Provide on company letter head

TO WHOMSOEVER IT MAY CONCERN

Item: (Product name)

Organic Volatile Impurities / Residual Organic Solvents

Based on the Organic Volatile Impurities / Residual Organic Solvents guidelines as per
ICH, USP and EP, We hereby confirm that
- # Class I solvents are used in the manufacturing process.
- ## Class II solvents are used in the manufacturing process.
- ### Class III solvents are used in the manufacturing process.

Following are the list of solvents used / formed in the manufacturing process of above
product.
Class I / # Class II / ## Class III / ### Others

Thus, (Product name) manufactured by us complies with Organic Volatile Impurities /

Residual Organic Solvents requirements as per ICH, USP and EP. We also hereby
confirm that, any change in solvents used in manufacturing process will be intimated to
you before shipment of consignment.

Signature :
Name :
Designation :
Department :
Date :
 TO WHOM SO EVER IT MAY CONCERN

GMP DECLARATION

We, (Name of company and address) declare and certify that the product (Product
name) is being manufactured according to ICH Q7 “Good Manufacturing Practice
Guide for Active Pharmaceutical Ingredients”.

We assure the continuous compliance of current Good Manufacturing

Practice is being practiced at our facility for the manufacture of (Product name)

Signature :
Name :
Designation :
Department :
Date :
Product name:
Date:

Statement

We, as the manufacturer of , hereby

declare that we are willing to be inspected by PAB Organics Pvt. Ltd.

Signature :
Name :
Designation :
Department :
Date :
 DECLARATION ON NITROSO IMPURITIES

We hereby declare that, (Company name) is not using Dimethyl formamide or Triethyl amine and Sodium

nitrite or Sodium Azide in any combination of these reagents in the manufacturing process of (Product

name) or in the site, which will cause for the formation of NDMA ( N-nitrosodimethylamine ) and NDEA

(N- nitrosodiethylamine) impurities. Hence, our products produced in our site are free from ntrosoamine

impurities.

Signature :
Name :
Designation :
Department :
Date :