Frederick National Laboratory for

Cancer Research, Frederick, MD

Standard Operating Procedure

Biopharmaceutical Development Program

Title: Good Documentation Practices

SOP Number: 21409 Revision Number: 03
Supersedes: Revision 02 Effective Date: APR 28 2020

Originator/Date:

Approval/Date:

Approval/Date:

Table of Contents

1.0 Purpose
2.0 Scope
3.0 Authority and Responsibility
4.0 Characteristics of Good Documentation
5.0 Good Documentation Practices
6.0 Records Retention
7.0 References and Related Documents

1.0 Purpose
This SOP defines the requirements for Good Laboratory Practices (GLP) and/or Good
Manufacturing Practices (GMP) documentation to ensure that documents are legible,
understandable, reproducible, permanent, and traceable.
2.0 Scope
This procedure applies to Biopharmaceutical Development Program (BDP) personnel
completing documentation subject to regulatory review. BDP documentation includes, but
is not limited to, batch production records, forms, logbooks, and laboratory notebooks.
3.0 Authority and Responsibility
3.1 The Director, Biopharmaceutical Quality Assurance (BQA) has the authority to
define this procedure.
3.2 BDP employees are responsible for complying with this procedure.
This procedure is made available through federal funds from the National Cancer Institute, NIH, under contract
.

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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

3.3 Supervisors/Managers of the Biopharmaceutical Development Program are

responsible for ensuring adherence to this procedure.
3.4 BQA is responsible for quality oversight of this operation.
4.0 Characteristics of Good Documentation
4.1 Accurate – documents must contain accurate data and an accurate account of
events.
4.2 Complete – required information must be included in the document.
4.3 Permanent – information cannot be erasable nor be obscured in any way.
4.4 Legible – documentation must be easy to read.
4.5 Timely – Manufacturing, testing, and support activities must be documented at the
time the work is performed.
4.6 Clear – the documentation must be clear to limit misinterpretation of what was
performed and recorded.
4.7 Traceable - documentation must provide information on:
4.7.1 The activity being documented.
4.7.2 The individual(s) performing the activities.
4.7.3 The materials and equipment used in the activity.
4.7.4 The activities preceding and following the process.
4.7.5 The location and proper identification of raw data.
4.8 Appropriate corrections and handling of deviations.
5.0 Good Documentation Practices
5.1 Accurate
5.1.1 Entries must accurately represent the data or activity. Data entries may
require either a "Performed By" or "Recorded By" signature/initials to
indicate the type of information being recorded.
5.1.1.1 "Performed By" indicates that the step was performed by the
individual signing/initialing the record.
Example: An operation requiring an operator to weight items and
record the readings of the weight in a table would require an entry
to record the individual's initials and date that the operation was
performed as stated.
5.1.1.2 "Recorded By" indicates that the entry or series of entries were
written by the individual signing/initialing the record.
Example: Recording Quantity Issued, BDP Part Number, Lot
Number, and Expiration Date in a table format would require an
entry to record the individual's initials and date that information
was written.
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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

5.1.2 Operations/Steps requiring a second person's independent review of the

operations conducted (checker) must be signed/initialed and dated as the
operation is performed.
5.1.2.1 Critical steps or operations that require this type of "Verification"
include calculations, measurements, addition of components, and
other critical actions as defined in the Master Production Record
(MPR).
5.1.2.2 The second person’s signature/initials indicates that he/she has
personally observed/witnessed the entire step being performed
and has accepted the responsibility for assuring that the entire
step was performed completely and correctly.
5.1.2.3 Verifications of calculations attest that the calculation has been
checked and the same result obtained. Calculations must be
verified prior to proceeding with the next step that uses the results
of the calculation.
5.1.3 If an operation requires a “Reviewed By” signature, it must be
signed/initialed and dated at the time the review is performed. The
reviewer’s signature/initials indicates that the data recorded has been
checked for accuracy, completeness, clarity, and the need for any
comments or explanations to the record have been made.
5.2 Complete
5.2.1 Activities must be completely documented so that events can be
reconstructed at a later time (for example, for troubleshooting, trending,
etc.)
5.2.2 Do not leave blank or unused spaces on documentation or records.
5.2.2.1 If data is not going to be entered, mark the space with N/A or
other appropriate code (refer to Section 5.10) and initial and date
this entry.
5.2.2.2 A sequential group of unused spaces or data entry lines may be
marked with a single line through all of the spaces and N/A written
across this line (including initials and date).
5.2.3 The use of extra pages to record additional information is acceptable and
encouraged as long as the pages are properly identified (see Section 5.8).
5.2.3.1 Raw data that is being attached to an additional page or to a page
from a BPR or similar document must be attached firmly enough
to preclude it from getting separated from the documents. Taping
of the data to the page or placing it into a plastic sleeve is
examples of acceptable methods.

