Good Documentation practice

1. GOOD DOCUMENTATION PRACTICES
Reference SOP No. IMH/QA/013

2. DATE FORMATING

3. DATE FORMATING
Date shall be written as DD/MM/YY
format:
Where:
“DD” : Represents the Date.
“/” : Represents Separator.
“MM” : Represents the Month.
“YY” : Represents the Year.

4. DATE FORMATING
 For Example: 01/12/18,
01 shall represent Date,
12 shall represent the Month and
18 shall represent the last two digits of the
current Calendar Year

5. TIME FORMATING

6. TIME FORMATING
 Time Entry shall be done in all Documents as
Twenty Four Hours Clock.
 For Example: 1:40 PM shall be written as
13:40, 12:00 Midnight shall be written as
00:00 and 12:00 Noon shall be written as
12:00.

7. DOCUMENT ENTRIES
 All Department, recording / signing the
documents / records shall use a ball point pen in
Blue ink.
 IPQA in-process check shall be recorded with
ball point pen in Black ink.
 Signing of all master documents shall be done
with ball point pen in blue ink.
 Never use the symbol such as “–do-” for
repeated observations.

8. DOCUMENT ENTRIES
 If any wrong entry made in documents:
For Example: If space available within the line then
01/12/18
01/12/2018 and shall put remark wrong entry rectified
with signature and date.
If space not available within the line then:
01/12/18
01/12/2018* and shall put where space is available *
wrong entry rectified with sort signature and date

9. DOCUMENT ENTRIES
Do not over write any data and do
not leave blank in process sheet,
batch manufacturing records,
logbooks and laboratory logbooks.
If, any page/column is not used,
draw line from left to right
diagonally and put remark as NA
(Not Applicable) with sign/date.

10. DOCUMENT ENTRIES

11. DOCUMENT ENTRIES

12. DOCUMENT ENTRIES

13. DOCUMENT ENTRIES

14. DOCUMENT ENTRIES

15. DOCUMENT ENTRIES
 Corrective fluid (white ink) or erasable
pens should not be used to correct the
original information.
 Master documents shall not be
stapled.

16. Verification of Data, Information, Calculations andTasks
 Verification of data, information, calculations or
tasks performed by another person means the
verifier shall independently determine that the
data, information, calculations, or tasks are
accurate and correct. For example-when a
calculation is being verified, the verifier shall
repeat the calculation before signing off it.
 When a performance of a task is being verified,
the verifier shall witness the task being
performed.

17. Verification of Data, Information, Calculations andTasks
 When data is being verified, the verifier
shall witness the display or printout of
the instrument providing the data.
 The entire format shall be filled by
concerned department officer/executive
and shall be verified by department head
or as written on the format.

18. Attachments, Printouts andCharts
 Identify all printouts, charts attachments that
are used to support an analytical record or
process with the applicable batch number,
time, and date and operator initial.
 Confirm that there is enough ink supply for all
print out and chart devices to make the
printout easily readable.
 Print outs need to be continuous and if broken
there needs to be an explanation included.

19. Ratification
• Ratification shall be made in the master
document for errors identified during
final review or during operational use.
 If there are any minor corrections like
typographical errors, then the concerned
department personnel shall raise the
‘Request for Document Ratification”

20. Ratification
• The request shall be justified by concern
HOD and shall be forwarded to QA
Head or designee for evaluation and
approval.
• The indicated ratification shall be made
in the soft copy after approval by QA
Head and shall be implemented on
upcoming revision of master document.