2-gmp documents & records+approach

8/14/2019 2-GMP Documents & Records+Approach

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DOCUMENTS

&

RECORDS

Dr ASHWANI VIG



Document ?

• Definition:

•Oxford: a writing or inscription.

•GMP: a written and authorized inscription

– logically designed & prepared,

–periodically reviewed to overcomedeficiencies as observed from the past

experiences and –Controlled

in order to perform a specific activity issued by

the QA Department.



According to GMP

• Documentation is an essential part to thequality assurance system and as such shallbe related to all aspects of GMP.

• Its aim it to define:

•the specifications for all inputs, inprocess & outputs.

•Method of manufacturing and control



According to GMP – contd.

• Designed, Prepared, Reviewed and Controlled.wherever applicable, shall comply with theseRules.

• Approved, Signed & Dated by the Appropriateand Authorized persons.

• Others

– Laid out in orderly fashion and easy to check,

– Regularly reviewed and kept up to date.

– Alteration if any, shall be signed and dated.



According to GMP - contd.

– To ensure that all personnel concernedwith manufacture know the information

necessary to decide whether or not torelease a batch of a drug for sale, and

– To provide audit trial that shall permitinvestigation of history of any suspecteddefective batch



According to GMP

•Practices: – Shall be made and completed at the

time of operation, in a way that allsignificant manufacturing activities aretraceable.

•Period of retention: – Records and associated SOPs shall be

retained for at least one year from Date

of Expiry of finished product.



Documentation Concept of GMP

Is based on: 5Ws+H

• What? Process

• When? Time & Duration

• Where? Location, Machine & Controls

• Why? Process validation• Who? Personnel

• How? Procedure



Alternative Recording System

• Electronic Data processing System:

•Only authorized person shall enter ormodify the data.

•Maintenance of Record in case Change

and Deletion.• Access restricted by Password or othermeans,



Alternative Recording System – contd.

•Result of entry of critical data shall beindependently checked,

•Suitable storage back up, and

•Readily available.

• Condition: Following records shall be

available in hard copy

•Master Formula Record, and

•Detailed Operating Proceduresrelating to the system in use



Type of Documents.

• Structural Documents (layout plans)

• Standards / Specifications (MFR, MPR etc.)

• Operational Documents (BMR, BPR etc.)• Functional Documents (SOPs)

• Authorization Documents (QA Clearances)

• Protocols and Reports (STPs)• Certificates (CoA)

• Status Labels.



Document Control

• Is designing of a system by virtue ofwhich licensee is able to ensures that all

documents are:•generated in orderly manner,

•authorized perfectly,

•communicated Precisely,

•reviewed periodically , and

•are in compliance with GMP.



Why Document Control?

• To control

– Issuance and receipt,

– Provide adequate knowledge, – Possession,

– Use and

– Revisionof master documents in order tomaintain Quality and improve Quality



Document Cycle

INITIAL DRAFTCONCERNED DEPTT.

FINAL DRAFTDEPARTMENT HEAD

FINAL DOCUMENTQA DEPARTMENT

CONTROLQA DEPARTMENT



SOPs?

Are detailed, written, authorized, functionalprocedures.

– They indicate exactly:

•how operation are carried out, and keptcurrent by

periodical review (annually)

In case where changes are made e.gprocess change, equipment changeetc.



Preparation of SOPs?

• SOPs follow a scientific format and arewritten with the view that they will be

used by persons trained in the procedure.• SOPs should be written with : – Specific instruction for each step in

sequential order.

– Instruction for Preparatory work which mustbe done before starting the main procedure.Instruction for recording and reportingresults.



S Gupta 13

Preparation of SOPs?

Person performing the procedure prepare SOP

Supervisor review

SOP for Completeness

& Correctness

QA Authorizes SOP



Format of SOPs?

Title of the SOP SOP No.

Deptt Revision

Prepared by: Checked by: Authorized by: Effective datesign sign sign Review date

name name name Replaces

Body of SOP



Format of SOPs -contd.

• Objective or Purpose :

Why is this procedure written and being

performed.• Scope :

When this procedure needs to be

performed.

•Where this procedure applies.



Format of SOPs -contd.

• Responsibility :•Who performs the procedure

•Who is responsible to see it is performed.

• Materials and Equipment :

• What are needed to perform the job.

• A complete and specific list.



Procedure

Clear, Concise, Step by Step instruction on how to

perform the procedure. Written as instruction forthe operator to follow.

It should include :

a) Preliminary steps before beginning the actual

procedure.

b) Safety considerations – precautions for workwith Physical, Chemical or Biological hazards

( clothing, mask, hoods, goggles, gloves etc.



