Documentation - The First and Last Exit in GMP

Documentation
The First & Last Exit in GMP
02 Nov 2019, Karachi
Document Integrity

Complete Accurate Consistent
Safety

Complete Accurate Consistent
Safety
Quality

Attributable
Legible
Contemporaneously
Original
Accurate

Attributable
Legible
Contemporaneously
Original
Accurate
Traceable to a unique individual

Attributable
Legible
Contemporaneously
Original
Accurate
Data must be recorded
permanently and be readable

Attributable
Legible
Contemporaneously
Original
Accurate
Activities must be recorded at the
time they occur

Attributable
Legible
Contemporaneously
Original
Accurate
First capture of data (not
transcribed data), must review the
original record, must retain the
original or certified copy of the
original record

Attributable
Legible
Contemporaneously
Original
Accurate
Records must be accurate, which is
achieved through the Quality
Management System

Attributable Legible Contemporaneous AccurateOriginal
A L AOC
Explanation was recorded by pencil

A L AOC
No editing performed without documented amendment

A L AOC
True copy was not sent to the Regulatory Agency

A L AOC
QA performed particular activity as documented

A L AOC
Real time was recoded in raw data, while this raw data
is not kept as a metadata

Lets review and have a grip on ALCOA

AttributableA
Attributable means information
is captured in the record
So that it is uniquely identified
as executed by the originator of
the data (e.g. a person or a
computer system).

LegibleL
The terms legible, traceable and
permanent refer to the requirements
that data are readable, understandable,
and allow a clear picture of the
sequencing of steps or events in the
record so that all activities conducted
can be fully reconstructed by the
people reviewing these records at any
point during the records retention
period.
Traceable
Permanent

ContemporaneousC
Contemporaneous data are data
recorded at the time they are
generated or observed.

OriginalO
Original data include the first or source
capture of data or information and all
subsequent data required to fully
reconstruct the conduct of the activity.

OriginalO
Original data
original data should be
original data and/or true and verified copies that preserve the
content and meaning of the original data should be
as such, original records should be complete, enduring &
readily retrievable & readable throughout the records
retention period.
reviewed
retained

AccurateA
The term “accurate” means data are
correct, truthful, complete, valid and
reliable.

Lets have an insight on ALCOA & understand ALCOA+

Complete
All data are available, nothing has
been deleted
(evidence: audit trail)
Available in order one by one & traceable

Consistent
Data are recorded chronologically
with date and time
(evidence: audit trail)

Enduring
Data are accessible for an
extended period of time – after 20
years.

Available
Data are accessible over the
lifetime of the product.

Static
Dynamic
Fix data document such as
paper record or an electronic
image

Static
Dynamic
Record format allows
interaction b/w the user &
record content

Life Cycle
Creation
Processing

Life Cycle
Creation
Processing
Archiving

Life Cycle
Creation
Processing
Archiving
Deposition

Trustworthy
Reliable Complete & Accurate

Trustworthy
Reliable
Authentic
Complete & Accurate

Trustworthy
Reliable
Authentic
Complete & Accurate
Proven to be what it purports to be

Trustworthy
Reliable
Authentic
Integrity
Complete & Accurate

Trustworthy
Reliable
Authentic
Integrity
Complete & Accurate
Complete & Unaltered

Trustworthy
Reliable
Authentic
Integrity
Useable
Complete & Accurate

Trustworthy
Reliable
Authentic
Integrity
Useable
Complete & Accurate
Can be located, retrieved, presented & interpreted

Data about the Data
Contextual information
required to understand data

Data about the Data
12
14
16
_______
42

Data about the Data
12
14
_______
26
16
_______
42
12
14
16
_______
42

Data about the Data
Structured information that
describe, explain or otherwise
make it easier to retrieve, use or
manage data

Data about the Data
Such as:
Date/time stamp, user ID,
instrument ID, audit trail etc.

Data about the Data
Relationship b/w
data & their metadata
should be preserved in a
secure & traceable manner

Secure, Computer generated, Time-
stamped, Electronic record that allows
for RECONSTRUCTION of events to
the Creation, Modification or Deletion of
an Electronic Record
Audit Trail is …

Chronology
Who, What, When & Why
of a Record
Audit Trail is …

Track actions
at the record or system level
Audit Trail is …

Audit Trail is …
cGMP Compliant
Record keeping practices prevent data
from being lost or obscured

It (AT) captures, such as …
Overwriting
Back dating
Deleting data
Altering data
Testing …. into compliance
Runs that have been aborted

Should AT be
reviewed
? AT capturing changes to critical data be
reviewed with each record & before final
approval of the record
1 / 3

Should AT be
reviewed
? AT subject to regular review for e.g.
Changes to Finished Product Test Result,
Sample Run Sequence,
Sample Identification,
Critical Process Parameter
2 / 3

Should AT be
reviewed
? Routine schedule is based on the
Complexity of the System &
its intended use
3 / 3

Data and Data
Policies and Practices
Integrity above all

Data Integrity
“Back up data are exact and
complete” and
“Secure from alteration, Inadvertent
erasures or loss” and that
“output from the computer”
“be checked for accuracy”

Data Integrity
Stored to prevent
deterioration or loss

Data Integrity
Certain activities be “documented
at the time of performance”
and that laboratory control be
“scientifically sound”

Data Integrity
Record be retained as “original
record”, “true copies” or other
“accurate reproduction of the
original record”

Data Integrity
Electronic signatures and
record keeping requirements
are defined everywhere and are
not choice but an emerging
obligation

Data Back up means …
True copy of the original data
that is maintained
Securely throughout the
Record Lifecycle
and Periodically Reviewed

Electronic cGMP data should
include relevant metadata

Data Exclusion
must be scientifically justified
with valid document, if it is used
in decision process of releasing
the product

Restrictions in Computer System
Appropriate control to assure only authorized personnel change in
computer (e.g. input of laboratory data into records)
Restricting the ability to alter
Specifications
Process parameters
Manufacturing or testing methods

Recommend system administrator
role including any right to alter files
and settings, be assigned to
personnel independent from those
responsible for the record content

Recommend maintaining a list of
authorized individuals and their
access privileges for each computer
system in use within GMP zone

Yes, it may not be practical
for small operation with
few employees BUT …

Share login account is a concern …
Do exercise appropriate control to
assure that only authorized personnel
make changes to computerized records
Do ensure actions are attributable to
specific individuals

Question
During processing of a batch, if action is not
attributable to a specific individual in a
document (such as moisture content of
granules), what action will be required?
Moisture content is a critical process control.
7

If
Actions are not attributable to a specific individual
Who was the individual
Who entered the values, performed review,
Whether he or she was authorized or not …
?

Lets Control Blank Forms …
Through a robust and sustainable
strategy of document control policy
and document control method

Issue a numbered sets of blank
forms
&
Reconciled at the completion of
activity

Keep incomplete or erroneous forms
as a part of permanent record along
with written justification for their
replacement
(don’t use loose papers, write at right
there on form)

Lets Control Papers…
Use
Bound paginated
Stamped for official use
Directions for any gaps if required

Lets Control Documents …
Capability to reconcile & document
the number of copies printed under
an electronic document management
system

Electronic Data & GMP Expectations…
Real time security, no temporary
memory
Always use permanent storage &
keep saving the document

Is it acceptable to only save the final
result from reprocessed laboratory
chromatography?
?

Is it acceptable to only save the final
result from reprocessed laboratory
chromatography?
?
NO

Because:
Analytical method should be
capable & stable
?

If:
Processed, written procedure must be
established and followed
?

Remember:
Laboratory records include complete data
derived from all tests is the requirement
?

Data Integrity … Why?
It is an issue of
public safety

It is an issue of
public safety
Efficacy & Quality of drug is
an obligation

It is an issue of
public safety
an obligation
Protection of public health is a
regulatory responsibility

It is an issue of
public safety
an obligation
Protection of public health is a
regulatory responsibility
Regulatory
actions may …

Drug may and would be
declared adulterated if
integrity issue is established

Make and keep your data

Reliable AccurateMake and keep your data

Trust is everything
Don’t breach, it will back fire

Data Integrity Issues … Examples
Back dating

Back dating
Fabricating

Back dating
Fabricating
Discarding

Back dating
Fabricating
Discarding
Turning off audit trail

Back dating
Fabricating
Discarding
Turning off audit trail
Password sharing

Deletion or manipulation of electronic records

Creating inaccurate & incomplete record

Inadequate control for access privileges

Inadequate, incomplete computer validation

Inadequate, incomplete computer validation
Inadequate investigation record

Repeated tests, trial runs, sample runs (testing into compliance)

Manipulating integration parameters to obtain passing results

Inaccurate reporting of microbial, sterility or endotoxin data results

Employees sign documents altogether or not in real time

Employees sign documents altogether or not in real time
Data loss … activities not recorded contemporaneously

Being accurately calculated, interpreted & recorded?
From the Eye of Inspectors … Is the Data

Source support the reported data and conclusion?

Source support the reported data and conclusion?
Relevant & metadata included to support conclusion?

Documentation - The First and Last Exit in GMP

Recommended

Recommended

More Related Content

Similar to Documentation - The First and Last Exit in GMP

Similar to Documentation - The First and Last Exit in GMP (20)

More from Obaid Ali / Roohi B. Obaid

More from Obaid Ali / Roohi B. Obaid (20)

Recently uploaded

Recently uploaded (20)

Documentation - The First and Last Exit in GMP