Organization Name

No.: SOP number

Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

1.0 PURPOSE:
To establish good documentation practices that includes entries and corrections to documents,
responsibilities and training requirements.
2.0 SCOPE:
The procedure outlines the only acceptable way to make entries and correction to the documents,
product batch records, laboratories records, product manufacturing documents and reports.
3.0 RESPONSIBILITY:
3.1. All employees who are involved in document entries and/or correction are responsible to record
accurate information.
3.2. It is the responsibility of the department head to assure that all new employees receive initial
training on this procedure.
4.0 DEFINITIONS:
4.1 Document: Is the official record or report which supports and /or records the activities for
development, inspection, testing, handling and distribution of raw materials, components, in-
process materials and finished products. Examples include but are not limited to: Batch records,
logs, protocols, reports etc.

4.2 Done by: Person that performs specific functions, tasks or steps.

4.3 Checked by: Person that cross checks specific functions, tasks or steps done by the other
employee.

4.4 Verified by: Person other than the original person who performs or documents the specific
function, task or step. Verification means to confirm or substantiate, to establish the truth, accuracy
or reality of the recorded entries or observed practice, machine setup, measurable values etc.
4.5 Correction: a modification and/or change to any entry within the document.
4.6 Additional Issuance: Document added to the batch record after it is issued by QA department.

4.7 Omission: Information not recorded at the time of performance.

Signatories Name/E-sign Designation Date and Time
Prepared By
Checked By
Approved By
Department: Quality Assurance Page 1 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

5.0 PROCEDURE:
5.1 GENERAL CRITERIA:
5.1.1 All documents should be designed, prepared, reviewed and distributed as per the current
version.
5.1.2 Ensure correct versions of records are used for data recording
5.1.3 Documents should be approved, signed and dated by the concerned authorized
signatories.
5.1.4 Documents should have unambiguous contents and title and scope and purpose
should be clearly stated.
5.1.5 Documents should be laid out in orderly fashion and should be easy to check.
5.1.6 Do what is written in the procedures and document what you do.
5.1.7 All entries must be made only in blue ball pen. Use of any other pen such as roller ball or
gel pen is prohibited. DO NOT use pencil, erasable ink and correction fluid.
5.1.8 All entries must be legible and entered on the document at the time the function/activity is
being performed. DO NOT document in advance, backdate or pre-date any information.
5.1.9 All entries must be signed/initiated and dated properly. Specific requirements are noted in
each document. Staffs are not permitted to sign for another member of staff unless
delegated.
5.1.10 No entry shall be over written.
5.1.11 Record data directly on the designated records. It is unacceptable to document information
on scrap paper, post-it-note or other materials that are not part of the record.
5.1.12 Documents and records should be reviewed by someone who did not perform the task to
ensure that the information is correct and accurate. A signature and date by the reviewer or
approver confirm that a review has taken place. Unsigned documents or records are in
complete and should not be used to perform any task or considered as evidence of a
completed task.
5.1.13 When a correction and/or comment to be made, those should be done by each person
individually. Never add onto someone else’s correction.
Signatories Name/E-sign Designation Date and Time
Prepared By
Checked By
Approved By
Department: Quality Assurance Page 2 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

5.1.14 Modification and/or changes to an SOP, specification or batch record document are not allowed without
review and approval by QA; a deviation may be required to document the error.
5.1.15 Ditto marks are not acceptable.

5.1.16 Columns of data cannot be extended by use of quotation marks.

5.1.17 All the document / records should have page numbers using the following standard ‘X of Y’
to indicate the total number of pages in a document.
5.1.18 All printouts made on thermal paper must be copied before attaching to a report or filing with
sign and date. After making a copy attached the original and the copy with the report.
5.1.19 Definitions of abbreviations should always be included in the document for reference.
5.1.20 There should be no intentional misrepresentation and / or fabrication of data.
5.1.21 Deliberately amending or destroying GMP records to hide or falsify data is fraud.
5.1.22 GMP records should not be discarded for any reason unless the retention period expiry is
reached.
5.1.23 If the information asked for in particular instruction/column is not applicable to the activity
performed, the words ‘NA’ should be written against such instruction. If the information
asked for in case for complete section or complete table or complete page then ‘NA’ shall be
written against such instruction, diagonal line shall be drawn across the section or table or
page and shall be initialed with date.
5.1.24 If an option is provided in the form, the applicable option shall be selected by crossing out
the non-applicable option for e.g. Required/Not required. If the option is to be indicated in
the boxes provided in the document, the applicability shall be indicated by putting a tick
mark (√) in the appropriate box.
Note: 1) Tick mark (√) SHOULD NOT be used instead of crossing out the non-applicable option or
vice-versa wherever applicable (until unless if it is clearly mentioned to do so)
5.1.25 Obtaining approval signatures from staff located at different sites / locations can be
completed using scanning rather than hardcopy:
5.1.25.1 Print the document to be approved.
5.1.25.2 Sign and date the hard copy and then scan the hardcopy with the signature.
5.1.25.3 The pdf file of the scan is emailed to the appropriate signatories, who sign and date
their signature field in each print out of the pdf file and then rescan the document and
email back to the preparer.

