Good Documentation Practices

SOPHIA LILY GM
CORPORATE 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 quality system, instructions and procedures in accordance with the requirements of this part and maintain the established quality system instructions and procedures effectively. No matter what type of product is developed and produced, it must be safe, effective and fit for its intended use. Quality characteristics are established in documents. Documents declare product standards and describe how to monitor, test and judge for compliance with these standards.

PURPOSE OF DOCUMENT SYSTEM

DOCUMENT SYSTEM BASICS

A document system is an interacting set of documents, each with a defined purpose and consistent document. The documents can: Assure that quality standards are consistently met Communicate these standards to all who interact with product Interact in a manner that reduce redundancy and increase the flexibility of the system when changes occur

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

Good 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 CHARACTERISTICS
To design an effective & efficient documentation process first identify the important characteristics of processing event.

The document directing the manufacturing event fulfills current regulatory commitments to the agency; it is appropriately written, reviewed and approved The directive document is appropriate for the task to be performed The data is authentic; the individual responsible for performing the work has entered the data on an appropriate data collection document The data is accurate The data is complete. There is no missing information, and there is no work as yet uncompleted that will impact the occurrence of the data presented.

ESSENTIAL CHARACTERISTICS

The data is legible, consistently recorded and trustworthy The data collected fulfills expectations (specifications) The data is accessible to those who need to review it, audit it or use it to perform trending analysis. The original data and the original documents (manufacturing record) is retrievable for review or audit The original manufacturing record is secure Proper control of documentation also requires that responsibility for each processing step to be assigned All documentation should be legible, clean, readily identifiable, retrievable and maintained in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss

DOCUMENTATION LIFE CYCLE

Document creation, Review Approval: Authorized document review and approval signatures are responsible for directing the manufacturing, the security, original, approved documents is the responsibility of QA. Document use & Data collection: Responsibility of all technicians, engineers, scientists, operating persons who are trained and authorized to collect and record data Data Verification: Responsibility of supervisors, managers and all individuals trained & authorized to review data Record Review & Product disposition / Approval: Responsibility of QA or those trained & authorized to review records

DOCUMENTATION LIFE CYCLE

Record Achieving:Records are Accessible, Retrievable, Secure is the responsibility of QA & relevant departments Record Destruction: As per SOPs that directs the destruction of documents Every signature associated with documents review & approval, data collection and record review and approval should add value to the document. Every one who signs a document or a record should know what their signature means. Only those individuals trained and authorized to sign documents should sign them.

WHY DOCUMENTATION ?

Cost for Good Documentation

Cost for Poor/No Documentation

THEREFORE, DOCUMENTATION BRINGS BUSINESS

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 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 :

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.

What Good Documentation 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

What Good Documentation requires :

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 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 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 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 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 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 didnt 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 didnt 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 designing documented processing control:

When documents or records are transferred from one department to another or from one building to another the transfer should be recorded When documents or records are waiting to be processed, they should always be stored in designated location. Apply the same principles to the security of documents during review process Critical processing steps should be checked include document issue, data collection, document review. More review signatures on a document does not necessarily result in a more through review

Records must always be completely identified and this identity should be consistent and easily available. Every page of every document should be consistently labeled with the document identification number/ code, the document revision number/code, the product identification number / code and product lot number. Every signature associated with document review and approval should add value to the document Every one who signs a document or record should know what their signatures means

Only those individuals trained and authorized to sign documents should sign them It remains a challenge in normal systems to know who is trained and authorized to sign what document Note: - This is a fundamental quality assurance requirement for the processing of documents Databases should be qualified or validated There should be procedure in place to direct 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 Dont assume knowledge.

Tips of Good Documentation

Errors in manual entries in various documents shall

be rectified in blue ink as follows :

Wrongly mentioned as 000.

001 08.09.2004 MPR Firmed up on the basis of Dev. 000 MPR effective

01.07.2004.
Draft MPR attached as Annexure I. .

Learnings.
Good Documentation Practices should be everyones 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.

Learning
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 if performed with proper perspective and documented in a right way.

Always to remember
Truly, documentation is our Business, and to remain profitable, we should forget the syndrome We can fix the documentation later ........

Any Questions??? Thanks