GDP: Good Distribution Practice

Good distribution practice (GDP) for pharmaceuticals requires a licensed supply chain and a consistent storage, transportation and handling under suitable conditions, as required by the MA or product specification. We follow the GDP for the export of pharmaceutical intermediates to Europe.

Linked File：Guidelines on Good Distribution Practice of medicinal products for human use

REACH: European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals

The European Community Regulation EC/1907/2006 entered into force on June 1, 2007. The main objectives of REACH are to ensure a high level of protection for human health and the environment. The legislation also promotes alternative methods to animal testing and aims to strengthen the innovativeness and competitiveness of the European chemical industry. We fully support these goals.

Linked File：Guidelines on REACH

Project Regulatory Process in China

We follow the china regulatory requirement on chemical project, from feasibility study to commercial production. The details vary depending on the location.

Linked File：Project Regulatory Process

Change Control Management

We manage the change of the manufacturing process, especially in the agrochemical section, with the target to be fully compliant with respect to the product registration and the product quality for the customer. The change is not limited to process itself, it includes the change of equipment, intermediates, raw materials, and manufacturing site. Any change will be reported to customer for approval before implementation.

HAZOP/PRA

Hazard and Operability study (HAZOP) or Process Risk Analysis (PRA) is a structured and systematic examination of a complex process or operation in order to identify and evaluate problems that may represent risks to the personnel or equipment. The intention of a HAZOP is to review the design to identify design and engineering issues that may otherwise not have been found.

We conduct HAZOP/PRA according to the regulation by working with qualified personnel. or companies, who has the instruments in place (E.g. RC1)