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.

For new plants or workshops, validation and verification are an important part of the GMP requirements and are the focus of the official inspection process. With the continuous updating of the concept and practice of confirmation in the western pharmaceutical industry, confirmation has become a major challenge for pharmaceutical companies to pass GMP certification in Europe and the United States. DST Durst has accumulated many years of confirmation experience, knows the nature of confirmation work, coupled with the inherent advantages rooted in the European pharmaceutical industry, we use modern confirmation concepts to provide customers with reliable confirmation solutions.

The following services are available:

1. Construction of plant verification system and system improvement consultation

l Verification scheme, report guidance and promotion:

l Validate management system consulting (establishment or improvement).

l Verify the establishment of key positions and personnel selection recommendations.

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

l 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:

L guide enterprises to draft URS documents of equipment, review FAT, SAT, FS, DS, DQ, IQ, OQ, PQ plans, records and reports, and provide feasible rectification suggestions and guidance for different equipment to upgrade them to ensure that they meet the requirements of the target regulatory market.

3. Validation Test Services:

L can provide complete verification and testing services, customized service plans according to enterprise needs, including verification plan drafting, verification risk assessment drafting, test execution, report drafting and deviation investigation in the verification process.

l Provide professional verification and testing services, and can provide necessary optimization suggestions according to the verification results or equipment conditions, and carry out systematic deviation investigation and treatment for the deviation in the test process.

4. Verification Test Implementation Guidance

l Provide on-site verification guidance, including new factory verification project management, verification test method training, supervision in the process of verification implementation, problem solving in the verification process, etc;

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

Test items:

Review of plant drawings, layout drawings,

-Serviced customers-

Lizhu Pharmaceuticals, Yinowi Pharmaceuticals, Reisipuli, Manulife Pharmaceuticals, Hainan Sanye Beautiful Pharmaceuticals, Kangzhi Pharmaceuticals, etc.