Policies
Quality Assurance

Quality Assurance Policies and QMS Procedure

Alvina

Quality Assurance Policies and QMS Procedure

Quality Assurance Policies

  • Document and Data Control Policies
  • Cleaning and Sanitization Policies
  • Personnel Hygiene Policies
  • Environmental Control Policies
  • Pest Control Policies
  • Training Policies
  • Risk assessment policies
  • Validation Policies
  • Vendor Policies

Quality Management System

  • Site Master File
  • Validation Master Plan
  • Quality Manual,
  • SOPs
  • STPs
  • Specifications

Quality Management Procedures

  • Change Control
  • Deviations
  • Non-conformances
  • OOS and OOT
  • Root Cause Analysis
  • Laboratory investigations
  • Market complain
  • Product recall
  • Internal audits/ self-inspection
  • Product quality reviews
  • CAPA
  • NCR

Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube