GOOD DOCUMENTATION PRACTICES (GDP)

R. SURESH

What is being made?

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Documentation

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• Most of us when attempting a task need some sort of documentation

• A large part of GMP involves written instructions, following those instructions and making records.

Documentation

• Documentation enables us to investigate complaints, failures, problems and trend analysis and as a tracker.

• Documentation helps us decide on, and take, any necessary corrective action.

• Another reason for documentation is that it helps to build-up a detailed picture of what a company has done in the past and what it is doing now.

•  Documentation is a mandatory regulatory requirement•  Finally as per GMP “if it is not documented it is a

rumour”.

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Documentation

• Documentation is an essential part of QA and relates to all aspects of GMP

• A reliable evidence for GMP compliance• The system of documentation devised or adopted

should have as its main objective to establish, monitor, and record “quality” for all aspects of the production, quality control and quality assurance

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Purpose of Documentation• Clearly written documentation prevents errors that may arise in oral or casually

written communication

• It provides assurance that quality related activities are carried out exactly the way they have been planned and approved

• The achievement of conformity and quality improvement

• Good documentation, on the other hand, conveys a message of intelligence, sincerity and professionalism

• Purpose of documentation : To ensure that there are specifications for all materials and methods of

manufacture and control Employees know what to do Responsibilities and authorities are identified Ensure that authorized persons have all information necessary for

release Provide audit trail Forms the basis for improvement

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QUALITY SYSTEMDOCUMENTATION

Quality System Documentation

• Documentation is the key to operating a pharmaceutical company in compliance with GMP requirements.

• All the elements, requirements and provisions adopted by pharmaceutical company for its quality system should be documented in a systematic, orderly and understandable manner in the form of policies and procedures.

• Documents should be designed, prepared; reviewed and distributed with care.

• It should be written in detail and in simple language that can be understood by the user.

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Quality System Documentation

• Informative

• Prescriptive

• Historical

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Quality System Documentation

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• GMP documentation includes:– Quality manual– SOPs– Annexure to Core SOP– Guideline (Company specific)– Form:

• Specification and method of analysis.• Master formulae.• Process flow sheets.• Batch records.• Training records.• Protocols and reports.• Records (related to change control, deviation, incident, complaint, recall, returned

goods, internal audits, qualification/ validation activities, register, log, labels, status board, check list, job responsibilities etc.)

– Raw data which include the documents other than specified in above

Quality System Documentation

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• Raw data includes:– Any laboratory worksheets, records, memoranda, notes, or exact copies

thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study.

– Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

– All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink.

– All data entries shall be dated on the date of entry and signed or initialed by the person entering the data.

– Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change.

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FORMAT OF DOCUMENT

Format of Document

No “best format” in documentation system. Each document should be suitable for all users In general, all quality documents can be written

in the following format : narrative flowchart combination narrative and flowchart electronic / computerized system Photographs can be documents provided they are

properly authorised and controlled

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Narratives Document

The most common format being used The narrative document can be described as the

following : Policy reference Objective : why and for what Coverage area Document reference Responsible person Detail procedure Record if needed

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Flow Chart Document

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Schematic representation which describe the flow of processes in certain target activity

Very clear and easy to read

Sample of the flowchart document can be written as beside schema

Combination Document

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Legend1 = Mixer2 = Intermediate bin with activated discharge3 = Feed metering unit4 = Metal separator5 = UPZ fine impact mill with pin discs6 = UPZ fine impact mill with pin discs7 = Automatic reverse-jet filter8 = Fan9 = Rotary valve10 = End-product bin with activated discharge11 = Bagging unit12 = Control cabinet

A = Feed productB = material additionC = End product

Sometimes narrative document & flowchart is supported by design / lay out

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Electronic Document

Geared towards assuring data integrity of computerized systems used to meet predicted rule requirements

Using ERES (Electronic Records; Electronic Signatures)

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HOW TO CREATE GOOD DOCUMENTATION SYSTEM

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1. Document is : complete history of each batch from starting materials to finished products record activities for :

• maintenance• storage• quality control• primary distribution• specific matter related to GMP

2. Documents should be designed, prepared, reviewed and distributed with care

3. All documentation must be organized into files which must be maintained for specified periods of time after the expiry date of the product.

