sop for of environmental conditions of control sample room 1.0. PURPOSE: To lay down the procedure for daily monitoring of environmental conditions i.e. Temperature and Relative Humidity in Control Sample Room 2.0. RESPONSIBILITY: 4.1 The Officer Quality Assurance shall be: 4.1.1 Responsible for daily monitoring the environmental conditions 4.1.2 Responsible for recording … Read more
sop for Handling of poisonous and hazardous chemicals . 1.0 OBJECTIVE 0y down procedure for handling of poisonous and hazardous chemicals. 2.0 RESPONSIBILITY Q.C. Chemist / Q.C Executive. 3.0 ACCOUNTABILITY Manager Q.A. 4.0 PROCEDURE 4.1 Store all poisonous chemicals in well isolated place under lock and key. 4.2 Always use necessary safety devices while … Read more
sop for swab sampling for validation of clean surfaces 1.0 OBJECTIVE To establish a procedure for swab sampling for validation of test surface to evaluate cleaning efficacy. 2.0 RESPONSIBILITY Quality Control Supervisor 3.0 ACCOUNTABILITY Quality Control Manager 4.0 PROCEDURE FOR CHEMICAL EVALUATION 4.1 SWAB : A clean room laundered polyurethane foam swab molded … Read more
sop for failure investigation 1.0 OBJECTIVE To lay down a procedure for investigation any failures in product, process or systems which may affect the quality of the finished product. 2.0 RESPONSIBILITY Production Manager/Quality Assurance Manager. 3.0 ACCOUNTABILITY Plant Head 4.0 Procedure 4.1 Failure investigation shall be carried out when a product does not … Read more
sop for generation of compliance report 1.0 OBJECTIVE To lay down a procedure for investigation and generation of compliance report after an audit by any of the external agencies. 2.0 RESPONSIBILITY All Departmental Heads. 3.0 ACCOUNTABILITY Head – Quality Assurance 4.0 Procedure 4.1 After the submission of the report from the auditors, a … Read more
sop for numbering and approval of formats 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe procedure for approval and numbering of Formats. 2.0. RESPONSIBILITY: 2.1 Head of the respective Department shall be: 2.1.1. Responsible for preparing the format as per their requirement. 2.1.2. Responsible for taking approval of Quality Assurance. … Read more
sop for rework procedure 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for Rework of dosage forms which require change of packaging components(s). 2.0. RESPONSIBILITY: 2.1 Initiating Department shall be: 2.1.1 Responsible to fill up the requisition for rework in the form 2.1.2 Responsible seeking recommendations of Head – … Read more
sop for tolerance in the schedule of calibration 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for acceptable tolerance limit for the frequency of calibration of instruments. 2.0. RESPONSIBILITY: 2.1 Officer of Concerned Department shall be: 2.1.1 Responsible for calibration of the instrument in co-ordination with the Engineering … Read more
sop for change control procedure 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure to be followed for experimental change / permanent change. 2.0 RESPONSIBILITY: 2.1 The Originating department shall be: 2.1.1. Responsible for requesting for the Change Control form to Quality Assurance. 2.1.2. Responsible for fill up the … Read more
sop for control of process deviation 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for handling of process deviations. 2.0. RESPONSIBILITY: 2.1 Head of the Concerned Department shall be: 2.1.1. Responsible for initiation as well as investigation on process deviation. 2.2 Quality Assurance shall be: 2.2.1 Responsible for … Read more