Nikki Dillard

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RECORD KEEPING

• Nikki Dillard
• Allison Lowry
• Tiffany Thomas

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IF YOU DIDNT WRITE IT DOWN, IT DIDNT HAPPEN!
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What is Record Keeping

• The maintenance of a history of ones
  activities, as financial dealings, by entering
  data into ledgers or journals, putting documents
  in files, etc

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Why should records be kept?
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Good Manufacturing Practices (GMP)
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Good Manufacturing Practices (GMP)

• 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.

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GMP

• 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.

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GMP Records and Reports

• 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

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GMP

• 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.

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GMP Recordkeeping Guidelines

• Record all necessary information immediately upon
  completion of a task.
• Dont trust your memory
• Write your name legibly and in ink.
• No white out or erasures allowed
• Report any deviations from written procedures to
  your supervisor.
• Dont document someone elses work unless you are
  designated to do so.
• Dont assume that undocumented work has been
  properly completed.

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Laboratory Record Keeping
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Laboratory Record Keeping

• 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.

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Rules for Laboratory Record Keeping

• RRecord...
• E Each
• C Corroborate
• O Original.
• R Review
• D Data..

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Rules for Record Keeping

• RRecord 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.

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Rules for Record Keeping

• 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

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Computer-Generated Record Keeping

• 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.

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Good Clinical Practices
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GCP

• 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.

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GCP Record Keeping

• 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.

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Investigator Responsibilities

• 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.

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Case-Report Form (CRF)

• 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

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Archiving of Data

• 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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References

• http//www.gmp1st.com
• http//www.rgp.ufl.edu
• http//www.who.int
• http//www.dicitionary.com