SOP on Preparation of Site Master File Objective: To lay down the procedure for the preparation of Site Master File. Scope: Site Master File covers Facility, Premises, Equipment, Personnel, Quality System, and Utilities to formulation plant. Responsibility: Officer / Sr. Officer- QA Accountability: Head – QA Procedure: Site Master File shall be prepared by QA … Read more
SOP on Quality Risk Management Objective : To describe the procedure for management of risks, arising from different operations, activities and discrepancies. Scope : This SOP shall cover overall management of risks that arise from different operations, activities, discrepancies, deviations and failures in the manufacturing operations. Responsibility : Each Operating Manager and the Department Head shall be … Read more
SOP on container closure integrity for Dry powder for injection Objective : To lay down the procedure for container closure integrity for Dry powder for injection. Scope: This SOP is applicable for container closure integrity for Dry powder for injection. Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Chemical … Read more
Sampling and testing of Sterile surgical Gloves Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring the compliance … Read more
SOP on Operation procedure for Dispensing Booth Objective: To lay down a procedure for operation of dispensing booth. Scope: This procedure is applicable to the warehouse. Responsibility: Officer or above, Warehouse shall be responsible for implementation of this SOP. Accountability: Head – Warehouse shall be accountable for implementation and compliance of this SOP. Procedure: Dispensing area shall be free … Read more
SOP on reconciliation of raw and packaging material Objective: To provide a procedure for reconciliation of raw materials & packaging materials Scope: This SOP is applicable to all raw material & packaging material available in the warehouse of formulation plant. Responsibility: Officer or above of warehouse shall be responsible for reconciliation of raw & packing material. Accountability: Head Warehouse … Read more
SOP on Operation and cleaning procedure for Vacuum Cleaner Objective : To lay down a procedure for operation and cleaning of vacuum cleaner. Scope : This procedure is applicable to the formulation plant. Responsibility : Warehouse technician / Assistant are responsible for these activities. Accountability : Head – Warehouse shall be accountable for implementation and … Read more
SOP on cleaning & operation of stacker. Objective: To lay down the procedure for cleaning and operation of stackers. Scope: This SOP is applicable for stacker cleaning & operation in warehouse in formulation plant. Responsibility: Officer/above of Warehouse shall be responsible for implementation of SOP. Accountability: Head – Warehouse shall be accountable for compliance of SOP. Procedure: Procedure … Read more
SOP on cleaning of air curtain. Objective: To lay down a procedure for cleaning of air curtains. Scope: This SOP is applicable to raw and packaging material storage receiving area of the formulation plant. Responsibility: Officer or above of Warehouse shall be responsible for Implementation of this SOP. Accountability: Head- Warehouse shall be responsible for compliance of SOP. Procedure: … Read more
SOP on Dispensing of Solvent / Liquid Materials Objective: To lay down a procedure for dispensing of solvent / liquid materials. Scope: This SOP is applicable for dispensing of solvent / liquid materials in warehouse. Responsibility: Supervisory staff of warehouse shall be responsible for implementation of this SOP. Accountability: Head – Warehouse shall be accountable for compliance of … Read more