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Alcon (CIBA Vision)

USA/Malaysia/Indonesia/Canada

Area: N/A
Estimated Cost: Confidential
PharmEng provided
technology transfer and start
up services, qualification
services, and cGMP expertise
to help the client conduct three
international technology
transfers and start-up projects.

Responsibilities:
Quality System Gap Remediation
Technology Transfer & Start Up

PharmEng also completed


validation activities that
involved transfer of processes,
equipment, and facilities from
the parent site to a recipient
site, while meeting the clients
quality requirements on time
and within budgets.

Facility & Utilities Qualification


o

New Clean Room Complexes HVAC


System

Manufacturing Area HVAC System

Cleaning Validation
Computer Validation
Equipment Validation
Process Validation
Quality Assurance
o

ISO 13485 Quality System

DIN/510(K) Submission

Export Certificate

SOPs Development

PharmEng Technology team has done a


tremendous effort and great team work to
ensure all the compliances according to
the regulatory requirements for the project
were completed as per schedule."
Jing Shyan Loh
Project Engineer, Multinational Medical
Device Manufacturer

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