Quality & Compliance
Accelerating, transforming challenge into success
Maintaining high quality standards is a cornerstone of our business
We maintain high Quality standards according to western pharma expectations. We have a well established Quality Management system in place which includes comprehensive SOP protocols and an extensive employee training program. Our people are continuously trained to maintain high quality standards and embrace quality as a key component of our business culture. Our production team is highly experienced and well versed in all aspects of pharmaceutical quality compliance.
Our organizational structure includes an independent Quality Control team which analyzes, evaluates and approves all operations and products according to well defined QC procedures. The QC team has the expertise, experience and equipment required to extensively analyze our products, as well as an in-depth knowledge of ICH and quality control standards.
Our facilities and equipment are well designed and maintained according to GMP principles and are ISO9001, ISO14001 and QHSAS18001 certified. We have a well defined Materials Management system, including a dedicated raw material storage area and controlled environment ( temperature and humidity) storage facility for the products we produce. All operations follow GMP guidelines and our sites are approved for the production of API intermediates and Regulatory Starting Materials (RSM).
Our sites have successfully completed audits by a number of large US and European pharmaceutical companies. One of our recent audit reports summarized that “AcceleDev QC department is knowledgeable, cooperative, sincere and honest” and “AcceleDev R&D operates with full transparency”. The outcome of this audit included zero (0) critical issues and zero (0) major issues.
We have a comprehensive document management and record retention policy in place, as well as a regular internal audit program.
We also have an expert logistics support team which assures the safe, secure, packaging and shipment to your designated site worldwide.
Additional information about our Quality Management practices can certainly be provided upon request, and we are always happy to arrange tours/audits of our sites.