1.0 Purpose
1.1 To describe the outline the procedure for the correct way to fill out documents which have a direct impact on the quality of the product as required by the code of Good Manufacturing Practices.
2.0 Scope
2.1 This Sop is applicable in all quality
documents and recorded information relating to the product manufacturing
and marketed by “NAME” Pharmaceuticals Ltd.
3.0
Responsibility
3.1
All persons who make an entry
in a GMP document are responsible to follow this procedure.
3.2
All departmental Head are
responsible to implement this procedure.
3.3
Head of QA is responsible to
monitor the overall activity of this SOP.
4.0 Abbreviations and Definitions
4.1 DOCUMENT: A document is a written, drawn, presented or recorded representation of thoughts. It is an editable file. Documents can be stored as paper or digitally. It can be changed and revised as needed.
4.2 RECORD: Records are historical files that provide proof of existence. They are used to prove a state of existence of the business. Records are not editable and cannot be recreated.
4.3 GOOD DOCUMENTATION PRACTICE (GDocP): Good Documentation Practice is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
4.4 DITTO MARK: The ditto mark ( ̎ ) is a typographic symbol indicating that the word(s) or figure(s) above it are to be repeated.
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Never use obsolete documents.
6.2 Unsigned documents or records should not be used to perform any task.
6.3 Don’t use Ditto ( ̎ ) sign. Give similar information in the space provided instead of putting ditto ( ̎ ) of any documents.
Examples:
|
Incorrect Way |
Correct Way |
|
........
Tablet box of fifty is ........... TK ......... ‘.
̎ ̎
̎ ̎ ........... ..........
̎
̎ ̎ ̎ ‘
........... |
.............
Tablet box of twenty is ............
TK ............. Tablet box of twenty is ........... TK ............. Tablet box of twenty is ......... TK |
6.4 Don’t draw single line instead of putting signature in each and every column/row of any documents.
Examples:
6.5 Don’t use stamped signature in lieu of handwritten signature.
6.6 Do not discard a page of a record just because the fields are not applicable.
6.7 Back dating & post dating of entry is not permitted.
6.8 Correction dates will be the current dates occurring after the last date that the record was checked are not compliant.
6.9 Do not use the page/sheet which are already faded and not properly photocopied.
6.10 Do not use scrap paper or sticky notes for recording the data.
6.11 Do not remove/replace any page or original data from the recorded document or from the imported devices.
7.0 Procedure
7.1 Follow the general requirements for documentation –
7.1.1.1 Write
the document accurately in a manner that prevents errors and ensure consistency
(e.g. laboratory log book, batch document, operation log books or computer
system).
7.1.1.2 Ensure
the documents and records are written in clear and unambiguous language to
avoid confusion.
7.1.1.3 Ensure
if documents are to be used together e.g. an SOP and a form/appendix, then each
will be the reference of the other.
7.1.1.4 Ensure
there is traceability between two or more documents/records using formal
document numbers or record identification.
7.1.1.5 Record
all information on the QA approved forms such as laboratory notebooks, batch
manufacturing records, cleaning records etc. and complete the document right
first time immediately after perform, never before.
7.1.2 Use
Indelible Ink
7.1.2.1 Fill
out record in indelible ink for long term legibility.
7.1.2.2 Use
blue ink (ballpoint pens) for entry in GMP documentations e.g: SOP, STP, BMR
and BPR etc.
7.1.2.3 Do
not use pencil or ink that can be erased.
7.1.3 Legible
Handwritten Entries
7.1.3.1 Ensure
the handwriting is legible.
7.1.3.2 Make
the entries at the time the tasks are performed and will be legibly signed and
dated.
7.1.3.3 Entry
data within the assign space. If there is space constrain in the specified
area, put asterisk (*) mark on the top of the entries and put necessary
information at the bottom where the space is made available with signature and
date.
7.1.3.4 Use
front side of the page to record all information and don’t use the opposite
side of the page. Use additional page if required with proper signature &
dated by QA person through raising a request form.
7.1.4 Review
And Approve
7.1.4.1 Review
and/or approve a document by someone who does not perform task but have
adequate knowledge about the system/process, cGMP regulations to ensure that
the information is correct and accurate.
7.1.4.2 Confirm
the review or approval completed by taking signature and date by the reviewer
or approver.
