Nirmal Kumar*1, Ajeya Jha1
1.Sikkim Manipal Institute of Technology, Majitar, Rangpo, Sikkim -737132, India
There are several approaches of quality system, which adequately take care of pharmaceutical manufacturing and distribution operations. In addition to conventional perspectives there is a need of specialized quality system during transportation and shipment of pharmaceutical products. An exploratory study on transportation quality system shows that as such there is no system with nomenclature ‘Good Transportation Practices’. The quality system during transportation is apparently a forbidden concept, although other pharmaceutical quality systems based on GXP nomenclature are available, such as Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) etc. Pharmaceutical Good Transportation Practices (GTP) is a novel approach to summarize the elements of quality systems during transit and shipment. The new GTP philosophy is based on core quality system elements like training, documentation, validations, qualification etc. This study on Good Transportation Practices proposes a new concept in pharmaceutical industry, which shall act in alliance with manufacturing and distribution operations to further strengthen the pharmaceutical quality system.
Keywords: GXP, GDP, Pharmaceutical Transportation, Temperature Excursions