1. OBJECTIVE:

To describe the Procedures for handling and storage of Various Innovator Samples or RLD (Reference Listed Drug) sample.            

2. SCOPE:

This SOP covers the procedures for management of Innovator Samples procured for comparative study with various ANDA products to be manufactured at [company name].

3. RESPONSIBILITY:

Head – Quality Assurance

4. PROCEDURE:

4.1 Receive the Innovator Sample and related documents.

4.2 Check the received innovator sample for integrity of pack and proper label details.

4.3 Make relevant entries in the Innovator Sample Record Register (Annexure – I, Format No. SOP/QAD/045/01).

4.4 Store the sample in an area that maintains the conditions as per recommended storage conditions of the innovator sample.

4.5 At the time of sending the Innovator sample to Quality Control Department for analysis, make applicable entries in the Innovator Sample Record Register.

5.0 Annexure:

Annexure – I Innovator sample Record Register

Annexure – I Innovator Sample Record Register

S. No.

Brand Name            

Mfd. By          

Generic Name         

Strength        

Mfg. Date      

Exp. Date      

Batch/lot/ Control No.         

Received Quantity  

Recommended Storage Conditions        

Received on

Received From        

Received By

Sample Sent to QC on       

Sent By         

Received By