Good Documentation Practices and

the USP-NF General Chapter <1029>

 Good Documentation Practices (GDP) and
USP–NF General Chapter <1029>
Kim Huynh-Ba
Expert Committee Chair

Last Update: May 2019

Antonio Hernandez-Cardoso
Course ID: CM-1029-01

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Disclaimer

Because USP text and publications may have legal implications in the U.S. and elsewhere, their language must
stand on its own. USP shall not provide an official ex post facto interpretation to one party, thereby placing other
parties without that interpretation at a possible disadvantage. The requirements shall be uniformly and equally
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In addition, USP shall not provide an official opinion on whether a particular article does or does not comply with
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Kim Huynh-Ba

USP Affiliation: Member of the USP Council of Expert chairing the Chemical Medicines IV
Expert Committee (2015-2020)
Title: Expert Committee Chair
Company: Independent Consultant

Instructor Photo Dr. Huynh-Ba has 28 years of experience in the quality management system, project management,
strategic drug development, and stability sciences. She is the Managing Director of Pharmalytik,
providing consulting and training services to pharmaceutical companies, including companies
operating under FDA’s Consent Decree and supporting their quality systems since 2003. She is also
the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP
Organic Impurities of Drug Substance and Drug Products Expert Panel (2012-present).

Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical
Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training
groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT)
teaching Quality Audit, Good Manufacturing Practices, ICH regulations, and Pharmaceutical Analysis. Kim has authored numerous
technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality
areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best
Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets (2010).

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Objectives

1. Define the purpose 3. Explain FDA

and importance of Good Guidance on data
Documentation Practice 2. Describe the general integrity
rules and principles of
• USP General Chapter GDP • cGMP requirements of
<1029> records and reports

5. Explain GDP
4. Describe CFR part
enforcement (483s) and
11, covering e-
samples of warning
signatures/e-documents
letters

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Scope

In this webinar, we will cover:

The role of good documentation practices in GMP environment

A discussion of GDocP principles and related documents

U.S. Pharmacopeia General Chapter <1029>

A review of 21 CFR GMP requirements

A review of guidance of industry of data integrity

Case study violations - documentation principles according to “Good Manufacturing Practices”

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Definition

Good Documentation Practices

Commonly abbreviated GDP or

GDocP

Recommended to abbreviate as
GDocP to distinguish from "good
distribution practice," also
abbreviated as GDP

GDP is a term in the
pharmaceutical industry that
describes the standards by which
documents are created and
maintained.
Good Documentation Practice
Ref: Wikipedia 7
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Raw Data Definition (21 CFR 58.3)

Raw data means any laboratory worksheets, records, memoranda, notes or exact copies
thereof that are the result of original observations and activities of a nonclinical
laboratory study and are necessary for the reconstruction and evaluation of the report of
that study.

In the event that exact transcripts of raw data have been prepared (e.g., tapes that have
been transcribed verbatim, dated and verified accurate by signature), the exact copy or
exact transcript may be substituted for the original source as raw data.

Raw data may include photographs; microfilm or microfiche copies;

computer printouts; magnetic media, including dictated observations; and
recorded data from automated instruments.

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Purpose

GDocP describes standards and

best practices on how to:
– Record data, information, observations,
and events
– Create, maintain and archive documents

It is considered to be a part of
current Good Manufacturing
Practices (cGMP)

Paper system and electronic
system

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Golden Rule

Data Integrity

“If it is not written Good Practice

down, it didn’t
happen.” Good Science

Good Business

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Why GDocP Is Important

The basic foundation of a quality system is to ensure the following

throughout the lifetime of the product:
• Proper documentation:
• Correct
• Complete
• Current
• Consistent

Adequacy of:

• Integrity
• Traceability
• Control
• Retention
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Who Must Follow GDocP

All personnel dealing with regulated materials

All activities related to the manufacturing of regulated materials:
– Holding
– Storing
– Transportation
– Manufacture
– Testing
– Support
– Packing/labeling

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Documentation Practices

Documents

Time

Site

Records

People

Process
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Definition–Records

Records

Based on ISO 9000:2005
(ANSI/ISO/ASQ 9000:2005 Quality Batch Record
management systems —
Fundamentals and vocabulary):
Validation Record
– “A record is a document stating results
achieved or providing evidence of activities
performed.” Batch Release Record

Instrument Calibration Record

Batch Processing Record

Batch Packaging Record

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Definition–Documents

Based on ISO 9000:2005 Information Medium

(ANSI/ISO/ASQ 9000:2005
Quality management systems Formulae Electronic Disk
— Fundamentals and
vocabulary): Master File Optical Disk

– “A document is information and its

supporting medium.” Protocol Magnetics Disk

Manual Thermal Paper

Drawing Paper

SOP Photograph

Master Record 15
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Definition - Documentation

Documentation

Based on ISO 9000:2005 Instrument Printout
(ANSI/ISO/ASQ 9000:2005 Quality
management systems — Fundamentals Electronic Lab Notebook (ELN)
and vocabulary):
– “A set of documents is frequently called Lab Notebook
documentation.”
Lab Information Management System (LMS)

Log Book

Spreadsheet

Data Sheet
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USP General Chapter <1029>
Good Documentation
Guidelines,
Official December 1, 2016
USP General Chapter <1029>

What is the purpose of this USP chapter?

The USP charged an expert panel to

establish an informative General Chapter
above 1000 (e.g., non-mandatory) with
information on good documentation
principles used in the pharmaceutical
industries.

The expert panel has representatives who
manage laboratories in the GCP, GLP and
GMP for many areas (e.g., registration
products , OTC, Dietary Supplements).

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Goals

Provide guidance to users in the

documentation of GMP activities

Assisting the users in
designing/preparation of
procedures to promote integrity and
quality control

Discussing good documentation
guidelines for records of all types

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Purpose

Documentation is the foundation of

all quality systems.

Clear, complete, accurate records
are essential to all operations and
procedures.

Used in the production and control
of pharmaceutical products, active
pharmaceutical ingredients (APIs),
excipients, dietary supplements,
food ingredients and medical
devices.

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Purpose (cont.)

Describes the principles of proper

documentation for GMP operations
to assist the user while working with
GMP activities.

Help to build the basic foundation of
a quality system that will ensure
record integrity and control.

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Scope

Includes:

Paper and electronic records that
consist of raw data, reports and
protocols.

Procedures related to
manufacturing controls and
analytical data.

Information that should be recorded
for various types of GMP
documents.

Electronic systems that should be
developed to meet guidelines.
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General Principles of <1029>

Truthful

(blank, N/A,
unused page,…) Complete Clear (interpretable by
anyone)

Concise Permanent

0 and 6
U and V
Legible Accurate
S and 5
1 and 7 (calculations, spelling, lot
3 and 8 and B No., SN, product code)
Consistent
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Good Documentation Principles

All steps related to the

manufacturing, testing, packing or
holding of pharmaceutical products,
APIs, excipients, dietary
supplements, food ingredients and
medical devices should be
documented.

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Good Documentation Principles (cont.)

Good documentation principles for

manual or electronic records
include the following, as applicable:
─ Records should be clear, concise,
accurate and legible.
─ Data entries should be recorded
promptly when actions are performed.
─ Backdating and postdating are not
allowed.

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Good Documentation Principles

All corrections to the original entries

should be initialed and dated (or
captured within an electronic audit
trail), with an explanation included
in cases where the reason for the
change is not obvious.

Data entries should be traceable to
the person who made the entry.

Uncommon abbreviations and
acronyms should be defined.

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Good Documentation Principles (cont.)

Controls should be in place to

protect the integrity of the records.

In the event that ink may have
faded over time (e.g., thermal
paper), a copy can be used with
verification of its accuracy; the copy
should be initialed and dated.

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Good Documentation Principles

Notebooks, data sheets and worksheets

should be traceable.

An adequate documentation system is
needed to ensure data integrity and
availability of current and archived records.

Records should be retained per regulatory
requirements and be readable during the
retention period.

All pages should be paginated.
Attachments (supporting documents)
should be paginated with a reference to
the parent document.

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Data Collection and Recording – FORMS

Formats for data collection and

recording include, but are not
limited, to the following:
– Paper forms, data sheets and
worksheets
– Notebooks and logbooks
– Instrument printouts
– Electronic data obtained with a system
such as an electronic data system,
laboratory information management
system (LIMS) or electronic laboratory
notebook (ELN)

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Data Collection and Recording

All data should be permanently

recorded directly and legibly when
the activity is performed.

