GMP/GLP RECORDKEEPING

 

Good data are required for patent writing, litigation, and product registration with the USDA, EPA & FDA. Government requirements are described in Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), and Good Laboratory Practice regulations (GLP) used by these agencies. Your data may have to be explained, defended, reconstructed or repeated without your assistance, so others must be able to understand what you did. Monsantos and Pfizers recordkeeping guidelines are among the most stringent in the biotech field and, therefore, will be used as the recordkeeping guidelines of the SLCC Biotechnology Program.

 

  1. Complete the title page when the notebook is issued.

  All persons recording in the notebook must also sign the title page and give an example of initials used.

 

  1. How is the index or table of contents recorded?

  If you have properly linked all pages as required, record only the first page number of each multi-page experiment.

 

  1. Each recorded lab should have the following parts:

  The objective or purpose of the experiment/lab

  The plan, outline or a flow diagram of the lab

  The step-by-step procedure

  The raw data produced

  The results, including graphs, tables, figures, photos and/or drawings

  The conclusion, which should include the biological and chemical concepts involved, whether the objective was met, any problems experienced and suggestions for further experimentation.

 

  1. When is data recorded?

  Entries should be made as the experiment proceeds but no later than as soon as it is done or when an idea is conceived.

 

  1. What is data?

  Raw data: original of handwritten information or a printout from equipment, such as a description of your observations, a description of your procedures, a description of the events.

  Calculated data: derived from a calculation or statistical evaluation of the raw data

  Transcribed data: copied raw or calculated data.

 

  1. What do you record?

  Objectives, ideas, experimental plans or outlines, preparations, procedures, data, observations, calculations, discussions, conclusions, future plans and potential uses

  What actually happened

  Results

  Notes of unexpected results or observations

  Deviations to a planned protocol

  All measurements and important test conditions (weights, volumes, temperature, etc.)

  All units (ml, g mg, etc.)

  Indicate if the numbers are estimated, rather than measured

  Indicate if the numbers were calculated and provide the equation.

  If using Excel spreadsheets, print out the formula(s).

  Indicate if a number has been rounded or truncated.

  Decide before you begin what the critical events will be so that you can record them, i.e., in a table, as proof that an SOP or previous procedure was followed.

 

  1. How do you record the data?

  Directly into your notebook not on scraps of paper, post-it notes, etc

  In black indelible ink although Monsanto now allows blue ink, Pfizer still requires black.

  Make entries only in the ruled areas of the numbered pages.

  Unnumbered pages can not be used they are not copied for legal proceedings.

  Only one experiment per page do not mix different studies on the same page.

  Attach forms or printouts

 

  1. What is the procedure for attaching forms and printouts?

  Attach only to numbered pages within the ruled area only

  Taped on at least 2 sides

  Fully exposed (no folding)

  NOT covering any previously recorded entries

  With hash marks on at least two corners

  Write the notebook and page number on the attachment

  Sign and date along the edge

 

  1. Who generated your data and when?

  Record your data on the same day it is generated, not after the fact.

  A single page can cover events from more than one day, but the dates must be indicated on each event.

  The person making the entries must sign the page.

 

  1. What materials and equipment did you use?

Important materials must be noted.

  The importance of a material is related to its impact on the reconstructability and repeatability of the experiment.

  Variability between batches or lots is often a prime consideration here.

  Do not use simple terms like the buffer but write the name of the buffer.

  List the purity, concentration and other pertinent information

  List the source or catalogue number of the product used.

  For complex solutions, the recipe or a record of the preparation should be recorded.

Equipment includes:

  Reactors

  Analytical instruments

  Hardware

  Software and version number

  Unique equipment ID numbers

  Date of last maintenance

  Date of last calibration

  Date of last performance check

 

  1. What routine or repeated procedures did you use?

The following can be referenced, by page number, rather than copying completely:

  A previously run procedure that was correctly recorded in your notebook

  A Standard Operating Procedure (SOP)

If any deviations were performed, they must be so noted.

 

  1. How do you record your conclusions?

As fact, not as opinion

  Fact: No reaction was observed. Opinion: These two chemicals dont react.

  Fact: Expected results were not obtained. Opinion: No good.

  Fact: Under these conditions, the reaction was unsuccessful. Opinion: Failed.

 

  1. How and when must notebook pages be witnessed?

  Within two weeks of completion of an experiment or procedure.

  By someone outside your team

 

  1. How clear and understandable is your data?

  Is it legible to others, not just to you?

  Is it clear and detailed enough so that a person in the same discipline could understand it and repeat it?

  Have you included drawings and flowcharts to provide clarity in complicated experiments, processes and equipment setups?

  Are all abbreviations defined or obvious? A preprinted list of abbreviations should be kept and attached in the front of your notebook after the table of contents.

 

  1. What portions of a notebook get Xed-out?

  Unused portions of > 3 lines

  Unused fields in forms and tables should be lined-out or marked as N/A.

 

  1. How do you fix mistakes?

  NEVER use white-out

  NEVER erase

  NEVER write-over

  NEVER discard or replace attached supplementary data

  ALWAYS record a defensible reason for the correction/edit

  ALWAYS circle the reason

  ALWAYS add your dated initials to corrected/edited data after the circled reason

 

 

  1. Where should your notebook be kept?

  In a company or academic lab, your notebook is not your own property and must not be removed from the premises.

  This is the one area where we will deviate from the rules because this is a class, and you must study for tests and answer questions about labs you perform, you will be allowed to take your notebooks home with you.

  YOU SHOULD NOT complete data outside of class, however. All data must be recorded on the day it is generated BEFORE leaving the lab.