Good Documentation Practices

Good Documentation Good Documentation PracticesPractices

SOPHIA LILYSOPHIA LILYGM – GM – CORPORATE QUALITY ASSURANCECORPORATE QUALITY ASSURANCE

Contents 1. Why good documentation is essential? 2. What constitutes good documentation? 3. Purpose of Document System 4. Document System Basic 5. What is Documentation? 6. Good Documentation Practices 7. Essential Characteristics 8. Documentation Lifecycle 9. Where Documentation 10.Types of Documents 11.Good Documents Requirement 12.Strenghts of Good Documents 13.Observations in Poor documents 14.How are mistakes corrected? 15.Tips for good documentation 16.Learnings

Why Good Documentation is essential?

An essential part of the quality assurance system and should exist for all aspects of GMP (reference: WHO GMP, Volume 2)

Good documentation practice is an expected practice!

Correct, complete, current, and consistent information effectively meet customer and stakeholder' requirements

Helps to reduce observations raised on inadequate documentation practices.

What constitutes Good Documentation?

Approve, review and update documents

Changes & current revision status of documents identified

Relevant versions of applicable documents available at points of use

Documents remain legible and readily identifiable

Documents of external origin identified and their distribution controlled

Prevent unintended use of obsolete documents, and archiving.

““Each manufacturer shall establish effective Each manufacturer shall establish effective quality system, instructions and procedures quality system, instructions and procedures in accordance with the requirements of this in accordance with the requirements of this part and maintain the established quality part and maintain the established quality system instructions and procedures system instructions and procedures effectively.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 and produced, it must be safe, effective and fit for its intended use.fit 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.

PURPOSE OF DOCUMENT PURPOSE OF DOCUMENT SYSTEMSYSTEM

A document system is an interacting set A document system is an interacting set of documents, each with a defined of documents, each with a defined purpose and consistent document.purpose and 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 Interact in a manner that reduce

redundancy and increase the flexibility of redundancy and increase the flexibility of the system when changes occurthe system when changes occur

DOCUMENT SYSTEM DOCUMENT SYSTEM BASICSBASICS

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

To Document each Activity you perform

What is Documentation ?What is Documentation ?

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.

Good Documentation PracticesGood Documentation Practices

ESSENTIAL CHARACTERISTICSESSENTIAL CHARACTERISTICS

To design an effective & efficient documentation process first

identify the important characteristics of processing event. The document directing the manufacturing event The document directing the manufacturing event

fulfills current regulatory commitments to the agency; fulfills current regulatory commitments to the agency; it is appropriately written, reviewed and approvedit is appropriately written, reviewed and approved

The directive document is appropriate for the task to The directive document is appropriate for the task to be performed be 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 and there is no work as yet uncompleted that will impact the occurrence of the data presented.impact the occurrence of the data presented.

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 (manufacturing record) is retrievable for review or auditaudit

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 identifiable, retrievable and maintained in facilities that provide a suitable environment to minimize that provide a suitable environment to minimize deterioration or damage and to prevent loss”deterioration or damage and to prevent loss”

ESSENTIAL CHARACTERISTICSESSENTIAL CHARACTERISTICS

Document creation, Review Approval: -Document creation, Review Approval: - Authorized document review and approval Authorized document review and approval

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

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

scientists, operating persons who are trained and scientists, operating persons who are trained and authorized to collect and record dataauthorized to collect and record data

Data Verification: -Data Verification: - Responsibility of supervisors, managers and all Responsibility of supervisors, 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 Records are Accessible, Retrievable, Secure is

the responsibility of QA & relevant the responsibility of QA & relevant departmentsdepartments

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

documentsdocuments Every signature associated with documents Every signature associated with documents

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

DOCUMENTATION LIFE CYCLEDOCUMENTATION LIFE CYCLE

THEREFORE, DOCUMENTATION BRINGS BUSINESS

Cost for Good Documentation

Cost for Poor/No Documentation

WHY DOCUMENTATION ?WHY DOCUMENTATION ?

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………...

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

There are three types of

Documents

Types of DocumentsTypes of Documents

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.

Some Examples are :Some Examples are :

What Good Documentation What Good Documentation requires :requires :

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

Observations on poor documentation practices

Document error correction not signed/dated, and didn’t include a reason for the correction

Write-overs, multiple line-through and use of "White-out" or other masking device

Sample sequence table and audit trail not documented (if its not documented, it didn’t happen)

SOP related to production, calibration, storage and maintenance not authorized by the QA head

The delegation for the batch release, in case of absence of the QA manager, not recorded / documented

Out-of-specification (OOS) procedure not detailed enough; flow chart and /or check-list not available.

How are mistakes corrected?

Draw a single line through the error

Make the correction next to the error

Write an explanation for the error

Sign and date the correction.

Following is a list of concerns when Following is a list of concerns when designing documented processing control: -designing documented processing 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 to designated location. Apply the same principles to the security of documents during review processthe security of documents during review process

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 identification number / code and product lot number.lot number.

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

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

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

assurance requirement for the processing assurance requirement for the processing of documentsof documents

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

direct the data entry processdirect the data entry process

Some tips on Good Documentation Practices

Records should be completed at time of activity or when any action is taken

Superseded documents should be retained for a specific period of time

Records should be retained for at least one year after the expiry date of the finished product

Concise, legible, accurate and traceable

Picture is worth a thousand words

Clear examples

Don’t assume knowledge.

.

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

01.07.2004.

Draft MPR attached as Annexure – I.

Errors in manual entries in various documents shall

be rectified in blue ink as follows : Wrongly mentioned as 000.

08.09.2004001

Tips of Good DocumentationTips of Good Documentation

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.

Learnings.Learnings.

“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.

LearningLearning

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

Any Questions???Any Questions???