SOP on pharmacopeial updating of documents as per the pharmacopeial changes Objective: To lay down a procedure for pharmacopeial updation of documents as per the pharmacopeial changes. Scope: This procedure is applicable to pharmacopeial updatio... Read more
INSTALLATION QUALIFICATION OF AIR HANDLING UNIT TABLE OF CONTENTS PAGE No. 1 Objective 03 2 Scope 03 3 Responsibility 03 4 System / Equipment 04 4.1 Air handling unit 04 4.1.1 Mixing chamber 05 4.1.2 Prefilter section 05 4.1.3 DX-cooling coil se... Read more
OBJECTIVE : To provide procedure for identification, selection, evaluation and qualification of Raw Material (Active and Inactive) and Primary / Printed Packaging material vendors. RESPONSIBILITY : Head-SCM for identification a... Read more
Chemical Sanitization Procedure for RO first Pass Objective : To Disinfectant the Bacteria in RO membrane Scope :- Procedure : Prepare (0.1 – 1) % Minncare Solution in any solution preparation tank having the capacity of 300 Ltr { Use 300m... Read more
Purpose The purpose of this protocol is to provide an outline for the inspection of the system for static attributes to verify that: Each installed sub-component complies with the engineering design and system data sheets/specifications. The sy... Read more
Objective: To lay down a procedure for sterilization of miscellaneous Items. Scope: This SOP is applicable for sterilization of Miscellaneous Items. Responsibility: Officers/above (Production-Injectable) is responsible for sterilization of Misce... Read more
Objective: To lay down a procedure for sterilization of cartridge filter. Scope: This SOP is applicable for sterilization of cartridge filter pre assembled in filter housings. Responsibility: Production Officers / Executive. Accountability: Prod... Read more
Objective: To lay down a procedure for cleaning of cartridge filter. Scope This SOP is applicable for cleaning of cartridge filter. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compl... Read more
Objective: To lay down a procedure for Delabelling and Repacking of vials. Scope This SOP is applicable on procedure for Delabelling and Repacking of vials for Production dry powder Injection facility. Responsibility Production Officers / Execut... Read more
Objective To lay down a procedure for cleaning of vial filling machine and its parts. Scope This SOP is applicable for cleaning of vial filling machine and its parts for Production dry powder Injection facility. Responsibility Production Officer... Read more