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On-site survey and assessment of plant layout, production area cleanliness, personnel and material flow pathways, etc.
Examination of the completeness and effectiveness of current quality management documentation, SOPs, and record-keeping systems
Providing corrective recommendations for findings and guiding the establishment of GMP-compliant production control systems
Conducting gap analysis against international GMP standards and assisting with system upgrades, laying the groundwork for export compliance
Delivering special training on GMP regulations, quality awareness, proper documentation practices, etc., to enhance team execution capability
Independent review of the production site's hygiene management system, identifying potential contamination risk points
Capture and culture of airborne microorganisms to assess air cleanliness levels
Quantitative microbiological testing of critical contact surfaces using appropriate sampling techniques (contact plates, swab samples, etc.)
Inspection of hand hygiene, workwear, and other personnel-related factors to assess the risk of human contamination
Customized training for employees covering hygiene regulations, contamination control, cleaning and disinfection practices, etc.
When hygiene-related deviations occur, assist in root cause investigation and propose corrective and preventive actions
Synthesize evaluation results to propose improvements to cleaning and disinfection protocols, operational workflows, etc., enhancing the level of hygiene assurance
Provide on-site sampling and rapid screening at the incoming stage to ensure the quality and compliance of input materials
Conduct release tests including microbial limits and physico-chemical parameters, providing data-backed assurance for product shipment
Assist in compiling and establishing a regulation-compliant Product Information File to support product registration/notification and compliance demonstration