SOP On Quality Management Objective : To lay down a procedure for Quality Management . Scope : This procedure is applicable for all formulation plants. Responsibility : Head Quality Assurance shall be responsible for compliance of this SOP. Heads of Production, QC, Stores, Engineering, Administration, HR, Materials Management, Regulatory Affairs, etc. shall be responsible for implementation and compliance … Read more
SOP on Corrective and Preventive Action (CAPA) Objective : To lay down a procedure to operate as a single control point for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and / or encountered non-conformities in order to prevent their occurrence and / or recurrence. Scope : This Standard Operating Procedure … Read more
SOP on Date and Time Format in Written Procedures Objective : To lay down a procedure for entering the date and time in all written procedures. Scope : This Standard Operating Procedure is applicable to all operational documents applicable at all pharmaceutical formulation plants / Operations. Responsibility : All concerned HODs shall be responsible for implementation of this … Read more
SOP on Document and Data Control Objective : To lay down a procedure for control of Documents and Documented Data. Scope : This Standard Operating Procedure is applicable for the control of documents and documented data of all the formulation plants/ operations. Responsibility : All HODs shall be responsible to follow this SOP for maintaining control on … Read more
SOP on Assessment of Contract Analytical Laboratory for Qualification Objective : To lay down a procedure for Assessment of Contract Analytical Laboratory for qualification. Scope : This Standard Operating Procedure is applicable for qualification of Contract Analytical Laboratory for analysis of samples for which in-house testing facility is not available. Responsibility : Heads of Quality Control and Quality … Read more
SOP on 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 … Read more
SOP On Release of Finished Goods Objective : To lay down a procedure for the release of finished goods for sale and distribution. Scope : This standard operating procedure is applicable for the release or hold or reject of finished goods manufactured at all formulation plants. Responsibility : Production personnel shall be responsible for transferring the … Read more
SOP on Review of Batch Manufacturing Record Objective : To lay down a procedure for review of batch manufacturing record. Scope : This Standard Operating Procedure is applicable for all formulation plants. Note: The BMRs may be reviewed as per site specific SOP, if available at the respective manufacturing location. Responsibility Officer / Executive, Quality Assurance … Read more
SOP On Preparation, Approval and Control of General Test Procedures Objective : To lay down a procedure for the preparation, approval and control of General Test Procedures. Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all General Test Procedures. Microbiological tests and testing methods for packaging materials (i.e. test methods common … Read more
SOP on New Product Design and Development Process Objective : To lay down a Procedure for New Product Design and Development Process. Scope : This Standard Operating Procedure is applicable all pharmaceutical formulation plants/ operations. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data for DCGI permission. … Read more