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The following is abstracted from our reprint, The Forgotten GLPs.  This article was originally published in BioPharm Magazine in April 1999, with permission to reprint given by Advanstar Communications.

1.    Use permanent, indelible ink when making entries.  Write clearly and legibly.  Remember that your audience includes not only you or your supervisor, but also the company’s regulatory and quality assurance employees, patent attorneys, and U.S. Food and Drug Administration (FDA) and other regulatory agency investigators who may be reviewing your data years after you record it.

2.    Describe and provide quantities for all materials used.

3.    For developmental or patentable work, state the object, purpose, and results of each experiment clearly and concisely.

4.    Record all operating details and conditions, including yields, product or compound names, lot numbers of standards and reference materials, suppliers, and any expiration dates.

5.    Use good scientific methods.  Narrow scientific variables to one; strive for reproducibility, accuracy, and precision.

6.    Develop and use approved methods.  Use compendial methods whenever available.  Validate noncompendial methods.  Make every effort to put these suggestions in place so that you can rely upon and consistently reproduce your results.

7.    Reference any methods, specifications, chromatographic data, and chart books.  Include document numbers, effective dates, and revision numbers for any controlled documentation.

8.    Each page must be signed and dated by the individual who makes the entry and who does the work.

9.    Attach graphs, charts, etc., to notebook pages with permanent adhesive.  When unfolded, attached documents should be within the confines of the opened notebook.

10.    Development data should be checked, signed, and dated, or witnessed (signed and dated, with the notation, “read and understood”) as soon as possible.

11.    Initials are acceptable in place of a signature if the initials are on file and if this practice is written and approved in the company notebook standard operating procedures.

12.    Avoid negative or extraneous comments.  Do not state opinion.  Be factual.

13.    For products under development, a witness must have the technical ability to witness the work but must not have conceived the idea nor have taken part in any way in the work performed by another employee.

14.    Each day’s work should be started on a separate page with lines drawn diagonally across the unused portion of the previous page.

15.    The supervisor or checker should sign under any diagonal lines across unused portions of a page.

16.    If work is continued on a second page, start the page with the phrase “Continued from page ____.”  Each page must show the date of entry.

17.    No entries should be made beneath attached sheets, and nothing should be obscured.

18.    Inserts should be signed and dated by the person making the entry and checked and dated, or witnessed, by another.

19.    If data are not kept in the notebook, they must be checked, signed, dated, and identified to provide a reference back to the pertinent page of the laboratory notebook.

20.    Lab notebooks must not be copied without the area supervisor’s or quality assurance manager’s knowledge and approval.

21.    Every notebook must be assigned a unique number when checked out.

22.    Lab notebooks are confidential and are the property of the company.  Multiple, completed notebooks should not be kept in the researcher’s or analyst’s work area.  Filled notebooks should be returned to company archives for proper storage.

23.    Every company should establish a laboratory notebook policy and a record retention policy.  All employees must have documented training in notebook procedures and in any revisions to those procedures.

24.    Take the time to organize your information with a table of contents – a table listing all experiments and the pages in which they are documented – so that the information can be easily retrieved when the company puts together a submission or prepares for an FDA inspection.

25.    To reference the notebook, include the analyst’s or researcher’s initials, notebook number, and notebook page.

Disclaimer
This information is not all-inclusive nor is it intended to replace the advice of an experienced quality assurance or regulatory compliance professional.  Every organization manufacturing pharmaceutical, biological, and medical device products must meet at least the minimum applicable current good manufacturing practices (CGMPs).