Good Documentation Practices –

A Real World Approach

Danielle DeLucy, MS
What you will learn today
• What is the definition of good documentation
practices?
• Examples of documentation practices that
should be avoided.
• Review of examples of good documentation
practices and what they apply to.
• Review of practices for correcting mistakes or
when space is limited for comments
• Review of FDA 483 citations give to companies
Definition
• What are Good Documentation Practices (GDP)?

▫ Good Documentation Practice is a term in the

pharmaceutical industry to describe standards by
which documents are created and maintained.

▫ While not law, authorities will inspect against these

guidelines and cGMP expectations in addition to the
legal requirements and make comments or
observations if departures are seen.
Why are Good Documentation Practices
Important?
• In a cGMP environment documentation needs to meet
certain requirements to ensure product quality and
product safety. If an instruction or record is poorly
documented, then the manufacture or Quality
assurance/control of a product can be negatively
impacted, potentially reducing patient safety.
• Documentation provides both: Information on when,
where, who, why and how to complete tasks, and
Evidence proving that the tasks have been completed
as they should be.
Different Types of Documents
• Documentation and records used throughout the
manufacturing process, as well as supporting processes (e.g.
Quality Control or Quality Assurance), must meet the basic
requirements of GDP. These include (but are not limited to):
Batch Records Policies Checklists Maintenance
Records
Lab Records Protocols COAs Metrology
Records
Bill of Materials SOPs Cleaning Records Training
Documents
Specifications Work Instructions Electronic Validation
Documents Documentation
The ABCs of GDPs:
A) Clearly Written Documents

• All documents must be accurate and and written in a manner

that prevents errors and ensures consistency. If documents
are to be used together, e.g. an SOP and a form, then each
should reference the other.
• Ensure there is traceability between two or more
documents/records using formal document numbers or
record identification.
• EXAMPLE:
▫ Data was recorded using SOP J000456 and Form 7187-4561.
The ABCs of GDPs:
B) Legible Entries
• Handwritten Entries must be made with care so as to
ensure the proper information is readable.
• Each entry should be signed and dated by the person
performing the entry.
• EXAMPLE:
▫ Result: 0 CFUs
▫ Recorded by: Jane Doe
▫ Date: 10/18/2014
The ABCs of GDPs:
C) Permanent Ink
• It may sound simple, but only blue or black indelible
ink is to be used for handwritten records.
• The ink needs to be waterproof.
• A document is unusable if it cannot be interpreted
and therefore causes a compliance concern.
The ABCs of GDPs:
D) Employee Signatures
• A company must keep a signature log documenting the
signature and printed name and initials of each employee
that will work on a task related to a product.
• Signatures must always be that of the person who did the
work, never forged.
• In the event the person who did the task is not available to
complete the signature, a note must be made indicating who
is signing for that person.
• EXAMPLE:
▫ Area Cleaned by: John Doe on 9/4/2014 signed for by
Danielle DeLucy on 9/30/2014
The ABCs of GDPs:
E) Review and Approval of Documents

• The person performing a task must always sign for

that task as stated previously. However, that person
can never review or approve his/her own work.
• This review and approval step must be done by a
third, independent party.
• A signature and date by the reviewer/approver
confirms that a review has taken place.
The ABCs of GDPs:
F) Permanent Records

• Deliberately amending or destroying GMP records to hide or

falsify data is fraud.
• Do not discard a GMP record just because you might have
made a mistake, it is still required for traceability.
• It is not acceptable to discard GMP records for any reason
unless the retention period expiry is reached.
• Loose unofficial papers, notes and uncontrolled documents
that can easily be lost or changed without appropriate
approval do not meet GDP requirements.
• Do not use notebooks/legal pads with easily removed pages,
scrap paper or post-it-notes to record GMP information.
The ABCs of GDPs:
G) Modifying Records
• The company GDP procedure should outline how
data or entries may be modified. This should include
details on:
▫ Any standard abbreviations used, e.g. ‘not applicable’ (NA
or N/A) etc.
▫ Unacceptable practices, e.g. using ‘ditto’ marks (“) to
indicate the same entry as above, leaving empty fields in a
form, etc.
The ABCs of GDPs:
H) Raw Data
• Attachments to forms
 Staple the attachment to the record; paperclips are not acceptable.
 Cross-reference the record and the form with each other, e.g. the
record references the SOP number and the SOP references the
record number
• Attachments to Logbooks
▫ Secure the attachment to the appropriate page of the
workbook/logbook – use tape or staples
▫ Do not obscure any data on either the workbook page or attachment.
▫ Ensure sufficient identification on the attachment to ensure traceability
in the event it becomes separated (cross-referencing)
▫ Sign and date both the workbook and attachment.
The ABCs of GDPs:
H) Comments and Explanations
• Some firms have a “comments/explanation” box
available on documents
• When entering information into these boxes, keep it
brief and to the point
• The box is not there as a way to explain in full why
something occurred
• These areas are to make a note of something that
may have occurred during the task that needs to be
documented.
Examples of How to Fix an Error
• Corrections may be made after the content of the
record has already been checked.