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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

5.3 Permanent
5.3.1 Do not use pencil or colored ink other than black or blue permanent ink to
record data. Red ink is reserved to suggest changes to the revision of an
approved document. The recorded data must be dark enough to be legible
and to be copied by machines.
5.3.2 Do not use correction fluid or tape, or cross out entries so that the original
entry becomes unreadable.
5.4 Legible
5.4.1 Entries in records must be legible to reviewers of the document.
5.4.2 Signatures and initials must be clear enough to identify an individual who
signed a record and must match the signature and initials on file with BQA.
5.4.3 Do not "overwrite." Overwriting creates confusion about the entry making it
difficult to identify the intended data.
5.5 Timely
5.5.1 Date records with the date on which the data is entered.
5.5.2 Entries into documentation and records must be made as each step is
completed, not after the entire process is performed.
5.5.2.1 Contiguous operations (performing aseptic processing in a hood)
that may jeopardize the work being performed should the operator
repeatedly stop to sign entries into a BPR, may be signed at the
end of the operation by the operator. In such cases, verifiers, if
any, shall initial and date each step as the written entry is
completed.
5.6 Clear
5.6.1 Documentation must be written so that anyone versed in the general field
can follow the document and reach the intended outcome. Avoid the use of
terms, symbols, phrases, etc., that may not be understandable to other
potential reviewers of the document.
5.6.2 Calculations must be documented and easy to follow. Use formulas or
equations to show how results were obtained. Calculations must include
units of measure, conversion factors, and equivalency factors.
5.7 Traceable to the individual(s) performing the activity
5.7.1 For GMP activities, use the approved form to document an activity. This
allows the activity to be traceable to the process approved by BQA. Forms
that are authorized for use will display information at the top left corner of
the form that includes the form number, associated SOP number, revision
level, and effective date.
5.7.2 Sign/Initial and date each notebook page, record, data form, etc., as
required.

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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

5.7.3 Signatures and Initials

5.7.3.1 Signatures and/or initials on a record or document identify who
was responsible for performing the work and who was responsible
for checking or verifying the work.
5.7.3.2 Signatures and initials must be unique and legible. There must be
a document available that correlates the person’s initials with
his/her signature and printed name (signature and initial log). This
log is maintained in BQA. See SOP 21406 - Personnel
Signature and Initial Verification System.
5.7.4 Signatures are required for the final approval of master documents such as
Master Production Records (MPR), Master Specifications (MS) (previously
known as Assay Profiles - AP), Certificates of Analysis (COA), Standard
Operating Procedures (SOP), and Installation/Operation/Performance
Qualification Protocols (IQ/OQ/PQ).
5.7.5 Do not sign for someone else’s work without authorization.
5.7.5.1 In rare circumstances (Vacation/Absence) and with prior approval,
a knowledgeable individual may sign as a substitute for another
person by acknowledging this action with their initials and date of
signature. See SOP 21007 - Alternate Signature Authority.
5.7.5.2 When a document must be signed and the individual designated
to sign the document is unavailable, an approved alternate may
sign the document. The designation of approved alternates is
described in See SOP 21007 - Alternate Signature Authority.
The approved alternate would sign/initial the document, date it,
and indicate the name of the person who was originally
designated to sign the document.
For example, Tom Johnson was designated to sign Document A
on November 20, 2013; he is unavailable, and Lori Jones is his
approved alternate. She would sign Document A "Lori Jones,
11/20/13 for Tom Johnson."
5.8 Protection and Traceability of Raw Data
5.8.1 Record data directly into the Batch Production Record (BPR), logbook
and/or laboratory notebook, form, or other data collection record.
5.8.2 If procedures require transcription of the data to a paper record or data
entry into a computer, reference the original raw data, if possible, and keep
the original raw data as part of the batch record package.
5.8.3 Information that is attached to another record (data printout, charts, raw
data) must be linked to that record by including (as appropriate) the
document number, project/part number, lot number, and section number (as
applicable) on each page of the attachment. Data printouts, charts, or other
data attached to another record must also be initialed and dated by the
person attaching this information.
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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

5.8.4 For data that is spliced or taped-in to the record, the initials and date of the
person adding the data should be written across the splice of pasted/taped-
in data.
5.8.5 Should a photocopy of a record be needed (e.g., oven or autoclave chart),
the individual making the copy will confirm that the copy is a true and exact
reproduction of the original document. The copy will be stamped or labeled
as “True and Exact Copy,” and the individual making this confirmation will
initial and date the copy near the "True and Exact" stamp.
5.8.6 Do not use “sticky” notes, paper towels, etc., to record data. However, if
they were used and they contain raw data, they must become part of the
permanent record and be identified properly.
5.9 Forward and Backward Traceability
5.9.1 Logbooks, laboratory notebooks, and data sheets have consecutively
numbered pages for accountability. Do not remove pages from bound
notebooks or logbooks.
5.9.2 Records must contain sufficient identifying information so that it is possible
to trace the activity forward and backward in time to associated
documentation. Record sample names, part numbers, lot numbers, and QC
test request numbers.
5.10 Appropriate Corrections (Explanation and Error Codes)
5.10.1 Correction of an entry must allow the original entry to be readable and
provides information on the date of the change, the person making the
change and the explanation of the change. Therefore, if a mistake is made,
do not correct it with whiteout or anything else that would hide or obliterate
the original entry. Erasures and overwriting of data are not allowed.
5.10.2 To correct an entry, the individual who made the mistake must line out the
mistake by putting a single line through the entry, write the correct
information next to the entry, initial and date the correction, and provide an
explanation for the change. All corrections must be clear and legible.
5.10.2.1 If there is insufficient room to write the correction next to the entry,
then place a numbered asterisk next to the entry and record the
correct information elsewhere on the page or use the comments
section of a BPR or similar document.
5.10.2.2 Indicate the reason for the correction and/or use the codes below.
Circle the codes to distinguish them from the initials of the
individual making the correction.
NOTE: If the reason for a change is not apparent, a written
explanation must be included.

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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

5.10.2.2.1 LE (Late Entry) – This code is used to reflect the fact

that a required entry was not made at the time the
step was being completed and that data is being
added at some point later. This code is not used to
correct previously-recorded data.
NOTE: Backdating of information is not allowed. The entry must
clearly show that information is being added currently
and must not be signed with the date the work was
performed.
5.10.2.2.2 CE (Calculation Error) – This code is used to explain
that recorded data is being revised as a result of a
calculation or math error.
5.10.2.2.3 UR (Upon Review) – This code is used by reviewers
of documentation (either by the Project Scientist, BQA,
or within the department itself) to indicate that a
change or addition is being entered as a result of their
review.
5.10.2.2.4 RE (Recording Error) – This code is used to indicate
that a result is being corrected at the time of entry by
the recorder (e.g., entering data into the wrong space
or recording the wrong date, etc.).
5.10.2.2.5 SE (Sample Error) – This code is used to indicate that
data is being changed because the sample used to
generate data was improperly collected, handled, etc.
NOTE: This code would not be used if the assay was completed
and generated an Out-Of-Specification result (OOS).
Refer to SOP 22004 - Managing Out-of-Specification
Test Results or Unexpected Test Results.
5.10.2.2.6 AE (Assay Error) – This code is used to indicate that
data is being changed because an assay was
determined to have been improperly conducted.
NOTE: This code would not be used if the assay were
completed and generated an OOS. In that case an OOS
investigation would be needed. Refer to SOP 22004 -
Managing Out-of-Specification Test Results or
Unexpected Test Results.
5.10.2.2.7 TE (Typographical Error) – Used for spelling errors
and changes in sentence structure, etc.
5.10.2.2.8 N/A (Not Applicable) – This code is used to indicate
that a data record section will not be filled out or
completed because the information is not applicable to
the activity being conducted.

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SOP Number: 21409 Revision Number: 03 Effective Date: APR 28 2020
Title: Good Documentation Practices

5.10.2.2.9 ES (Equivalent Substitution) – Used when an

equivalent substitution is being made for a
requirement (e.g., raw material substitution, using a
higher resolution balance to conduct weighing, etc.).
5.10.2.2.10 VD (Verbal Data) – used to indicate that data was
recorded based on a verbal communication of
information. The entry must include the names of the
individual who provided the verbal data and who
recorded it.
5.10.3 If any of the changes have a significant impact on the documentation or
process they are used in, or result in (or cause) a deviation from specified
requirements, bring it to the Supervisor's/Manager's attention.
5.11 Handling of Deviations
5.11.1 Data that represents a deviation from specified requirements must be
registered as a deviation following SOP 21301 - Deviations from Written
Documents and Corrective and Preventative Actions or SOP 21526 -
Engineering Event Management.
5.11.2 Data associated with a deviation must be identified in the record by cross-
referencing the deviation number. This allows traceability to the record that
documents the review, assessment of product impact, corrective/preventive
action, and approval of the deviation.
6.0 Records Retention
6.1 Documentation and records must be stored in a manner that ensures integrity,
security, and accessibility. Documents completed in accordance with GMPs and
GLPs must be forwarded to BQA for storage (see SOP 21402 – Document Storage
and Archival Process).
6.2 Documentation will be retained as per the requirements specified in SOP 21407 –
Record Retention.
7.0 References and Related Documents
7.1 SOP 21007 Alternate Signature Authority
7.2 SOP 21301 Deviations from Written Documents and Corrective and
Preventative Actions
7.3 SOP 21402 Document Storage and Archival Process
7.4 SOP 21406 Personnel Signature and Initial Verification System
7.5 SOP 21407 Record Retention
7.6 SOP 21526 Engineering Event Management
7.7 SOP 22004 Managing Out-Of-Specification Test Results or Unexpected Test
Results

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