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Copy of Good Documentation Practices for GMP Operations

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Arturo Gil

on 10 December 2014

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Transcript of Copy of Good Documentation Practices for GMP Operations

During this course you will:

Define Good Documentation Practices
Review Case Study: Consequences of not following GDPs.
Identify the Do’s/ Don’t of GDPs
Describe ways to avoid documentation pitfalls
Demonstrate your knowledge of GDPs


Common GDP Mistakes / Errors
Signing for Someone else / Correcting someone else’s errors
New Form generation – no explanations
Untimely documentation
Gaps in chronological recording in logs
Missing Calibration Notices / Stickers
Incorrect Calculations / Improper Rounding
Leaving out data
Improper labeling

Documentation compliance is NOT an option!
Consequences when you do not follow GDPs
Build in time to check your work
Good Documentation Practices (GDPs)
Generals Rules
Data Entry/Recording
Error Corrections
Late Entries

May 2014
Good Documentation Practices for GMP Operations

Why GDP’s
Ensures safe, quality product developed
Demonstrates compliance
Evidence of work conducted and results achieved
Allows you to reconstruct you work
Define our process and spec

Good business sense
Provides a reliable consistent guide
Eliminates confusion
Training Tool
Ensure authorized personnel have all the information that they need to make a sound decision on product disposition
Provides an audit trail

Data Attachment
Date/Time format
Rounding/Significant Figures

General Rules of GDPs
Must be Legible, Clear, Accurate, Permanent and Traceable
No documentation should be changed without authorization and/or approval
i.e. Approved Forms
All changes must be signed and dated
i.e. Changes after management approval
Electronic documentation – only authorized persons should enter/modify data
Do NOT shorthand or use text message form of words
Never use SLANG

Data Entry/Recording
Must be Clear and Legible

‘The calibration record page was discarded by the QC tech because of several errors. For appearances, a new record was generated which represents transcribed data generated months after the fact.’

Generation of New Forms
Rewrite for Clarity
Damage to documents causing it to be illegible
Do NOT discard Original
Must footnote Original by Referencing New Form and vice versa

Must be Permanent
Blue/Black permanent ink only-water and alcohol resistant
Whiteout, Correction Tape
Erasable Ink

‘record sheet for calibration…recorded in pencil…’

Example of Non-permanent Record:
Thermal Paper

Polyolefin Stock Labels: use permanent, alcohol/water resistant marker

Data Entry/Recording
Data entry/Recording
Colored Pens are used for REDLINING unofficial documents
Zeros: Use of “Ø” is acceptable

Log of Finished Products- Sterile
No Write-over’s
Data Entry/Recording
“Raw data annotations for drawing length and dimension recorded on ‘Post-it’ pads were discarded after transcribing the individual values on the Device History Record drawing. Other use of ‘Post-it’ notes was noted throughout the in-process activities”

Do NOT record on Scrap paper, POST-its, Gloves, etc…
Record all information on the appropriate document
i.e. Notebook, Form, Device History, Logbook, etc…
Timely: all work must be documented as it is performed
Always use CURRENT form
Do NOT pre-fill out forms (i.e. Sample Submission documents)
Always include Units of Measure (UoM)

Data Entry/Recording
"While there is no specific FDA documentation or guidance that discusses the practice of using ditto marks and arrows in place of required information, the use of these instead of specific information, initials, or signature is not fully informative. Ditto marks and arrows are not sufficiently descriptive where actual values are needed, and more importantly cannot be directly related to the recorder.”
-FDA cGMP Notes

Duplicate information is treated as separate entries
No Dittos marks (“)
No Arrows ( )

Data Entry/Recording
Copies of Documentation
Must be identified as COPY with initial and date.
Not required for Copies of a Copy
Copies of Multiple Pages
Documents must be attached
COPY with initials/date on first page. Include “Page 1 of X”
Documentation for training Purposes Only
Identify for Training Purposes Only with initials and date
Draft documents
Identify as DRAFT with initials and date

Blank Spaces
Blank spaces attract attention
Be sure to single line out; N/A; Initial & date

I.N. May 15, 2014
Data Entry/Recording: N/A
“N/A” check boxes and blank spaces
N/A’s require initial and date

Error Corrections
Warning Letter Excerpts

“…cold vault log contained numerous cross outs neither signed nor dated, ditto marks, arrows and spaces where information has been omitted…”

“…white-out used… cross out not signed or dated… improper form of making a correction was used…”
Common Error Types
Calculation Error
Date Error
Data Entry Error
Spelling Errors
i.e. entered incorrect lot number
i.e. entered incorrect measurement
Missing Data/Info

Error Corrections
Never Obliterate
Cross out ENTIRE word/number; NOT part of the word/number
Single Line cross-out
Make Correction near the error
Initial and Date
Provide an explanation only when the error is not obvious

SI May 15, 2014
SI May 15, 2014
Transcription Error

What: used to provide explanations/comments
When: to be used when…
Late Entries
Further comments/explanation on corrections is needed
Referencing other documents
Multiple corrections
Not enough room for explanations
Writing on the back of a document-NOT RECOMMEND
Must be Copied and Referenced

