OBJECTIVE: To describe the Good Documentation Practices (GDP) to be followed throughout all departments to ensure that all data and records generated, handled, and maintained are complete, legible, traceable, and compliant with EU-GMP, WHO, and national regulatory expectations.  SCOPE: All GMP/GLP documentation

OBJECTIVE: To define the procedure for preparation, review, approval, implementation, and periodic review of Technical Quality Agreements (TQAs) between the manufacturing site and external parties (contract manufacturer, contract laboratory, API supplier, or product importer) to ensure compliance with EU-GMP / WHO GMP

OBJECTIVE: To define a risk-based, documented process to evaluate, qualify, approve, and periodically re-qualify suppliers of materials and services so they consistently meet specifications and GMP requirements.  SCOPE: Applies to APIs, Excipients, Primary/printed/secondary packaging, Process aids, Lab chemicals, Contract testing, Calibration and

OBJECTIVE: This SOP establishes a comprehensive and EU-GMP–compliant system for receiving, recording, investigating, and resolving market complaints associated with both own manufactured and imported finished pharmaceutical products handled by Company SCOPE: This SOP applies to all market complaints received from distributors, healthcare

OBJECTIVE: This document outlines the procedure for administering corrective and preventive actions (CAPA), including tracking and reporting their status. SCOPE: This SOP is relevant for procedures for tracking, following up on, and verifying the completion and effectiveness of corrective and preventive actions

OBJECTIVE: The objective of process validation is to establish documented evidence that a manufacturing process, when operated within defined parameters, is capable of consistently producing a product that meets its predetermined quality attributes and specifications. SCOPE: This procedure applies to: All new

OBJECTIVE: The objective of this SOP is to establish a systematic and documented procedure for conducting self-inspections to verify compliance with EU GMP, WHO, FDA, and other applicable regulatory requirements. This SOP ensures: Continuous compliance with cGMP. Early identification of potential gaps

OBJECTIVE: The objective of this SOP is to outline the procedures for conducting Quality Management Review Meetings. These meetings aim to ensure continuous improvement, compliance with regulatory requirements, and the enhancement of overall quality management practices. SCOPE: This SOP applies to all

OBJECTIVE: To define the standard procedure for the qualification of equipment, instruments, and systems to ensure they are fit for intended use and consistently operate within established limits as per EU GMP / WHO TRS requirements.  SCOPE: All new equipment, instruments, utilities,

OBJECTIVE: To establish a comprehensive procedure for training and development of all personnel to ensure competence, compliance with Regulatory requirements, and continual improvement of knowledge, skills, and performance.  SCOPE: This SOP applies to all employees, contract staff, and temporary staff at [Company

OBJECTIVE: To define the procedure for initiation, recording, investigation, evaluation, approval, trending, and closure of deviations, and for handling of rejections and destruction of materials and products, in compliance with regulatory requirements. SCOPE: All deviations related to documented systems, procedures, RM/PM/FP specifications,

OBJECTIVE: To prepare a procedure for formal risk management process comprising the identification, analysis, evaluation, controlling and review of risk factors associated with business and product quality across the life cycle.  SCOPE: This procedure provides the procedure for Quality Risk Management (QRM)

OBJECTIVE: The purpose of this procedure is to define a systematic, risk-based process for initiating, evaluating, approving, implementing, verifying and closing changes that may impact product quality, patient safety, data integrity, regulatory compliance or business continuity.  SCOPE: This procedure applies to all

1.0 OBJECTIVE: 1.1 This SOP shall describe the requirements and procedures for planning, execution, documentation, and control of preventive maintenance activities for equipment, instruments, utilities, and facility systems to ensure reliable operation, prevention of breakdowns, and compliance with GMP requirements. 2.0 SCOPE:

OBJECTIVE: This SOP shall describe the requirements and procedures to be followed to ensure proper receipt, storage, handling, control, and dispatch of raw materials, packaging materials, intermediates, finished products, and returned goods in compliance with Good Warehouse Practices. SCOPE: This SOP shall

OBJECTIVE: To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GMP, and local regulatory requirements. SCOPE: This SOP applies to all PV activities in the