Logical Level of Documentation in Pharma World (Why? What? and How?)

In all Pharmaceuticals and Biopharmaceuticals industries, documents play an important role. 
A very practical saying says that,


"IF IT IS NOT DOCUMENTED, IT WAS NOT DONE"

But, how documents come into existence and what is flow of documents in the industry.

The hierarchy of documentation makes a lot of sense and it is interesting.

Hierarchy of Documentation
Level of Documentation system

One must understand that,

Any organization or industry starts with the some motive and vision/objective. This one line note which is known as "Visionary Note" or "Objective line".  

This one-line message is very directive as it provides the general idea to the people of the foundation.    

"Visionary Note" is owned by the Founder or the chairperson of the Organization.

Based on the Visionary Note, Board of Members writes the "Policy".

What is Policy?

A policy is a deliberate system of principles to guide decisions and achieve rational outcomes.

It is also known as "Concept Note"

There are many types of Polices are available in the pharmaceutical industry. Such as Quality Policy, HR Policy, Health policy, Safety Policy, Manufacturing Policy and many more.

Most important policy is the "Quality Policy."

Now concept note is ready, then what is next?

Next is an elaboration of the concepts and Principle. 

This conceptual and Elaborative document serves as a guidance document. These include the SMF (Site master file), VMP (Validation Master plan), Developmental documents, Agreements and Licenses. 

They are regulatory assets of any pharmaceutical industry.

Regulatory guidance is available for the preparation of such guidance documents.

Now organization have guidance documents. But how to guide the employees at the multilevel ?

That is why SOPs come in pictures.

SOP: Standard Operating procedures.

SOPs are directive and instructive document.

All the procedure, flowchart, definition and respective references are given in the SOPs.

Once we have the Standard Operating Procedure then next requirement is Instruction and its Recording system. 

Instruction shall be provided in form of SOPs, EOPs (Equipment Operation procedures), STPs (Standard Test Procedures), GTP (General Test procedure) and many a time protocol driven instructions are provided.

Based on the instructions activity shall be carried out and results are recorded. 

Where to record results?

In the Recording system!!!

Results are recorded in the form of Formats, Master formula records, Data recording sheet (DRS), Annexures, Planner, Maintenance records, Calibration records, Dispatch record, Environment monitoring record, Cleaning records, Sampling records, validation records, Self-inspection records etc. These all are recording systems/platforms

These all records are controlled and regulated. 

Regulatory guidance is available for the preparation, modification and destruction of all levels of documents starting from Guidance documents to Recording formats.

With the increasing emphasis on harmonization efforts and standard setting, understanding of documentation system is very important.

That is why this is small try to explain it!!!


Location: Ahmedabad, Gujarat, India

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