Home

News / Events

Our Services

Techniques to Success

About Us

Contact Us

Ask the Experts

Resources















Techniques to Success


Step 1: Pre-Audit of your current compliance assessment (This is the audit time saver).
  • Client supplies latest FDA Form 483 Audit on site observations and compliance issues or notice of deficiencies

  • Documentation of SOPs, Training, Process Flow Diagrams,
    Protocols, and Validation Methodology

  • Other pertinent information from the Client that may be required by A.R. Pharmaceutical Services.



Step 2: On-Site Audit
  • Approached based on Pre-Audit findings

  • Audit will bring current site compliance level up to regulatory compliance level

  • Review of QA and QC procedures, training, SOPs, operator interpretation of current tasked spelled out in SOPs, validations, and controls in place


Step 3: Audit Report
  • System deficiencies, detailed report, and follow-up recommendations



Step 4: Plan of Action - Development and/or Improvements
  • Client can choose package(s) that will meet their specific needs.




Step 5: Post Audit and the Horizon
  • Techniques to stay in compliance



Step 6: Outscourcing Services

  • Supplier Audits, Courier Services, Distribution, Environmental Audits & Inspections, Business Start-up Techniques, Technical Writing, Notary Public




© 2002, A. L. Robinson Pharmaceutical Services, Inc. All Rights Reserved.