All data should be traceable to who
recorded the data and when it was
recorded

Electronic records follow Title 21
(21 CFR), Part 11.

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Data Collection and Recording

Any change to an entry should:

– Not be obscure the original entry
– Include an explanation
– Note who made the change and when

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Data Collection and Recording

All dates should be expressed in a format

that clearly indicates the day, month and
year.
– Must be consistent

All GMP records for data collection should
undergo appropriate review and signature
by a second person.
– Accuracy, compliance and completeness

Signatures should be based on local SOPs
– Different levels of review based on
accountability (e.g., performed by, verified by,
checked by, reviewed by, approved by)

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Data Collection and Recording

Log of signature and initials

Controls for assigning signature
approval and delegation

Verified copies of raw data can
replace originals.

Multiple-page data sheets
– First or last page with total pages
– Uniquely identified
– Reference

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Laboratory Records

Laboratory records should be concise, clear, legible, accurate and include the
following details:

Description of materials (i.e., reagents)

Identification of the equipment used

Procedures used

Measurements used

Formulae and calculations

Results and conclusions

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Equipment-Related Documentation

All equipment used in the manufacturing, testing, packing or holding of a raw

material, component, API, finished product or other similar item should be
maintained and qualified for its intended use.

The documentation related to equipment includes:
― Policies and procedures for operation and maintenance
― Equipment use
― Maintenance records
― Calibration or qualification records
― Instrument labeling

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Deviations and Investigations

All aberrations, anomalies and exceptions related to the manufacturing, testing,

packing or holding of a raw material, component, API, finished product or other
similar item should be documented.

Once documented, the deviation should be evaluated and investigated, as
appropriate.

Procedures should be in place for documenting, evaluating and investigating
such events.

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Deviations and Investigations

Documentation of the investigation should include the following:

Description of the event

Root-cause investigation

Evaluation of the data trend

Responsibilities of people involved in the investigation or deviations

Impact assessment

Corrective Action and Preventive Action (CAPA) with timelines

Review and approval

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Batch Records

A Master Batch Record (MBR) is created as a template.

An Executed Batch Record, based on the MBR, is used to document the steps
and materials involved in the production of a specific batch of a raw material,
component, API, finished product or other similar item.

Typically, sections on the next slide are included in a Batch Record and should
be approved by an appropriate representative from the manufacturing site or
packaging site.

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 Batch Records–Content

Sections on the right are included in a

Batch Record:
Header information (e.g., product name, batch
number, manufacturing site)

Unit of operation (e.g., blending, coating, filling)

Manufacturing process

Target weights (raw materials)

Conditions (time, temperature)

Deviations and investigations

In-process sampling or testing

Other critical information, as applicable

Sampling plan for release, stability and
retention

Review and approval
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Certificate of Analysis

The purpose of the Certificate of Analysis (C of A or CoA) is to report analytical

results for a specific batch of a raw material, component, API, finished product
or other similar item.

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 Certificate of Analysis–Content

Sections on the right are typically included

in a CoA:
Vendor, supplier, or manufacturer information
(as applicable)

Product information (name and strength)

Results for the specific batch, with name of test,
acceptance criteria, and result for each test

Conformance statement or equivalent

Reference to procedure and specification
document

Reference of data source

Approval and date (by an appropriate
representative of the testing site)

Expiration date or retest information

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Standard Operating Procedures

The purpose of an SOP is to provide directions to trained personnel regarding a

given set of activities. SOPs should be clear and concise.

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Standard Operating Procedures - Content

Sections on the right are typically

included in an SOP:

Purpose and scope

Instructions and procedure

Responsibilities and roles

Materials or equipment, as
appropriate

Definitions or references, as
needed

Review and approval

Revision history

Protocols and Reports

Examples of tasks and activities executed based on predefined or preapproved

protocol:
– Equipment qualification
– Analytical method validation or verification
– Manufacturing process validation
– Analytical method or manufacturing technology transfer
– Cleaning validation
– Stability study or testing
– Comparability study

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Protocols and Reports

The protocol and report should typically include the following sections:

Purpose

Plan or instructions

Predetermined acceptance criteria

Deviations or investigations, or a reference to (for report only)

Assessment or evaluation (for report only)

Data reference (for report only)

Review and approval

Revision history

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Analytical Procedures

Analytical procedures provide direction to an operator on how to perform a

given analytical test.

