SOP For Preparation of User Requirement Specification (URS) Objective: To lay down a procedure for preparation, review and approval of user requirement specification. Scope: This procedure outlines the requirements which shall be followed when creating a User Requirement Specification (URS), which is referred to as system or equipment design documentation. This procedure applies to all systems … Read more

SOP on Validation Master Plan (VMP) Objective: To lay down a procedure for preparation of Validation Master Plan (VMP) for facility. Scope: This SOP describes the preparation of validation master plan for the facility, area, equipments, processes, instruments, utilities and analytical methods for Formulation plant. Responsibility: Officer/Executive-QA shall be responsible for preparation of Validation Master … Read more

SOP on function of quality assurance department Objective: To describe the guideline for the function of quality assurance department. Scope: This SOP applicable for the function of quality assurance department of the Formulation plant. Responsibility: Quality assurance department. Accountability: HEAD – QA shall accountable for compliance of SOP. Procedure: Ensures that:- Medicinal products are designed and developed in … Read more

SOP on job responsibilities of personnel working in Quality Assurance. Objective: To lay down the procedure for providing the job responsibilities of personnel working in quality assurance department. Scope:  The scope of this SOP is limited to the Quality Assurance department at formulation plant. Responsibility:  Head – Quality Assurance is responsible for assigning the job responsibilities … Read more

SOP on In-process checks during Dry powder injection manufacturing & packing. Objective: To lay down a procedure for in process checks during Dry powder injection manufacturing & packing. Scope: This procedure is applicable to formulation unit. Responsibility: IPQA Officer/Executive shall be responsible for preparation & execution of the SOP. Accountability : Head QA shall be accountable for … Read more

SOP on Allocation of Bar Code Objective: To lay down a procedure for allocating Bar Code to Products. Scope: This SOP applicable for allocating Bar Code to Products. Responsibilities: Personnel QA is responsible for allocation & verification of Bar Code. Accountability: Head- Q.A shall be accountable for implementation and compliance of this SOP Procedure: To use bar code, company … Read more

Document Management System in Quality Assurance Department Objective: To lay down a procedure for Management of Documents in Quality Assurance Department. Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Head- Q.A shall be accountable for compliance of this SOP. Procedure: Storage of Documents in Record Room. Documents shall be stored in record room … Read more

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