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Service

Pharmaceutical Research

service content

API(Active pharmaceutical ingredients) quality research service:
◊ measuring the solubility and pH- saturated solubility curves of API in various media；
◊ Effect of particle size of API on dissolution in vitro；
◊ improving API quality standards.

Auxiliary material quality research service：
◊ improving auxiliary material quality standards

Develop and validate analysis method services：
◊ Preliminary establishment and verification of content methods；
◊ Preliminary establishment and verification of material methods；
◊ Preliminary establishment and verification of dissolution methods.

Stability inspection service：
◊ investigating the effect of different packaging materials on product quality；

◊ Scheme design for stability study providing, Stability sample retention and testing, Data trend analysis, Drug shelf life assessment；

◊ Influencing factors, acceleration and long – term testing.

Research on the compatibility of packaging material
◊ The compatibility research scheme of drug packaging system design such as ampoules, syringes and rubber plugs, assisting to declare drugs.
◊ Using the semi-quantitative scanning method to extract the additives from pharmaceutical packaging materials, including antioxidant, plasticizer, vulcanization agent, lubricant and so on.
◊ Use specific detection of element impurities for different drug delivery routes.

Verification study on packing tightness
◊ Test and verify the integrity of closed containers；
◊ Check the seal integrity of the entire package or container.

service content

Pre-prescription Study：
◊ Solubility, water content, particle size, crystal characteristics, biological activity and osmotic pressure of API；
◊ The effect of excipients on drugs, such as anti-oxidation, enhance penetration, control release and so on；
◊ Compatibility test of raw materials.

Prescription Technology Research：
◊ Screening of small trial prescription and process exploration；
◊ Research and optimization of process parameter range of small test prescription；
◊ Analysis method optimization and sample detection；
◊ 30 days investigation of the influencing factors of the small sample.

Pilot Plant Study：
◊ At least three batches of pilot batch samples shall be produced in the sponsor's GMP workshop or Chemical Medicine Research's GMP pilot test workshop;
◊ Establish quality standard of raw materials；
◊ Investigation of process parameters of pilot plant；
◊ Establishment of key process parameters, central control standards and methods；
◊ Validation of finished product inspection methods, establishment of quality standards and finished product quality inspection；
◊ Stability study of pilot products (more than 3 months).

Preparation and production process research before commercial amplification：
◊ endorsement of production plan and record；
◊ Check the quality standards and inspection procedures of raw materials, accessories and packaging materials；
◊ Verify the required material for production；
◊ Confirm cleaning method, verify chemical residue analysis method;
◊ Parameter groping before registration batch (Sampling of intermediate products, Production of finished product research report).

Commercial batch/Registered batch production：
◊ Registered batch production training；
◊ Registered batch production；
◊ Registered batch summary report.

Service scope

◊ Pilot study before production transfer of solid and liquid preparations;
◊ Solid and liquid preparations on phase Ⅰ clinical research in the preparation of the sample;
◊ Solid and liquid preparations were prepared with placebo in clinical studies.

advantage

◊ Successfully developed and completed the preparation study of nearly 50 varieties, some projects have passed the NMPA field inspection for many times.
◊ The r & d team has more than 3 years average of industry experience.
◊ With nearly 100 sets of quality analysis equipment.
◊ Verify the capability of detection, obtained the certificate of ability verification issued by China national inspection institute.
◊ The laboratory and quality shall be operated and managed according to the relevant standards of China National Accreditation Service for Conformity Assessment (CNAS).

Advantage

◊ We have the test site and personnel for the entire research chain, providing one-stop service, improving the speed and degree of connection between departments, so that ensure the quality and schedule of the project；
◊ Ensuring the flexible production scheduling of research varieties for pilot test With 500 square meters of GMP pilot plant, improved research speed and technology transfer success rate;
◊The preparation research of nearly 50 varieties has been successfully developed and completed, and some of the projects have successfully passed the NMPA field inspection for many times;
◊ The average of r & d team industry experience has more than 3 years, and the average of project manager experience has more than 6 years;
◊ The laboratory and project are operated and managed according to relevant standards of China national accreditation service for conformity assessment (CNAS);
◊ From the beginning to the end, each project is managed by technical transfer personnel with rich experience in GMP production.

advantage

◊ To ensure product quality is stable and reliable and quality profile can be traced, production is managed according to GMP standard；
◊ It has complete functions and can be produced flexibly, especially suitable for the preparation of samples for phase I clinical research and placebo for clinical research.

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