"Pharmaceutical production quality management standard" on the validation of equipment put forward specific requirements. (Article 36: Production equipment should have obvious status signs, and regular repair, maintenance and verification. (Article 57: The validation of drug production shall include plant, facilities and equipment design confirmation, installation confirmation, operation confirmation, performance confirmation)
☆? The current stage of equipment validation content:
(a) the equipment in the selection, design, manufacture, installation, operation and performance of various aspects of the inspection and evaluation, in order to confirm that the equipment is in line with the requirements of drug production, whether to meet the equipment safety and effective function to ensure.
(ii) each part of the equipment validation are recorded, and validation of the plan, program, report, recommendations and evaluation. Validation documents are filed and stored for easy traceability.
(C) the main procedures for equipment verification:
Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ )
Performance Qualification (PQ)
☆? Applicable Regulations and Guidelines
1, Mechanical Safety - Mechanical and Electrical Equipment
2, Guide to Pharmaceutical Manufacturing Validation, 2003 Edition
3, Manufacturing Automation Management Specification 5th Edition
4, Good Engineering Practice
5, Good Manufacturing Practice for Pharmaceuticals (2010 Revision)
6. Chinese Pharmacopoeia 2010 Edition
☆?4Q Details:
1.DQ Design Confirmation
Design Confirmation (DQ) is clearly explained in the Drug Manufacturing Validation Guidelines as "Pre-confirmation, i.e., Design Confirmation, which usually refers to the review of the adaptability of the technical specifications of the equipment to be ordered and selection of the supplying manufacturer. " At the same time, in the "Drug Manufacturing Quality Management Code Implementation Guide" that "pre-confirmation: is the design of the equipment and selection of confirmation
DQ design confirmation, including the performance of the equipment, materials, structure, parts, measuring instruments and suppliers to confirm
2. IQ installation confirmation
Installation confirmation (IQ) is mainly by After the equipment is installed, it is confirmed that the equipment is installed in accordance with the design requirements, the documents and accessories are complete, and the existence of the equipment is proved through inspection and in the form of documents. In other words, by checking the documents and other items to confirm that the equipment and systems are installed as designed and meet the equipment and system design requirements and standards, and have been installed correctly.
IQ Installation Confirmation includes
Packaging Confirmation Equipment Inventory Installation Process Confirmation Material Confirmation (direct product contact)? Lubricant confirmation (lubricants in contact with the product must be food? Product grade) A variety of technical drawings and operating instructions to confirm and so on3.OQ operation confirmation
Operation confirmation (OQ) is to run through the no-load test, check and test the equipment operation, operation and control performance of the record and documented to confirm that the pharmaceutical machinery (equipment) in line with the requirements of the production process. In the installation confirmation of the equipment after the confirmation of the operational performance of the conformity and coordination of the confirmation.
OQ operation confirmation includes
Test instrument calibration
Equipment / system parts of the functional test
Indicators, interlocking devices and safety control testing
Alarm testing
Power outage and repair
4. PQ performance confirmation
Performance Qualification (PQ) Performance Qualification (PQ) Performance Qualification (PQ) is the actual operating effect of the equipment to confirm, performance qualification is the actual operating effect of the equipment. The actual operation of the equipment to confirm the effect of performance confirmation should be completed in the operation of the confirmation and has been recognized? After carrying out. Is in the pharmaceutical process technology under the guidance of industrial load production, with the simulation of production methods, through observation, recording, sampling and testing and other means to collect and analyze data to prove the reliability of pharmaceutical machinery (equipment) operation and adaptability to production.
3Q certification is valid for 1 year.