Quality Assurance

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

SOP for Numbering of compactor and Storage of documents in the compactor system of Documentation cell-QA Objective : To lay down a procedure for numbering of compactor and storage of documents in the compactor. Scope : This Standard operating procedure is applicable for formulation plant. Responsibility : QA Officer/Executive Doc Cell : Shall be responsible … Read more

SOP on Line Clearance Objective : To lay down a procedure for Line Clearance before proceeding to another product/ batch or step in the production. Scope : This Standard Operating Procedure is applicable for formulation plant. Responsibility : Executive/ Officer/ Supervisor- Production / Stores to ensure line clearance as per this SOP. Executive/ Officer- IPQA to give … Read more

SOP for Assigning of Numbers for Qualification Documents, Protocols and Reports Objective : To lay down a procedure for assigning of number for qualification documents, protocols and reports. Scope : This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and the reports … Read more

SOP for Assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number to the Drug Products Objective : To lay down a procedure for assigning number to Master Formula Card, Master Formula and Packaging Formula of a Drug Product. Scope :  This Standard Operating Procedure is applicable for assigning Master Formula Card Number, Master … Read more

SOP for Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS Items Objective : To lay down a procedure for Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS items in various departments. Scope : This Standard Operating Procedure is applicable to various departments of formulation plant. Responsibility : Head of departments or his / … Read more