Documentation Practices 10-06-08 - Validation Plus, Inc.

Documentation Practices in GXPs If It Isn’t Documented, It Didn’t Happen. Presented By: Validation Plus, Inc. 14 Penwood Rd. Livingston, NJ 07039 www.validationplusinc.com (866) 760-2483

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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 cGXPs regulations (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) 3

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 4

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 5

Why Is Documentation Important? ! 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. 6

Why Is Documentation Important (Cont’d)? ! Comply with regulations ! Provide a standard for

recording, reviewing and approving data ! Keep track of activities ! Create legal documents ! Provide a historical record ! Inform ! Instruct (procedures, specifications) 7

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 !Stradivarius Violin – – – –

work of art expensive object of high quality no information available on how it was created

– – – –

work of art expensive object of high quality no information available on how it was created 10

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 12

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 14

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 20

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 21

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). 23

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. 24

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..25 weights, formulas, quantities, base units, etc.).

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 26 prohibited

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): !Question: Is sharing a password

considered falsification?

! Answer: Absolutely. This is a violation of GxPs

and company policies.

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Use of Passwords & Electronic Signatures (Cont’d): ! Question: Are associates, consultants, and

contractors required to be trained on electronic signatures and passwords? ! 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. 29

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 30

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. predated or post-dated)

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Falsification: ! Changing original / non-retrievable data without

supporting documentation.

! Destroying original documentation or data. ! Documenting verification of data without

INDIVIDUAL 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: ! 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

! Consistent

! Legible

! Complete

! Accurate

! Direct

! Prompt

! Truthful

! Clear

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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 38

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 39

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! 41

Learning Assessment

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Multiple Choice - #1 ! The main purpose of a record or document is to: A) B) C) D)

Meet regulatory requirements Be able to recreate an event, decision, or activity Prevent lawsuits 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) B) C) D)

Legible Accurate Direct Clear 44

Multiple Choice - #3 ! The (US) standard way (s) to record time uses: A) B) C)

A twelve hour clock A twelve hour clock with AM or PM designation A twenty-four hour clock

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Multiple Choice - #4 ! The ink to be used when recording data is: A) B) C) D)

Blue or Black Erasable Water soluble All of the above

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Multiple Choice - #5 ! An explanation for a recordkeeping error is: A) B) C) D)

Not needed Needed only when the reason is not obvious Needed for all records Needed only for GLP records

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Multiple Choice - #6 ! Properly prepared documents can: A) B) C) D)

Satisfy an inspector’s questions Help solve problems, deviations, or OOS results Reduce waste and improve quality All of the above

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Multiple Choice - #7 ! Document entries must be made: A) B) C) D)

At the time when it is most convenient After the set of all related activities is completed Immediately after completion of a step or process Before the document is sent for review by quality personnel 49

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) B) C)

Sign and date it using the original date Sign and date it using today’s date Review the document for accuracy, sign and date it using today’s date, and write a brief explanation as to what happened 50

Multiple Choice - #9 ! Which of these records are not GXP records? A) B) C) D) E)

Equipment logbooks Approval of Components Packaging and Labeling Financial reports 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?

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