Retention period

It is to be expec ted that four to six retention periods will pass before the effects of an upset will be damped out. Thus, the recoveiy period may last from 8 to 36 h. 

Effluent quahty from facultative lagoons is related primarily to the suspended solids created by living and dead microbes. The long retention period in the lagoons allows the microbes to die off, leaving a small particle that settles slowly. The release of nutrients from the dead microbes permits the algae to survive by recycling the nutrients. 

Procedures and controls shall include protection of records to enable their accurate and ready retrieval throughout the records retention period. 

What is the relationship of the single file to the database Demonstrate the functionality to accurately and readily retrieve archival records throughout the record retention period (e.g., backup and restore or archive/ retrieve or other). Include ... 

Are records protected during record retention period Accessible by database commands, SQL, etc. ... 

In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation. 

The archiving of electronic data poses more specific challenges. GLP requires records retention and retrieval of archival records. Since software used for the creation of electronic records is upgraded at a rapid pace, the requirement of retrievable archived records can be difficult to comply with. Even when stored on electronic media, the records have to comply with the records retention period and be retrievable. The collection, storage, and retrieval of electronic records should address all GLP aspects, including environmental conditions to ensure the integrity of the media. 

Now consider the gradient-pH case, with pHD 3 and pHa 7.4. In Fig. 3.5b, the dashed curve (donor concentration) corresponding to pH 3 decreases more steeply after the retention period than that of the previous iso-pH example. Furthermore, there is not the large initial drop due to the disappearance of the sample into the membrane in the gradient-pH case, retention drops from 56% to 9%. Thus, more of the compound is available for sample concentration determination. The solid curve (acceptor concentration) corresponding to pH 3 also grows more rapidly than in the iso-pH example. The dashed and solid curves cross at 7 h, with C(t)/CD(0) close to the 0.5 value. Note also, that about 70% of the compound ends up in the acceptor well at the end of 16 h - much higher than is possible with the iso-pH method. 

In terms of records in electronic format, the requirements are much the same as for paper records. There will be some extra work involved if the final record is in an electronic format. The integrity of records has to be maintained over the normal retention period. This can pose a problem for electronic records because not only has the integrity to be maintained but the readability also has to be assured. It may be necessary to move/transfer the records to a new/different system. Every five years, or as recommended by the media manufacturer, it is reasonable to check the stored tapes and transfer the information to a new tape. There should be checks built into the transfer process to ensure that the integrity of the material is retained. It is important that this process is validated to ensure that there is no loss of information or changes to the data. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

In the absence of a required retention period, the final disposition of materials is documented. When samples are disposed of before expiration date for any reason, this should be justified and documented. 

The one exception to FDA s pohcy of not seeking access to QA records of findings and problems or of corrective actions recommended and taken is that FDA may seek production of these reports in htigation imder apphcable procedural rules. The QAU should therefore seek the advice of house counsel as to the retention period for such records. 

Under these conditions, the elution period is a maximum of 35 minutes, and the separation results are said to be satisfactory. Although bis-2-ethylhexyl, bis-2-ethylbutyl, and dibutyl phthalates in mixtures are not distinguishable by infrared spectroscopy, these three components are separated sharply by gas chromatography, which can even provide quantitative analyses of such mixtures. Thus, gas chromatography is useful in plasticizer analysis, however, exact analyses and a detailed compilation of the retention periods still remain to be worked out. 

Documents that cannot easily fit into the validation file or may be required on a day-to-day basis (e.g., supplier system manuals, calibration schedule, and records) may be filed elsewhere, and these should be identified on the document schedule stating where they are located and identifying who is responsible for them. All documentation provided by the supplier must be suitably marked to easily identify its location in the validation file. It is acceptable to have the system development records archived by the supplier. If the pharmaceutical manufacturer requires the supplier to store and maintain the documents there needs to be a formal agreement on the retention period. 

It must be possible to reproduce the archived data in human-readable form throughout the retention period. Where applicable, the method of data transfer to any other system must also be formally documented and controlled. 

It is a requirement of Part 11 that all data produced from electronic files is in human readable form and that true copies are available. In the case of data retirement, the planning must include the technologies needed to support the retired records, for the duration of the retention period required in the applicable regulations. If electronic records which have been retired need to be accessed in the future for review, the data and the application source code need to be readily accessible. The qualification of any... 

The retention periods for supporting documentation such as maintenance records,... 

You may now submit ANDAs in electronic format in place of paper. We have placed the ANDA on public docket 92S-0251 as a submission acceptable in electronic format as allowed under 21 CFR Part 11. It should be noted that Part 11 requires that data sets provided in electronic format and used in the review process meet the requirements for archiving, i.e., protection of those records to enable their accurate and ready retrieval throughout the records retention period. 

Grandet et al. [807] have described a method for the determination of traces of bromide and iodide in potable water which permits determination of 50pg bromide L 1 and 5pg iodide L 1 without preconcentration of the sample or 0.5pg bromide and 0.2pg iodide L 1 after preconcentration. The method is based on the transformation of the halides into 2-bromo- or 2-iodo-ethanol. These derivatives are extracted with ethyl acetate and determined with an electron capture detector. The difference in the retention periods enables both halides to be determined simultaneously in one sample. The method is substantially free of interferences and is suitable for use on many types of water. 

Reports and records (1) final report (2) storage/archive retrieval of records and specimens and (3) retention period of records and specimens. 

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