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
SOP for Control of Stamps in Quality Assurance Department Objective : To lay down a procedure for Control of Stamps in Quality Assurance department. Scope : This standard operating procedure is applicable to formulation plant. Responsibility : Officer/Executive QA shall be responsible for implementation of procedure as per this SOP. Head QA/ designee shall be responsible … 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 … Read more
SOP for Access control system numbering and usage Objective : To lay down a procedure for assigning of identification numbers to access control system and usage of the system. Scope : This Standard Operating Procedure is applicable to various departments of formulation plant. Responsibility : Head-User department shall be responsible for sending the request to QA department … Read more