GIMP Conforming Documentation Part 02 توثيق متوافق مع مبادئ التصنيع الجيد الجزء الثاني

In the pharmaceutical industry in Egypt, the EDA (Egyptian Drug Authority) requires GIMP (Good Importation and Manufacturing Practices)-conforming documentation to ensure compliance with national and international standards. Key requirements include:
Complete and accurate documentation of all importation and manufacturing activities.
Detailed Standard Operating Procedures (SOPs) for each step in the production and importation processes.
Comprehensive batch records for every production run, including raw material sources and quantities.
Validation protocols and reports for all equipment and processes to ensure consistency and reliability.
Quality control and assurance records, including test results and deviation reports.
Regular reviews and updates of all Quality Management System (QMS) documents.
Training records for all personnel involved in manufacturing and quality control.
Documentation of cleaning and maintenance schedules for all manufacturing equipment.
Proper archiving and protection of all documents to ensure their integrity and accessibility.
Compliance with national regulations and alignment with international GMP standards to ensure product safety and efficacy.