Establishing standard operating procedure for regulated products in a pharmaceutical company

Date of Publication

2017

Document Type

Master's Thesis

Degree Name

Master of Business Administration

College

Ramon V. Del Rosario College of Business

Department/Unit

Decision Sciences and Innovation

Thesis Adviser

Jaime T. Cempron

Defense Panel Chair

Raymund B. Habaradas

Defense Panel Member

Patrick Adriel H. Aure
Rachel A. Quero
Brian C. Gozun
Maria Victoria P. Tibon

Abstract/Summary

This action research is about the establishment of a standard operating procedure for the management of regulated products and ensuring compliance of regulated products in a pharmaceutical company. The issue addressed in this action research project was the lack of standard operating procedure which resulted in a process gap and consequently led to loss sales and non-compliance to local regulations.

The Global Supply Chain and Affiliate Quality Operations departments have had several meetings, dialogues, and email exchanges together and with other stakeholders, such as our third party brokerage service providers, regional colleagues and the Philippine Drug Enforcement Agency of the Philippines (PDEA) to plan and facilitate the necessary change. The SOP was documented and cascaded to responsible colleagues and was successfully utilized in GSC and AQO operations. The interventions we made have brought about quality improvements in our operations and further developed GSC and AQOs partnership in handling regulated medicines.

Abstract Format

html

Language

English

Format

Electronic

Accession Number

CDTG007256

Shelf Location

Archives, The Learning Commons, 12F Henry Sy Sr. Hall

Physical Description

2 discs ; 4 3/4 inches

Keywords

Pharmaceutical industry; Pharmaceutical industry--Philippines

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