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
Mapping of the Environmental Conditions (Temperature and Relative Humidity) Objective : The objective of this validation study is to provide a document evidence of Temperature and Relative Humidity distribution in Ware House area against predetermined acceptance criteria. Scope : The scope of this protocol shall be applicable at formulation Plant. The validation study of the Temperature … Read more
SOP for Preparation of Validation and Qualification Protocols Objective : To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may affect the quality … Read more