7.1.5 Staff
Signatures
7.1.5.1 Keep
Signature Register containing signatures and initials of all staff from all
Department in the QA Department to ensure that the signature is traceable to a
member of staff according to SOP: ‘Specimen Signature Authentication &
Regulations For Use’.
7.1.5.2 Signature
is to be used, for signing any approval, authentication of any document. Such
as: Standard Operating Procedure (SOP), Standard Testing Procedure (STP), Batch
Manufacturing Record (BMR), Batch Packaging Record (BPR), Bill of Material
(BOM), Quality Manual, Site Master File, Validation Master Plan, Regulatory
documents, Certificate of Analysis (COA), Different Labels, Under Test, Sampled
Slip, Quarantined Slip or Wherever ‘signature’ is mentioned.
7.1.5.3 Initial
can be used in regular routine checks (e.g. In-process control papers or
wherever ‘initial’ is mentioned).
7.1.6 Job
Delegation of Responsibility
7.1.6.1 Do
not permit staff to sign for another member of staff unless delegated.
7.1.6.2 Delegate
responsibility to another qualified person in absence of key member of employee
or staff by issuing an authorization letter/ circular signed by the member and/
or a more senior member of staff. For this activity write name, designation,
department of the responsible person if not found as printed and use tick (√)
symbol in front of signature of the signatory. Otherwise, only use tick (√)
symbol in front of signature of the signatory person. Preserve authorization
letter in the department file.
7.1.7 Page
Numbering
7.1.7.1 Use
page number in Documents following standard ‘X of Y’ to indicate the total
number of pages in a document. e.g. 1 of 2.
7.1.7.2 Limit the use of standard page numbering system in case of logbooks, notebooks and few other related documents
7.2 Correct The Handwritten Data In The Following Manners –
7.2.1 Ensure the original record legibility by the following instruction
7.2.1.1 Make a single line through the error – never use correction fluid, multiple cross-outs or marker pen to obscure the original record.
7.2.1.2 Record the correction close by – numbering corrections is acceptable when space is limited. If the record becomes too congested with corrections, an attachment may be used.
7.2.1.3 Provide a brief comment why the change is required (as appropriate).
For example:
Ø Transcription Error (e.g. Transcr. Err)
Ø Recording Error (e.g. Rec. Err)
Ø Technical Error (e.g. Tech. Err)
Ø Wrong Date (e.g. Wr. Data)
Ø Translocation Error (e.g. Transl. Err)
Ø Spelling Error (e.g. Spel. Err)
Ø Calculation Error (e.g. Cal. Err)
7.2.1.4 Initial the change so that it is clear that the correction is deliberate.
7.2.1.5 Record the date of the correction next to the initials so that there is a record of when the change was made.
7.2.2 Enter Data That Is Omitted In An Entry Following Instruction
7.2.2.1 Indicate clearly the date and the activity was performed and recorded on the documentation.
7.2.2.2 Document an explanation to substantiate the entry and the reason for the delay in recording.
7.2.2.3 Sign and date the change.
7.2.3 Completing All Fields On A Record
7.2.4.1 Enter ‘Not required’ or actual statement as appropriate in the field no data entry needed.
7.2.4.2 Mark out the multiple blank spaces/rows/columns on a record with a single line cross (from left upper corner to right lower corner) or Z type marking the whole field/space, enter ‘Not required’/ ‘Not Applicable (N/A)’ with sign & date.
7.2.4.3 Fill up remark option or comment option of the document with appropriate writing such as OK, Satisfactory.
7.2.4 Checking Correction
7.2.4.1 Check any correction by the same person who checked the rest of the documentation while correction or amendment needed to be made after the content of the record has already been checked.
· Review the change and ensure that it has been made in a compliance manner – clear, legible, accurate, original entry is still visible etc.
· Review the change with respect to the content of the rest of the document.
· Sign and date the correction.
7.3 Recording Numbers
7.3.1 Significant Figures
Record all numbers to the appropriate number of significant figures. This should be determined from the SOP or specification or method being used. For example: If a limit in a specification is defined as 0.45 to 0.55% then the result will be reported two decimal places (Significant figures).
If the limit is expressed as 0.450 to 0.550%, then the result will be reported to three decimal places.
