Pharmaguidances

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