Document

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Content of Document

What should be written in the document:• Name of document• Name of company, department or division of the

maker• Document number• Page and number of pages of document• Number of revision• Date of approved• Name and signature of the person who prepared

the document• Names and signatures of the person who

reviewed and person approved the document • Body of document• Document receiver

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Numbering System

Every document should have a number from the Control Division

Document numbering system should be made, to make easy on saving and controlling the document

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Document Control

• Documents should be dated and authorizedDocuments should be dated and authorized approved, signed and dated by appropriate

authorized persons no document should be changed without

authorization• All document records should be completed as the

process proceeds.• Distribution list of documents should be recorded• Obsolete documents should be :

taken from users , based on distribution list marked “obsolete” and archived

• Create a list of running documents , centralized • Use only updated documents

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Document Distribution

Distribution of documents should be the up-to-date documents

Copy of documents should be distributed to relevant parties

The list of distribution should be made Document Data Control Division or QC can

distribute the document Main document should be received by Production

and Quality Control Department Supporting document is distributed to related

division only

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Revision & Renewal

Should be made periodically, or if needed Obsolete documents should be retrieved

from all relevant parties and its original copy should be archived

The date of revision should be stated in the new documents

Every revision should be approved by authorized person

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GOOD DOCUMENTATION PRACTICES

Four Golden Rules on Proper Documentation

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• 1. If it isn’t written down, it didn’t happen.

• 2. If it isn’t written down correctly, it didn’t happen either.

• 3. If it can’t be understood, it wasn’t documented.

• 4. Don’t forget Rules 1, 2 & 3.

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Think….before you document!!

In spite of workload & tight work schedule……

Be sure that you have understand &written correctly!!

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Always fill in the blanks

Record all requested information, Do not keep it blank.

If it’s truly not applicable, write ‘NA’ with your initial s &date .

If pages or sections of forms are not applicable ,line through them &write ‘NA’ with your initials &date ,wherever required state the reasons.

Use indelible ink

• All the entries should be made by using black/blue permanent indelible ink because it photocopies well and does not smear.

• Pencil &water soluble inks are unacceptable because it smears easily & can be erased.

• Green ink pen can be used by QA for getting clear view of verification.

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“Practice to do on-line documentation, record result as you get them”.

Common GMP error is to speed through the document at the end of the day or at the end of the shift, filling in all the blanks records at one time.

Because it is a fact that it is impossible to remember all what we did five minute ago and much is missed eight hours back.

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Whitener or correction fluid not permissible

• Do not alter or overwrite letters or numbers, all entries should be legible, write or print always clearly.

• The correct way to make the corrections or editorial changes is to line through the error once and put initial & date all corrections.

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….signature is a legal & ethical Responsibility

• Before signing anything, check for the accuracy, completeness & correctness of the text/calculation. therefore you must ,to the best of your ability, review the document thoroughly & completely.– Make sure that everything that needs to be attached is

attached.– Never sign something that you know to be wrong, get it

corrected and signed by concern person.– Never sign the document with which you are not aware of.– Never correct the error which was committed by other

person.– Provide the explanation for the corrected error where it is

required.– Put the date below signature as far as possible.

• One who sign is fully responsible for it …..04/08/23 32

…Never do backdate or falsify records !

• Always use current date when documenting your work,if you do not ,You are falsifying records.

• Always use approved format for documentation. • Adopt format for documenting date & time as per SOP.

E.g.:

DD-MM-YY (for other than effective dates)

DD-MM-YYYY (for effective dates)• Time as 24 hrs, clock such as 23:01 Hrs.• Use rounding of numbers or decimals as per SOP policy.

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Good Handwriting

• Definition - The sentences written in a clear, uniform & legible manner so that it is readable understandable to all.

• It shall be written in a straight line with correct word spacing & using correct form of sentence case.

