ISPE GCLP COP GoodDocumentationPracticesPresentation

7/27/2019 ISPE GCLP COP GoodDocumentationPracticesPresentation

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R Raghunandanan

Mumbai

February 2010

Good Documentation Practices

27-02-2010 RRNANDAN@GMAIL.COM 2

Quality Assurance

• The sum total of organized arrangements

made with the object of ensuring that

products are of the quality required fortheir intended use and that quality

systems are maintained.

Good Manufacturing Practice

• That part of quality assurance which ensures

that medicinal products are consistently

produced, controlled and distributed to the

quality standards appropriate to their

intended use and as required by regulatory

commitments and specification

Documentation

• Written procedures, instructions and records

associated with manufacturing, required to

demonstrate compliance with GMP, quality

control requirements, company standards and

any applicable regulatory requirements

Good Documentation Practice

• Deals with good and acceptable practices in

document -

– Generation

– Handling

– Distribution

– Archival

– Retiring

Document hierarchy

Policy

Procedures

Records

Policies

• High level documents, depicts management

principles, e.g.:

– Quality Policy

– Validation Policy

– Training Policy

• Describes what should be achieved (not necessarily

how)• Also include the various plans like quality plan,

validation plan, calibration plan etc.

Procedures

• The “how” of policies

• Describes what need to be done to achieve

the policy requirements

• Provides details

• Also called SOPs (standard operating

procedures), work instruction etc.

• Examples include – production procedures,

testing procedures, maintenance procedures

Records

• Proof of having carried out an activity

• Proof of having achieved what is

required to• The final document at the end of a

process

• Tells you how a process was carried out

• A statutory document

Documentation fundamentals

• Simple, clear and complete

documentation is at the heart of any

Quality Management System• Use simple, clear language to ‘state what

we do’ - then only we can ‘do what we

state’

• Good documentation is the only proof that we

are (and we were) under control

– Since your documents may be seen after

few years of generation

– Since auditors have not witnessed what you

have done

– Since they depend only on documents

• All document users should

– Have ready access to relevant documents

– Understand the contents clearly – Work with only current version

– Be trained in new versions before

introduction – Not make unauthorized changes

Standard Operating Procedures

– Only write documents that are needed

– Involve the right people at the right

stage – Understand the full process first and

then write the document

– Write what is actually being or is to be

– Write documents to an elementary reading

– Use simple sentences

– Use legible font

– Avoid crowding on one page

– Use flow charts

• They are like one way traffic

• Just follow directions

- No more- No less

• If you can not follow an SOP

• Tell Your SupervisorIMMEDIATELY

Never• Erase an entry

• Write over an entry (over-writing)

• Use typist’s fluid to erase entries• Use a pencil to make entries

• Use undefined abbreviations

• Make stray marks• Record data on scrap paper

• Always check before you sign

Advantages of

• Provides traceability

• Easier investigations

• Consistency and compliance• Clarity in communication

• Easier product approvals and registrations

• Continued regulatory compliance• Confidence and less work pressure !!

Golden rules of documentation

• If it is not documented,…… It is a rumor !!!!

• If it is documented, but not signed and dated……It is invalid !!!!

• In God alone we trust…….All others must provide data !!!!

Why high standards of

documentation

• To ensure that we make safe and effective medicines

• To comply with GMP

• To comply with regulatory requirements

• Always remember the innocent unsuspecting patient

far away from you!

What causes

documentation errors

• Procedures not followed

• Time pressure to complete the job

• Casual attitude, lack of seriousness (will younot be serious while writing your own bank

cheque??)

• Cumbersome and complex formats

• Based on assumption instead of physical

checks

What can you do to prevent

documentation errors

Follow approved procedures

Understand that quality takes time

Ensure paperwork is correct

Perform your check as if it is the only check

Train everyone touching the document

Keep it simple, avoid complexities in documents

Have the right attitude towards documentation

Regulatory requirements (1)

• Schedule M of Drugs and Cosmetics Act –

Section 12 on “Documentation and Records”

• Stipulates document design, contents,

approvals, archival, retention periods

• Compliance to the rules are mandatory

• WHO Technical Report Series 823 Annex I,

Section 14

• Narrates principles and requirements of

documentation

• Describes the various documents, their

contents and records

• US FDA, 21CFR Part 11, Electronic records and

Electronic signatures

• Part 11 applies to records in electronic form

that are created, modified, maintained,

archived, retrieved, or transmitted under any

records requirements

Training on

• Class room training for all who touch documents

• Read through SOPs relevant to documentation in

groups and deliberate

• Carry out gap analysis of the relevant SOPs withrespect to documentation principles

• Read through EU / WHO / US FDA / Guidance

chapter on documentation in groups and deliberate

• Review Schedule U and Schedule M in groups and

deliberate

In summary remember

• When we mistakes people could die !!

• Don’t assume there will be no errors

• Don’t rely on others getting it right• Do not backdate documents

• Do not sign off until the task is complete

• If instructions are wrong, stop and report it• Do not carry on with incorrect procedures

27-02-2010 RRNANDAN@GMAIL COM 32

ISPE GCLP COP GoodDocumentationPracticesPresentation

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