gdp

“ “ Quality is never an accident, it is Quality is never an accident, it is the result of high intention, sincere the result of high intention, sincere

effort, intelligent direction and skillful effort, intelligent direction and skillful execution. It represents the wisest of execution. It represents the wisest of

many alternatives”.many alternatives”.

DOCUMENTS: - DOCUMENTS: - As discrete packages of recorded information As discrete packages of recorded information

are the tools of quality assurance.are the tools of quality assurance. Used to establish standard specification and Used to establish standard specification and

processes that assures compliance with processes that assures compliance with standard specifications and processesstandard specifications and processes

Quality can not be assured in a regulated Quality can not be assured in a regulated industry without good documents and good industry without good documents and good documentation practicesdocumentation practices

A document system is an interdependent, A document system is an interdependent, interrelated set of documents, each with a interrelated set of documents, each with a defined purpose and a consistent format.defined purpose and a consistent format.

Documentation is a process that involves the Documentation is a process that involves the systematic interaction of people, events and systematic interaction of people, events and documents to create the records of the documents to create the records of the organization / corporation.organization / corporation.

PURPOSE OF DOCUMENT PURPOSE OF DOCUMENT SYSTEMSYSTEM

““Each manufacturer shall establish effective Each manufacturer shall establish effective quality system, instructions and procedures in quality system, instructions and procedures in accordance with the requirements of this part accordance with the requirements of this part and maintain the established quality system and maintain the established quality system instructions and procedures effectively.instructions and procedures effectively.

No matter what type of product is developed No matter what type of product is developed and produced, it must be safe, effective and fit and produced, it must be safe, effective and fit for its intended use.for its intended use.

Quality characteristics are established in Quality characteristics are established in documents.documents.

Documents declare product standards and Documents declare product standards and describe how to monitor, test and judge for describe how to monitor, test and judge for compliance with these standards.compliance with these standards.

BASIC REQUIREMENTS FOR BASIC REQUIREMENTS FOR ASSURING THE QUALITYASSURING THE QUALITY

Establish the quality.Establish the quality. Determine which attributes of the resources, Determine which attributes of the resources,

process or product are critical to product process or product are critical to product use or performance.use or performance.

Chose quality parameters and test methods Chose quality parameters and test methods that are scientifically rigorous and then that are scientifically rigorous and then document themdocument them

Maintain the Quality / Monitor the quality Maintain the Quality / Monitor the quality Established quality system parameters to be Established quality system parameters to be met routinely and asssure control is met routinely and asssure control is effectiveeffective

BASIC REQUIREMENTS FOR BASIC REQUIREMENTS FOR ASSURING THE QUALITYASSURING THE QUALITY

Manage Charge:Manage Charge: Recording the change and providing Recording the change and providing

appropriate rationale in writing for that appropriate rationale in writing for that changechange

Evidence:Evidence: Have written evidence of the established Have written evidence of the established

quality standards, of the maintenance and quality standards, of the maintenance and monitoring programs, of the monitoring monitoring programs, of the monitoring data and of any changes that occurdata and of any changes that occur

DOCUMENT SYSTEM BASICSDOCUMENT SYSTEM BASICS

A document system is an interacting set of A document system is an interacting set of documents, each with a defined purpose and documents, each with a defined purpose and consistent document.consistent document.

The documents can:The documents can: Assure that quality standards are Assure that quality standards are

consistently met consistently met Communicate these standards to all who Communicate these standards to all who

interact with productinteract with product Interact in a manner that reduce redundancy Interact in a manner that reduce redundancy

and increase the flexibility of the system and increase the flexibility of the system when changes occurwhen changes occur

A DOCUMENT SYSTEM OF A DOCUMENT SYSTEM OF YOUR OWNYOUR OWN

The types of documents, number of documents The types of documents, number of documents and the level of detail in documents will vary and the level of detail in documents will vary from company to company depending on the from company to company depending on the following:following:

The type of product (its classification of risk)The type of product (its classification of risk) The unique nature of the product, the product The unique nature of the product, the product

delivery system or the manufacturing processdelivery system or the manufacturing process The size of the companyThe size of the company The education and training of the employeesThe education and training of the employees How much the company does (Develops, How much the company does (Develops,

manufactures, packages, distributes products)manufactures, packages, distributes products) Keep the expectations in corporate documents Keep the expectations in corporate documents

simple and relevant, make them your own simple and relevant, make them your own

What is Documentation ?What is Documentation ?

