports, which must be adhered to without exception. Immediate reports to FDA are required for any serious and unexpected adverse experience associated with the drug. Annual reports are required for every IND. Records must be kept to document all aspects of the IND. 

Registration Prescribing physicians and dispensing pharmacies must be registered with the DEA, PO Box 28083, Central Station, Washington, DC 20005. inventory. Separate records must be kept of purchases and dispensing of controlled substances. An inventory of controlled substances must be made every 2 years. 

The GLP standards require that an adequate number of trained personnel are available for the study. T3q)ical anal5di-cal laboratories keep minimal records on the training of personnel, assuming that the quality control results in the individual tests speak for the capability of the analyst. Under GLP standards additional records must be kept and be available for audit. This includes at a minimum... 

The laboratory must have policy and procedures for all purchasing requirements, whether laboratory consumables, equipment, or calibration services. Records must be kept and any checks to ensure the products are fit for purpose documented. Records of purchases should be sufficiently detailed to identify what was purchased, when it was purchased, and any other relevant information, and the management system standard under which they were made should be identified. 

The samples collected can either be assayed individually or combined, and then a subset of the gross sample is assayed as depicted in Figure 1 and described below. Sample increments should be combined on a clean, dry surface or in a suitable container or bag. All containers that the sample comes into contact with should be inert and not chemically or physically react with the sample. In addition, accurate sample labeling and records must be kept. If the sample is divided, then the retained portion should be kept for possible future analysis and labeled with at least the date, gross field sample number, lot number, and/or reference number from bill of lading. The material to be tested should be labeled with at least the date, gross field sample... 

The certification committee allows the farm to purchase conventional feed and forage during a shortage of organic feed. Flowever, the conventional feed and forage cannot exceed 15% for non-ruminants on a dry matter basis. Daily maximum intake of conventional feed intake cannot exceed 25% of the total daily feed intake on a dry matter basis. Exemptions due to severe weather and disasters are permitted. Detailed feed records must be kept and the conventional feed must be OFDC-approved. 

Records must be kept of all data derived from tests performed to ensure compliance with established specifications and standards. 

Accurate and up-to-date records must be kept of the production activities and must be of a nature to demonstrate to the inspector that the standards of the certification body have been met. In the case of a mixed unit where crops are grown both organically and non-organically, records must be kept for both units. They include origin, nature and quantities of bought-in materials such as quantities of each product sold. 

Record-keeping. Animal production records must be kept as proof of conformity to organic standards. These include movements of animals entering and leaving the farm, veterinary treatments, feedstuffs and feeding regimes. 

Professional conservation is labor intensive by nature. It requires highly skilled staff and takes a lot of time. Thorough examination must proceed treatment. Every step must be done by hand and should be documented thoroughly. A photographic record must be kept. Even in a nonprofit, regional center, conservation cannot be performed cheaply. In general, our services are appropriate for rare materials but not for the mass of research collections. 

Tests not conducted as part of the System Testing must be included in User Qualihcation. Safety functions should include Functional Testing to ensure that the safety devices operate as intended in normal operating conditions and include exploring the consequences of a component failure as well as the effect this will have on the system. Calibration records must be kept to support User Qualihcation as required." ... 

For the monitoring of the released liquid effluents the following methods are used. Samples of effluents are collected by simple dipping devices and analyzed before release. In the case of monitoring streams in the neighbourhood of installations, automatic samplers collecting samples over a 24-hour period are used. Samples are analyzed and records must be kept of results. The water effluent meter monitors water or coolants and may be connected to a rate meter, recorder or alarm system. On site and off-site environmental monitoring at and near nuclear power plants, nuclear reactors and other fuel cycle activities are shown in Tables 7.5 and 7.6. 

All records must be kept for at least one year after the expiration date on the label of the drug with the exception of raw material and packaging/labelling materials testing which must be kept for five years. Internal audit and sanitation inspection records must be kept for three years. 

Record keeping and record retention The investigator must maintain adequate drug usage records, and must prepare and maintain, for each subject, adequate and accurate records of all observations and data pertinent to the clinical trial. The records must be kept for a minimum of 2 years till the marketing application s approved or a sponsor has discontinued an IND and notified the Food and Drug Administration (FDA). 

TSCA Section 8(c) records must be kept at a company s headquarters or at a site central to the chemical operations and must be retrievable by the alleged cause of the reaction (i.e., specific chemical identity, mixture, article, company process or operation or site emission, effluent, or discharge). The records must be maintained by the company for 30 years (for allegations made by employees) or 5 years for allegations made by plant site neighbors or customers. 

As mentioned in section 3.1.2, smooth polished surfaces are most readily cleaned. Floors and horizontal surfaces should be cleaned and disinfected daily, walls and ceilings as often as required, but the interval should not exceed 1 month. Regular microbiological monitoring should be carried out to determine the efficacy of disinfection procedures. Records must be kept and immediate remedial action taken should normal levels for that area be exceeded. 

Generally, records must be kept as set out in Notice 206 Revenue Traders Accounts and Records. Specifically ... 

Records must also be kept of all the checks carried out on receipts, storage and use of the spirits. Normal business records may be used for these purposes provided there is a clear audit trail from receipt to final disposal. Records must be kept up to date. 

Those operating at wholesale level must similarly hold an appropriate authorisation and are also subject to inspection to ensure that they are operating in accordance with legal requirements, including good distribution practice ( GDP ) rules established under Directive 92/25/EEC. Specified paperwork and records must be kept (in particular to facilitate tracing of product and batch recall) and proper systems and operating procedures adhered to. 

Medicinal products must be fit for their intended use, comply with the requirements of Market Authorization and not place patients at risk because of inadequate safety, quality or efficacy. These objectives are easy to state, but to achieve them requires a comprehensively designed and correctly implemented system of quality assurance. It is important that this is documented and its effectiveness monitored. Records must be kept that are open to inspection by validating bodies, and there must also be procedures for selfinspection and quality audit that allow appraisal of the quality assurance system. Management must be adequately trained and their responsibilities minutely defined. Two key posts are the Heads of Production and of Quality Control. These posts are required by the guidelines to be independent of one another. 

Clinical trials can be extremely cosily. Hundreds or thousands of patients must be recruited and monitored for the duration of the trial. Many physicians, nurses, clinical pharmacologists, statisticians, and others participate in the design and execution of the trial. Closts can run from tens of millions to hundreds of millions of dollars. Extensive records must be kept, including documentation of any adverse reactions. These data are compiled and submitted to the FDA. The full cost of developing a drug is currently estimated to be from 400 million to 800 million. 

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