Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0      PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]

Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0       PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]

Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant.  Handling and Control Procedure for Incident / Deviation  1.0       PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]

Standard Operating Procedure (SOP) for Qualification of Instrument, Equipment, Facility & Utility in the pharmaceutical manufacturing plant.  Qualification: The action of proving and documenting that equipment or utility is properly installed, work correctly, and actually produce the expected results consistently. Procedure for Qualification of Equipment, Instrument, Facility & Utility 1.0      PURPOSE: The purpose […]

Standard Operating Procedure (SOP) for Handling of Data Integrity Observations (DIO) and Data Integrity Breach (DIB). Data Integrity is the extent to which all data are complete, consistent, truthful, traceable and accurate through the data life-cycle. Procedure For Handling of Data Integrity Observations 1.0      PURPOSE The purpose of this Standard Operating Procedure (SOP) […]

Standard Operating Procedure for the handling of Corrective and Preventive Action (CAPA). Corrective and Preventive Action (CAPA) is a concept with current Good Manufacturing Practice (cGMP) that focuses on the systematic investigation of root causes of unexpected incidences to prevent their recurrence (corrective action) or to prevent their occurrence (preventive action) Handling of Corrective and Preventive Action […]

Standard Operating Procedure for Waste Disposal in Pharmaceutical plants. Waste can be classified as Hazardous Waste, E-Waste, Biological Waste, etc. SOP for Disposal of Waste Materials in Pharma   1.0      Purpose : The purpose of the SOP to provide the written guidelines for the disposal of various types of waste material generated in […]

Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as  Filled Copy of Batch Manufacturing/Packing Records.  Procedure for BMR & BPR Review 1.0       PURPOSE: The purpose of […]

Standard Operating Procedure for maintenance of the building in different seasons/weather for cracks, chocked and drainage systems in a pharmaceutical manufacturing plant. Building and facilities demand continue up keeping, repair works or up-gradation work for floor, wall, and ceiling. Whenever it happens painting, rack repair, floor repair, surrounding maintenance are done is called Building Maintenance. […]

Standard Operating procedure (SOP) for material movement in pharmaceutical manufacturing premises form dispensing to the final product. whether material movement from one department to another or within the department. SOP for Material Movement In Manufacturing Premises 1.0      PURPOSE: The purpose of this SOP is to lay down the procedure for material movement procedures […]

Standard Operating Procedure (OOS) for the handling of Out of Specification Test Results, This SOP is designed based upon MHRA and WHO guideline for Handling of Out of Specification (OOS) results. In the SOP, Detailed procedure provided for the handling of out of specification (OOS) test results, preliminary investigation, Phase I, Phase II and Phase […]

Standard Operating Procedure (SOP) for Calibration of Gas Chromatography (GC), parameters are Carrier Gas flow Accuracy,  Calibration of Flame Ionization Detector (FID) by linearity Measurement, Calibration of Auto-injector by linearity measurement, Calibration for Column Oven temperature measurement, etc. SOP / Protocol for GC Calibration GC Calibration Procedure: At the time of calibration enter the details […]

Standard Operating Procedure (SOP) for Laboratory Instrument Qualification including User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Interim Qualification of Legacy Systems in Quality Control Laboratory. Procedure for Laboratory Instrument Qualification 1.0      PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for […]

Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control. In case of stability out of trend (OOT) results describes as “A results that are within the specification but do not follow the trend, with respect to previous station […]

Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good Manufacturing Practices Guideline). Raw Material sampling is the process of abstraction of a representative portion of material or a group of units from a larger quantity of material or collection of units. Procedure for Raw […]