Nikki Dillard Allison Lowry Tiffany Thomas

 “The maintenance of a history of one’s activities, as financial dealings, by entering data into ledgers or journals, putting documents in files, etc”

 A record is a document that recalls or relates past events.  Records should also relate the exact steps that were completed to manufacture the product.  GMP regulation requires a company to keep complete and accurate records about its products.

 The FDA has the right to examine your records when they inspect your plant.  POOR AND INADEQUATE RECORDS ARE A VIOLATION OF THE LAW AND ARE OFTEN CITED BY FDA INSPECTORS IN THEIR REPORTS OF PLANT INSPECTIONS.

 General Requirements  Equipment Cleaning and Use Log  Component, Drug Product Container, Closure, and Labeling Records  Master Production and Control Records  Batch Production and Control Records  Production Record Review  Laboratory Records  Distribution Records  Complaint Files

 Any production, control, or distribution record that is required to be maintained and specifically associated with a drug product shall be retained for at least 1 year of the expiration date of the batch.  For OTC products, records should be kept 3 years after distribution.

1. Record all necessary information immediately upon completion of a task.  Don’t trust your memory 2. Write your name legibly and in ink.  No white out or erasures allowed 3. Report any deviations from written procedures to your supervisor. 4. Don’t document someone else’s work unless you are designated to do so. 5. Don’t assume that undocumented work has been properly completed.

 In the industrial setting good laboratory record keeping has always been necessary in order to preserve intellectual property rights, such as patents and know-how.  Due to the increased scrutiny of the academic laboratory by the taxpayer, academic laboratories will have to bring their record keeping up to industrial standards.

 R Record…...  E Each……  C Corroborate………  O Original……….  R Review……  D Data……..

 R Record all laboratory information in a bound notebook, and use indelible ink. Each page of the notebook should be used. If blank spaces must be left, a line should be drawn diagonally through the blank space, and the line signed and dated. Everything must be permanently recorded. State your hypothesis, materials and methods, data and conclusions. All labels and other materials must be permanently glued into the laboratory notebook.  E Each entry must be signed and dated by the person doing the work. Your reputation, career and inventions rest on your written documentation.

 C Corroborate all entries by an additional, knowledgeable party who reads, co-signs and dates all entries.  O Original entries should never be erased. If a mistake is made, draw a single or double line through the mistake and sign and date the correction.  R Review and retain all records. Records should be safely retained as long as necessary. For example, invention records should be retained for a minimum of 30 years.  D Data generated or stored on a computer must be printed out, permanently bound, signed and dated, and corroborated

 Computer-assisted research  Pieces of data are collected, stored, and analyzed by computer  Some difficulty include: ◦ Access from many people ◦ Hard to prove that the data was not added to, deleted from, or in some way tampered with  To withstand legal scrutiny, one has to print out the data from the computer, bind the printed data, and sign and date each page as described above ◦ Corroboration is also required.

 Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

 The aim of record keeping and handling data is to record, store, transfer and, where necessary, convert efficiently and accurately, the information gathered on each trial subject into data that can be used in the report.  All steps involved in data management should be documented in order to allow step-by- step retrospective assessment of quality of the data and the performance of the clinical trail.

 Investigator is a person responsible for the conduct of the clinical trial at a trial site and has overall responsibility for insuring the accuracy and completeness of data entry ◦ Must ensure that observations and findings are recorded correctly and completely in the case- report forms (CRF) and signed by the responsible person designated in the protocol. ◦ If he/she enters a trial data into a computer, it must have adequate validation. ◦ Ensures that a subjects participation is clearly marked in his/her medical records.

A printed, optical or electronic document designed to record all of the protocol-required information to be report on each trial subject All corrections to CRFs and to all data must be made in a way that does not obscure the original entry. Laboratory values should be always be recorded on the CRF or be attached to it. Other data may appear on a CRF, if clearly marked as additional or optional findings. Units of measurements must always be stated

 The investigator must arrange for the retention of subject identification codes for a sufficient period of time to permit any medical follow-up which may be warranted.  Subject files and other supporting data must be kept for a period of time required by local regulations.

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