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Documentation Practices Documentation Practices in in GXPsGXPs

Presented By: Validation Plus, Inc.14 Penwood Rd.Livingston, NJ 07039www.validationplusinc.com(866) 760-2483

If It Isn’t Documented,It Didn’t Happen.

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Course Objective!To increase the level of awareness on the

importance of good documentation – Applicable to all colleagues involved in the

production, review and/or supervision of records and reports required by cGXPsregulations (Subpart J - Records and Reports)

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Definitions

!Document - the record that describes how an activity, event, or process was actually performed (noun)

!Documentation- the preparation of a record describing an activity, event, or process. It is sometimes called record keeping (action)

!GXP – Good X Practices where X can be: C (Clinical), M (Manufacturing), or L (Laboratory)

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What Are GXP Documents?!These are documents that are subjected to the

scrutiny of the FDA: – SOPs– Training Records– Equipment and Computer System

Validation Protocols and Records– Complaint Forms– Reference Standard Labels and Records

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More GXP Documents

– Manual Temperature and Monitoring Records– Equipment Log Books– Lab Reports and notebooks– Batch Records– Controlled Substance Transfer Forms and Log

Books – Stability Records

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! Identifies Roles, Responsibilities and Requirements

!Creates an Audit Trail!Serves As Evidence!Details the Event!Historical view of activities

!Remember…. Documentation is what remains after production, packaging, release, distribution and sale of our products.

Why Is Documentation Important?

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Why Is Documentation Important (Cont’d)?

!Comply with regulations !Provide a standard for

recording, reviewing andapproving data

!Keep track of activities!Create legal documents!Provide a historical record! Inform! Instruct (procedures, specifications)

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Why Is Documentation Important (Cont’d)?

!Reduce errors!File and defend patents (for

research/development) successfully!Prevent fraudulent behavior

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Commonalities???

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What Do These Two Objects Have In Common?

!Egyptian Pyramids

– work of art– expensive– object of high quality– no information

available on how it was created

!Stradivarius Violin

– work of art– expensive– object of high quality– no information

available on how it was created

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Have Poor Documentation Practices Caused You ...

!Problems in general?!Wasted time?!To redo a tedious and lengthy task?!Wasted materials/money?!Embarrassment?!Frustration?

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Practices To Internalize

! In our business we must:• Follow written procedures• Document practices• Document as it happens• Use validated systems• Make products that are safe, pure,

effective and of the highest quality

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Repercussions

! Injury or death to consumer!Company reputation - industry, regulatory

agencies!Stockholders!Reduced company revenue!Your job

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What YOUR SIGNATURE Means

! your written approval ! you have reviewed document for accuracy and

completeness! you have agreed to any conclusions! you support the information! you are taking responsibility! your signature is legally binding in a court

of law

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Examples of 483s Related to Documentation Issues

!No record of this (GXP training) is in the individual training files.

!One cross out without an explanation and two transcription errors were observed in two different validation reports.

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Examples of 483s Related to Documentation Issues

!There were no reports of investigations of lots and batches failing specifications.

!There were no laboratory records for the preparations of standardized volumetric solutions.

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Examples of 483s Related to Documentation Issues

!Some production records were not accurate in that, processing steps were not documented as they were being performed - records for the manufacturing of Product Y show step# 6 was signed off, yet previous steps were not completed.

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Examples of 483s Related to Documentation Issues

!Records of manufacturing deviations lacked standardized information and/or format. Records failed to include pertinent information such as cause of the problems and conclusions.

!Line stoppages are not documented.

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The FDA says:“In God we trust, everyone else must write it down!”

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Written Procedures

!Written procedures must define– Responsibilities for review and approval– Distribution– Authorization, Implementation and Change

Control – Changes that affect regulatory filing or

the validated status of a process, method or equipment must be evaluated by the Change Control Committee or alike

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Documentation Practices

!All GXP Documents must:– Be current and approved - never use deleted

or obsolete– Define scope and purpose– Be clearly stated and followed– Have revision or version number, if

appropriate– Have an issue/effective date, if appropriate– Be easily retrieved

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Entering Information:

!Enter information using only permanent ink (no pencils, flairs or water-soluble pens). In manufacturing areas, use only pens without caps. Use only black or blue ink.

!Record entry, signature and date immediately following completion of step or tasks.

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Entering Information (Cont’d):

!ONLY record information resulting from INDIVIDUAL performance, verification or observation of task(s) performed.

!Unused blanks or entries must be marked “N/A”or Not Applicable, with a signature and date.

!Note: If full signature appears within the document , then initials and a corresponding date may be acceptable. Further reference to “signature/date” will include initials/date (as appropriate).

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Approvals/Verifications:

! An individual cannot perform and approve / verify the same task(s).

ALLOWABLE:One individual performs an action. A second individual approves or verifies that action. The result is completion or confirmation of the specified action.

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Correcting Entry Errors:

! Use a single line to cross out errors. Sign and date the correction.

! A note(s) to explain a correction(s) are entered on the same page as the corrected entry. Place the note as near to the entry as possible. (Provide an explanation when the reason may not be clear.)

