QA021: SOP FOR INCIDENT REPROTING
OBJECTIVE: To describe the procedure for identifying, documenting, investigating, and reporting any incident or deviation that may impact product quality, Good Manufacturing Practices (GMP) compliance, safety, or regulatory requirements within the pharmaceutical manufacturing facility. SCOPE: Applicable to all departments of the manufacturing site such as Production, Quality Assurance (QA), Quality Control (QC), Engineering, Microbiology, Warehouse, […]
QA020: SOP FOR PREPARATION, REVIEW, AND CONTROL OF VALIDATION MASTER PLAN (VMP)
OBJECTIVE: The purpose of this SOP is to define the procedure for the preparation, review, approval, issuance, and control of the Validation Master Plan (VMP) in compliance with WHO TRS / EU-GMP Annex 15 and other applicable regulatory guidelines. The VMP serves as a high-level document summarizing the site’s validation policy, strategy, responsibilities, scope, and […]
QA019: SOP FOR PREPARATION, REVIEW, AND CONTROL OF SITE MASTER FILE (SMF)
OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to define the procedure for the preparation, review, approval, distribution, and control of the Site Master File (SMF) in accordance with the requirements of WHO / TRS / EU-GMP Part III and other applicable regulatory guidelines. The SMF provides a detailed overview of the site’s […]
QA018: SOP FOR DISASTER RECOVERY PLAN (DRP) FOR GMP-RELEVANT COMPUTARIZED SYSTEMS
OBJECTIVE: To define the documented and controlled procedure for recovery and restoration of GMP-relevant computerized systems following any disaster or system failure, ensuring data integrity, traceability, business continuity, and compliance with WHO TRS / EU GMP Annex 11 and Annex 15. SCOPE: It shall be Applied to: All GMP-critical computerized systems and associated databases. Data […]
QA017: SOP FOR PRODUCT QUALITY REVIEW
OBJECTIVE: To define the procedure for the preparation, review, and approval of Product Quality Review (PQR) in compliance with regulatory, ensuring continued process consistency, product quality, and suitability of current specifications. SCOPE: Applicable to all finished pharmaceutical products manufactured by Company. This SOP covers collection, evaluation, trending, and reporting of production, analytical, and quality data […]
QA016: SOP FOR PRODUCT RECALL
OBJECTIVE: To establish a uniform procedure for prompt, efficient, and effective withdrawal or removal of finished pharmaceutical products from the market whenever a quality, safety, or regulatory defect is identified. This SOP ensures full compliance with regulatory expectations, providing for coordination, communication, and documentation of all recall activities. SCOPE: This procedure applies to all finished […]
QA015: SOP FOR DATA INTEGRITY
OBJECTIVE: To define a robust system to ensure that all data generated, recorded, processed, and reported across manufacturing, laboratory, and computerized systems are complete, consistent, accurate, and reliable throughout their entire lifecycle, in compliance with EU GMP, and WHO guidelines on Data Integrity. SCOPE: This SOP applies to all departments involved in the generation, review, […]
QA014: SOP FOR GOOD DOCUMENTATION PRACTICES
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 including Batch Manufacturing and Packaging Records, analytical and laboratory data, logbooks, equipment records, […]
QA013: SOP FOR EXECUTION OF TECHNICAL QUALITY AGREEMENT
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 / local regulatory requirements. SCOPE: This procedure applies to all contract manufacturing, testing, […]
QA012: SOP FOR SUPPLIER QUALIFICATION
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 HVAC Validation Contract Manufacturing organizations, Distributors Service agreements for Equipment / Instrument in […]