Operations & Manufacturing Engineering
Validation, Verification and Qualification, Good Manufacturing Practices (GMP), Process Improvement, Process Development, Document Preparation, Clean Room Qualification and Remediation.
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.