Name: D. DeLucy Date: 15Oct2013

Calibration Date: 01Jan2013 Equipment #: N/A
Solution expiry: 15Oct2013 Solution Name: HCl

16 Oct 2013 (incorrect expiry assigned)

D. Delucy 17Oct2013.
Checked by A. Stevens 17 Oct2013.
Examples of How to Fix an Error
• Making a Legible Correction to a document
▫ Make a single line through the error (30Sep2015)
▫ Record the correction close by
▫ Provide a brief comment why the change is required (as
appropriate).
▫ Initial the change so that it is clear that the correction is deliberate.
▫ Record the date of the correction next to the initials so that there is
a record of when the change was made

30Sep2015
29Sep2015 Date Error
DD 29 Sep2015
Examples of How to Fix an Error
• Handling empty fields on a record:
▫ All fields on a record should have an entry, even if it is ‘N/A’.
▫ Alternatively, multiple blank spaces/rows/columns on a record must be
marked out with a single line across the whole field/space. This ensures
that the record cannot be added to at a later date without appropriate
checking or approval
▫ An explanation may be required why the field/space is ‘not applicable’.
DATE RESULT PERFORMED BY

N/A D. Delucy
30Sep2015
Handling Recording of Numbers
• Rounding – The company should outline rounding
procedures in a SOP. Using significant figures should
be considered
• Time – Military or Standard time can be used, but one
should be used consistently throughout a document.
• Decimals – should be documented the same way
throughout the document. For example, if one
records 0.53 kg, any remaining decimals should be
recorded the same, i.e. 0.46 kg, not .46 kg.
Documentation is Important!!
E-records related to GDP
• At least as secure as paper records
• Maintain data security and integrity
• Reliable / Validated Software
• Ability to copy and retrieve
• Controlled access
• Time stamped audit trails
• Training
• SOPs
Regulations and E-records
• 21 CFR 11 Electronic Records and Electronic Signatures Section
11.1 Scope. (a) The regulations in this part set forth the criteria
under which the agency considers electronic records, electronic
signatures, and handwritten signatures executed to electronic
records to be trustworthy, reliable, and generally equivalent to
paper records and handwritten signatures executed on paper.

• (b) This part applies to records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted, under
any records requirements set forth in agency regulations. This
part also applies to electronic records submitted to the agency
under requirements of the Federal Food, Drug, and Cosmetic Act
and the Public Health Service Act, even if such records are not
specifically identified in agency regulations.
483s – Good Documentation
• One major observation made by FDA also regarded documentation
procedures, which FDA said had in at least one case resulted in "questionable"
information.
• Such documentation is meant to provide a record of when certain activities,
such as cleaning, took place and the circumstances of the activity.
• FDA pointed to logbooks used by Company X during the cleaning and
sanitization of biosafety hoods used in the manufacture of Product A and
Product B, and said it could find no details about the cleaning materials used
or the adequacy of the cleaning procedures.
• Similar violations were found in four other cases, with FDA pointing to a lack
of documentation about the buffers used to standardize pH-measuring
probes, the purification of Product B, and a lack of assurance "that entries in
the logbook are always made when the operations documented actually
occur.”
483s – Good Documentation
• Written records of major equipment cleaning and
use are inaccurate and do not provide assurance that
persons double-checked the performance of
equipment cleaning, because there is no assurance
that those persons responsible for determining that
work was performed were present at the time of
equipment cleaning [21 CFR 211.182].
483s – Good Documentation
• During the inspection, our investigative team uncovered fourteen (14) instances
(Observation# la, b, c, e, f, g, h, k, l, m p, q, t, and u on the FDA 483) where
cleaning records for equipment used in manufacturing operations (V-blender,
[redacted], etc) included initials or signatures of employees who reportedly
verified cleaning of equipment but were not shown as present by security log
records.
• According to the security log used to record the entry of all personnel entering
and exiting the Company X (Unit II) facility, the supervisors who initialed or
signed the "Checked by Production Executive" or "Cleared by QA Executive"
block were not present in the Company X facility on the days this equipment
was cleaned.
• For example, two of these records each involved entries for five separate dates
where the employee signing for verification (hereafter "Employee 1") was not
present according to the security log records (Observations #1(a) and (b)).
483s – Good Documentation

• 'The firm did not retain complete raw data from testing
performed to assure the quality of API. The inspector
revealed the firm did not properly maintain a back-up of
HPLC chromatograms that form the basis of the product
release decisions. The inspector revealed as well
discrepancies between the printed chromatograms and the
OQ protocol for the HPLC system, which is intended to
demonstrate correct operation of the system (e.g. injection
sequences and values to calculate relative standard
deviation'
When in doubt, what do I do?
• Always ASK your Quality group, your
manager, a peer.

• You are legally responsible for these

documents!!

• If it is not documented, it is not done!

Conclusion
• The rules set forth in documentation apply to all personnel in a company.
Individuals involved with holding, storing, transportation, manufacture,
testing, support and packaging of FDA regulated materials will be
expected to know and abide by the common rules of documentation.
Your particular company should inform you what documentation is
expected of you.

• The requirement for proper documentation applies to all staff whether

they are permanent, temporary or interns. Companies that manufacture
food and drugs are regulated and inspected by the US Food and Drug
Administration on products made for consumption in the United States.

• When you place a signature on a cGMP document, you have proven that
you have completed a step in the view of the FDA.
THANK YOU

Any Questions?