Quality

AspireBio provides quality support to companies in all phases of product development, from the design and implementation of phase appropriate quality management systems (QMS) to vendor qualification, auditing and ensuring GMP compliance. Our team efficiently prepares and reviews quality documents (i.e., quality technical agreements, standard operating procedures, qualification protocols, product specifications and batch records) to meet each client’s specific needs. 

We pride ourselves on establishing high-quality, robust documentation that ensures process and product compliance and safety.  

  • Design and implement phase appropriate QMS 
  • Support instrument qualification (IQ, OQ, PQ) and facility design and qualification to enable GMP manufacturing 
  • Write and review quality technical agreements 
  • Prepare and review quality documents (SOPs, product specifications, process or method qualification protocols/reports) 
  • Conduct internal, mock and supplier audits & assess inspection readiness 
  • Provide deviation, out-of-specification, root cause analysis, risk assessment and change control support and implement corrective and preventative actions