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Quality : Overview

Chemical Solutions Ltd. (CSL) is committed to analytical data of the highest quality and to the continuous improvement in all areas of operation. Only officially approved procedures and techniques will be used, when available. Analyses will be performed with an emphasis on exacting quality, timeliness and legal defensibility.

CSL maintains a Quality Manual and SOPs which meet the standards for our NELAP accreditation. This accreditation is held to the standards of ISO/IEC/EN/17025. These documents include quality policies and objectives as well as a documentation of technical procedures. CSL is one of the only laboratories in the United States that is ISO 17025:2005 accredited to the USP Chapters <232>, <233>, <2232>, <1225>, and <1226>. Copies of the Quality Manual and CSL internal SOPs are available upon request.

Quality Assurance Reviews

Performance/System Audits. Audits are a fundamental component of a quality system. Internal audits are performed at least annually. In addition, CSL analyzes blind proficiency samples supplied by the state of NY twice per year to maintain our NELAP accreditation.

External Audits. These audits include regulatory agencies, customers, or their representatives. CSL undergoes on-site audits by the state of Pennsylvania (every 3 years), the FDA (every 2 years), and various clients for cGLP/cGMP compliance. All clients are welcome and encouraged to visit our facility. During customer audits confidentiality is a priority. Only records for that client and those records which do not violate other clients’ confidentiality shall be reviewed.

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