The two parties will exchange some information related to the project and agree on the scope and progress of the project. On this basis, the two parties will continue to work hard to ensure that the client project successfully executed.

Our sales and marketing personnel will provide customers with information about our services and capabilities, and in the process obtain a general understanding of customer requirements. In the early stage of this process, we will assign a project manager to be responsible for technical negotiation with the customer with the necessary support from various relevant departments, so as to reach a final customized agreement with our customer.

Once the agreement was reached, a project team composed of personnel from various departments led by the project team leader was formed. The project team includes personnel from various functional departments, including sales, research and development, production, QA/QC, procurement, and other departments necessary to ensure the success of the project.

The project manager is usually the key contact of the customer in Kinlam. The project manager will keep the customer informed of a series of progress from the start to completion of the project. Its main purpose is to ensure that the project can progress according to the corresponding time and budget and meet the quality standards expected by the client.

Quality Policy: 

Implement quality requirements throughout the product's life cycle, and follow cGMP and industry standards set by regulatory agencies.

Discover and correct system deficiencies, continuously improve and improve, and constantly strive for excellence.

Quality Slogan:

Customer first, quality-oriented, continuous improvement, and the pursuit of excellence. 

KINLAM's quality management system is synchronized with international standards. It is a quality management system based on FDA QMS as the guiding principle, ISO9001 as the basis, ICH as the guide, 21CFR and China GMP as the basis.

Quality Activities and Workflows-Creating Product Quality in the Process

In KINLAM, product quality is achieved through layer-by-layer quality assurance starting from raw materials, which includes testing and release of raw materials, review and approval of master batch records, issue of batch records, supervision of batch record execution, QC Intermediate control and intermediate testing, review of batch records, product release, pre-shipment inspection and sample delivery, shipment tracking, etc. Quality activities run through the entire life cycle of a product.

KINLAM believes that product quality is not obtained through testing, but through quality assurance activities in the entire supply chain, including product process design, production, and sales. The FDA also explicitly proposed this concept in its guidelines for the construction of industry quality systems.

We Provide a Safe, Accident-Free Operation. 

Large investment will be made to build a waste treatment facility. We encourage the development of environmental protection projects to reduce energy consumption and pollution with high technology. We implement strategies for cleaner production to achieve sustainable development.

Air and Wastewater Treatment

•    The condenser and the purifier are dismantled to emit steam and gas.
•    All onsite wastewater treatment wastewater flows before leaving the site.

Process Safety Management

•    Process hazard analysis
•    Develop procedures
•    Develop emergency response procedures

Employee Safety and Health Management

•    Sound personal protection
•    Regular health check

Safety Training

•    Pollution Prevention
•    Reduce or prevent solid and hazardous waste
•    Recycling and assessment of garbage and reuse
•    Non-process waste recycling related

 KINLAM Advantages:

1. Has rich experience from small to medium-scale to commercial production.
2. The project is carried out according to plan and budget, and communicates with customers in a timely manner.
3. Quality system and EHS conform to international practice.
4. Strictly support intellectual property protection policies.
5. Comply with cGMP, FDA audit, DMF, EDMF or COS file support.
6. Technical Capability

Facility

Small Scale and Pilot:

• 1200 square meter process development workshop, 2 kilogram laboratories, reactor volume from 10 to 100 liters.

Analysis equipment

We have excellent analytical capabilities and can provide reports such as NMR, IR, HPLC, GC, LC-MS, OR, EA, XRD, etc.

• Aglient HPLC 1200
• Aglient GC 7890
• Stability study
• Sample retention room

Production Site

41,000 square meters cGMP production base, 400 square meters clean area (class 100,000), 66700 square meters None-GMP production base, reactor area from 100L to 3000L

• Workshop 
• Clean room
• Water purification workshop
• Warehouse