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; […]
EG001: SOP FOR PREVENTIVE MAINTENANCE
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: 2.1 This SOP shall be applicable to all equipment, instruments, utilities, and facility […]
WH001: SOP FOR GOOD WAREHOUSE PRACTICES (GWP)
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 be applicable to all warehouse areas including: Raw material warehouse Packaging material warehouse […]
PV001: SOP FOR PHARMACOVIGILANCE (PV) SYSTEM MANAGEMENT & QPPV RESPONSIBILITIES
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 organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and […]
HR001: SOP FOR RECRUITMENT AND SELECTION
OBJECTIVE: To define a uniform procedure for recruitment and selection of qualified and competent personnel to ensure that all positions are filled with individuals meeting the required education, experience, and skill levels as per WHO GMP and company requirements. SCOPE: This SOP applies to all departments and categories of employees (permanent, temporary, contractual, and trainees) […]
QA001: SOP for SOP
OBJECTIVE: To define the procedure for preparation, approval, distribution, control, revision, training, a destruction of Standard Operating Procedures (SOPs) in compliance with international standards (ICH Q7, WHO GMP, EU GMP, PIC/S). SCOPE: This SOP applies to all SOPs prepared and implemented in all departments of Company. RESPONSIBILITIES: Initiator / Section Head: Draft new SOPs or […]