Retention of records

Disposition in this context means the disposal of records once their useful life has ended. The requirement should not be confused with that on the retention of records. Retention times are one thing and disposal procedures quite another. 

Reporting of study results 9.1. General 9.2. Content of the final report 10. Storage and retention of records and materials Subpart J - Records and Reports Sec. 58.185 Reporting of nonclinical laboratory study results. Sec. 58.190 Storage and retrieval of records and data. Sec. 58.195 Retention of records. 

Produce from trial animals may not enter the food chain unless authorised by the CVM on the basis of data showing that residues will be either safe or not present in produce from animals treated at the maximum dosage with the minimum allowed withdrawal period. The CVM must be notified of the date and place of slaughter at least 10 days prior to each shipment for slaughter. The regulations also address the retention of records and the competence of study investigators. Records of drug shipments must be maintained for at least 2 years after the date of shipment. Data and results of trials must be retained for either 2 years after completion of the trial, or... 

Documentation - procedures, specifications, retention of records, electronic data... 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

Additional statements regarding records retention, which do not supersede the previous statements, are presented in the Retention of Records paragraph (EPA 160.195 and FDA 58.195). The period of time specific records must be retained is indicated here. 

Conduct of a nonclinical laboratory study Reporting of nonclinical laboratory study results Storage and retrieval of records and data Retention of records Purpose... 

The investigator in the institution conducting the study should be aware of what happens to the medical records of study subjects who have participated in clinical trials. The medical authorities or the institution should have guidelines for the retention of records before they are changed into an electronic form by scanning, microfiched or destroyed. Usually when they are changed into another form, the medical records will be reviewed by administration staff and those items deemed not essential will be... 

The QAU schedule, activities, in-process inspections, including the review of the final report and retention of records, must be verified. 

Table E-l. Regulations Which Require the Retention of Records.

Secure retention of records to instantly reconstruct the analysis... 

Japanese Ministry of Health and Welfare (1997), Regard to Retention of Records by Using Magnetic Media, Concerning Manufacturing Control and Quality Control of Pharmaceutical Products and Medical Devices, Open Letter to Every Prefectural Health Lead Officer, Inspection Guidance Division of Pharmaceutical and Medical Safety Bureau, September 18. 

Protection and retention of records and audit trail documentation to enable their accurate and ready retrieval for review and copying throughout the records retention period. 

The Data Handling and Record Retention section of the protocol will address the requirement to maintain data (whether on a paper CRF or using an electronic data collection tool (DCT)) of each trial subject. It will address expectations of ownership of the completed CRF data, the investigator s responsibility to ensure accuracy and completeness of data recording. This section will also address the requirements for retention of records at the trial site in accordance with relevant guidelines and regulatory requirements. 

Records are considered as software focus is placed on accuracy, security, access, retention of records, review, double checks, documentation and accuracy of reproduction. 

Records should be retained for each delivery. They should include the description of the goods, quality, quantity, supplier, supplier s batch number, the date of receipt, assigned batch number and the expiry date. National regulations which state a period for retention of records must be observed. Where no such regulations exist, records should be retained for one year after the end of the shelf-life of incoming products. 

The underlying principle of GLP requires that the retention of records, other documentation, samples and specimens should provide, wherever possible, the means for full study reconstruction. Thus, it follows logically that also samples from each batch of test and reference item should be collected and retained. In this way it can be ensured that any questions regarding the quality, purity, stability and identity of the test item, that might turn up during the Quality Assurance audit or the scientific assessment of the study, could be resolved by an independent analysis of the reserve sample, without necessitating the repetition of the study itself in case of major doubts about the test item. The requirement that a sample for analytical purposes from each batch of test item should be retained would therefore not seem to pose major problems of interpretation and implementation. 

PURPOSE To determine whether the facility has generated adequate records and reports and whether adequate provision has been made for the safe storage and retention of records and materials ... 

---