To Document each Activity you perform

No, Documentation is a Process, Which comprises of Following :

- Recording of Data- Review of Documents- Approval of Documents- Issuance and Disposal of Documents- Retrievability of Documents- Presentation of Documents

What is DocumentationWhat is Documentation

The information provided by a creator which provides

enough information to establish basis, history and context

and to enable its use by others.

It needs to be sufficiently detailed to allow the data creator to

use the material in the future, when the data creation process

has started to fade from memory.

It also needs to be comprehensive enough to enable others

to explore the resource fully, and detailed enough to allow

someone who has not been involved in the data creation

process to understand the data collection and the process by

which it was created."

Good Documentation PracticesGood Documentation Practices Just creating documents is not enough; you must follow

specific standards when doing so. Following established

practices allows everyone who reads your documentation to

understand exactly what you mean.

Key documents with the potential to impact product quality

must be retained to provide a traceable, historical record of

all activities. Documentation must be readily retrievable in

order to meet requirements associated with product

investigations, periodic product review, or formal audits

It is necessary to document anything that directly impacts a

product. Record every procedure you write, form you fill out,

and test you perform. Using a standard format eliminates

discrepancies between documents from different sources.

ESSENTIAL CHARACTERISTICSESSENTIAL CHARACTERISTICS

The document directing the manufacturing event fulfills The document directing the manufacturing event fulfills current regulatory commitments to the agency; it is current regulatory commitments to the agency; it is appropriately written, reviewed and approvedappropriately written, reviewed and approved

The directive document is appropriate for the task to be The directive document is appropriate for the task to be performed performed

The data is authentic; the individual responsible for The data is authentic; the individual responsible for performing the work has entered the data on an performing the work has entered the data on an appropriate data collection documentappropriate data collection document

The data is accurateThe data is accurate The data is complete. There is no missing information, The data is complete. There is no missing information,

and there is no work as yet uncompleted that will impact and there is no work as yet uncompleted that will impact the occurrence of the data presented.the occurrence of the data presented.

To design an effective & efficient documentation process first

identify the important characteristics of processing event.

ESSENTIAL CHARACTERISTICSESSENTIAL CHARACTERISTICS The data is legible, consistently recorded and The data is legible, consistently recorded and

trustworthytrustworthy The data collected fulfills expectations (specifications)The data collected fulfills expectations (specifications) The data is accessible to those who need to review it, The data is accessible to those who need to review it,

audit it or use it to perform trending analysis.audit it or use it to perform trending analysis. The original data and the original documents The original data and the original documents

(manufacturing record) is retrievable for review or audit(manufacturing record) is retrievable for review or audit The original manufacturing record is secureThe original manufacturing record is secure

Proper control of documentation also requires that Proper control of documentation also requires that responsibility for each processing step to be assignedresponsibility for each processing step to be assigned

“ “All documentation should be legible, clean, readily All documentation should be legible, clean, readily identifiable, retrievable and maintained in facilities that identifiable, retrievable and maintained in facilities that provide a suitable environment to minimize deterioration provide a suitable environment to minimize deterioration or damage and to prevent loss”or damage and to prevent loss”

DOCUMENTATION LIFE CYCLEDOCUMENTATION LIFE CYCLE Document creation, Review Approval: -Document creation, Review Approval: - Authorized document review and approval signatures Authorized document review and approval signatures

are responsible for directing the manufacturing, the are responsible for directing the manufacturing, the security, original, approved documents is the security, original, approved documents is the responsibility of QA.responsibility of QA.

