LAB-025 Laboratory Workbook

1. The Laboratory Workbook

1.1. Type of workbook:  The workbook is ideally bound, with consecutively numbered pages and ideally waterproof.

1.2. Issue of workbook: Laboratory staff issues a consecutively numbered workbook.  The workbook front cover page is labelled with the analyst’s name and the first testing date and when the workbook is completed, the last testing date.

1.3. Archiving of workbook: A logbook is kept for laboratory workbooks.  The bound logbook records the owner, date, Workbook number and archived workbook location.

1.4. The Laboratory staff is responsible for archiving of the workbooks.

1.5. Contents page:  A contents page(s) is established on the front or last page to detail materials tested and experiments carried out.

The table of contents page includes the following columns: by ruling lines to divide the table of contents column into three to include

a. Date

b. Title

c. Comments

d. Page number column is present.

The ‘Comments’ column can be used for additional information such as cross-referencing updates to earlier work or for noting data used in reports.

1.6.  All data is to be neat and legible.  (See SOP QMS-020 for procedure on documentation.)

a. All entries must be in either Black or Blue ball-point ink suitable for waterproof paper.  A Yellow, Green or Orange highlighter may be used to highlight entries as these colours are suitable for photocopying.  Red ball-point ink for underlining may be used for ease of work flow identification.

b. Scribbles, liquid paper, pencil, red pen writing are not permitted.

c. Red ink is not suitable for photocopying and can be interpreted as incorrect information.

d. Manual calculations must be clearly shown.

1.7. All raw data must be reviewed and approved prior to the release of the material.  Calculations and results for finished goods and raw material release require a daily second check by a colleague. The results are verified by signing the “Read and Understood By” page containing calculations and results.

1.8. A periodic review of the Workbook is carried out by a Laboratory colleague using form Form-275.  This person then signs the “Read and Understood By” section of the Workbook pages to indicate they have reviewed the Workbook pages against the checklist. The completed checklists are filed in the “Laboratory Workbook – Review Folder”.

1.9. The Laboratory Manager randomly reviews Workbooks, and the logical flow of an experiment should be assessed against the checklist.  Internal or external auditors may also randomly audit Workbooks.

1.10. There should be a link between any analytical work, and any internal reports or reports to the Regulatory authorities.

The key point is that all data can be traced to an original raw data or collection source.

2. Format of Laboratory Workbooks for Daily Testing

2.1.  Information required in the workbook:

a. Name, Batch Number (and/or Inspection Lot Number), Trial Number (if applicable) of product tested.

b. Testing date and all raw data, e.g. weights, volume.

c. Equipment system, where applicable, (e.g. if several instruments of the same type are available in the one Laboratory and a choice is possible).

d. Control Method number or protocol (if applicable).

e. Column serial number for HPLC and GC.

2.2. It is not necessary to write all the testing steps/methods in the workbook only those tests that require measurements that affect a calculation (see SOP LAB-060 & LAB-065).

2.3. Record in the Workbook the following information for chemicals used to make up testing reagents: Manufacturer, Lot No., Expiry Date, date when container opened.

2.4. Qualitative and quantitative test results can be directly entered onto the Raw Material / Finished Product Specification and Test Report (see SOP QMS-030, TEM-005, TEM-060). Terms such as “negative”, “positive” or “conforms” are used to describe limit and identity test results.  All entries on the specification reports must signed and dated.

2.5. All calculations for raw materials/finished products must be entered in the Analyst’s workbook and Raw Material / Finished Product Specification and Test Report are to given the book page reference number of the work book .  All entries on the workbooks and the Specification and Test Reports must signed and dated.

2.6.  Corrections or modifications of data entry must not obscure the original entry.  Correction Fluid (Liquid Paper) is not permitted.  The correct procedure (see SOP QMS-020) is to put a single line through the incorrect entry, write in the new entry next to it and initial and date it.  The reason for making the new entry must also be recorded.  The abbreviation, EE, for entry error may be used.  Entry error is the most common reason for making corrections or modifications.

2.7. No pages are to be removed from the workbook. If any page are to remain blank cross through the page and write “Void” and date and sign the page.

2.8. The out-of-specification procedure detailed in SOP LAB-055 must be followed for all non-conforming results.  The appropriate testing information, including problem solving is reported allowing a decision to be made on the result disposition.

2.9. Primary or secondary standard information used in the testing is noted, i.e. Code Number, Batch Number, expiry date and assay.  See SOP LAB-020for the correct procedure on use of standards.  If an expiry date is not known, then it must be recorded as not known.

2.10. Reference to other records, computer print outs, charts, samples, standards, instruments, or calibrations must be detailed as required in any testing of materials or experimental write up.  Print outs of chromatograms or other documents may be fixed into the workbook either as originals or photocopies.  These documents must be initialled and dated, and they must be described and referenced in the workbook, adjacent to where they are fixed.  Original documents (such as chromatograms, printouts and charts) must be filed either in soft or hard copy form.

3. Format of Laboratory Workbooks for Experiments or Project

The table below outlines a format for experimental or project work not covered in raw material or finished goods control methods. No specific format for writing up experiments exists under GLP.  However, within the context of GLP data being traceable, a useful format is as follows:

Note: All the requirements in the previous sections still apply.

4. Common Scenarios

4.1. Scraps of Paper

It is not permitted to record information and data on scraps of paper.

GLP requires you to write and record all information directly in your workbook.  It encourages and trains you to become more organised, and keeps raw data recording accurate.

4.2. Incomplete Experiments

For experimental/project work:

Often an experiment is not completed on the day it is started.  A second experiment may commence in parallel.

How do you complete the write up of the first experiment?  It is important that you do not leave blank spaces or page(s).  If a page is left blank, or partly blank, at the conclusion of an experiment and the commencement of the next experiment, a Z must be drawn through the blank section of the page.

The completion of the write up of the first experiment must be completed where the next available space in the workbook appears, that being on the day the experiment is completed.  Reference to the page number(s) of when the experiment began must be noted.

4.3. Additional Data

You may have thoughts or additional data to add to a particular experiment some time after that experiment is completed.

Extra data cannot be added to the original entry in your workbook.

This additional information must be added on the page you are presently on in your workbook.  Reference to previous work is noted on that page.  The original entry can be forward referenced to the new entry, using the space available (“Continued to”) at the bottom of the page and must be signed and dated.

Updates can also be included in the comment column of Contents where the original entry is referenced forward to the updated entry and where the updated entry is referenced to the original entry.

4.4. Bad Day on the Job

Despite all your intentions to input information in an organised manner, you may make a real mess of the page.

Do not remove the page or use correction fluid.

Put a line through the whole page, sign and date the page and commence on a new page.

5. Summary of Changes