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Good Documentation Practices

The document discusses good documentation practices including checking for errors, making corrections properly, not leaving blanks, using consistent date formats, and ensuring accuracy. It provides guidelines for documentation responsibilities, principles, and proper error correction.

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Phu Tran
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68 views

Good Documentation Practices

The document discusses good documentation practices including checking for errors, making corrections properly, not leaving blanks, using consistent date formats, and ensuring accuracy. It provides guidelines for documentation responsibilities, principles, and proper error correction.

Uploaded by

Phu Tran
Copyright
© © All Rights Reserved
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Good Documentation Practices

Prepared By‫­׃‬Rashid Khan


Asst.Manager Quality Assurance
PURPOSE
 The purpose of good documentation practices is to
provide basic guideline and standard ways for
correction of errors in documentation
SCOPE
 This good documentation practices applies to all the
documents prepared at Opal Laboratories.
RESPONSIBILITY
 It is the responsibility of all persons who are
involved in preparation, completion or reviewing of
documents to implement these practices.
BSIC PRINICIPLES OF
DOCUMENTATION
 Check double check the entries to sort the mistakes in documents.
 Be sure that document is correct and complete prior to forwarding for
next process.
 Look at the documentation that essential part of whole job and not as
an inconvenience.
 Write each word clearly and legibly.
 Know the procedure for cross-out the wrong word or sentence.
 Never use WHITO/BLANCO.
 Proper completion of documentation is important to ensure the
traceability and accountability.
 Every process must be documented.
 Never trust your memory and record all necessary information
immediately.
 The work is not completed until it is documented.
 Don’t use pencil on document.
 Back dating on any document is not allowed.
CORRECTION OF WRONG ENTRIES,
WRITE OVERS, MISSPELLED WORDS
 Use a single line to cross out the mistake.
 Never use WHITO/BLANCO.
 Never erase or remove wrong written information.
 Ensure that original entry is still legible.
 Make the correction with initial and dates.
 Write a short explanation, if required.
 Initial must be done on cutting with date.
 If any entry is made wrong in a document for example if batch # of any
product is written like 389 instead of 398 then the wrong batch # should
be cut as a whole and not partly. It should be initialed and dated.
 38­9 → Wrong practice
 389 → Correct practice
 In case if an option is given in production BMR such as a.m/p.m, then
one option can be omit/cut without any sign.
 Spellings of words in documents are critical especially in case of
ingredients, equipments names and technical data. Such information if
spelled wrong should be corrected, initialed and dated.
INSTRUCTION
 Only the person responsible for the error should be
notified to correct the error. In case the person is
absent or has left the company only then supervisor/
manager of the person responsible for the error
should be contacted to do the correction.
USE OF COMMENTS/REMARKS
 Whenever comments or remarks column is given in
the document, comments should be entered with
initial and date.
BLANK SPACES
 No column space, box should be left blank in
document. It should be marked as dash (-).
MISSING ENTRIES
 Missing information in a document should be filled
only by a person responsible for the job. It should
not be done a second person. If the person
responsible is absent or has left the company the
supervisor/ Manager of person should fill relevant
information along with initial and date.
SIGNATURES AND INITIALS
 Signatures are required such as BMR, SOP, change
control forms, protocols and procedures. In case of
working documents Initials can be done such as
batch record sheets, in process sheets, QC reports
etc.
USE OF INK COLORS
 Blue ink color should be used by production/ QC/
QA for documentation. It should be used for all
entries and signatures on original documents such as
master BMR, SOP, Change control form, and
protocols to distinguish the original signatures.
 QA should use different color ink such as green to
mark errors in batch record sheets while auditing the
documents and also during in process checks.
GRAMMER CHECKS
 If a document such as a log guide or a SOP is under
review, corrections related to grammar can be done
at this stage. If grammar correction is required in an
approved document, it should be done whenever
next revision is due.
DATE ENTRY
 All the dates in a document should be entered in a
consistent manner such as DD/MM/YY
(30-07-2010).
FINAL APPROVALS
 Final approval in all QC reports such as test reports,
stability reports, validation and calibration reports
should be dated.
ON TIME ENTRIES
 All the entries must be completed at the time the
task is completed. Don’t depend on memory or
memory of others.
FINAL WORDS
 It is the responsibility of everyone who complete or
review a document to ensure its accuracy.
 Documentation error that have not been properly
corrected should be reported to the immediate
supervisor.
Thank you,

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