Good

documentation
practices
and
Data integrity

Basic principles
Training SPI – 2023
Prepared via
Ahmed monir mohamed
 Good documentation practice

• Definition

• Is a term in pharmaceutical industry that describes the

standards by which documents are created, maintained and
archived
• ( commonly abbreviated as GDocP ) that is a crucial part of
cGMP that can be applied either on paper or electronic
systems
 Good documentation practice
• Raw data

• The term that means any lab : (work sheets – records – notes
– exact copies ) , therefore they are the results of original
abbreviations and activities of the nonclinical lab studies
and so crucial for reconstruction and evaluation of reports of
these studies

• May be
• photo – printout
• magnetic media
Good documentation practice
• Golden rule

If it is not written
it did not happen
 Good documentation practice
• Importance of GDocP

• 1- It is considered as the foundation of a quality

system

• 2-Through the product life time it ensures

• - correct , complete , consistent and current data

documentation

• -adequacy of ( data integrity ,traceability , control and

retention )
Good documentation practice
• Who must follow GDocP principles ?

• All personnel dealing with the regulated materials must

follow GDocP
 Good documentation practice

For which activities GDocP is crucial

for ?
For all activities related to manufacturing of regulated
materials like

- -Holding
- -storing
- -transportation
- -testing
- -pack and labeling
 Good documentation practice
Deference between document and record

A document : is information with its supporting

medium like
( e.disk – optical disk – paper – photo )

A record : is a document with stated results that

achieved and provided evidence of the performed
activity like :( BMR – BPR – Calibration record –
Validation record )
 Good documentation practice
Documentation system

Is considered a set of

- -Instrument print out

- -LIMS
- -Logbooks
- -Lab notebooks
- -Data sheets
- -Spread sheets
 Good documentation practice

Documentation scope

1-papers and e-records ( raw data – protocols – reports )

2-Manufacturing procedures and analytical data

3- E-system the should be developed to meet guidance

 Good documentation practice

Documentation principles
• 1- general

• complete
• clear
• permanent
• accurate
• consistent
• legible
• concise
• truthful
 Good documentation practice
2- for manual and e-records
- -Records should be clear , concise , accurate and legible
- - data entries should be recorded promptly with actions
performed
- -back and post dating not allowed

3- all corrections for the original entries should be initiated and

dated ( or captured with an electronic audit trail ) , with
explanation included in cases where the reason for the change
is not obvious
 Good documentation practice

4-data entries should be traceable to the person who made the

entry

5- uncommon abbreviations should be defined

 Good documentation practice

6-controls should be in place to protect the integrity of the record

7-in the events that ink may be faded over time ( ex : thermal
paper ) , a copy can be used with verification of its accuracy , the
copy should be initiated and dated
 Good documentation practice
8-notebooks , data sheets and worksheets should be traceable

9-adequate documentation system is needed to ensure data

integrity and availability of current and archived records
 Good documentation practice

10-records should be retained per regulatory requirements and

be legible through out the retention period

11-all pages should be paginated and attachments ( supported

with documents ) should be paginated with reference to the
parent document
Data collection and recording

Data recording can be in different forms

- -Paper form
- -Data sheets
- -work sheets
- -logbooks
- -Note books
- -Instrument printout
- -Electronic data ( like LIMS )
 Data collection and recording
• All records dates should be in format that clearly indicates
• ( day – month – year ) in a consistent manner

• Signatures should be based on local sop s

• Different levels of reviews based on accountability

• ( ex : performed by – verified by – check by – reviewed by –
approved by )

• Controls for assigning signature ( approval and delegation )

• Verified copies of raw data can be used to replace the

original one
 Data collection and recording

Examples of records
• 1- Lab records

• should be concise , clear , legible , accurate

• includes : materials description like : reagents – used
procedures – used measurements – calculations – results
and conclusions
 Data collection and recording
• 2-Equipments related documentation

• polices of operation and maintenance

• manual for use
• maintenance records
• calibration and qualification records
• instrument labeling
 Data collection and recording
• 3- Deviations and investigation records should
include

• event description
• RCA
• Data trend evaluation
• review and approval
• responsibility of personnel involved in the investigation
• CAPA with time lines
• review and approvals
 Data collection and recording
• 4- Batch records

• MBR created as template

• Executed BR based on MBR used to document the steps and
materials involved in specific batch production as specific
RM – API – FP
 Data collection and recording
• BR including the following sections
•
• 1- Header

• 2-Machines

• 3-Manf. Process

• 4-Target weight RM

• 5-Environmental conditions
• approvals
 Data collection and recording
6-IPC tests

• 7-Sampling plan
• ( stability –release – retained)

• 8-Yeilds

• 9-Deviations and investigations

• 10-Review and final approvals

 Data collection and recording
• 5- Certificate of analysis
• Including the following

• vendor information
• product information
• test results with its acceptance criteria
• conformance statement
• reference to procedures and specs documents
• expiration and retest dates
• approval dates
 Data collection and recording
• Retention of documents

• Policy of record retention and archiving should be

established

• Required length time depends on regulations or company

local procedures , it should have at least one year after batch
expiration date

• Document retention applied to both paper and electronic

documents
 Data integrity
• Definition

• According to FDA

• Data integrity refers to the completeness, consistency, and

• accuracy of data
 Data integrity
DI associated with various 21CFR guidance such as

1-back up data must be : exact , complete and secured against

any alteration
2-data should be will stored to avoid loss
3 - data should be performed at time of performance
4 -records should be retained as original records as true
copies or other accurate reproductions of the original record
5 - complete information and records should be applied
6-records should be reviewed for accuracy , completeness and
compliance with standards
7- Records should be checked , verified and finally reviewed
 Data integrity
• Previous aspects of DI expressed as

1-ALCOA
- A : attributable
- L: legible
- C : contemporaneous
- O: original
- A: accurate

2-ALCOA +
- C: complete
- C:consistent
- E: enduring
- A:available
 Data integrity
• Note
• DI is a critical aspect of cGMP data lifecycle that including
• - creation
• -modification
• -processing
• -maintenance
• -retrieval
• -transmission
• -archival
• -disposition of data after record retention period ends

• So, with this system design and control it is easy to

detect errors , omissions throughout data life cycle
 Data integrity
• Meta data
• Definition
• it is often described as data about data
• it is the information that describes , explains , makes it
easier to retrieve , use or manage raw data

• Note
• raw data should be maintained throughout the records
retention time with all associated meta data required to
reconstruct the current cGMP requirement

• relation between raw data and their meta data should be

preserved in a secured traceable manner
 Data integrity
• Static and dynamic records
•

• Examples

• 1- static : paper – electronic image

• 2- dynamic : chromatographic diagram ( peak )

 Data integrity
• Backup

• Definition the true copy of the original record that is

maintained safely through out record retention time

• Backup should be exact , complete and secured from

alteration or loss

• Backup should be in original format or in a format

compatible with the original format

• Backup should contain associated metadata

• Temporary backup copies would not satisfy the

requirements to maintain a backup file of data
• ( ex : if computer crash or other interruption )
 Data integrity
• E – data and records

• e-data can be used as accurate reproduction of paper or

electronic records

• true copies of the dynamic e – record can be made and

maintained in format of the original record

• ( ex : software and hardware including media reader and

printer )
 Data integrity
• E – signature

• needs appropriate control to be used instead of handwritten

one

• firms that using e – signatures should document the control

used to ensure that they are able to identify the specific
person who signed the record electronically
 Data integrity
• DI quality related issues

• Any alteration or falsification of the record should be fully

investigated under cGMP quality system to determine the
effect of the event on patient safety , product quality and
data reliability

• Thus can be determined by root cause analysis to ensure

corrective actions to be taken

• We should allow authorized inspection through review and

record and copying that including copying of electronic data
 GdocP enforcement
• Common GdocP observations examples by FDA

• 1- Lack of
• QA manager delegation in case of absence
• QA related sop authorization by QA manager
• In complete investigation and recording of OOS event

• 2- Using
• Write overs
• Multiple line through
 GdocP enforcement
• Common GdocP FDA related frauds

• Back entering data with out proper traceability

• Back dating

• Creating , altering or deleting data to meet acceptance limits

• Signing on other personnel partition

• Discarding of undesired data

 References

• WHO - TRS 996 – Annex 5 (2016)

• WHO- TRS 1033 - Annex 4 ( 2021)
• USFDA – cGMP : 2018
• 21CFR
• MHRA - 2015
• PICS/S – 2016
• ISO 9000 - 2005
 Thanks
• Prepared by

• Ahmed Monir Mohamed

• QA unit head