We provide guidance for factories, facilities and equipment suppliers in the whole process of verification implementation in China and Europe and the United States, including verification training, assisting in drafting the verification master plan VMP, verification scheme VP, organizing the implementation and management of the whole verification process (DQ, IQ, OQ, PQ), completing the verification report and evaluation and document standardization, specifically, it includes the verification of plant facilities and three major systems, equipment verification, cleaning verification, method verification, computer software system verification, process verification, etc., to ensure that the latest GMP requirements and global verification guidelines are met.

The following services are available:

1. Verification system construction and system improvement consultation

Validation Protocol, Reporting Guidance and Enhancement:

Validate management system consultation (establishment or improvement).

Verify the establishment of key positions and personnel selection recommendations.

Based on the risk, formulate the establishment strategy of the verification management system to ensure compliance with the requirements of regulations or guidelines of China, FDA or EU, and close to the actual situation of the enterprise to ensure the efficient operation of the system.

Propose the document structure of the verification management system, draft/adjust the system document catalogue, and guide the enterprise or directly prepare the verification management system document. Or audit the existing verification system and guide the optimization of the system.

2. Verification scheme, report guidance and promotion:

Guide enterprises to draft URS documents, FAT, SAT, FS, DS, DQ, IQ, OQ, PQ plans, records and reports, and provide feasible rectification suggestions and guidance for different equipment to improve it to ensure that it meets the requirements of the target regulatory market.

3. Validation Test Services:

Can provide a complete verification test service, customized service plan according to enterprise needs, including verification plan drafting, verification risk assessment drafting, test execution, report drafting and deviation investigation in the verification process.

Provide professional verification and testing services, and provide necessary optimization suggestions according to the verification results or equipment conditions, and conduct systematic deviation investigation and treatment for deviations occurring during the test.

4. Verification Test Implementation Guidance

Provide on-site verification guidance, including new plant verification project management, verification test method training, verification implementation process supervision, verification process problem solving, etc;

Assist enterprises to train their own verification personnel, supervise the work of third-party testing services, etc.

Public System Service Items

1. Air Conditioning System Verification and Validation

Test items:

Wind speed, self-cleaning time, air volume (air exchange rate), tightness detection, temperature and relative humidity, high efficiency filter leak detection, suspended particle number, ozone concentration, floating bacteria, ultraviolet intensity, settling bacteria, total bacterial colony count in air, static pressure difference, total bacterial colony count on worktable surface, illuminance, total bacterial colony count on workers' watch surface, noise, static electricity, airflow pattern

Testing instrument:

2. Compressed Air Verification and Validation

Test items:

Oil content

Moisture content

number of dust particles

planktonia

Testing instrument:

3. water system verification

Service items:

Periodic sampling

water sample detection

4. pure steam verification

Test items:

Sampling of condensate water

non-condensable gas

dryness

superheat value

Testing equipment:

British SVMS steam quality testing device

-Serviced customers-

Lizhu Biology, Yinowi Medicine, Rippley Biology, Longsha Biology, Kangzhi Pharmaceutical, Hainan Senqi Pharmaceutical, etc.