D-102

Laboratory Notebook, Equipment Use Logs, Data Handling, and Data Review

Section D — Laboratory Operations and Specifications Revision 7 10 pages

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1.0 Purpose

This procedure outlines the assignment of laboratory notebooks to both laboratory analysts and

laboratory equipment. This procedure also gives guidance on proper documentation of tests
and experiments recorded in laboratory notebooks and use logs, and provides guidance on

review of that documentation. This procedure is intended to give additional specific guidance
for laboratory notebooks in addition to SOP A-106 Documentation Guidelines for cGMP

Records.

2.0 Scope

This procedure is applicable only to official, registered laboratory notebooks that are property

of Ion Nutritional labs. This procedure applies only to notebook entries and data handling for
QC Laboratory Analysts. In the event that there is a conflict between this procedure and SOP

A-106 Documentation Guidelines for cGMP Records, the most conservative option of the two

will be followed.

3.0 Responsibility

Sul It is the responsibility of DC to oversee the logging of notebook inventory.

3.2 It is the responsibility of QC Chemists to follow this procedure.

3.3. It is the responsibility of Quality Management to implement this procedure and to

ensure that personnel are following this procedure.

3.4 It is the responsibility of QC Laboratory Management to keep this procedure current

with latest Ion Nutritional Labs practices.

[SOP

Standard Operating Procedure SOP No Rev
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4.0 Definitions

4.1 DC — Document Control

4.2 QC — Quality Control

43 OTC — Over the Counter (Referencing nonprescription drugs)

4.4 eGMP — Current Good Manufacturing Practices

4.5 OOS — Out of Specification

Checklist — tool to be used by both the analyst and data reviewer to assist in defining
4.6 required pieces of a data packet needed to complete data packet review.

Redzone (RZ) — a software application used to collect data during the production
4.1 process; used to track production data, as well as cGMP data

4.2 Data Sheet — an RZ component of the RZ Compliance Module, configured to collect

data

4.3 SOP — Standard Operating Procedure

5.0 References

Sel A-106, SOP, Documentation Guidelines for cGMP Records

5.2 D-102-F1, form, General Data Review Checklist

5.3 C-111, SOP, Redzone General Use

5.4 C-107, SOP, Redzone Reviewer Activities

[SOP

Standard Operating Procedure SOP No Rev
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6.0 Procedure

6.1 Notebook Assignment

6.1.1 Notebooks are released in sequential order.

6.1.2 Each notebook is assigned to a single individual for individual use only, to a

single specific test (i.e. loss on drying, weight variation), or to a specific piece of

equipment (i.e. balance).

6.1.2.1 Notebooks assigned to specific tests or equipment will be kept in a

centralized location and the department for the assigned notebook will
be responsible for the notebook.

6.2. Notebook Inventory Control

6.2.1 DC will oversee the maintenance of a ledger which summarizes the following

information:

6.2.1.1 Notebook number

6.2.1.2 Name of person, test, or equipment assigned to notebook.

6.2.1.3 Date when the book is put into service.

6.2.1.4 Date notebook is retired.

6.3 Entries for identifying test and laboratory information in a notebook.

6.3.1 The assigned notebook number (found on the inside front cover) should be filled
out at the top of every page on the Book line if applicable.

6.3.2 When documenting a new write up, the first page of the document should read

Start/new on the Continued from page line. If multiple pages are required to
fully document the information the next page should be filled in on the

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Continued on page line, the previous page number should be filled in on the
Continued from page line and end if it’s the final page.

6.3.3. The name of the product, raw material, test, or experiment should be listed on
the Title line at the top of each notebook page along with any associated batch

numbers, R numbers, or sample identifiers.

6.3.4 An analyte, buffer, test abbreviation, OOS designator, protocol designator or

other project identifier should be listed on the Project line, if applicable.

6.3.5 On the first line of the first page, list any SOPs, monographs, or other test

identification information that references the methods or procedures used to

execute testing.

6.4 Components of a Write Up

6.4.1 A hypothesis/purpose statement should be added when applicable at the
beginning of the first page to describe/identify the experiment being performed

and the expected outcome. A hypothesis statement is not required for finished
product and raw material release testing, standard certification, buffer

preparation, or if assigned to equipment.

6.4.2 If samples are being analyzed, the product or material names and associated lot

numbers should be listed. For stability testing, testing time points should be

included.

