1.0 OBJECTIVE: 1.1 The objective of this SOP is to describe, in a clear and comprehensive manner, the step-by-step operation of the Compression Machine (SUMA PRESS MAX – 37D / 45DB) to ensure safe, consistent, and reproducible compression of tablets as per

1.0 OBJECTIVE: 1.1 The objective of this SOP is to describe, in a clear and comprehensive manner, the step-by-step operation of the Octagonal Blender (OB – 1000 LTR) using the integrated PLC/HMI system. 1.2 The SOP outlines the correct method to operate

1.0 OBJECTIVE: 1.1 To define the procedure for operating of Multimill machine. 2.0 SCOPE: 2.1 This Sop applies to the operating procedure for Multimill machine in the company. 3.0 RESPONSIBILITY: 3.1 Production Operators: 3.1.1 Responsible for operating the Multimill strictly as per

1.0 OBJECTIVE: 1.1 The objective of this SOP is to describe, in a clear and comprehensive manner, the step-by-step operation of the Rapid Mixer Granulator (RMG – 500 L) using the integrated PLC/HMI system. 1.2 The SOP outlines the correct method to

1.0 OBJECTIVE: 1.1 The objective of this SOP is to describe the operational steps for running the Fluid Bed Equipment (FBE – 200 KGS) using the integrated PLC/HMI interface in Auto Mode, Manual Mode, Charging Mode, and Maintenance Mode. 1.2 This procedure

1.0 OBJECTIVE: 1.1 This SOP shall describe the procedure for maintaining cleanliness and orderly conditions in warehouse areas to prevent contamination, deterioration of materials, pest infestation, and mix-ups. 2.0 SCOPE: 2.1 This SOP shall be applicable to the following warehouse areas: 2.1.1

1.0 OBJECTIVE: 1.1 This SOP shall define the procedure for controlled issuance of materials to production and controlled dispatch of finished goods to ensure traceability, prevent mix-ups, and maintain compliance with Good Manufacturing Practices. 2.0 SCOPE: 2.1 This SOP shall be applicable

1.0 OBJECTIVE: 1.1 This SOP shall describe the procedure for safe handling and controlled movement of materials and finished goods to prevent mix-ups, contamination, damage, and loss of traceability during warehouse operations. 2.0 SCOPE: 2.1 This SOP shall be applicable to: 2.1.1

1.0 OBJECTIVE: 1.1 This SOP shall describe the procedure for implementation and control of First In First Out (FIFO) and First Expiry First Out (FEFO) principles to ensure proper material rotation, prevent use of expired materials, and maintain product quality. 2.0 SCOPE:

1.0 OBJECTIVE: 1.1 This SOP shall describe the procedure for status labeling and identification of materials and finished goods to ensure clear identification, prevent mix-ups, and maintain traceability throughout warehouse operations. 2.0 SCOPE: 2.1 This SOP shall be applicable to: 2.1.1 Raw

1.0 OBJECTIVE: 1.1 This SOP shall define the procedure for receipt, verification, identification, and initial handling of raw materials, packaging materials, and finished goods in the warehouse to ensure compliance with Good Manufacturing Practices and to prevent mix-ups, damage, or unauthorized use.

1.0 OBJECTIVE: 1.1 The objective of this Standard Operating Procedure is to define a structured and systematic approach for ensuring compliance with global pharmacovigilance regulatory reporting requirements applicable to medicinal products marketed by the company or managed through contractual pharmacovigilance responsibilities. 1.2

1.0 OBJECTIVE: 1.1 The objective of this Standard Operating Procedure is to define a structured and comprehensive Business Continuity Plan for Pharmacovigilance that ensures uninterrupted access to essential PV systems, tools, communication channels, and critical safety functions during any emergency or disruption

1.0 OBJECTIVE: 1.1. The purpose of this SOP is to define a structured and controlled Disaster Recovery Plan (DRP) to ensure the rapid restoration of all Pharmacovigilance (PV) systems, applications, critical data, and communication channels in the event of a system failure,

1.0 OBJECTIVE: 1.1 The purpose of this SOP is to describe the standardized process for the preparation, review, approval, and submission of the Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) in accordance with the requirements of the World

1.0 OBJECTIVE: 1.1 To define a standardized process for Signal Detection, Signal Evaluation, and Signal Management for all medicinal products. 1.2 To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) Module IX. 1.3 To ensure early