Document use & Data collection: -Document use & Data collection: - Responsibility of all technicians, engineers, scientists, Responsibility of all technicians, engineers, scientists,

operating persons who are trained and authorized to operating persons who are trained and authorized to collect and record datacollect and record data

Data Verification: -Data Verification: - Responsibility of suppervisors, managers and all Responsibility of suppervisors, managers and all

individuals trained & authorized to review dataindividuals trained & authorized to review data Record Review & Product disposition / Approval: -Record Review & Product disposition / Approval: - Responsibility of QA or those trained & authorized to Responsibility of QA or those trained & authorized to

review recordsreview records

DOCUMENTATION LIFE CYCLEDOCUMENTATION LIFE CYCLE

Record Achieving:-Record Achieving:- Records are Accessible, Retrievable, Secure is the Records are Accessible, Retrievable, Secure is the

responsibility of QA & relevant departmentsresponsibility of QA & relevant departments

Record Destruction: -Record Destruction: - As per SOPs that directs the destruction of documentsAs per SOPs that directs the destruction of documents

Every signature associated with documents review & Every signature associated with documents review & approval, data collection and record review and approval approval, data collection and record review and approval should add value to the document. Every one who signs should add value to the document. Every one who signs a document or a record should know what their a document or a record should know what their signature means. Only those individuals trained and signature means. Only those individuals trained and authorized to sign documents should sign them.authorized to sign documents should sign them.

Why DocumentationWhy Documentation There is a saying in the pharmaceutical

industry: 'if it hasn't been documented, then

it hasn't happened!' Good documentation practice constitutes an

essential part of the QA system. Documentation system must be proactive

vehicle of communication.

Your documentation is an advertisement for

your work.

WHY DOCUMENTATION ?WHY DOCUMENTATION ?

Cost for Poor/No Documentation

Cost for Good Documentation

THEREFORE, DOCUMENTATION BRINGS BUSINESS

Here are some selected GDP Here are some selected GDP references from 21CFR58: references from 21CFR58:

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

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

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

WHERE DOCUMENTATION ?WHERE DOCUMENTATION ? Documentation during Project Design, Documentation during Construction Phase, Documentation during Commissioning and

start-up, Documentation during Qualification and

Validations Documentation during Commercial

Production, Documentation during Testing and Release,

Documentation for Regulatory submissions. Documentation beyond………...

Types of DocumentsTypes of Documents

There are three types of

Documents Commitment Documents : Relationship

between industry and the regulatory

authorities Directive Documents : Relationship

between the Management and Employees Record Documents : Relationship

between the Employees and the Work

they perform

Some Examples are :Some Examples are :

Commitment Documents : New Drug

Applications (NDAs), Drug Master Files

(DMFs) etc. Directive Documents : Specifications,

STPs, SOPs, MPRs etc. Record Documents : Protocols, BPRs, Log

Books, Calibration Records etc.

DIRECTIVE DOCUMENTSDIRECTIVE DOCUMENTS

Working documents that establish the standards for Working documents that establish the standards for resources, processing, products & quality systemresources, processing, products & quality system

Describe how to do it……???Describe how to do it……??? Describe how to do routine workDescribe how to do routine work Several types of directive documentsSeveral types of directive documents The different types are determined by the specific, The different types are determined by the specific,

functional purpose of the document in the document functional purpose of the document in the document systemsystem

In order to facilitate the development, production, In order to facilitate the development, production, testing and distribution of a product in a defined testing and distribution of a product in a defined mannermanner

Reviewed and approved by both management and the Reviewed and approved by both management and the individuals responsible for performing the workindividuals responsible for performing the work