Sections typically included in the analytical procedure are below:
– Purpose
– Test information
– Product information
– Safety information, if applicable
– Materials and equipment
– Procedure, as applicable

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Analytical Procedures, cont.

Sections typically included in the analytical procedure are below:

– System suitability
– Preparation of solutions and reagents
– Preparation of standards and samples
– Instrument parameters
– Calculations and reporting
– Review and approval with approval dates
– Revision history

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Training Documentation

Personnel should be trained to perform

their assigned tasks.

Training should be documented and the
training records should be retained and
kept readily accessible.

In general, training documentation should
include the training:
– Description (i.e., name of the training,
version and mode (i.e., self-study,
instructor led, etc.)
– Completion date
– Information about the trainer, as
applicable
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Retention of Documents

An adequate policy for record retention and archiving should be established

for the above records.

The required length of time depends on the regulatory requirements or
company procedures; however, it should be at least one year after the batch
expiration date.

Retention of documents applies to both paper documents and e-documents.

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General Chapter <1029> Expert Panel

Kim Huynh-Ba (Chair)

Linda L Ng (Government Liaison)

Craig D Hamilton

Kevin Swiss (Expert Committee Liaison)

Frank Diana

Anjan Mittal

Lisa A Fink

Robert Iser (Government Liaison)

Judy Lin

Kathleen Brady
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FDA Guidance for Industry

“Data Integrity and
Compliance With Drug GMP,”
December 2018
Various 21 CFR Regulations–Data Integrity

Backup data are exact and complete,

secure from alteration, inadvertent
erasures or loss, and output from the
computer … be checked for accuracy
(211.68)

Data [should] be stored to prevent
deterioration or loss (212.110)

Documented at the time of performance
(211.100 and 211.160)

Records [should] be retained as "original
records,” “true copies," or other “accurate
reproductions of the original records”
(211.180)

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Various 21 CFR Regulations–Data Integrity

“Complete information,” “complete data

derived from all tests,” “complete record of
all data,” and “complete records of all tests
performed (211.188, 211.194 and
212.60(g))

Production and control records [should] be
“reviewed” and that laboratory records
[should] be “reviewed” for accuracy,
completeness and [in] compliance with
established standards (211.22, 211.192
and 211.194(a) )

Records [should] be “checked,” “verified”
or “reviewed” (211.182, 211.186(a),
211.188(b)(ll), and 211.194(a)(8))
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Data Integrity

Data Integrity = ALCOA = ALCOA + =

 Accuracy  Attributable  ALCOA plus
 Completeness  Legible  Complete
 Compliance of  Comptemporaneously  Consistent
Data Recorded
 Enduring
 Original or True Copy
 Available
 Accurate

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Data Integrity

Data integrity is critical throughout the cGMP data life cycle, including:

 Creation
 Modification
 Processing
 Maintenance
 Archival
 Retrieval
 Transmission
 Disposition of data after the record’s retention period ends
System design and controls should enable easy detection of errors, omissions, and aberrant
results throughout the data’s life cycle.
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Controlling Computer Systems

cGMP workflow on a computer

system must be validated toward
intended use and based on risks.

Access to CGMP computer
systems must be restricted.

Shared login accounts for computer
systems is prohibited.

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Blank Forms

Should blank forms be controlled?

An SOP for document controls is required.

For example, bound paginated notebooks, stamped for official use by a document control group,
provide good document control because they allow easy detection of unofficial notebooks as
well as any gaps in notebook pages.

If used, blank forms (e.g., electronic worksheets, laboratory notebooks and MPCRs) should be
controlled by the quality unit or by another document control method.

As appropriate, numbered sets of blank forms may be issued and should be reconciled upon
completion of all issued forms.

Incomplete or erroneous forms should be kept as part of the permanent record along with written
justification for their replacement.

All data required to recreate a CGMP activity should be maintained as part of the complete
record.

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Audit Trail

Audit trail means a secure, computer-

generated, time-stamped electronic record
that allows for reconstruction of the course
of events relating to the creation,
modification or deletion of an electronic
record.
– For example, the audit trail for HPLC run
should include the user name, date/time
of the run, integration parameters used
and details of a reprocessing, if any.

Documentation should include the change
justification for the reprocessing.

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Audit Trail (cont.)

Audit trails include those that track the

creation, modification or deletion of data
(such as processing parameters and
results) and those that track actions at the
record or system level (such as attempts to
access the system or rename or delete a
file).

cGMP-compliant record-keeping practices
prevent data from being lost or obscured
and ensure that activities are documented
at the time of performance.

Electronic record-keeping systems, which
include audit trails, can support these
CGMP requirements.
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Metadata

Metadata is often described as data about data.

Metadata is structured information that describes, explains or otherwise makes it
easier to retrieve, use or manage data.
For example:

The number “23” is meaningless without metadata, such as an indication of the unit “mg.”
Among other things, metadata for a particular piece of data could include a date/time stamp
documenting when the data were acquired, a user ID of the person who conducted the test or
analysis that generated the data, the instrument ID used to acquire the data, material status
data, the material identification number and audit trails.

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Metadata (cont.)

Data should be maintained

throughout the record’s retention
period with all associated metadata
required to reconstruct the CGMP
activity.

The relationships between data and
their metadata should be preserved
in a secure and traceable manner.

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Static and Dynamic on Forms

For the purposes of this guidance, static is used to indicate a fixed-data record,
such as a paper record or an electronic image, and dynamic means that the
record format allows interaction between the user and the record content.
For example:

A dynamic chromatographic record may allow the user to change the baseline and reprocess
chromatographic data so that the resulting peaks may appear smaller or larger.

It also may allow the user to modify formulas or entries in a spreadsheet used to
compute test results or other information, such as calculated yield.

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Backup

FDA uses the term backup to refer to a

true copy of the original record that is
maintained securely throughout the record
retention period.

Backup data must be exact, complete and
secure from alteration, inadvertent
erasures or loss.

The backup file should contain the data
(which includes associated metadata) and
should be in the original format or in a
format compatible with the original format.

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Backup

FDA’s use of the term backup is consistent

with the term archive as used in guidance
for industry and FDA staff General
Principles of Software Validation.

Temporary backup copies (e.g., if a
computer crash or other interruption
occurs) would not satisfy the requirement
to maintain a backup file of data.

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Electronic Data and Records

Electronic data can be used as accurate

reproductions of paper or electronic
records…
– If copies (reproductions) preserve the content
and meaning of the original file and includes
all metadata.

True copies of dynamic electronic records
may be made and maintained in the format
of the original records or in a format that
allows for the content and meaning of the
original records to be preserved if a
suitable reader and copying equipment
(e.g., software and hardware, including
media readers) are readily available.
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Stand-Alone Paper Printouts (i.e., spectra)

During data acquisition, for example, pH meters and balances may create a
paper printout or static record as the original record. In this case, the paper
printout or static record, or a true copy, must be retained.

You must ensure that original laboratory records, including paper and electronic
records, are subject to a “second-person” review to make certain that all test
results and associated information are appropriately reported.

Similarly, in microbiology, a contemporaneous written record is maintained of the
colony counts of a petri dish, and the record is then subject to a “second-person”
review.

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E-signatures

Electronic signatures with the appropriate

controls can be used instead of handwritten
signatures or initials in any CGMP required
record.

Although § 211.186(a) specifies a “full
signature, handwritten,” an electronic signature
with the appropriate controls to securely link the
signature with the associated record fulfills this
requirement.

See part 11, which establishes criteria for when
electronic signatures are considered the legally
binding equivalent of handwritten signatures.

Firms using electronic signatures should
document the controls used to ensure that they
are able to identify the specific person who
signed the records electronically.
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E-Data

When does E-data become cGMP record?

Do Don’t
When generated to satisfy a CGMP requirement, all data become a CGMP record.

Document or save the data at the time of performance

Data can’t be modified without a record of the modification.

It is not acceptable to record data on pieces of paper that will be discarded after the data are
transcribed to a permanent laboratory notebook.

It is not acceptable to store electronic records in a manner that allows for manipulation
without creating a permanent record.

It is acceptable to employ a combination of technical and procedural controls to meet cGMP

documentation practices for electronic systems.

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Example–Chromatographic Data

Chromatographic data should be saved to durable media upon

completion of each step or injection (e.g., peak integration or processing
steps; finished, incomplete or aborted injections) instead of at the end of
an injection set, and changes to the chromatographic data or injection
sequence should be documented in an audit trail.
Aborted or incomplete injections should be captured in audit trails and
should be investigated and justified.
For example:

LIMS or EBR is designed to automatically save after each entry.

