1.0 OBJECTIVE: 1.1. To define the procedure for performing local and global literature screening to identify published information related to Adverse Events (AE), Adverse Drug Reactions (ADR), product safety issues, signals, and risk-related information. 1.2. To ensure compliance with World Health Organization

1.0 OBJECTIVE: 1.1 To describe the standardized procedure for processing Individual Case Safety Reports (ICSR) including triage, data entry, medical terminology coding using Medical Dictionary for Regulatory Activities (MedDRA), and causality assessment. 1.2 To define the process for reporting ICSRs to local

1.0 OBJECTIVE: 1.1 To define the procedure for receiving, recording, documenting, and forwarding Adverse Events (AE) and Adverse Drug Reactions (ADR) reported from any source. 1.2 To ensure compliance with World Health Organization (WHO), European Union Good Pharmacovigilance Practices (EU-GVP), and local

1.0 OBJECTIVE: 1.1 To describe the procedure for the operation of the Digital Tablet Hardness Tester for the determination of tablet hardness (crushing strength) and, where applicable, tablet thickness, diameter, length, width and weight, to ensure accurate, reliable and reproducible test results

1.0 OBJECTIVE: 1.1 To describe the procedure for the operation of the Tablet Disintegration Test Apparatus for determining the disintegration time of tablets in accordance with applicable pharmacopeial requirements. 2.0 SCOPE: 2.1 This SOP shall apply to the operation of the Tablet

1.0 OBJECTIVE: 1.1 To describe the procedure for the operation of the Vernier Caliper for measuring the thickness, diameter, length and width of tablets. 2.0 SCOPE: 2.1 This SOP shall apply to the operation of the Vernier Caliper used in the Quality

1.0 OBJECTIVE: 1.1 To describe the procedure for the operation of the Leak Test Apparatus for determining the integrity of pharmaceutical packaging systems by detecting leakage under vacuum conditions. 2.0 SCOPE: 2.1 This SOP shall apply to the operation of the DBK

1.0 OBJECTIVE: 1.1 To describe the procedure for the operation of the Digital Friability Test Apparatus for determining the friability of tablets in accordance with the approved method. 2.0 SCOPE: 2.1 This SOP shall apply to the operation of the Digital Friability

1.0 OBJECTIVE: 1.1 To describe the procedure for the operation of the Shimadzu Moisture Analyzer for determination of moisture content/loss on drying of pharmaceutical raw materials, in-process materials, finished products, and packaging materials. 2.0 SCOPE: 2.1 This SOP applies to all personnel

1.0 OBJECTIVE: 1.1 To establish a standardized procedure for planning, coordinating, conducting, and managing inspections performed by Regulatory Authorities, Certification Bodies, Government Agencies, Customers, and other authorized external organizations. 1.2 To ensure inspections are managed in compliance with WHO GMP, cGMP, GDP

1.0 OBJECTIVE: 1.1 To establish a systematic and documented procedure for planning, conducting, evaluating, recording, and maintaining Good Manufacturing Practice (GMP) training programs to ensure that all employees, contractors, consultants, service providers, and other personnel working within the company possess the knowledge,

OBJECTIVE: To define the procedure for establishing, reviewing, approving, and maintaining Safety Data Exchange Agreements (SDEA) with all partners involved in safety-related activities. To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) requirements. To clearly define

OBJECTIVE: To define the procedure for preparation, approval, maintenance, and control of the Pharmacovigilance Master File (PSMF) in accordance with World Health Organization (WHO) guidelines, European Union Good Pharmacovigilance Practices (EU-GVP) Module II, and applicable national PV regulations. SCOPE: This SOP applies

OBJECTIVE: To define the controlled procedure for entry and exit of personnel into/from the manufacturing block.  SCOPE: Applicable to all personnel entering or exiting the manufacturing block. RESPONSIBILITIES: All Personnel: Follow the procedure strictly Production/Area Supervisor: Ensure compliance during entry and exit.

OBJECTIVE: To establish a procedure for preparation, approval, maintenance, and revision of the organizational chart (organogram) to ensure a clear definition of reporting structure, roles, and responsibilities in compliance with WHO GMP requirements.  SCOPE: This SOP applies to the preparation, control, review,

OBJECTIVE: To establish a procedure for preparation, control, issuance, and maintenance of Specimen Signature Records of all authorized personnel involved in GMP activities.  SCOPE: This SOP shall be applicable to all personnel authorized to sign GMP documents and any other documents related