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When affixing supporting documentation to a page ,special care may be needed….

o Use appropriate size & color of paper.o Check that large size paper is properly folded to a desired

size.o Check that all the attached document shall align properly.o If it more than one sheets, use binder, folder or staple it, but

never use paper clip or U-pin ,tape or glue.o Always do indexing for the attachments if more than one

sheets are attached.o Do sing& date for correctness on each attachments.o Always verify the documents received from the external

agency before attaching.

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Comment & clarifications should be FACTUAL,CONCISE & TRACEABLE!

o Be factual… State fact, not supposition.

o Concise… Be descriptive yet brief.

o Traceable…Easily tracked within the document or to related records.

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Record data directly on the appropriate format or notebook

o Do not write original data on scrap paper, hand or paper towels and then transfer to format or notebook.

o Always attach printouts and labels where indicated.o Never missed original data or documents.o Use additional page or sheet when more space is

needed given appropriate identification number.o Finally original information or data should not be lost &

manipulated.

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All Documentation errors require correction!

o Corrections must be legible, never cross obliterate an entry by use of correction tape or white fluid.

o Use asterisk or star or circle number to the error correction to item being corrected.

o Correction made after review require re-review.o Correction made after verification require the

verifier be present when correction is made.o Write the reason for correction as close to the

error as possible.

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Data Correction

If there is a mistake, neatly cross it with single line, do the correction, keep initial and date.Also indicate the reasons for correction.

16.35 → 16.55

Ditto marks to indicate “all date or data in a column are the same” are not allowed.

Arrowing down or across to indicate data are the same is not allowed.

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Please note!

o “Checked by” or “Reviewed by” cannot be signed prior to the “Done by” sign.

o The same person cannot sign both “Done by” & “Checked by”.

o Department responsible for the activity should sign at designated place provided.

o No other department /person can sign on behalf unless authorized.

o Pages or blank columns can be pre-signed.

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Please remember !

o Signing for someone else in the same department only.

o For the planed absences, one person may give permission to another to sign in their absence.

o The signer will list the person they are signing for and then affix their own signature & date.

o Behalf signature for the junior can be allowed but not senior without official authorization.

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Good Documentation Practices

* Permanent * Truthful

* Legible * Traceable

* Accurate * Complete

* Clear * Consistent

* Timely

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REMEMBER

If you have a question – Ask

If you don’t understand the instruction –Ask

If you aren’t sure who is responsible – Ask

If it’s your responsibility – make sure it get done

properly.

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Roles & Responsibilities.

The performer /Doer :The individual executing each step in the set of instructions.

The Verifier :The second qualified individual responsible for witnessing the steps or evaluating a calculation, results to ensure the procedure is followed and documented appropriately ,accuracy in real time.

The reviewer : A supervisor or other qualified individual responsible for reading the documentation. He is responsible for ensuring that all appropriate procedures have been followed and documented in correct and as per the Standard policy and area of specification.

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Conclusion…

Did we achieve today’s training Objectives?

• Requirements of cGMP documentation

• What is Good documentation?

• Importance of GDP .

• Is there Good and bad documentation?

• Examples of good & bad documentation.

• Current issues

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Record Keeping Rules “Do Not” Rules DO NOT scribble out mistakes (obscures entry) DO NOT write correct entries over incorrect

entries (writing over obscures original entries) DO NOT forget to enter all required info DO NOT forget to initial and date entry DO NOT use colored ink/pencil DO NOT leave mistakes uncorrected (check your

entries)

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Train the Trainer – L&D

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Module Outcome

Module 1 :Learning styles/Adult Learning 1hr

Making the participants to understand there are different learning styles and if we call 15-20 people they learn things in their own way. What all things a Trainer must consider?

Module 2 :Trainer competencies 1 hr

Helping the participants to understand what are the competencies a Trainer need to have. This will help them to understand which of their competences will be helping them to become a good trainer. competencies

Module 3 :Designing a Learning Solution 1 hr

This will help the participants to understand the essential components of a module and what must be the sequence.

Module 4 :Facilitation & Accelerated learning techniques 1 hr

The module help the participants to understand the importance of involving the people while conducting a training session.

Module 5 : Practise sessions 3hrs

The practise session will help to learn how effective, useful & practical the above techniques are.

Thank you for your Thank you for your attention!attention!