1.0
OBJECTIVE:
To lay down a procedure to describe the steps to be
followed for good documentation practices to ensure that each personnel
receives a clear and detailed description of the relevant job assignment to
minimize the risk of misinterpretation and error.
2.0
SCOPE:
This SOP is applicable to the entire documentation involved throughout the facility of Plant Name, Address--------------------------
3.0
RESPONSIBILITY:
The responsibility for Good Documents
Practices lay with all departments’ employees, Chemist, officer, and Executive
and HOD.
4.0
ACCOUNTABILITY:
Concerned Department Heads and
Quality Assurance Head shall be accountable for the implementation and complies of
the SOP.
5.0
PROCEDURE:
5.1 In accordance with cGMP requirements all batch production
and control records and laboratory records shall be reviewed by a second person
(supervisor or checker) for accuracy, completeness, and compliance with
established standards.
5.2 If any discrepancies are found in the review, they
shall be investigated using an Incident Report. The investigation shall
include, review of the raw data, reference documents, etc. After satisfactory
review, necessary corrections shall be made to the records. An additional sheet
with the corrections shall be attached to the original records, if necessary.
The corrections shall be countersigned by the checker/supervisor on the current
date. Training shall be imparted to the concerned persons, if the
investigations revealed the need for training, as per Training of Personnel. For the record to be considered reliable and trustworthy they must comply with the
Principles of ALCOA, i.e.
·
A-Attributable: Who made the record or created the data
and when?
·
L-Legible: They must be able to be read and
understood for the lifetime of the record, without having to refer to the
originator for classification. The information may be needed as per pre-defined
time period, perhaps after the originator is no longer available.
·
C-Contemporaneous: The record must be made at the time
the activity was performed.
·
O-Original: The earliest record of the data could be
a written observation, printout or electronic file, or a certified copy thereof.
The information must not be written on a post-it, piece of scrap paper, sleeve
of a lab coat, etc., and then transcribed or saved in a temporary location.
·
A-Accurate: No errors or editing without
documented changes
ALCOA+ focused on Complete, Consistent, Enduring
and Available data.
·
Complete: When data is complete in nature, it
means there is no deletion that has taken place from the date of documenting.
This includes any changes that have been made during the life of the data.
·
Consistent: The data should be chronologically
arranged, with time stamps included for any addition to the original data.
Consistency should be ensured by applying
various audits over the life of the data.
·
Enduring: The material used to record the data
should be in a manner which will last a long duration of time without losing
the readability.
·
Available: Data should be accessible whenever
needed, over the life of the data. Availability ensures the data meets its use,
since it can be applied when the need
arises.
5.2.1
Key Qualities of Regulated Documents:
Documents must be Concise, Legible, Accurate &
Traceable Records.
Concise: The document must be tell the entire
story and must be easily understood without misinterpretation.
Legible: The information must be readable.
Traceable Records: Documentation should be traceable.
Each aspect of document must be traceable like who recorded it, when, where and
why.
5.3 All GMP documentation at PREET
REMEDIES LIMITED, shall be done with indelible blue ink ball point pen only
5.4 All entries, except IPQA, should be
made with blue ball pen in clear and legible handwriting.
5.5 All entries by IPQA for verified by/
checked by (where IPQA is counter checking) shall be done in green ball pen.
5.6 Any cancellation made to the entry on
a document should be struck with a single line, along with abbreviation for
reason as per section 5.9, & sign and date. White outs, blade and eraser
should not be used and no information should be obscured by any means.
|
5.7 Overwriting in the documents shall be
avoided.
5.8 Date of the correction strike with
single line and write the correct value above, below, right or left of the
wrong Date along with abbreviation for reason as per section 5.9, sign and date,
the correction was made, not the date the error was made.
|
05.02.20
5.9 Following abbreviations shall be used
for reason of the correction.
|
Abbreviation |
Type of
Error |
Explanation
of the error |
|
WE |
Wrong entry |
Error arising during writing i.e. entry of data |
|
SP |
Spelling error |
Error in the spellings |
|
NL |
Not legible |
Not clearly readable entry |
|
EE |
Empty entry (Found) |
Entries which are not filled |
|
WD |
Wrong date |
Wrong date during entry |
|
CE |
Calculation Error |
Error due to wrong calculation |
|
WS |
Wrong Selection |
Error due to wrong selection of options |
5.10 In case an empty entry is found, then
put a strike mark and write the correct data/value and mention ‘’EE’’ as per
table in section 5.8.
5.11 In case of wrong selection put a strike
mark on the selection and write ‘’WS’’ and mention the correct selection.
5.12 If space is not available, then put
asterisk mark (*) there and put this mark (*) wherever space available on the
same page and put the correct entry here.
5.13 In single page not more than three
corrections (as per GDP procedure) are permitted, retraining to be provided to
the concerned if it exceeds.
5.14 Supplements or any other printout
attached to records should be signed with date.
5.15 Wherever more than one option is
available, strike off the options which are not applicable.
Example:
Equipment No. PROBAL-01 / PROBAL-02 / PROBAL-03.
5.16 Entry should be made or completed at
the time of each action taken or activity is performed.
5.17 All the entries should be done online
and the records shall be made or completed at the time each action is taken and
in such a way that all significant activities concerning the manufacturing of
medicinal products are traceable.