Procedure

c) Chronological instruction – numbering of

steps is useful in case of repeat step.

d) Calculation (wherever applicable)

explanation and sample of how to do

any required calculation



Reporting

Indicate where the result should be recorded.

a) Explain what to do if there are problems

during operation of the procedure.

b) Deviation of procedure must be approved and

recorded.

c) Identify the person to whom the final result

should be reported.

• Reference document :

List of other SOP s which are relevant to this procedure.



Reviewing Documents

– All new and revised documents must bereviewed by the unit using the document fortechnical accuracy, completeness andconsistency with related procedure.

– QA will review for compliance to internal

documentation procedures and compliance toregulatory requirements.



Approving Documents

• Signatures are required from

The Author(s) The Department/Unit

(Supervisor/Manager)

The QA in-charge



Notification of Approval

– All personnel who will be using new orrevised documents must be informed

about the approval.

– All users must be trained in the use of

the new document and an effective dateestablished for its initial use.



Revising Approved Documents

– Responsibility of user unit.

– Unit must keep documents current.

– Revisions should be done by the personfamiliar with procedure or operation.

– Reason for change must be given.

– Revisions of documents must be approvedby QA before change can be instituted.



Obsolete Documents

• QA must notify documents which an unit maydesire to make obsolete

• The master documents should be changed fromactive to obsolete file.

• All copies should be delivered to QA for

destruction.



Why GMP ?

re we not :

– incorporating right input materials? – Assigning right job to right personnel ?

– maintaining proper records?

– Selling product having therapeutic equivalence?

– committed towards our social responsibilities?



Answer is

YES ?



But !

Do I have right

Practices

&

Approach?



Approach:

Which is not Casual

Which is Consistent

Which is Organized

Where, there is a Commitment

Where, there is a Mission



How to build an Approach?



Change mind set

• You are not just anindustrialist .

• You are responsibleCitizen of INDIA

• Feel fortunate on thisearth you have beenassigned the job ofserving mankind.



You have to admit !

• Raise your self andadmit that you are theone, responsible for

providing better healthto the people of: – Your family

– Your relations

– Your town – INDIA

– Globe



You must believe !

• Enlighten your selfand believe that you

are playing a vital rolein the health caresystem.



Develop a passion !

• Ignite the passion inyou and dedicate yourlife in serving themankind on this earth.



You have to maintain a balance !

• You have to justify between the patientinterest v/s your owninterest.



You have to be socially responsible

• you have to protectthe society .



You have to be equally committed….

• for the animal

kingdom. Theyare as good ashuman being.



Time has come to understand

YOU

ARE NOTJUST

SELLING

DAWA



YOU ARE

COLLECTING

DUWA



DUWA of …..

A

Doctor

- whohas

truston You



DUWA of …...

A

Relation

-You

are

Building

With

PATIENT



DUWA of ….

A

Child,- Who

is future

ofthe

NATION



DUWA of …...

A

MOTHER

- the

most

caringHands on this

earth



DUWA of …...

A

Father

- Who has been ansource of

inspiration behind

every successfulman.



and above all DUWA of …...

Almighty

who has

blessed uswith

an

Opportunity

to serveHIS

MANKIND



Difference between

DAWADUWA



Is U only,

and that is

YOUmean

‘AAP’



It is YOU…

who

makesthe

DIFFERENCE



Because…..

making

DAWAis an

PRACTICE

feeling

DUWAis an

ATTITUDE



and if you have….

An

ATTITUDEnothing is

IMPOSSIBLE



and never ever let …..

DUWAto

Become

a

BADDUWA



fight against BAD things…..



Self Sensitization & Realization

• Before you go to sleep, – ask your self ?

how many times it iscompromised by you for not

doing things in a way, as itshould have been done.



If , yes

• You’ll never have a sound sleep.

• Analyze, whether it was reallynecessary to do so.

•Keep your self at the other end andthink accordingly.

•Whether you really exist to do such

thing on this earth?•Develop self control not to repeat itagain.



If, No

• You have purposeful mission

of serving mankind on thisearth and GOD is happy withyou.

• You deserve a sound sleep.



So! as the sun rise …...

Lets

start

collecting

DUWA

from

tomorrow

morningIt self



Make QUALITY an ATTITUDE

Documents

andRecords

will automatically comein your system



I feel fortunate…..

If ,

I have

ReachedTo your

Mind

By this

ort of mine



Because……

Every

Thing

ReachesHeart,

through

Ones

mind only



Thank you