6.4.3 If prepared solutions are being used, the solution’s name, notebook/ page

identifier and expiration date should be listed.

6.4.4 If chemicals are being used, the manufacturer, lot number and expiration date

should be listed for each chemical. For each standard used, the unique identifier,

purity, and expiration date should be documented.

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6.4.5 If equipment is utilized during testing, the special ID or Ion# and/or calibration
due date should be documented in notebooks (this includes balances, pH meter,

HPLC, ICP, FTIR, HPLC Column, etc.).

6.4.6 Testing performed on different days should include different write-ups.

Referencing a previous write-up is not allowed.

6.4.7. All documentation will be signed by the analyst on the day it occurred. Ifa

write-up occurs over the course of multiple days then the analyst should write

“end of day” and sign/ date after each days entries.

6.4.8 If following a procedure or a monograph and a deviation from the referenced

procedure is used, cite the procedure being used and describe in detail any
deviations from referenced procedure. If an undocumented procedure is being

used such as in a method’s development, list in detail each step and
measurement used while conducting the experiment and document in a

notebook.

6.4.9 Hard copy data such as weigh tapes should be permanently affixed to the page

and signed and dated across tape or edge.

6.4.10 Where applicable, for procedures where a result is reported, a section labeled
‘results’ should be included. In the results section document or reference all

calculations associated with the generation of final result as required.

6.5 Raw Data Handling

6.5.1 When digital raw data is generated, a raw data report needs to be printed in hard
copy to include all digital data associated with the test. Examples of sources are:

HPLC, UV/VIS Spectroscopy, and ICP. FTIR does not require a write up or test

ticket and the scans are archived electronically.

6.5.2 All electronic data generated will be assessed for system suitability acceptance

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criteria prior to submitting for data review, if applicable.

6.5.3. A hardcopy of a spreadsheet including the data summary and result(s) or a

photocopy of the associated notebook page(s) can be attached to the front of the
data packet.

6.5.4 Ifa spreadsheet is used the spreadsheet must reference the laboratory notebook
and page number(s) associated with the data when not accompanied by the

photocopies of the notebook pages.

6.5.5 The data packet will be submitted with the associated finished product and/ or

raw material and then scanned in by DC.

6.5.6 Stability data packets are maintained by the QC Laboratory.

6.6 Data Review

6.6.1 Analysts will review their write up to verify completion of the documentation

then sign and date before review. The analyst will submit all supporting

documents for each write-up to the reviewer including, but not limited to:
copies of standard preparations, electronic reports generated from analytical

runs, and checklists, if applicable.

6.6.2 Ifa portion or an entire page was not used, a single line will be drawn across the

unused portion of the page. The line will be initialed and dated in the middle.

6.6.3. Data review includes but is not limited to:

6.6.3.1 Review documentation against all current practices, testing methods,

and procedures. Ensure that procedures were followed as written.

6.6.3.2 All equipment used was within calibration.

6.6.3.3 All system suitability acceptance criteria met.

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6.6.3.4 Results are within specification and reported correctly as per rounding

rules.

6.6.3.5 Handwritten or manual calculations shall be verified for correctness.

6.6.3.6 All documents needed are present in data packet.

6.6.4 The originating analyst is responsible for correcting, signing and dating any
changes made as a result of the review.

6.6.5 When the procedure has been reviewed and all corrections made, the reviewer
will sign and date the page(s) associated with the write up on the Disclosed and

Understood by line.

6.6.6 Where applicable, notebook review must be signed off within three business

days of the primary Analyst’s sign-off or the date of last correction, whichever

is most recent.

6.7 Checklist

6.7.1 Each data packet should include a checklist that is used by both the analyst and
data reviewer to ensure the packet contains all required documentation.

6.7.2 Additionally, the checklist should be used to show assessment of all method
suitability requirements by both the analyst and data reviewer.

6.7.3. As applicable, testing specific checklist are included as an official controlled
form associated with each testing process. Form D-102-F1 General Data Review

Checklist can also be used if a test specific checklist is not available.

6.8 Laboratory Equipment Use Logs

6.8.1 Laboratory equipment used in or supporting the manufacture or testing of GMP

materials that requires a record of traceability shall have a use log. Exceptions

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to this requirement are listed below.

