Good Documentation Practices
Transcript of 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!
What Good Documentation What Good Documentation requires :requires :
FORMAL PRESENTATION - controlled
documents should be prepared in accordance
with a written procedure, now a days
probably using a computerised
documentation control system.
What Good Documentation What Good Documentation requires :requires :
What Good Documentation What Good Documentation requires :requires :
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.
What Good Documentation What Good Documentation requires :requires :
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???