! For correction of a calculation result, such as percent yield, a comment such as “Math error” is the only explanation required. This does not apply to the data entries on which the calculation is based. Further explanation if a change is required for data on which the calculations are based (i.e.. weights, formulas, quantities, base units, etc.).

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Use of Passwords & Electronic Signatures:

!Electronic signatures and passwords represent the individual who owns them.

!Passwords and electronic signatures are to be executed solely by the individual who owns them.

!You are responsible for the confidentiality of information entrusted to you.

!Persons utilizing electronic signatures must be trained in the application.

!Sharing your personal password with others is prohibited

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Use of Passwords & Electronic Signatures (Cont’d):

!Sharing of passwords and entry of data using another individual’s log-on and/or password is considered falsification and may result in disciplinary action up to and including removal, dismissal or termination.

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Use of Passwords & Electronic Signatures (Cont’d):

!Answer: Absolutely. This is a violation of GxPs and company policies.

!Question: Is sharing a passwordconsidered falsification?

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Use of Passwords & Electronic Signatures (Cont’d):

!Answer: GxP training is required annually, for all individuals who use, develop support or maintain computer based systems or programs in the performance of their job.

! Question: Are associates, consultants, and contractors required to be trained on electronic signatures and passwords?

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Falsification:Falsification:!Altered data

– generating biased data or changing data that is legitimately obtained

!Omitted data– not reporting data

!Manufactured data - “Dry Lab”– fabricating information or creating results

without performing the work

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Falsification:Falsification:

!Entering data when testing or other activities have not been performed.

!Signing for work prior to that work being performed, even if the task is about to be started.

!Signing for another person’s work with your name.

!Using other than today’s date where signature/initials and date are required (e.g. pre-dated or post-dated)

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Falsification:Falsification:

!Changing original / non-retrievable data without supporting documentation.

!Destroying original documentation or data.

!Documenting verification of data withoutINDIVIDUAL observation.

!Entering or approving data / information using someone else’s log-on identification.

!Sharing of passwords and entry of data using another individual’s log-on and/or password is considered falsification

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Consequences of Falsification:Consequences of Falsification:

!Falsifying data or intent to conduct or participate in a fraudulent activity will result in DISCIPLINARY ACTION UP TO AND INCLUDING REMOVAL, DISMISSAL or TERMINATION.

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Nine Characteristics of a Quality GXP Record

!Permanent

!Legible

!Accurate

!Prompt

!Clear

!Consistent

!Complete

!Direct

!Truthful

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BREAK ?????

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Group Observations

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Group Activities!Break up into groups of 3-4 people!Select a spokesperson! Identify documentation errors on provided

examples!Present them to

class

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In Summary ...!Documenting your work speaks to the

information, product, or service you produced

!The documents you prepare should allow someone in the future to reliably, clearly, completely, and easily re-create an activity, event, or process

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In Summary ...!Data must be clear (so everyone who reads it

arrives at the same understanding)!Proper record keeping techniques need to be

applied in ALL documents– Apply the 9 characteristics of a well-made

document! It takes less time and energy to produce a

quality document than to deal with the frustration and potential regulatory issues that result from inadequate documentation

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In Summary ...

If you don’t do it right the first time, when will you have the time???

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Remember...

The job is not done...Till the paperwork is

complete!

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Learning Assessment

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Multiple Choice - #1

!The main purpose of a record or document is to:

A) Meet regulatory requirementsB) Be able to recreate an event,

decision, or activityC) Prevent lawsuitsD) Justify a patent application for a

new drug

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Multiple Choice - #2

!The phrase, “so everyone who reads the information arrives at the same understanding of it”, is part of:

A) LegibleB) AccurateC) DirectD) Clear

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Multiple Choice - #3

!The (US) standard way (s) to record time uses:

A) A twelve hour clockB) A twelve hour clock with AM or PM

designationC) A twenty-four hour clock

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Multiple Choice - #4

!The ink to be used when recording data is:

A) Blue or BlackB) ErasableC) Water solubleD) All of the above

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Multiple Choice - #5

!An explanation for a recordkeeping error is:

A) Not neededB) Needed only when the reason is not

obviousC) Needed for all recordsD) Needed only for GLP records

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Multiple Choice - #6

!Properly prepared documents can:

A) Satisfy an inspector’s questionsB) Help solve problems, deviations, or OOS

resultsC) Reduce waste and improve qualityD) All of the above

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Multiple Choice - #7

!Document entries must be made:

A) At the time when it is most convenient

B) After the set of all related activities is completed

C) Immediately after completion of a step or process

D) Before the document is sent for review by quality personnel

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Multiple Choice - #8!You are handed a document by your manager

written 3 months ago. You inadvertently forgot to sign and date it. What do you do now?

A) Sign and date it using the original date

B) Sign and date it using today’s dateC) Review the document for accuracy,

sign and date it using today’s date, and write a brief explanation as to what happened

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Multiple Choice - #9

!Which of these records are not GXP records?

A) Equipment logbooksB) Approval of ComponentsC) Packaging and LabelingD) Financial reportsE) Production or Processing

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Multiple Choice - #10

!You have recorded an entry erroneously. The right entry is 53.12 grams. You have entered 51.32 grams.

How would you correct the wrongful entry?

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Multiple Choice - #11

!What is an acceptable standard to record the date of July 25, 2003?