6.8.1.1 Laboratory equipment that uses an electronic software to collect data and

presents the ability to create reports that summarizes all samples tested
during a specific time period.

6.8.1.2 Equipment used exclusively for R&D purposes (non-GMP).

6.8.2 Use log requirements

6.8.2.1 Laboratory equipment use logs may be manually captured in a
laboratory notebook or electronically captured, i.e. using RedZone.

6.8.2.1.1 If applicable and available, RedZone may be used to
capture equipment use using RedZone datasheets.

6.8.2.1.2 The appropriate configuration of Redzone occurs during the
development and verification of the datasheet as covered by

SOP C-107 RedZone Reviewer Activities.

6.8.2.2 Use logs entries should be in chronological order.

6.8.2.2.1 If an entry is mistakenly omitted, it can be added at a later

date with justification as a footnote. The use entry should
be verified against other supporting documentation as

applicable.

6.8.2.3. The following must be documented at time of use as applicable

6.8.2.3.1 Date

6.8.2.3.2 Product Details

6.8.2.3.3. Lot Number or other sample traceability details

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Handling, and Data Review

6.9 Data Review Audits

Periodically, the data reviewer shall check entries in logbooks of instruments
6.9.1 and equipment used for analysis and shall verify the calibrations/ qualifications

at random. This check can be captured by the data reviewer signature of audit in

the logbook.

Periodically, Laboratory management should audit data that has been previously
6.9.2 reviewed by the data reviewer. This check can be captured by using a

“checkmark” and initials/ date next to the data reviewers’ original approval.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/06/10 | New - : | - | - |
| 1 | 01/24/12 | Made SOP more detailed. - - Generalized procedure for documenting in a laboratory notebook. | - | - |
| 2 | 01/30/13 | Instituted a section breakdown of a procedure. Updated SOP format. Update format. Expanded responsibilities. Use of cGMP and cGLP 2 O120/15 n I o n t c e re b a o s o e k d s . d e A t d ai d l e t d o h i a m n p d r l o i v n e g c o l f ar r i a ty w . d C a h t a a n n g o e t d e n S t O er P e d ti t i l n e t . o B n i o e t n e ni b a o l o k. 15-0058 i, JOnbs Review. | 13-030 | B. Johns |
| 4 | 03/04/16 | Updated SOP to reflect current practices. Updated SOP to reflect current practices. Add responsibilities for . lid t C h h e a R ng & e D d S De O p P a r t t it m l e e n t t o . o U bs p o d l a e t t e e d D f - o 1 r 1 m 3 a t “ t Q o C i n L c a l b u o d r e a t O o T ry C N t o es t t e i b ng o . ok Ea LeGomett | 16-0213 | D. Thompson |

and Data Handling
Defined review process in more detail. Added additional
requirements for laboratory write-up. Added data review audits.
6 11/22/22 | trctuded Data Review in SOP title. Added data checklists. COgae | J. passival
Removed R&D from scope. Created Form D-102-F1.
7 08/30/23 Added Equipment Use Log Requirements. Added RedZone to CC-23-0439 | J. Sassman
scope of SOP. Changed logo on form and SOP.

[SOP

General Review Checklist ytti %Y aw
Form: D-102-F1 CC-23-0439 Revision: 1

Notebook/ Page (s) #: Method Reference/ Rev#:

Testing Description: Batch/Lot#:

1) All required documents are attached and
write-up is complete. Including:
a) Notebook write-up complete/ signed
b) Standard (s) are prepared as directed
in method
c) Sample (s) are prepared as directed
in method
d) All solutions used are appropriately
captured/ documented/ within
expiry
e) All equipment used is within
calibration
2) All blocks are filled out properly, affixed
items are signed and dated. N/A lines used
properly.
3) Sample numbers are consistent across all

4) Sample weight matches the weigh tape on
sample prep documents.
5) Final volume, dilution multiplier and unit of
measure are aligned with product
documentation
6) Product profile referenced to ensure all
reported values meet acceptance criteria.
7) Measurement of Uncertainty is evaluated for
if applicabl
8) All data recorded is legible and accurate.
(Calibration dates, lot numbers, units of
measure, etc.)
9) All required copies are present in packet.

10) All data recorded is verifiable through other
pages attached to packet.

11) Other:

12) Other:

Performed By: Date:

Reviewed By: Date: