Handling of Errors in Production Batch Record (PBR) 2023.ppt

presentation for handling PBR errors in a manufacturing site.

1. GOOD DOCUMENTATION PRACTICES
(GDP)
GDP IN
PRODUCTION
BATCH RECORD
(PBR)

2. GDP IN PRODUCTION BATCH
RECORD (PBR)
Quality Assurance Department

3. 3
Solve this equation:
79+51=

4. 4
Solve this equation:
79+51=130

5. 5
Why Documentation:
If it’s not documented,
it didn’t happen!
“ثدحي مل هنإف ،قّثوُي مل اذإ!
”
“”

6. A Famous Proverb Says:
“IF YOU HAVE NOT
DOCUMENTED AN ACTIVITY,
YOU HAVE NOT DONE IT”.
"هب مقت مل اذا ،طاشن يا قيثوت مل اذإ."

7. GDP:
Everyone involved in the “manufacturing” is responsible for assuring the
GDP. “What you see, hear and say matters” Otherwise, we are silent
conspirators.
 يف كراشي نم لك"عينصتلا "تانايبلا ةملاس نامض نع لوؤسم" .مهم هلوقتو هعمستو هارت ام " لاإو
نوتماص نورمآتم اننإف.

8. Production Batch Record Types:
-Paper Based PBR
-Electronic PBR

9. Find the ERROR
In the pharmaceutical industry, errors in production batch
records can have significant consequences, impacting
product quality, regulatory compliance, and patient safety.
جاتنلإا تلاجس يف ءاطخلأا نوكت نأ نكمي ،ةيودلأا ةعانص يف اهل تلايغشتلل
سو ، ةدمتعملا تلايجستلاو ،جتنملا ةدوج ىلع رثؤت ثيح ،ةريبك تاريثأت ةملا
ىضرملا.

10. General Principle of Documentations
•Design(correct,complete,current&traceable)
•Prepared دادعلاا
•Reviewed ةعجارملا
•Approval دامتعلاا
•ProperDistributionعيزوتلالثملاا
•Archiving/Archiverequirements ظافتحلااقئاثولاب
•RetentionPeriod(PBROneYear+ExpiryDate)ةرتف
ظافتحلااقئاثولاب
•Destroy مادعاقئاثولا

11. All data or information in GxP recordings
should be:

12. Signatures:
Signatures must be traceable
•One must always be able to determine who signed a
document
•Always sign your name in the same way
•A signature list of all staff signatures (and initials)
should be kept in each department
•This list should be updatedwhen staff leave, or new
employees join

13. Common Errors
Here are examples of errors that might occur in production batch records:
A-Documentation Errors:
1. Incomplete or Missing Information:
-Omissions of critical details such as batch numbers, dates, equipment used, or
operator signatures can render the record invalid.
2. Incorrect Data Entry:
-Typographicalerrors, transcription mistakes, or inaccurate recording of
quantities, temperatures, or timings can lead to incorrect data representation.
جاتنلإا تلاجس يف ةعئاش تلاكشم هذه:
.تامولعملا صقن :
- عيقاوت وأ ،ةمدختسملا ةزهجلأا ،خيراوتلا ،تلايغشتلا ماقرأ لثم ةمساحلا ليصافتلا يف تلاافغلإا
حلاص ريغ لجسلا لعجت نأ نكمي نيلغشملا.
.حيحص ريغ تانايب لاخدإ:
- نأ نكمي تاقولأا وأ ،تارارحلا ،تايمكلل قيقد ريغ ليجست وأ ،لقنلا يف ءاطخلأا ،ةعابطلا ءاطخأ
حيحص ريغ تانايب ليثمت ىلإ يدؤت.

14. Common Errors
1.Missing signature and dates at the time of activity
performed.
2.The write-over
3.Non-uniform date and signature entry
4.Writing a note that activity was performed on one
day and signed for on other day.
5.Blank spaces
6.Illegible writing
7.Too many corrections

15. Common Errors
1.Don’t removeany pages or portions from
logbook
2.Don’t make any temporary entries in Hand/Notes,
you will lose it.
3.Preservethe notebooksintact.
4.Don’t use stickynotes.
5.Don’t back date or post date.
6.Avoid Use of Unbound logbooks or Notebooks

16. •Data Recording:
1.All data shall be recorded in valid, correctand current
effective versions of work instruction documents and
their recording formats.
2.All documents/records shall have page numbers (preferred
format: “Page X of Y”).
.1ح ةلاّعفو ةحيحصو ةحلاص خسن يف لجسُت نأ بجي تانايبلا عيمج نم ةيلا
اهليجست تاقيسنتو لمعلا تاميلعت قئاثو.
.2قئاثولا عيمج يوتحت نأ بجي/ تاحفصلا ماقرأ ىلع تلاجسلا(سنتلا قي
لضفملا" : ةحفصلاX نمY").

17. •Data Recording:
1.Discard or destroy of any documents is not allowed unless
retention period expiry is reached.
2.For each activity/document (as applicable), each person
shall sign (with current date) either as a Doer or a
Verifier/Checker or a Reviewer or an Approver and no
employee is authorized to sign for an activity performed
by another employee.
1 .لا ظافتحلاا ةدم غولب متي مل ام قئاثو يأ ريمدت وأ ءاغلإب حامسلا مدعةددحم.
2 . صخش لك ىلع بجي(ءاضتقلاا بسح )طاشن لك عيقوت/اتب ةقيثو ،يلاح خير
ققدملا وأ لمعلاب مئاقلا ةفصب ناك ءاوس/و ،قفاوملا وأ عجارملا وأ ققحملا لا
رخآ فظوم هب ماق طاشن عيقوت فظوم يلأ قحي.

18. •Data Recording:
1.All records are written in the Englishlanguage and /or
ArabicLanguage. (Preferred both Languages).
2.All documentation entries should be made with indelible
blueink in clear and legible handwriting.
3.Using of pencil, eraseror ink remover kits, white ink or
correction fluid, or correction tape are not allowed.

19. •Data Recording:
1.Use of ditto marks (“) or down arrows ( ) to fill
in repetitive entries are now allowed.
2.Dates are current; predating or postdating is not
allowed; date should be entered/expressed as
DD:MM:YY or DD/MM/YY or DD-MM-YY.
3.Abbreviationsmust be defined upon the first
instance used within a document (abbreviations
used in planned schedules should be defined
clearly in the plan).

20. (Section: 2) Deviation Historical Data & Risk Assessment:
1.
1.Historical Occurrence of Current Case (Q.A Info):
- Deviation case history: □Occurred □Not Occurred
- Previous deviation no.:
- Previous deviation criticality: □Minor Deviation □Major Deviation □Critical Deviation
- Previous deviation opening date:
- Previous deviation closure date:
1.Deviation Risk Assessment:
Deviation Consequences/Potential Risk Details S O
Rati
ng
S*O
D RPN Comment
S = Severity O = Occurrence D = Detectability RPN = Risk Priority Number
Prepared By Title Department Sign/Date
1.Deviation Criticality (Based on above Risk Assessment):
□Minor Deviation □Major Deviation □Critical Deviation
Q.A Manager Name Sign/Date

21. •Data Recording:
1.If an entire line/paragraph/page to be deleted from
sequential record (logbook) follow the following steps:
(a)Completely cross out the line/paragraph/page as
mentioned in step.
(b)Write a comment close to the cross out explaining the
root cause behind the deletion.
(c)Initial/sign and date close to the cross out.

22. •Data Recording:
1.Numeric Entries:
(a)On reports that require numeric entries, zeros are
entered for zero accounts. If there is no result,
the N/Anotation is entered –do not leave any
entry blank.
(b)All numerical entries that include a decimal point
have a number preceding the decimal point (i.e.
to the left of the decimal point). This includes
writing a zero (0) to the left of the decimal point
when the value is less than one (1). For example:
0.1 and not written as .1

23. How are mistakes corrected?
•Draw a single line through the
error
•Make the correction next to the
error
•Write an explanation for the error
•Sign and date the correction.

24. How are mistakes corrected?

25. How are mistakes corrected?

26. How are mistakes corrected?

27. How are mistakes corrected?

28. How are mistakes corrected?

30. U.S. FDA Warning Letters Related to DI:
U.S. FDA Warning Letters Related to DI:
DI is amongst the top items cited on Warning Letters. In fact, the FDA cited DI
on 79% of the Drug Warning Letters over the last years, and they have
increased the number of Warning Letters citing DI by over four times (Figure
1):

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