To lay down a procedure for good documentation practices.
This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances.
It is the responsibility of all concerned who are involved directly or indirectly manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances.
4. Definitions :
Document: A record that describes how an activity, event or process was actually performed
Documentation: A reliable (written) record that can be used at a future time to clearly and completely recreate an activity, event or process.
Raw data: Supporting data generated during the activity, which shall be recorded and physically attached with the main record.
Electronic Record: A combination of text, graphics, data, audio, pictorial or other information represented in digital form that are created, modified, maintained, archived, retrieved or distributed by a Computer system.
Good documentation practice (GDP):A systematic procedure of preparing, reviewing, approving, issuing, recording, storing and archival of documents associated with GxP activities.
GMP Records: GMP records are defined as all records which directly or indirectly; individually or collectively control the strength, identity, safety, purity and quality of a drug product or drug substance.
5.1 GMP records provide information on when, where, who, why and how to complete tasks. These records are always prepared/ completed
contemporaneously with the performance of the tasks.
5.2 The basic requirements of Good Documentation Practices (GDP) shall be followed while handling the GMP records as follows :
In the context of GMP: – “If it is not written down, then it is not
All the GMP documents shall accurate, contemporaneously, legible and
permanent, truthful and complete, readily retrievable and traceable.
All controlled documents shall have unique identification number and a
Always record the date along with the signature in GMP records.
Always use indelible ink to record data in GMP records.
Never use pencil, erasable pen or Removable/water-soluble ink pen to complete GMP records.
Never use white ink or correction fluid or eraser in GMP records.
Only sign for work that you have performed yourself.
Handwritten signatures must be unique to the individual and listed
within the signature log to ensure that the signature is traceable.
The management of the signature log should be governed by a
procedure and routinely reviewed so that it remains current.
New staff members should sign the signature log during induction.
Pre dating or Post dating (back dating) either documents or corrections
are strictly prohibited.
Never discard original raw data of any kind.
Never use scratch papers, loose papers or “post it” to record data.
Never discard or destroy any GMP record. In the exceptional case of
accidental document destruction, QA shall be notified to initiate an
incident and conduct an investigation to assess the impact of GMP record destruction
Handwriting is legible. All entries must be made at the time
the tasks are performed and should be legibly signed and dated
The same is true of electronic documents and records;
Language should be clear and unambiguous.
Never put ditto (—-“—) or any other similar marks in the GMP record.
On receipt/issuance of document for filling, Analyst/ Lab technician /QA person shall evaluate the sufficient margin is available for punch without any loss of printed information.
In case of less left margin available in documents and possibility to lose
the printed information while punch, in this case document shall be kept in protective sheet and filed.
5.3 Recording the time and date in GMP records:
Time shall be entered in 24:00 hour cycle.
Record the time in HH:MM format. For example 07:15 AM shall be written as 07:15 while 07:15 PM shall be written as 19:15.
In case time is printed from a machine or a computer, the
time format of the machine or the computer shall be followed.
Record the date in DD.MM.YY OR DD/MM/YY (YYYY) format.
5.4 Issuance & Retrieval
All forms associated with the activity shall be part of respective SOPs.
All the GMP impacting forms shall be issued by QA of current version only & User department shall ensure that all the issued GMP forms shall be returned to QA after completion of the activity.
Records for issuance and retrieval of such forms shall be maintained.
5.5 Preparation of Master Documents:
“Performed by / Done by/ Prepared by/Reviewed By/Analyzed by” signature has to be of the person who is actually carrying out the activity.
The Signature of the “Doer” denotes that the “Doer” has performed the
activity and confirms the authenticity of the data as that of the activity
“Verified by/Checked By” signature denotes that the person is responsible for witnessing or conducting and independent check to ensure the operation, test, inspection, calculation or other actions followed required instructions and procedures and verifies the entries made by the Doer.
“Checked by/verified by” shall record and sign concurrently for the
ongoing activity being checked.