COMMITMENT DOCUMENTSCOMMITMENT DOCUMENTS Presents corporate goals, expectations and Presents corporate goals, expectations and

standard of practicestandard of practice Describes what to doDescribes what to do Consensus of purpose, direction and Consensus of purpose, direction and

authorization for projectsauthorization for projects Organize the work in a manner that assures Organize the work in a manner that assures

efficient and effective work flowefficient and effective work flow Commitments documents can also be written to Commitments documents can also be written to

establish internal commitments.establish internal commitments. These documents such as master plans; These documents such as master plans;

organize and prioritize the work in a manner that organize and prioritize the work in a manner that supports good business practice as well as supports good business practice as well as regulatory complianceregulatory compliance

COMMITMENT DOCUMENTSCOMMITMENT DOCUMENTS Written to lead and guide the work and Written to lead and guide the work and

workersworkers To be used as active documents that are To be used as active documents that are

consulted and followed routinelyconsulted and followed routinely Content must be consistent and rigorous in Content must be consistent and rigorous in

order to lead and guide the work and the order to lead and guide the work and the workersworkers

Must describe the work as it will be doneMust describe the work as it will be done Deviations from regulatory submissions can Deviations from regulatory submissions can

have signification impact on product qualityhave signification impact on product quality Any deviation must be documented and Any deviation must be documented and

managedmanaged

What Good Documentation What Good Documentation requires :requires :

APPROVAL - this applies particularly to

work instructions, procedures,

manufacturing formulae and specifications. Approval should be by the relevant technical,

management and quality personnel, to

ensure that documents comply with the

principles of GMP and the specific product

marketing and manufacturing authorisations


CLARITY - they should not be open to

misinterpretation by the users. They should

be written in a way that makes them easy to

check, particularly when they will form part

of a product manufacturing history.

Good documentation design will help to

minimize errors


REGULAR REVIEW AND UPDATE -

documents must be kept up-to-date with

changes in regulations or processes and

should be distributed in a controlled manner

to ensure that only the most recent versions

are available for use. They must also be

available to those who need them, where

they need them!


FORMAL PRESENTATION - controlled

documents should be prepared in accordance

with a written procedure, now a days

probably using a computerised

documentation control system.


Records should be made at the time of

each action - do not rely on memory for their

completion. Records relating to manufacturing or testing

operations should be kept for at least one

year after their expiry.


If documents or data are stored

electronically, the computer system must be

validated to assure data security and

integrity. Provisions must also be made to retrieve the

stored data, possibly years after they have

been generated:

Strengths of Good DocumentationStrengths of Good Documentation

Clear Objective of the document

Clarity of Scope

Who should prepare ? Should know ?

Layout of the document in mind

Put pieces together

Explain the activity performed logically

Use short, simple, easy to understand

sentences

Strengths of Good DocumentationStrengths of Good Documentation

Maintain flow of script

Match script to the sequence of events of

the activity

Use correct data format

Meaningful data will give meaningful

information

Draw neat and correct inference

Conclusion & Summary

Get your document edited by an expert

What are our Major DocumentsWhat are our Major Documents CCIFs Failure Investigation & Reports Planned & Unplanned Deviation Reports Filling of BPRs APRs

Validation Protocols & Reports Raw Data & proper Recording Log Sheets Sketches - Diagrams - P&Ids – Schematics Plant Development Reports Engineering Documents

CCIFsCCIFs Incomplete Forms / columns Justification for change not in line with the

changes proposed. Attachments accompanying the CCIF :

Not attached in sequence Total no. of pages not mentioned All annexures not referenced on the CCIF Annexures do not have reference of CCIF Unsigned annexures

Items which are not required are left blank

(“Not required” to be entered)

OOSOOS

Many OOS Results unreported, therefore

no investigations Investigations not thoroughly performed Investigation should lead to assignable

reason, at least probable reasons Report should include back-up notes on

points covered during investigation Follow SOP on Investigation of OOS

result(s)

Filling of BPRFilling of BPR

Missing signatures & dates Over-writing without correction, sign,

date No remarks for correction Control Number not recorded correctly Time/Date and PC Number recorded in

