INTRODUCTION

                 Ø It has sterile formulations of

Ø  Vials

Ø  Ampoules

Ø  Pre-Fill Syringes

Ø  Blow Fill syringes

Ø  Ophthalmic

Ø  Infusions (Bag FFS)

 

Departments:

1.      Production: For Manufacturing & packing of Products as per the instructions of BMR (Batch Manufacturing Record) & BPR (Batch Packaging Record)

2.      Quality Assurance: QA is responsible for giving Line Clearance & Assurance for Quality and ensuring the production activities during manufacturing & Review the Documents and compile and Submission & Storage of documents.

3.      Warehouse: WH responsible for the Receiving & issuance of Raw materials, Primary Packaging materials, Secondary packaging materials. They co-ordinate with QC persons for sampling & approval of Quarantine materials and destroy the rejected materials in presence of QA. Final Batch dispatch with the clearance of QA head to market.

4.      Quality Control: QC Responsible for the receiving the samples from Production & do the Analysis Give results based on results further activities done.

5.      Engineering: Responsible for the co-ordinate with production persons for rectifying machine related activities & Instrumentation, HVAC, Water system & Lyophilizer handling.

6.      Research & development: R&D responsible preparation of TTD, scale-up execution. Based on TTD BMR will prepare & product manufacturing done.

7.      Information technology: IT responsible for the System & soft ware related activities.

8.      Security: For secure the organization & Allowing Authorized persons inside the plant

9.      Administration: Admin responsible for arranging the requirements to employee, it mainly for employee Safe & secure.