“Reviewed by” signature of the person denotes that person is responsible for examining the documentation and certifying that the document / record were prepared / filled appropriately and in compliance with requirements.
Authorized by signature of the person denotes that person is responsible for providing official permission of approval to another individual to perform a particular task.
Designee: reviewers/Approvers may delegate authority to another
suitably qualified person to review/approve records, as applicable. The
designee shall be qualified to perform the delegated task based upon
relative job position, training, experience and subject matter expertise.
Clear and concise titles shall be used for headings, tables, graphs, etc.
All documents/records shall have page numbers preferred format “Page
X of Y”).
All documents shall contain the signature, date person who prepared the document, reviewed the document and approved the same.
Full text spelling with the abbreviation in brackets shall be used for the
first time in the document. The abbreviation may then be used in place
of the full text spelling in the remainder of the document.
All master documents shall have an effective date, approval date and
All Master Documents shall be typed or preprinted. Handwritten
documents shall not be used.
5.6 Data Recording in the GMP records
The signatory shall confirm the accuracy and completeness of information and data before signing.
Data shall be recorded contemporaneously on approved and authorized formats only in concurrently and in chronological order.
All entries shall be concise, legible, unambiguous and accurate.
Data recording shall be done by trained and authorized persons & shall
record actual result obtained at the time of performing an activity,
Data shall be recorded as it is displayed on the respective equipment
Unusual observations during the activity shall be recorded, signed, dated & reported to the next level.
Ditto (—-“—) marking or “as above” or “do” or “down arrows (↓)”shall not be used.
Only validated Excel spreadsheets shall be used for calculations.
Wherever such Excel spreadsheets are not available, calculations shall be re-verified with qualified calculators.
Bracketing (}) in any form shall not be done.
Printouts made on thermal paper should be photocopied & shall be attached to the concerned record.
Time generated from all equipment and computers used for GxP
activities shall be synchronized with the company clock provided in the
area & time should not be recorded from personal watches. .
In the case of continuous pages of a notebook that are not being used to
record data, continuity shall be denoted by recording the reference of the
notebook number of page numbers at appropriate places
When one option is to be selected form several text options, the correct
option shall be preferably “encircled’’ or marked with “√”. Other options selection procedures may also be adopted, however, explanation of the use of these shall be provided in related procedures.
One person shall not sign for multiple roles for the same activity of entry (e.g. a doer cannot be the ‘Verifier / reviewer / Approver’ for the same activity or entry recorded).
5.7 Correction of entry in GMP records:
Entries in documents /records shall not be cancelled, erased, obliterated
or otherwise rendered illegible by using correction fluid / tape,
overwriting or crossing out with multiple strokes.
When a correction is necessary the erroneous entry shall be strike out
with a single horizontal line & a brief reason for the correction shall be noted as to why the change was made along with sign & date.
(For example Entry)
Errors / Missed entries identified after a document has been
approved / Closed by QA shall be corrected/filled in by the doer only in
the presence of QA and QA shall counter sign near the correction.
Errors / Missed Entries identified at the time of verification/
review/approval of a document/record may be managed at the level of
verifier/reviewer/approver, as applicable; that is, the doer may correct
the erroneous entry/fill in the missed entry and mark it as “Error
Corrected”/”Late Entry” (as applicable) and sign (with current date) in
the presence of the Verifier/Reviewer/Approver, as applicable.
In case of a Transcription Error/Typographical Error/Missed Entry
observed in a Summary/Certificate of Analysis (COA)/any other
secondary compiled data, which is already submitted to Regulatory
Agencies, Regulatory Affairs (RA) shall be notified of the incident and,
if required, the responsible person shall submit a corrected summary
identifying the cause for the revisions that shall be verified by QA and
forwarded to RA for submission to regulatory agencies.
Blank / unused space in the GMP records shall be strike out with a single line, signature and date as shown below.
Note: In case of space is less or multiple unused space in one page shall
be strike out with a single line, signature and date followed by one place only.