BPR not matching with in-process

production Log Books

BPRs are the first major Exhibits reviewed by FDA

DOCUMENTATION: PROCESSING DOCUMENTATION: PROCESSING & CONTROL& CONTROL

The documentation process defines the The documentation process defines the relationship between the corporation and relationship between the corporation and regulatory authorities. (Commitment regulatory authorities. (Commitment Documents)Documents)

Corporate management and the workers Corporate management and the workers (Directive Documents)(Directive Documents)

The workers and the work that they perform The workers and the work that they perform The record of the events directed in directive The record of the events directed in directive

documents is evidencedocuments is evidence Records can be used as evidence against a Records can be used as evidence against a

company by FDA- in courtcompany by FDA- in court

DOCUMENTATION: PROCESSING DOCUMENTATION: PROCESSING & CONTROL& CONTROL

Evidence can be used by a company to Evidence can be used by a company to defend it self in courtdefend it self in court

The quality of the documents can be directly The quality of the documents can be directly and adversely affected by the quality of the and adversely affected by the quality of the document processing procedures that directsdocument processing procedures that directs

creation, review, approval, distribution, creation, review, approval, distribution, change and archiving of documentschange and archiving of documents

Every person must be trained to complete Every person must be trained to complete documents properly; improper use of the documents properly; improper use of the documents can lead to inaccurate, inadequate documents can lead to inaccurate, inadequate or incomplete documentsor incomplete documents

The Resources and raw materials of The Resources and raw materials of the documentation processes are as the documentation processes are as follows:-follows:-

– Directive documents that provide instructions Directive documents that provide instructions – Data collection documents that provide a format for data Data collection documents that provide a format for data

collectioncollection– Data or information observed or collected from Data or information observed or collected from

processing eventsprocessing events– Operating personals or scientists who have been trained Operating personals or scientists who have been trained

to follow instruction and collect datato follow instruction and collect data– Quality of these resources and materials must be Quality of these resources and materials must be

assured assured – These resources / raw materials interact in a systematic These resources / raw materials interact in a systematic

mannermanner– Data is collected according to an established processData is collected according to an established process

– To produce the final product data documentTo produce the final product data document– Quality of interaction of these resources that can have Quality of interaction of these resources that can have

the greatest impact on the quality of final the greatest impact on the quality of final documentation documentation

– Proper design and control of this documentation Proper design and control of this documentation process is essentialprocess is essential

– Many things that can go wrong, when moving Many things that can go wrong, when moving hundreds of documents through the documentation hundreds of documents through the documentation processprocess

– Process controls are added to assure the integrity and Process controls are added to assure the integrity and reliability of the documentation processreliability of the documentation process

The Resources and raw materials of The Resources and raw materials of the documentation processes are as the documentation processes are as follows:-follows:-

Controls are either industry standard or Controls are either industry standard or corporate –based controls that help corporate –based controls that help assure efficient and effective assure efficient and effective processing.processing.

21 CFR 211.188 (a) Controlled, Documented issue of production

batch records.

21 CFR 211.194 (a) Verification of laboratory test data for “Accuracy, Completeness compliance with established standards”

DOCUMENT PROCESSING DOCUMENT PROCESSING PROCEDURES TO BE SURVEYEDPROCEDURES TO BE SURVEYED

Why are delays occurring?Why are delays occurring? Is there redundancy in the system?Is there redundancy in the system?

Do records disappear?Do records disappear? Are documents inconsistently completed?Are documents inconsistently completed? Has the product been released with records Has the product been released with records

missing?missing?

Note:- More Control does not necessarily lead Note:- More Control does not necessarily lead to greater order or more security.to greater order or more security.

