QA011: MARKET COMPLAINT
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 professionals, patients, and regulatory authorities concerning products that are either: Manufactured at company […]
QA010: SOP FOR CAPA
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 (CAPA). RESPONSIBILITIES: Production Department: Identify and report any deviation, non-conformity, or trend observed […]
QA009: SOP FOR PROCESS VALIDATION
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 products prior to commercial batch release. Existing products when significant changes occur (formulation, […]
QA008: SOP FOR SELF-INSPECTION
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 affecting product quality, patient safety, and regulatory compliance. Implementation of effective Corrective and […]
QA007: SOP FOR QUALITY MANAGEMENT REVIEW
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 departments and personnel involved in quality-related activities, including but not limited to Quality […]
QA006: SOP FOR QUALIFICATION OF EQUIPMENTS / INSTRUMENTS / SYSTEM
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, and systems used in production, quality control, and support areas. Requalification after relocation, […]
QA005: TRAINING
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 Name] whose activities may affect product quality, patient safety, or GMP compliance. It […]
QA004: SOP FOR DEVIATION MANAGEMENT
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, analytical methods, and equipment. Rejection and destruction of raw materials, intermediates, packaging materials, […]
QA003:SOP FOR QUALITY RISK MANAGEMENT
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) that can be applied to different aspect at Company. This procedure covers identification, […]
QA002: SOP FOR CHANGE CONTROL PROCESS
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 GMP-relevant changes within the company, including but not limited to facilities and utilities; […]