KriSan Biotech has established an independent Quality Management (QM) team to build up a quality system that complies with authority regulations and standards. Our Pharmaceutical Quality System (PQS) ensures quality and current Good Manufacturing Practices (cGMP) compliance throughout the lifecycle of manufactured products at KriSan Biotech. The PQS adheres to the following guidance as a basis for organizing systems and processes, and to assure quality products and services provided to our business partners. KSB’s senior management is dedicated to provide the resources necessary to maintain the company quality management system and committed to continual improvement, meeting authority regulations and customer requirements, and provide a basis for the establishment and review of the quality objectives.

The PQS is based on:

  • The International Conference on Harmonization Quality (ICH) Guidance Document, Q7 Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients.
  • PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part II
  • EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines Part II – Basic Requirements for Active Substances used as Starting Materials
  • ICH Q9 Quality Risk Management
  • ICH Q10 Pharmaceutical Quality System and other relevant Health Authority regulation
  • Code of Federal Regulations 21 CFR part 210 and 211

Listing below is the typical quality system established at KriSan Biotech:

  • Personnel Qualifications
  • Equipment and Facilities
  • Materials Management
  • Production and In-process Control
  • Labelling control
  • Storage and Distribution
  • Laboratory Control
  • Change Control
  • Non-Conformance Event Management and Corrective Action and Preventive Action (CAPA)
  • Quality Risk Assessment
  • Documentation and Records
  • Data Integrity
  • Contractor and Consultant Management
  • Internal audit
  • Complaints and Recalls

Regulatory Services

KriSan Biotech Co., Ltd. offers regulatory support from early stage drug substance development to commercial API manufacturing, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Drug Master Files (DMF).

  • Regulatory and strategic consultation for new drugs at early development stage
  • Compilation of registration materials, including CMC, pharmacological and toxicological data and clinical research protocol
  • Preparation and submission of registration documentation