Following is a list of concerns when Following is a list of concerns when designing documented processing designing documented processing control: -control: -

When documents or records are transferred from When documents or records are transferred from one department to another or from one building one department to another or from one building to another the transfer should be recordedto another the transfer should be recorded

When documents or records are waiting to be When documents or records are waiting to be processed, they should always be stored in processed, they should always be stored in designated location. Apply the same principles designated location. Apply the same principles to the security of documents during review to the security of documents during review processprocess

Critical processing steps should be checked Critical processing steps should be checked include document issue, data collection, include document issue, data collection, document review. More review signatures on a document review. More review signatures on a document does not necessarily result in a more document does not necessarily result in a more through reviewthrough review

Records must always be completely Records must always be completely identified and this identity should be identified and this identity should be consistent and easily available.consistent and easily available.

Every page of every document should be Every page of every document should be consistently labeled with the document consistently labeled with the document identification number/ code, the document identification number/ code, the document revision number/code, the product revision number/code, the product identification number / code and product lot identification number / code and product lot number.number.

Every signature associated with document Every signature associated with document review and approval should add value to the review and approval should add value to the documentdocument

Every one who signs a document or record Every one who signs a document or record should know what their signatures meansshould know what their signatures means

Only those individuals trained and Only those individuals trained and authorized to sign documents should sign authorized to sign documents should sign themthem

It remains a challenge in normal systems to It remains a challenge in normal systems to know who is trained and authorized to sign know who is trained and authorized to sign what documentwhat document

Note: - This is a fundamental quality Note: - This is a fundamental quality

assurance requirement for the processing of assurance requirement for the processing of documentsdocuments

Databases should be qualified or validatedDatabases should be qualified or validated There should be procedure in place to direct There should be procedure in place to direct

the data entry processthe data entry process

Here are some selected GDP Here are some selected GDP references from 21CFR211: references from 21CFR211:

To assure uniformity from batch to batch, master production and To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature,thereof, shall be prepared, dated, and signed (full signature,handwritten) by one person and independently checked, dated, handwritten) by one person and independently checked, dated, and signed by a second person.and signed by a second person.

An accurate reproduction of the appropriate master production An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;or control record, checked for accuracy, dated, and signed;

The initials or signature of the person who performs each test The initials or signature of the person who performs each test and the date (s) the tests were performed... The initials or and the date (s) the tests were performed... The initials or signature of a second person showing that the original records signature of a second person showing that the original records have been reviewed for accuracy, completeness, and have been reviewed for accuracy, completeness, and compliance with established standards... Complete records shall compliance with established standards... Complete records shall be maintained of any modification of an established method be maintained of any modification of an established method employed in testing. Such records shall include the reason for employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material results that are at least as accurate and reliable for the material being tested as the established method.being tested as the established method.

Example of typical guidelines found in Example of typical guidelines found in Good DocumentationGood Documentation

Practices/Recordkeeping procedures: Practices/Recordkeeping procedures:

All entries must be clear and legible All entries must be clear and legible Never make erasures or writeovers. Any written error must be Never make erasures or writeovers. Any written error must be

crossed out in such a manner that the original information is crossed out in such a manner that the original information is still legible. Do not scribble out or "whitestill legible. Do not scribble out or "whiteout" entries. Thus, the integrity of the record will not be in out" entries. Thus, the integrity of the record will not be in question.question.

The crossed out section must be initialed and dated by The crossed out section must be initialed and dated by originator. Corrections must be made adjacent to the deleted originator. Corrections must be made adjacent to the deleted entry.entry.

Data may be attached to the page, however, it must be firmly Data may be attached to the page, however, it must be firmly attached. Label, sign and date the attachment. The location of attached. Label, sign and date the attachment. The location of the attachment in the record is indicated with "bridging". the attachment in the record is indicated with "bridging". Approved methods of bridging are cross hatching or signing Approved methods of bridging are cross hatching or signing across the edge of the attachment and page.across the edge of the attachment and page.

When portions of a page or a complete page remain unused, a single When portions of a page or a complete page remain unused, a single line must be drawn angularly across the unused portion. Sign and line must be drawn angularly across the unused portion. Sign and date the crossed out section and provide an explanation when date the crossed out section and provide an explanation when necessary. This is not applicable to blank portions on preprinted necessary. This is not applicable to blank portions on preprinted documents such as MBRs.documents such as MBRs.

