Documentation in Pharmaceutical

Industry
 Golden Rule

If it’s not documented, it did

not happen
Example: PC50521003
Where,
PC5 – Paracetamol 500
0521 – May 2021
003 – Serial no. of
batch manufactured in
this month (May 2021)
 3 Tier Documentation

Tier 1 – Manuals, Policy Documents

Tier 2 – Procedures, Work Instructions

Tier 3- Records/ Forms/ Logs / Files

Typical Drug Product Manufacturing Plant Company Owned
Distribution Channel
in India Usually Company
Storage Depot
Owned

Clearing & Usually Agent

Forwarding

Apointed External
Wholesale Distributor
Agency

Retailer Medical Store

Retailer