PURPOSE: To lay down procedure for tube filling, crimping & batch coding. RESPONSIBILITY : Q. A. Chemist Production Manager. PROCEDURE :- A) Tube Filling :- Load clean...
PURPOSE: To lay down procedure of cleaning room through the exposure of ultra-violet rays. RESPONSIBILITY : Production Manager INTRODUCTION :-Range of UV rays that kills micro organisms is 253.7 nm. Ultraviolet rays kill microorganisms by an...
PURPOSE: To avoid contamination with microorganisms during manufacturing of sterile products, careful attention to the special handling requirements, aseptic techniques and observance of good manufacturing practices must be maintained. Hence the aseptic filling...
PURPOSE: To ensure that DHS must be validated and they meet their design criteria and existing ovens must be rechecked, when they are significantly changed. RESPONSIBILITY : 1. Production Manager PROCEDURE 1. Maximum loads of vials or ampoules are washed as...
PURPOSE: To lay down procedure for cleaning of storage tank for Injection. RESPONSIBILITY : Production Manager INTRODUCTION:- As the name itself indicates the tank is used to store water for injection I.P. Tank is kept in sterile area & the water...
PURPOSE: To lay down the procedure for re-sterilization of Container which are not used within specified time. RESPONSIBILITY: Manufacturing Chemist Q. A. Manager Washing In charge PROCEDURE : – 1. Reload the containers (Amp/vial) which are not...
