Useful Formats
Pharma Industry Guidelines
IQ Protocol
Installation Qualification is defined as, establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier...
Pharma Industry Guidelines
MSDS Format
It is a document that contains information on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product.(MSDS : Material Safety Data Sheet)
MSDS FormatDownload
Pharma Industry Guidelines
CVP : Cleaning Validation Protocol
Adequate cleaning procedures play an important role in preventing contamination & cross-contamination. Validation of Cleaning Methods provides documented evidence that an approved cleaning procedure will provide clean equipment, suitable for the intended use.
Cleaning Validation...
Pharma Industry Guidelines
Process Performance Qualification Protocol/Process Validation Protocol
PV ProtocolDownload
Process Performance
Qualification Protocol
Name
of Product:
Stage:
Product
Code:
Plant:
Sr. No.
Table of Contents
Page No.
1.
Purpose
...
Pharma Industry Guidelines
Formats for change control , deviation & categorization of changes.
Change Control FormDownload
Excerpt-
1) Do not retain this form and forward to the next after completion of review.2) Put N/A where not applicable.3) Attach an additional sheet if required as annexure.4) Please specify the details...
Pharma Industry Guidelines
CAPA Formats- CAPA Request Form & CAPA Register
Corrective Actions and Preventive Actions (CAPA). Download formats from links below-
CAPA Request FormDownload
CAPA RegisterDownload
For any Feedback or suggestion, mail at: info@pharmastate.com
Pharma Industry Guidelines
SOP on CAPA | Corrective Actions and Preventive Actions in Pharma Industry
Objective :
To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA).
2.Scope:
This SOP is applicable for all Corrective
Actions and Preventive Actions (CAPA) initiated for...