Quality Management

QA&QC

QA:Quality Assurance

QA Operations have been in place for several years to insure that products at our company are prepared responsibly and in accordance with ISO 9001 standards.

With QA available in every shift, compliance to the demands of cGMP is now in-use. Our pharmaceutical/biotech customers are welcomed and considered an integral part of our commitment to continuous quality.

Activities and Responsibilities.

  • Release of qualification and validation protocols;
  • Release of documents: e.g. specifications; Master Batch Records, SOPs;
  • Batch review and release, archiving;
  • Release of batch records;
  • Change control, deviation control, investigations;
  • Approval of validation protocols;
  • Training;
  • Internal audits, compliance;
  • Supplier qualification and supplier audits;
  • Claims, recalls, etc.

QC:Quality Control

Analytical support for lab and production ranges from the release of raw materials to in-process control. This includes the development of chromatographic methods as well as structural determination of impurities and by-products for release testing. Validation of analytical methods, and the preparation and characterization of reference standards are also available for more advanced projects. Major analytical equipment pls see Analytical Facilities

Activities and Responsibilities:Development and approval of specifications;

  • Development and approval of specifications;
  • Sampling, analytical check and release of raw materials, intermediates and cleaning samples;
  • Sampling, analytical check and approval of APIs and finished products;
  • Release of APIs and final products;
  • Qualification and maintenance of equipment;
  • Method transfer and validation;
  • Approval of documents: e.g. analytical procedures, SOPs;
  • Stability tests;
  • Stress test.

IP Assurance

We knows that our customer’s IP (Intellectual Property) is of utmost importance to them. We take comprehensive measures to safeguard and insure the confidentiality of projects. We has a strict IP assurance policy company-wide.

  • All our employees are required to sign a CDA agreement before joining the company.
  • We have a comprehensive information security system on our network.
  • Our lab’s are organized in a way that different projects are strictly segregated from each other; Cross project information flow is prohibited.
  • Laboratory notebooks are strictly regulated, filed, and never leave the premises. Laboratory notebooks can be returned to the client upon request.

EHS

EHS:Environment & Health & Safety

  • Emergency response plan in place for fire fighting, first aid, chemical spills, accidents, etc. in our safety manual;
  • Fire alarm system is present in all buildings;
  • Material Management system in place to control chemical transfers and inventory;
  • In-house training for all employees;
  • ISO 9001:2015 certified;
  • Video monitoring security system implemented throughout site;
  • Module setup to handle potent compounds.

Certifications

ISO 9001:2015