Use only black or blue permanent ink. The ink should not run or Use only black or blue permanent ink. The ink should not run or smear if the record is splashed with liquid. Pencil is not acceptable, smear if the record is splashed with liquid. Pencil is not acceptable, since all entries must be permanent and able to be photocopied.since all entries must be permanent and able to be photocopied.

Make the required entries on the record as the work is performed. Do Make the required entries on the record as the work is performed. Do not record information on a separate piece of paper and enter on the not record information on a separate piece of paper and enter on the record laterrecord later

All planned and unplanned deviations from the approved production All planned and unplanned deviations from the approved production procedure or testing/inspection plan as described in GMP controlled procedure or testing/inspection plan as described in GMP controlled documentation must be documented using a Discrepancy Report. documentation must be documented using a Discrepancy Report. The DR# should be indicated in the record at the location of the The DR# should be indicated in the record at the location of the change.change.



Use correct rounding off procedures and significant figures Use correct rounding off procedures and significant figures When a comment or explanation is required, make all When a comment or explanation is required, make all

statements objective. Avoid personal comments and statements objective. Avoid personal comments and opinions.opinions.

When dating a signature, use the actual day the signature When dating a signature, use the actual day the signature was signed.was signed.

If the activity being recorded occurs on more than one day, If the activity being recorded occurs on more than one day, the record must clearly indicate where the "break" occurred. the record must clearly indicate where the "break" occurred. This can be accomplished by drawing a horizontal line This can be accomplished by drawing a horizontal line through the procedure at the break" and indicating the new through the procedure at the break" and indicating the new date or making entries that are initiated and dated date or making entries that are initiated and dated appropriately.appropriately.

If a record becomes messy and extremely difficult to read, do If a record becomes messy and extremely difficult to read, do not discard. Consult supervisor prior to transcribing the data not discard. Consult supervisor prior to transcribing the data to a clean record sheet and attaching the original record to a clean record sheet and attaching the original record sheet. Provide an explanation for the transcription.sheet. Provide an explanation for the transcription.



SUMMARYSUMMARY

Documentation must be consistent Documentation must be consistent and systematicand systematic

Documentation practices must Documentation practices must assure that records meet GMP assure that records meet GMP requirementsrequirements

Documentation process must be Documentation process must be controlled to minimize redundancies controlled to minimize redundancies in the work flow in the work flow

Tips of Good DocumentationTips of Good Documentation

Each entry in the record shall be legible (readable)

and be written in blue ink.

Never use Pencil, Correction Fluid, Eraser etc.

No page or column shall remain blank/ unfilled. NA

shall be entered.

All records/documents are maintained in a

presentable manner.

Tips of Good DocumentationTips of Good Documentation

Errors in manual entries in various documents shall

be rectified in blue ink as follows :

.

MPR Firmed up on the basis of Dev. 000 MPR effective

01.07.2004.

Draft MPR attached as Annexure – I.

001 08.09.2004

Wrongly mentioned as 000.

Learnings.Learnings. Good Documentation Practices should be

everyone’s concern. Foundation of a sound documentation

system begins with the engineering

documents as well as their management. Engineering is the provider Production is the customer QA is the gatekeeper. Validation is the hold-up and Everyone just wants to pass the

baton.

LearningLearning “More the better” is not the right dogma

More entries we make, the greater

the opportunity for error. But, if we reduce the documentation,

we may omit critical and vital data. Any activity becomes creative, if the Doer

cares about doing it right or better. Each Activity is a “forward Certification”“forward Certification”

if performed with proper perspective and

documented in a right way.

Always to rememberAlways to remember

Truly, documentation is our Business, and

to remain profitable, we should forget the

syndrome “We can fix the documentation

later .......”.

ThanksThanks

gdp

Technology

effective quality system

quality monitor

established quality

processes quality

quality standards areassure

good documents

established quality

tools of quality assurance