7.3.2 Rounding
7.3.2.1 The observed or calculated values shall be rounded off to the number of decimal places that is in agreement with the limit expression. Numbers should not be rounded until the final calculations for the reportable value have been completed. Intermediate calculations (e.g., slope for linearity) may be rounded for reporting purposes, but the original (not rounded) value should be used for any additional required calculations. Acceptance criteria are fixed numbers and are not rounded. When rounding is required, consider only one digit in the decimal place to the right of the last place in the limit expression. If this digit is smaller than 5, it is eliminated and the preceding digit is unchanged. If this digit is equal to or greater than 5, it is eliminated and the preceding digit is increased by 1.
|
Illustration of rounding numerical values for comparison with requirements |
|||
|
Compendial Requirement |
Unrounded Value |
Rounded
Result |
Conforms |
|
Assay limit ≥98.0% |
97.96% |
98.0% |
Yes |
|
97.92% |
97.9% |
No |
|
|
97.95% |
98.0% |
Yes |
|
|
Assay limit ≤101.5% |
101.55% |
101.6% |
No |
|
101.46% |
101.5% |
Yes |
|
|
101.45% |
101.5% |
Yes |
|
|
Limit test ≤0.02% |
0.025% |
0.03% | No |
|
0.015% |
0.02% |
Yes |
|
|
0.027% |
0.03% |
No |
|
|
Limit test ≤3 ppm |
3.5ppm |
4 ppm |
No |
|
3.4ppm |
3 ppm |
Yes |
|
|
2.5ppm |
3 ppm |
Yes |
|
7.3.2.2 Do not round the value of machine print out.
7.3.2.3 Do not round a number until final calculation for the reportable value has been completed.
7.3.2.4 Round the intermediate calculations for reporting purposes, but the original value should be used for any additional required calculation.
7.3.3 Date Format
7.3.3.1 Record dates following common practice of the country such as Day/Month/Year. For example - 25/07/24 or 25/07/2024.
7.3.3.2 Give sign with date. If date is present in that column or row give only signature.
7.3.4 Time Format
7.4.1 Record time in 12 hour format mention ‘am’ & ‘pm’ for example - 7.00am & 1:00pm.
7.4.2 Record a period of time in hours and minutes, for example - 1 hr 36 min or 1:36 hours.
7.4 Dealing With Attachment And Printout
7.4.1 Attachments to Forms
7.4.2.1 Attach one record to another (for example if a report is to be attached to a form):
· Staple the attachment to the record; paperclips are not acceptable.
· Cross-reference the record and the form with each other, e.g. the record references the report number and the report references the record number
7.4.2 Attachments To Workbooks/ Logbooks
7.4.3.1 Secure the attachment to the appropriate page of the workbook/logbook – use tape or staples but glue or paperclips will not be acceptable.
7.4.3.2 Do not obscure any data on either the workbook page or attachment.
7.4.3.3 Ensure sufficient identification on the attachment to ensure traceability in the event it becomes separated (cross-referencing).
7.4.3.4 Indicate on the original document that there is an attachment.
7.4.3.5 Sign and date both the workbook and attachment.
7.4.3 Thermal Printout
7.4.4.1 Put initial and date on any thermal paper print out.
7.4.4.2 Copy all thermal paper printouts in Normal Paper (A4 size preferably) before attaching to a report or filing.
7.4.4.3 Do not tape over information on thermal paper as the tape will cause the data to rapidly fade.
7.4.4.4 Secure the original and the copy with the report, after making a copy.
7.4.4 Other Machine Printout
7.4.4.1 Enter or modify the data in the computer and there is a record of changes and deletion, if documentation is handled by electronic data (where applicable) processing methods, restrict the access by passwords or other means and ensure that the result of entry of critical data is independently checked.
7.4.4.2 Put sign and date on any machine print out.
8.0 Reference Document
8.1 ISO Clause 7.5 of ISO 9001:2015 Standard
8.2 Guidelines of European Commission, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4: Documentation
8.3 US FDA CFR sections, 21 CFR 11, 210 & 211
8.4 USP-41, 2018-General Notices, Page: 09, Volume-01
9.0 Annexure
9.1 Not Appreciable
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
11.0
Training
11.1 Head of Quality Assurance or his nominee give the training of all concern person involved in documentation.
