OBJECTIVE: 1.1        To describe the procedure for preventive maintenance of HPLC’s 2. RESPONSIBILITY: 2.1       Executive  – Quality Control– To perform the preventive maintenance activity. 2.2        Head - Quality Control  - To ensure compliance against established schedule. 3. PROCEDURE       Precautions: 3.1       Ensure that the power supply to the instrument is switched “off” before starting the … Continue reading Preventive Maintenance of HPLC’s →

OBJECTIVE 1.1 To lay down a procedure for  training and a mechanism to evaluate a chemist on General Analytical techniques. 2.          RESPONSIBILITY 2.1        Personnel who are knowledgeable with the subject virtue of their qualification and   experience, to train the analyst as required. Head – Quality Control – To ensure the compliance of SOP.  PROCEDURE All … Continue reading Qualification of Analyst in Quality Control →

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 1.0 OBJECTIVE To lay down a procedure for Procurement, Inspection, Storage, Usage, Polishing and Cleaning of Punches and Dies, which are used as tabletting tools. 2.0 RESPONSIBILITY Technical Assistant – To follow the SOP. Executive – To comply the SOP. 3.0 PROCEDURE 3.1 PROCUREMENT OF PUNCHES AND DIES: Production department shall identify the required tabletting … Continue reading Procurement, Inspection, Storage, Usage, Polishing and Cleaning of Punches and Dies →

1.0 OBJECTIVE To provide the detail procedure for qualification of an area. 2.0 SCOPE This SOP applies to qualification of all areas which are used for storage and process of material and which may affect the product quality, safety, efficacy and storage. 3.0 RESPONSIBILITY Officer/designee - QA:  To prepare area qualification protocol and report. To … Continue reading SOP for Performing Area Qualification →

OBJECTIVE:To provide the procedure for performing temperature and/or relative humidity (RH) mapping study.To establish that the temperature and/or relative humidity conditions across the room or area are within the prescribed limits during extreme external weather conditions.To identify the locations where the monitoring sensors should preferentially be located. 2.0 SCOPE:Applicable to (but not limited to) cold … Continue reading Temperature / Relative Humidity Mapping, Re-Mapping and Monitoring →

  Equipment Name :Vacuum Tray DryerEquipment Model No.:XYZEquipment Sr. No.:XYZEquipment ID No.:VTD/XYZEquipment Area :Drying roomEquipment Manufacturer Name :Equipment Application :For drying of wet granules and pelletsReport Date :  REPORT APPROVAL:           Prepared byChecked byApproved bySignature       Date     Name     DepartmentMaintenanceQuality AssuranceProductionHead -MaintenanceHead - Quality Assurance Corporate Office: -                                                                                XYZ Factory:-     Sr. No.TitlePage No. Report approval ………………………………………………………1 Table of contents … Continue reading Installation, Operational and Performance Qualification Report of Vacuum Tray Dryer (VTD) →

What is Acceptable Quality Level (AQL) : Acceptable Quality Level (AQL) is a percent defective that is the base line requirement for the quality of the product. The sampling plan required to be prepared or design in such a way that there is high probability of accepting a lot that has a defect level less … Continue reading Acceptable Quality Level (AQL) in Pharmaceuticals →