5.18 Postdating (entering a date in the
future) and backdating (entering a date on a day after the entry was performed)
are not permitted.
5.19 Wherever issued document requires the
entry of additional data, information which is not provided in the document,
the same should be handwritten legibly and should be signed with date by the
personnel making the entry.
5.20 All the columns of the document
should be filled. If any column of the document does not require an entry,
mention “NA” (Not Applicable) or a line diagonally across the page from left
top to right bottom, put “NA” with a signature and date at the bottom example
given:
Table/Sheet not in
use
|
S.
|
Particular |
Observation |
Checked by |
Remarks |
|
1 |
|
|
|
|
|
2 |
|
|
|
|
|
3 |
|
|
|
|
|
4 |
|
|
|
N.A |
sign and date
5.21
|
 |
Page not in use
5.22 If an observation / recording is
found ok / acceptable, the same should be indicated with a tick (ü)
mark. Wherever legends such as ‘ü’ or ‘û’ are used, the same should be
specified at the bottom of the document.
5.23 Reason / Remark should be entered in
the record for any significant cancellations.
5.24 If any observations / signature /
date to be repeated, the same should be rewritten. Ditto (----“----) marking
should not be used.
5.25 For each activity, signature for
operation done by and checked by should be done.
5.26 As far as possible short forms or
abbreviations should not be used. In unavoidable circumstances, full form for
the used abbreviation must be given at the end of the document.
5.27 Where logbooks are used in place of
loose formats for recording, each page of the logbook should be numbered.
5.27.1 Date shall be written in DD/MM/YY
form only. E.g. 25/04/20
5.28 The time format shall be in HH:MM and
24 hour only.
E.g. 09:00 Hrs for 09.00 AM, and 13:00 Hrs for 01:00
PM
5.29 Document entries should be done by
the responsible person for that operation.
5.30 Document entries made using carbon
should be legible and clear.
5.31 Do not use pencil, ink pens and flair
pens at any time.
5.32 Do not reuse scrap paper or sheets
for recording any data.
5.33 No handwritten change or corrections
shall be made to the printed text of an approved cGMP document. Any change
required to an approved cGMP documents shall be handled as per change control
system
5.34 If any document/ page has to be
change due to legibility, wrong entry purpose, it shall be reissued as
“DUPLICATE” and the original page shall be retained along with it in the
original document with the file note that this document has “duplicate page”.
5.35 Any instruction / information / data
stored in computer hard disc or soft copies (electronic copy) of such documents
shall not be considered as official for regulatory purposes. The printed
copies, which are signed and distributed in accordance with the instructions,
shall be considered as official documents.
5.36 Product and operation related
electronic data such as issue of a batch formula and instructions for batch
manufacturing, specifications for testing, indents of materials; price
information etc. shall have limited access control by providing password.
5.37 Backup data shall be stored in hard
disk as well as in CD’s as appropriate by the document controller.
5.38 Soft copies of the master documents
shall have limited access (only by Document controller) and issuance of such
soft copies to other department shall be only on the approval by the QA Head.
5.39 Preparation, Review and Approval of Documentation:
5.39.1 Documents shall be prepared by user
department, reviewed by user department Head/designee & QA and approved by
QA Head/designee (As per the approved format of the document)
5.39.2 During review if any mistake is
observed by reviewer, same shall be corrected by the doer on the data the
mistake observed. If doer is not available, the mistake shall be reviewed and
corrected by the reviewer or the person who is trained for the same activity.
5.39.3 IPQA Personnel are authorized to
check and approve the activities which are performed by production personnel
but production personnel are not authorized to check the activities performed
by IPQA personnel.
5.40 Authorized document (i.e.
SOPs/Protocols) can only be made effective after users have been trained.
5.41 All documents shall have a unique
document number.
5.42 Every page of a document shall be
marked with the page number as well as the total number of page in the
document.
5.43 While preparing or designing a
document adequate space shall be provided for recording the required
information.
5.44 The reviewer shall verify that the
header of the table (if any) shall be repeated on each page.
5.45 Whenever IPQA personnel perform
in-process test, in verify column ‘’NA’’ shall be mentioned.
5.46 ACCEPTANCE CRITERIA: All documents should be prepared and filled as per SOP.
5.47 FREQUENCY: Whenever
new document prepared and filled the documents/records.
6.0
LIST OF ANNEXURE AND FORMATS:
|
Sr. No. |
Title of Format |
Format No. |
|
01 |
NA |
NA |
7.0
REFERENCES:
7.1 SOP-QA-001
7.2 F/QA-001-01
8.0
REVISION HISTORY:
|
Sr. No. |
Date |
Reason for Revision |
Revision No |
|
1.
|
31/10/2018 |
New SOP |
R0 |
|
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
|
Sr. No |
Abbreviations |
Details |
|
1.
|
SOP |
Standard
operating procedure |
|
2.
|
QA |
Quality
assurance |
|
3.
|
Kg |
Kilogram |
|
4.
|
CD |
Compacted Disk |
|
5.
|
IPQA |
In-process
Quality Assurance |
|
6.
|
cGMP |
Current Good
Manufacturing Practices |
|
7.
|
NA |
Not Applicable
|
END
OF DOCUMENT
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Pharmaceutical guideline only