Number with circle ①
Each error must correspond with a unique number
Must be noted on the same day
Must be sequential by page
i.e. Same Person, Same Type of Error, Corrected at the same time can use one footnote
Do NOT share footnotes with others
Preferred – Capture at the bottom of the page.
Footnotes must be signed and dated separately from a corrections initials/date
May be documented in the comments sections, if available
i.e. if the comment section has NOT been “N/A”
Explanation must be a true reflection of the documentation error/correction
It was 3pm on a Friday afternoon. Catherine was looking forward to getting off of work after wrapping a long 12 hour workday (EPC project). On her drive home, she realized that she did not document her recorded results in the equipment logbook. Upon arrival to work the next morning, Catherine retrieved the equipment logbook and documented her time results. Being that she used the equipment just one day prior and she recalled performing this task before lunch, she decided to sign and date using Friday’s date.

Did Catherine handle her late entry appropriately?
Late Entry
...a case study
Late Entry: Data Integrity
Backdating: is the practice of going back to a previously completed task that has not been properly initialed and dated and placed the date that the task was completed on the date line, as thorough filling in the date has been done in a timely fashion.
Illegal and fraudulent.

“During the current inspection, we observed that this step was signed by Quality Assurance,” and backdated to the original date, the investigators reported. Sunrise procedures specifically require that documents not be backdated.
Late Entry
Must identify documentation as a Late Entry
Must provide clear explanation
“Late Entry” is not enough
Must identify the date that the task was performed
Must sign and date on the date entry was documented
Include reference to support data, if available
Data Attachment
Attach loose data to page i.e. label print out
May use glue, staple, tape
Attachment must be labeled, signed and dated
Initial and Dating across the edge of attachment and page
‘=“ across the edge of attachment and page
Date Format
Preferred is MMMDDYYYY
Use 3 letter code for month
May 15, 2014
Other acceptable formats
MM-DD-YYYY i.e. 05-15-2014 or 05-15-14
MM/DD/YYYY i.e. 05-15-2014 or 05/15/14

Time Format
Record time in Military Time (24hr clock)
12:00am 00:00 hrs AND 3:00pm 13:00 hrs
Must document time and time zone received if time received id captured in another time zone.
i.e. Document faxed from Burlington with a EST time note. Document PST time received.

Do NOT include
Do NOT round
Material expiring in days
Expires at midnight of indicated day
Example: expiring in 14 days-expires midnight of day 15

Material expiring in hours
Expire 1 minute past hour time
Example: expires in 48 hrs-expiration at 48:01

Material expiring in minutes
Expire 1 minute past minute time
Example: expires in 30 minutes-expiration at 31 minutes
“…a lack of signatures and dates for handwritten…"
Legally Binding
Verify Data prior to signing
All work must be signed and dated by appropriate person involved in operations
Operator: Performing the step
Verifier: Independently confirmation accuracy/integrity (i.e. visually observe the task performed)
“…failure to consistently verify by a second person the documentation for Device History Records, and validation records…”
Reviewer: Review of completed GMP document to ensure accuracy and compliance
Approver: Final Review for approval; ensures accuracy, compliance; final disposition
Do NOT sign for someone else’s work or correct their work
Authorized persons should sign on behalf of the person who performed the task in the event that the person is not available
i.e. Manager John Doe for Sr. Associate Catherine Young
Signatures are NOT valid without a date
“PRINT” where print, “SIGN” where sign; “INITIAL” where initial
Any changes in signature or name should be brought to the attention of your supervisor.
Fill out a new signature form
Rounding / Significant Figures

Ensure that you are following the appropriate SOPs on Rounding and Significant Figures
Check and Double check your work
Verifier must independently verify Calculations
Scrap Paper or Non-official Forms
Steps Not signed for
No explanation for corrections / Lack of corrections
Lack of References to data
Use of outdated forms
Correcting approved documents without management / QA consent
ILLEGIBLE and UNCLEAR documentation
Common GDP Mistakes
Inspection: Signs of Trouble
Illegible writing
Excessive changes or corrections
Raw Data unavailable or recorded on scraps
Inconsistent/missing dates or units of measurement
99.9% of the time…
12 newborns will be given to the wrong parents daily.
Two planes landed at LAX will be unsafe every day.
20,000 incorrect drug prescription will be written this year.
880, 000 credit cards in circulations will turn out to have incorrect cardholder information on their magnetic strips.
291 pacemaker operations will be performed incorrectly.
How to avoid these common errors?
Be Knowledgeable
Don’t rush!
Verify that you have all of the tools you need prior to performing task
QC Your WORK!!!
When in doubt, contact management/QA
If you see errors, be sure to communicate to appropriate persons these findings
Don’t let your correction make a bigger MESS!!!

When we care enough to make GMP’s a lifestyle, not just a regulation, we are not just signing & documenting on a piece of paper. We are also signing the record of a job well done!

Remember… Someone’s smile depends on YOU!
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