Establishing standard operating procedure for regulated products in a pharmaceutical company

• Main Author: Claravall, Maria Josefina N.
• Format: text
• Language: English
• Published: Animo Repository 2017
• Subjects: Pharmaceutical industry; Pharmaceutical industry > Philippines
• Online Access: https://animorepository.dlsu.edu.ph/etd_masteral/5319
• Institution: De La Salle University

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.