This document outlines rules for manually recording data according to cGMP guidelines. Key points include: only using blue or black ink for legible entries; signing and dating all entries; not erasing errors but rather striking through with initials and date; explaining any abbreviations; consistently formatting dates; following instructions for attachments; and only rounding numbers as outlined. Additional requirements address use of logbooks, legible notebooks with numbered pages and no blank spaces. The goal is to establish a robust documentation system for accurate record keeping.

1. cGMP Training Program
Based On GDP
Manual Data Recording System
By Deepak Amoli
CERTIFIED TRAINER FROM QUALITY COUNCIL OF INDIA
deepakamoli@gmail.com

2. Manual data recording system
Data recording rules are an essential part of a good
documentation system.

3. Data recording rules
• If you can not follow the procedure, or if you are unsure
what to do next or if you believe the document you are using
is incorrect, IMMEDIATELY CONTACT YOUR
SUPERVISOR for advice.
• Make all entries with green or blue ink. Pencil or water
soluble inks are not permitted.
• All entries must be legible and clear. It will help in proper
understanding of data and correct interpretation.
• Put initials to all the entries with date by the person
generating the data.
• Make entries at the time the operation is performed. Always
sign records with the current date and time. NEVER back
date entries.

4. Data recording rules
• If the data to be entered are the date and it is later
discovered that this date has not been filled in, first verify
the date of performance, fill in this date, sign and date with
the current date to show that the performance date was
verified retrospectively.
• When the initials column is divided into two sections for
doer and checker. The responsible person performing the
operation – initials first section for DOER. Second
responsible, person i.e. the Section In-charge verifies the
operation and initials under the CHECKER section.

5. Data recording rules
• Before making entries for data that have been defined to meet
set limits, check to ensure that the actual data meets the
specified limits before signing off.
• Inform your supervisor, if the data is outside the set limits
and follow the “Deviation” or “OOS” reporting procedure.

6. All spaces must be filled in
• If the space provided is not applicable to the product or not
needed, the space must be crossed out and marked as “N/A”
(Not applicable), initialed and dated.
• If the reason for blank spaces is not clear, explain why the
entry is not applicable.
• For the Pages that are partially filled out, the unfilled out
portion must have a diagonal line through the remainder
and be initialed and dated.
• Cross out, initial and date any blank pages.
• Ditto marks are not allowed.
• Each line required for a signature, initials, date or other
information must be filled in or crossed out with initials and
date.

7. Correct entry errors with a single line
through the error.
Initial and date the correction.
• Each error must be individually corrected.
• Errors must not be obliterated or erased. Corrections must
permit the reading of the original information. Use of white
fluid is not allowed.
• Write an explanation with initials and date after making the
corrections

8. On the records, TITLE, NAUTRE and
PURPOSE of documents should be clearly
stated. Identify all printouts and attachments
correctly.
• When specified follow the attachment instructions in the
document.
• Make sure that the printouts are identified with :
Associated document number / procedure title,
Operator’s initials & date,
Equipment identification
or any other relevant details

9. • Explain any terms or abbreviations which are not standard.
• We must use only one system of entering time. Better to
use 24 hour clock time.
• Record the dates in a consistent way to avoid
misinterpretation of data. As a international rule the
following system is best suited.
DD MM YYYY
Where; DD is day of the month
MM is two letter of the month
YYYY is the last four digits of the year.
For example – day of May 2016 can be recorded as
: 27/05/2016

10. Photocopies of controlled documents may
be made for reference use only.
• Each photocopy must be marked or stamped suitably.
• The person making the copy must initial and date the
photocopy.
• Photocopies must be clearly legible.

11. Numeric data recording rules
• To avoid possible confusion with decimal points, do not
comma in number.
• If the value is between –1 & +1; use ZERO before the
decimal point.
• Always use units of measurement unless already clearly
identified on the document.

12. Rounding Numbers
• Do not round off numbers prior to use in a final
calculation.
• Round off numbers as follows :
a. Round numbers between 0 to 4 to the lower
number.
b. Round numbers between 5 to 9 to the next higher
number.
c. Do not DOUBLE ROUND the number. For
example:
Correct: 5.448 rounded to 2 significant digits is 5.4
Incorrect: 5.448 rounded to 2 significant digits is first
rounded to 5.45 and then again rounded to 5.5

13. Numeric Recording
• When recording original data record either the same
number of digits as is displayed on the measuring
instrument or record at least as many digits as are specified
in the document.
• If the number of digits is not specified in the document,
record all digits displayed on the instrument.
• For example – While weighing on a balance, record all the
digits on the display.

14. Calculations
• When checking the calculation, first verify that
correct data were used in the calculation.
• Use only un-rounded numbers in calculations.

15. Additional data recording rules
• Only serial numbered bound notebooks should
be used.
• Every information in the notebook must be
clearly legible with complete information.
• Pages must be numbered. Do not tear out any
pages from the notebook.
• There should be no blank entries, large blank
spaces or blank pages in the notebook. Otherwise
it will appear that the practices might permit
alteration of data.

16. Practice the learning
Share the KNOWLEDGE gained with others
to make them aware of cGMP
The more we share, more we learn.
THANK YOU
deepakamoli@gmail.com