Signatories Name/E-sign Designation Date and Time

Prepared By
Checked By
Approved By
Department: Quality Assurance Page 3 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

5.1.25.4 The coordinator receives a pdf file from each signatory indicating their approval.

5.1.25.5 Attach the signatory page from each approver to the original hard copy.

5.1.26 If any hard copy of document is required to be given to an outside agency or to another site
of Micro-labs each page of each copy should be stamped with UNCONTROLLED COPY.
5.1.27 If any scan copy of document is required to be given to an outside agency or to another
site of Micro-labs each page of each copy should be stamped with UNCONTROLLED
COPY and then scan the document and email.

5.2 REQUIREMENTS FOR RECORDING DECIMAL NUMBERS AND ROUNDING OF VALUE:

5.2.1 If a decimal value is fraction of 1 then a zero must be placed before the decimal point.
Example: record 0.95 rather than .95
5.2.2 The number of decimal places to be recorded should be as per specification.
Example: When a specification limit is 2.55-2.85 and the result is 2.7 then record the
result as 2.70 and not 2.7.
5.2.3 When rounding off is required, consider only one digit and apply following rules:
5.2.3.1 If the digit is smaller than 5, then the preceding digit is unchanged.
5.2.3.2 If the digit is equal to 5, then the preceding digit is increased by one.
5.2.3.3 If the digit is greater than 5, then the preceding digit is increased by one.
5.2.4 Rounding of price value (printed on the packing material) shall not be done.
5.2.5 The reading of instruments shall be recorded as displayed on the instrument.

5.3 REQUIREMENTS FOR TIME AND DATE:

5.3.1 When a date is recorded, the acceptable format is DD/MM/YY only, where DD standsfor
date, MM stands for month and YY stands for last two digits of the year.
Example: 12/08/14.
5.3.2 Time is recorded in 24:00 hour time (24 hr. clock), where 00:00 is midnight and 12:00 is
noon.
Signatories Name/E-sign Designation Date and Time
Prepared By
Checked By
Approved By
Department: Page 4 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

Time in Time in Time in Time in

Time 24hrs Time 24hrs Time 24hrs Time 24hrs
format format format format
12:00am 00:00 7:00 am 07:00 2:00 pm 14:00 9:00 pm 21:00

1:00 am 01:00 8:00 am 08:00 3:00 pm 15:00 10:00 pm 22:00

2:00 am 02:00 9:00 am 09:00 4:00 pm 16:00 11:00 pm 23:00

3:00 am 03:00 10:00 am 10:00 5:00 pm 17:00

4:00 am 04:00 11:00 am 11:00 6:00 pm 18:00

5:00 am 05:00 12:00 pm 12:00 7:00 pm 19:00

6:00 am 06:00 1:00 pm 13:00 8:00 pm 20:00

5.3.3 For documentation of production activities time is recorded from calibrated Hygrometers or
from digital clock for each process step from start to finish.

5.4 REQUIREMENTS FOR CORRECTIONS, UNUSED SPACES AND DATA TRANSCRIPTION:

5.4.1 When an erroneous entry is made or discovered within a document, such errors shall be
corrected.
5.4.2 Correction to an original is acceptable for obvious errors prior to the approval of the
document. Examples of obvious errors include, but are not limited to: a missed initial, date,
calculation error, transcription error, etc.
5.4.3 Correction made by an individual other than the person that made the original entry shall be
limited to obvious errors.
5.4.3.1 Corrections of non-obvious errors in production batch record are acceptable only
when accompanied with a justification and/or proof of the correction by verification
against an appropriate reference document. The corrective actions should be
approved by QA Head. Additionally, if the observations / deficiencies reveal an
impact on quality and / or require replacement of pages such corrective actions
should be handled through deviation investigation in accordance with instructions of
QAP, Handling of Deviations,

Signatories Name/E-sign Designation Date and Time

Prepared By
Checked By
Approved By
Department: Page 5 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

5.4.3.2 If an explanation and/or proof cannot be provided, a deviation report may be

required.
5.5 METHOD OF MAKING CORRECTION:
5.5.1 Strike off the entire entry. DO NOT obliterate the original entry.
Note: It is incorrect to cross through only one digit within a number and correct it.
Example:
Correct method 20/05/12
Incorrect methods 20/05/12 or 20/05/12 or 20/05/12 or 20/05/12

5.5.2 For paragraph entry error, draw a single line across the paragraph. Initial and date.
e.g AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB
CCCCCCCCCCCCCCCCCCCCCCCCCCCCC
DDDDDDDDDDDDDDDDDDDDDDDDDDDDD
EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE
5.5.3 Enter the correct information above or near the lined-through entry.
5.5.3.1 At the bottom margin of the page, footnote the correction to an available space
using sequential numbers.
5.5.3.2 Sign and date the correction using your initial and the date that the correction is
being made. The date should reflect the date of the correction.
5.5.3.3 Provide an explanation for ALL corrections.
Example: 20/04/12 (1) 20/05/12
(1) WD, 20/05/12
5.5.3.4 The following abbreviation may be used for common error types, however if
none of these abbreviations apply, a brief explanation must be provided.

