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License to Operate Application Guide

Mary Colleen Gomiega-Ibanez has worked in various roles in the pharmaceutical industry since 2010. She graduated with a BS in Pharmacy in 2010 and has since worked as a pharmacy instructor, product development specialist, production supervisor, quality assurance manager, and regulatory officer. The document then outlines revised guidelines from the Food and Drug Administration simplifying license to operate application requirements and processes. It provides details on license application requirements and qualified persons required for different establishment types.

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John Melby
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54 views16 pages

License to Operate Application Guide

Mary Colleen Gomiega-Ibanez has worked in various roles in the pharmaceutical industry since 2010. She graduated with a BS in Pharmacy in 2010 and has since worked as a pharmacy instructor, product development specialist, production supervisor, quality assurance manager, and regulatory officer. The document then outlines revised guidelines from the Food and Drug Administration simplifying license to operate application requirements and processes. It provides details on license application requirements and qualified persons required for different establishment types.

Uploaded by

John Melby
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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License To Operate

Application
Mary Colleen
Gomiega – Ibanez
Registered Pharmacist
2010
– Graduated as BS Pharmacy from the Univ. of San Agustin
– Passed Pharmacist Licensure Examination
2011 – 2014
– Pharmacy Instructor / Internship Coordinator, Univ. of San Agustin
2014 – 2016
- Product Development Specialist for Food, Drug, & Cosmetic Products
- Production Supervisor – Drug Production
2016 – 2020
- Quality Assurance Manager
- Plant OIC
2020 – present
- Regulatory Officer
- Senior Pharmacy Internship Preceptor
- Company Consultant
AO 2020-0017

◍ Revised Guidelines on the Unified


Licensing Requirements & Procedures of
the Food & Drug Administration
Repealing AO 2016-0003
Objective of the AO
◍ To simplify the requirements and processes for initial,
renewal, and variation of License to Operate (LTO)
applications; and
◍ To re-engineer and streamline FDA’s processes and
automate its system in compliance with the provisions
of RA 11032 in the maximum prescribed processing
time depending on the complexity of the transaction.
Implementation of the AO
◍

◍
Guidelines:
◍

◍
◍
Guidelines:
Requirements for LTO Application
Requirements for LTO Application
Application of License to Operate
Qualification/
Type of Establishment Qualified Person
Requirement
CDRR Registered Pharmacist (RA PRC ID
Drug Manufacturer, Trader & 10918) Certificate of Attendance to
Distributor, and Drug Outlet, Seminars or Trainings on drug
RONPD safety, quality, and efficacy

CFRR Company Regulatory Officer & Certificate of Attendance to


Food Manufacturer, Trader & Food Safety Compliance Officer Seminars or Trainings on Food
Distributor – Food-Related Course (Food Safety, GMP, or HACCP
Technology, Food & Nutrition,
Chemistry, Microbiology,
Chemical/Sanitary Engg,
Veterinary Medicine, Fisheries,
or Agriculture)

CDRRHR Registered Professional or PRC ID / Diploma


Manufacturer, Trader and graduates in the field of allied Certificate of Attendance to
Distributor of MD, radiation health profession Seminars or Trainings on
emitting devices, etc. medical devices safety etc.

CCRR Registered Professional or PRC ID / Diploma


Manufacturer, Trader & graduates in the field of allied Certificate of Attendance to
Distributor health profession Seminars or Trainings on
-Cosmetics Establishment -Registered Chemist, Chem cosmetics, HUHS, HUP etc.
-HUHS Establishment Engg, Pharmacist
LTO Registration

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