DOCUMENTS

& RECORDS

Dr ASHWANI VIG

Document ?
Definition: Oxford: a writing or inscription. GMP: a written and authorized inscription
logically designed & prepared, periodically reviewed to overcome deficiencies 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 the
quality assurance system and as such shall be related to all aspects of GMP. Its aim it to define: the specifications for all inputs, in process & outputs. Method of manufacturing and control

According to GMP contd.

Designed, Prepared, Reviewed and Controlled.
wherever applicable, shall comply with these Rules. Approved, Signed & Dated by the Appropriate and 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 concerned with manufacture know the information necessary to decide whether or not to release a batch of a drug for sale, and
To provide audit trial that shall permit investigation of history of any suspected defective batch

According to GMP

Practices:
Shall be made and completed at the time of operation, in a way that all significant manufacturing activities are traceable.

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?

When? Where? Why?

Process Time & Duration Location, Machine & Controls

Who?
How?

Process validation Personnel Procedure

Alternative Recording System

Electronic Data processing System:
Only authorized person shall enter or
modify the data. Maintenance of Record in case Change and Deletion. Access restricted by Password or other means,

independently checked, Suitable storage back up, and Readily available. Condition: Following records shall be available in hard copy Master Formula Record, and Detailed Operating Procedures relating to the system in use

Alternative Recording System contd. Result of entry of critical data shall be

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 of
which 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 Revision

of master documents in order to maintain Quality and improve Quality

Document Cycle
INITIAL DRAFT
CONCERNED DEPTT.

CONTROL
QA DEPARTMENT

FINAL DRAFT
DEPARTMENT HEAD

FINAL DOCUMENT
QA DEPARTMENT

SOPs?
Are detailed, written, authorized, functional procedures. They indicate exactly: how operation are carried out, and kept current by periodical review (annually) In case where changes are made e.g process change, equipment change etc.

Preparation of SOPs?
SOPs follow a scientific format and are
written 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 must be done before starting the main procedure. Instruction for recording and reporting results.

Preparation of SOPs?
Person performing the procedure prepare SOP

QA Authorizes SOP

Supervisor review SOP for Completeness & Correctness

S Gupta

13

Format of SOPs?
Title of the SOP
Deptt
Prepared by: Checked by: Authorized by: sign sign sign name name

SOP No.
Revision Effective date Review date

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 for the operator to follow. It should include : a) Preliminary steps before beginning the actual procedure. b) Safety considerations precautions for work with 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 SOPs which are relevant to this procedure.

Reviewing Documents
All new and revised documents must be reviewed by the unit using the document for technical accuracy, completeness and consistency with related procedure.
QA will review for compliance to internal documentation procedures and compliance to regulatory 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 or revised documents must be informed about the approval.
All users must be trained in the use of the new document and an effective date established for its initial use.

Revising Approved Documents

Responsibility of user unit. Unit must keep documents current. Revisions should be done by the person familiar with procedure or operation. Reason for change must be given. Revisions of documents must be approved by QA before change can be instituted.

Obsolete Documents
QA must notify documents which an unit may
desire to make obsolete

The master documents should be changed from

active to obsolete file.

All copies should be delivered to QA for

destruction.

Why GMP ?

Are 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 an
industrialist .

You are responsible

Citizen of INDIA

Feel fortunate on this

earth you have been assigned the job of serving mankind.

You have to admit !

Raise your self and
admit that you are the one, responsible for providing better health to the people of:
Your family Your relations Your town INDIA Globe

You must believe !

Enlighten your self

and believe that you are playing a vital role in the health care system.

Develop a passion !
Ignite the passion in
you and dedicate your life in serving the mankind on this earth.

You have to maintain a balance !

You have to justify

between the patient interest v/s your own interest.

You have to be socially responsible

you have to protect

the society .

You have to be equally committed.

for the animal

kingdom. They are as good as human being.

Time has come to understand

YOU
ARE NOT JUST SELLING

DAWA

YOU ARE COLLECTING

DUWA

DUWA of ..
A Doctor - who has trust on You

DUWA of ...
A Relation
-You are Building With PATIENT

DUWA of .
A Child,
- Who is future of the NATION

DUWA of ...
A MOTHER - the most caring Hands on this earth

DUWA of ...
A Father Who has been an source of inspiration behind every successful man.

and above all DUWA of ...

Almighty who has blessed us with an Opportunity to serve HIS MANKIND

Difference between

DAWA DUWA

Is U only,
and that is

YOU
mean

AAP

It is YOU

who makes the DIFFERENCE

Because..

making

feeling

DAWA
is an

DUWA
is an

PRACTICE

ATTITUDE

and if you have.

An

ATTITUDE
nothing is

IMPOSSIBLE

and never ever let ..

DUWA
to Become a

BADDUWA

fight against BAD things..

Self Sensitization & Realization

Before you go to sleep,

ask your self ?

how many times it is compromised by you for not doing things in a way, as it should have been done.

If, yes
Youll never have a sound sleep. Analyze, whether it was really
necessary to do so. Keep your self at the other end and think accordingly. Whether you really exist to do such thing on this earth? Develop self control not to repeat it again.

If, No You have purposeful mission

of serving mankind on this earth and GOD is happy with you. You deserve a sound sleep.

So! as the sun rise ...

Lets start collecting

DUWA
from tomorrow morning It self

Make QUALITY an ATTITUDE

Documents and Records will automatically come in your system

I feel fortunate..
If , I have Reached To your Mind By this Effort of mine

Because
Every Thing Reaches Heart, through Ones mind only

Thank you