Signatories Name/E-sign Designation Date and Time

Prepared By
Checked By
Approved By
Department: Page 6 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

ABBREVIATION MEANING OF CORRECTION WHEN TO USE

All unused space should be clearly

NA Not applicable
marked with NA

WE Wrong entry Place something in wrong column/space

Inverted a number in copying from

TE Transcription error
equipment to document

WD Wrong date Entry of incorrect date

Pen skips, writing something over

WO Write over
something else

WT Wrong time Entry of incorrect time

IW Illegible writing Entry not readable

EE Entry error Entry made on wrong place.

NOTE:
I) If the reason for NA is not clearly evident, a comment/justification must be provided.
II) EE (entry error) is not appropriate for every correction. A justification may be required to
explain the correction.
III) Correction to the data critical to the operation, product or process other than calculation, must
contain a clear justification or a deviation as detailed under step No.
5.5.4 Correction or amendments may be made after the content of the record has already been
checked. Therefore, the correction must also be checked by the same person who checked
the rest of the document. The checking person should:
5.5.4.1 Review the change and ensure that it has been made in a complaint manner- clear,
legible, accurate, original entry is still visible etc.
5.5.4.2 Review the change with respect to the content of the rest of the document.
5.5.4.3 Sign and date the correction.
Signatories Name/E-sign Designation Date and Time
Prepared By
Checked By
Approved By
Department: Page 7 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

In the event if any entry was omitted and must be made at a time later than the
activity was performed, a clear justification shall be provided or deviation report shall
be filled as detailed under step No. 5.3.3.1.
5.5.4.4 Clearly indicate the date the activity was performed and the date the activity is
recorded on the documentation.
5.5.4.5 Document an explanation to substantiate the entry and the reason for the delayin
recording.
5.5.4.6 Sign and date the change.
Note: Back dating entries is not permitted.
5.5.4.7 TRANSCRIPTION OF DATA:
5.5.4.7.1 In the event that the original paperwork becomes illegible (due to liquid
spills, ink blotches, multiple changes etc.) or data is recorded onto the
incorrect document, a deviation report shall be filled and a request for
new forms shall be made. Data shall be transcribed from the old
document to the new forms. Such forms shall be issued by site QA after
confirming proper justification for issue. Do not discard the original
documentation. Both new and old form will be included in the batch record
or data packet, the old document will be affixed (e.g. stapled) to the new
document. The additional pages required should be obtained from
respective departments as per the SOPs applicable.
5.5.4.7.2 When transcribing individual entry or entire document sign and date and
provide explanation.
5.5.4.7.3 All transcribed entries have to be verified for accuracy and correctness by
lead personnel.
5.5.4.8 UNUSED SPACE:
5.5.4.8.1 All unused spaces in the documents should be clearly addressed by
writing NA in the unused space.
5.5.4.8.2 Not applicable (NA) shall be written on the immediate line next to the data
entered and not elsewhere. If the information asked for in case for
complete section or complete table or complete page then ‘NA’ shall be
written against such instruction, diagonal line shall be drawn across the
section or table or page and shall be initialed with date.
Signatories Name/E-sign Designation Date and Time
Prepared By
Checked By
Approved By
Department: Page 8 of 10
 Organization Name No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

Example:

Signatories Name/E-sign Designation Date and Time

Prepared By
Checked By
Approved By
Department: Page 9 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

NOTE:
I) A GMP record is incomplete when fields or spaces for entries have not been
filled. Do not discard a page of a record just because the fields are not
applicable because the page could be mistaken as missing.

5.6 IMPLEMENTATION OF REVISED DOCUMENTS:

Prior to the implementation of revised documents concerned QA/AQA personnel should verifythe
existing version of the respective document and other related documents for any impact.

6.0 REFERENCES:

7.0 ENCLOSURES:

7.1 Typical Examples of Batch Document Review and :

Guidance for Handling the observations

8.0 ABBREVIATION:

8.1 SOP: Standard operating procedure

8.2 QA: Quality Assurance

8.3 e.g.: Example

8.4 etc: Etcetera

Signatories Name/E-sign Designation Date and Time

Prepared By
Checked By
Approved By
Department: Page 10 of 10
 Organization Name
No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

Version No. Effective Change Control No. Change Description

Date

Signatories Name/E-sign Designation Date and Time

Prepared By
Checked By
Approved By
Department: Page 1 of 1
 Organization Name No.: SOP number
Logo Effective Date:
STANDARD OPERATING PROCEDURE
Next Review Date:
Supersedes No.:
Title: GOOD DOCUMENTATION PRACTICES Dated:

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