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System Suitability

“System suitability” or test, prep or

equilibration runs in warning letters.

Testing into compliance is
prohibited.
– Follow USP General Chapter <621>

If another sample is used in the
SST, it must be established as a
secondary standard and…
– must be from a different batch other than
the samples being tested.

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System Suitability

Transparency is necessary. All

data—including obvious errors and
failing, passing and suspect data—
must be in the cGMP records that
are retained and subject to review
and oversight.

Documented investigation is
necessary.

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Reprocessed Chromatography

Lab processing should not be

regularly needed.

If chromatography is reprocessed,
written procedures must be
established and followed and each
result retained for review.

Complete records include
notebooks, worksheets, graphs,
charts, spectra and other types of
data from laboratory instruments.

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Quality Issues

Regardless of intent or how or from

whom the information was
received, suspected or known
falsification or alteration of records
required under parts 210, 211 and
212 must be fully investigated
under the cGMP quality system to
determine the effect of the event on
patient safety, product quality and
data reliability; to determine the root
cause; and to ensure the necessary
corrective actions are taken.
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Quality Issues (cont.)

Report at [email protected];
“cGMP data integrity” should be
included in the subject line of the
email.

People must be trained to prevent
and detect data integrity issues
(i.e., personnel must have the
education, training and experience,
or any combination thereof, to
perform their assigned duties).

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Quality Issues (cont.)

All records required under CGMP are subject to FDA inspection.

– This applies to records generated and maintained on computerized systems, including electronic
communications that support CGMP activities. For example, an email to authorize batch release is a
CGMP record that FDA may review.

You must allow authorized inspection, review and copying of records, which includes copying of
electronic data.

You must demonstrate that you have effectively remediated your problems.
― Retaining a third-party auditor
― Removing individuals responsible who can influence cGMP - related or drug application data at your firm.
― Improving quality oversight, enhanced computer systems and creation of mechanisms to prevent
recurrences and address data integrity breaches (e.g., anonymous reporting system, data governance
officials and guidelines).

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 Enforcement
of Good Documentation
Principles
GDP Enforcement

Common GDP-Related Observations by FDA

Lack of:
– Assignment of a delegate for QA manager in case of absence
– QA-related SOP authorization by QA manager
– Documentation for sample sequence tables
– Out-of-Spec (OOS) events:
• Correction of errors in a document without proper reasoning, signature/initial, date

Using:
– Write-overs
– Multiple line-through
– White-out/masking devices

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GDP Enforcement

Common GDP-Related Fraud (FDA)

Back-entering data without proper traceability (data entry without initials/dating)

Back-dating the data

Creating, altering or deleting information to meet acceptable criteria

Signing on behalf of another person

Hiding/discarding undesired data

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GDP Enforcement

56 Cases (21 CFR 211.188)

“Batch production and control records [are not prepared for each batch of drug
product produced] [do not include complete information relating to the
production and control of each batch].”

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GDP Enforcement

34 Cases (21 CFR 211.180e1)

“Written procedures are not [established] [followed] for evaluations conducted

at least annually to review records associated with a representative number of
batches, whether approved or rejected.”

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GDP Enforcement

32 Cases (21 CFR 211.192)

“Written records of investigations into [unexplained discrepancies] [the failure of

a batch or any of its components to meet specifications] do not [always] include
the conclusions and follow-up.”

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Summary

Key Takeaways True

1. GDP is critical in any scientific and regulatory environment.

2. GDP will strengthen the value of data and the evaluation of a scientific study.

3. GDP is important in legal or patent cases.

4. GDP is applicable to scientists in all disciplines.

5. GDP is the cornerstone of any quality system.

6. Every company should have an SOP on good documentation principles.

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References

ISO 9000:2005: http://www.iso.org/iso/catalogue_detail?csnumber=42180.

Accessed November 15, 2016.

Guidance for Industry, “Data Integrity and Compliance with Drug cGMP,
Questions and Answers, “FDA, December 2018.

EudraLex Volume 4, Good Manufacturing Practice, Medicinal Products for
Human and Veterinary Use (Chapter 4: Documentation, Revision 1).
(http://ec.europa.eu/health/files/eudralex/vol4/ chapter4_012011_ en.pdf).

CFR - Code of Federal Regulations Title 21.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.
Accessed November 15, 2016.

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