Quality Assurance (QA) Services PDF Print E-mail
Amreteck® offers following QA services:
  • Review current QA set-up and procedures (for the existing system)
  • Perform Gap Analysis on QA to meet current regulations
  • Develop and implement remediation plan to meet export countries regulations
  • Develop QA procedures and Quality Systems (for the new system)
  • Develop and implement CAPA system
  • Develop and implement Deviation system
  • Develop and implement Incident reporting procedure
  • Develop and implement Batch release/disposition procedure
  • Develop and implement Batch hold procedure
  • Develop and implement material flow procedure
  • Develop and implement required SOPs and other documentation.
  • Provide guidance on developing better batch record(s) and provide quality attributes
  • Develop and implement Annual Product Review (APR) Template and procedure.
  • Develop Audit requirements, plans, SOPs and reports.
  • Review and provide strategic plan on QA Departmental Structure
  • Review and provide strategic plan on QA personnel qaulification and training
  • Provide hands-on QA Training to meet USFDA, MHRA, ANVISA (Brazil), Health Canada, EU, WHO and other export countries expectation and regulations.