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Validation, Verification and Qualification:

APOMed Consultants have the capability to perform Validation, Verification, and Qualification. We provide support to meet FDA, ISO, and IC requirements that include:

  • Process Development
  • Master Validation Plan
  • Master Validation Report
  • Test Method Validation
  • Process Verification
  • Product Performance Qualification
  • Operational Qualification
  • Installation Qualification

Good Manufacturing Practices (GMP):

We provide onsite audit support and review

for Good Manufacturing Practices in accordance with FDA standards. Also, our consultants perform unbiased and rigorous review of your manufacturing process and documentation (GMP, QSR, CFR, ISO guidelines). Any audit gaps APOMed can resolve in an expedient manner.

Clean Room Qualification:

APOMed Consultants has the capability to provide an all-inclusive clean room or controlled environment qualification.

Document Preparation:

  • Standard Operating Procedure, Manufacturing process instructions (SOP/MPI)
  • MVP/MVR
  • IQ/OQ/PQ
  • CAD (SolidWorks, AutoCAD, PRoE) generation via in house procedures

Remediation:

APOMed supports analysis and as applicable can remediate gaps and implement process mitigation and documentation updates to reflect actual manufacturing process instructions consistent with client’s expectations.

Process Development:

Our consultants are experts in developing manufacturing processes to accommodate the specific requirements of new and/or existing products.  Our consultants practical approaches in designing for manufacturability and the yearn to have a consistent and robust process have earned praises from our clients.

Process Improvement:

APOMed provides systematic approach to the closing of process and system performance gaps. This is accomplished through streamlining, cycle time reduction, identification, Kaizen, Poke Yoke, DOE, Six Sigma, and elimination of root cause problems and removal of non-value added activities. Our knowledge is what matters most in these activities, for most likely, we have encountered similar issues in the past.