Implementation of good storage practice guidelines : a case study of Sudanese pharmaceutical manufacturing facilities

مقدم أطروحة جامعية

al-Tayyib, Lina Salah al-Din Abbas

مشرف أطروحة جامعية

Abd al-Karim, Abd al-Karim Muhammad

الجامعة

جامعة أم درمان الإسلامية

الكلية

كلية الصيدلة

دولة الجامعة

السودان

الدرجة العلمية

ماجستير

تاريخ الدرجة العلمية

2012

الملخص الإنجليزي

This is a descriptive study design based on a survey form, to evaluate the storage practice in Sudanese pharmaceutical manufacturing facilities and compliance to good Storage Practice guidelines.

There were twenty seven Sudanese pharmaceutical manufacturing facilities at the time this study was conducted.

Sixteen facilities have been included in the study.

The information was collected under eight headings and statistically analyzed to reach the following results : The personnel qualification, hygiene and ongoing training in areas of store keeping, organizations, regulations and working condition.

This section consisted of eight questions.

Only about 57 percent of the facilities investigated complied with the guidelines in areas organization, personnel qualification, ongoing training in areas of store keeping and regulations.

In contrast, about 17 percent not exactly comply, compared to 26 percent don’t comply with the guidelines. The general appearance, premises and facilities of the pharmaceutical manufacturing stores.

This section consisted of ten questions.

About 75 percent of the facilities studied complied with the guidelines in areas of general appearance, premises and facilities of the pharmaceutical manufacturing stores.

However, about 11 percent not exactly comply, compared to about 14 percent don’t comply with the guidelines.

Warehousing and storage conditions in the stores of pharmaceutical manufacturing facilities.

This section consisted of thirty eight questions.

Only about 59 percent of the facilities investigated, complied with the guidelines in areas of warehousing and storage conditions in the stores of pharmaceutical manufacturing facilities.

In the contrary, about 16 percent not exactly comply with the guidelines compared to about 25 percent don’t comply with the guidelines. Equipment used in the store of pharmaceutical manufacturing facilities.

This section consisted of eight questions.

About 62 percent of the facilities surveyed comply with the guidelines in areas of equipment used in the store of pharmaceutical manufacturing facilities.

On the other hand, about 26 percent not exactly comply, compared to about 12 percent of the facilities don’t comply with the guidelines. The storage requirements including documentation, and labeling.

This section consisted of twenty three questions.

About 73 percent of the facilities investigated comply with the guidelines in areas of documentation.

In contrast, about 14 percent not exactly comply, compared to about 13 percent don’t comply with the documentation guidelines. The procedure of handling returned pharmaceutical products.

This section consisted of four questions.

About 83 percent of the facilities surveyed comply with the guidelines in areas of procedure of handling returned products.

However, about 4 percent not exactly comply, compared to about 13 percent don’t comply with the guidelines. The procedure of handling recalled pharmaceutical products.

This section consisted of six questions.

About 60 percent of the facilities studied comply with the guidelines in areas of procedure of handling recalled products.

In the contrary, about 20 percent of the facilities not exactly comply, compare to 20 percent don’t comply with the guidelines. The procedure of dispatch and transportation.

This section consisted of three questions.

only about 38 percent of the facilities studied comply with the guidelines in areas of dispatch and transport.

On the other hand, about 6 percent not exactly comply, compared to about 56 percent don’t comply with the guidelines. To sum up, about 65 percent of the manufacturing facilities investigated comply with the good storage practice guideline.

On the other hand, approximately 19 percent of the facilities investigated not exactly comply with the guideline, compared to about 16 percent of the manufacturing facilities don’t comply with the good storage practice guidelines.

التخصصات الرئيسية

علم الصيدلة

الموضوعات

• الأدوية
• السودان

عدد الصفحات

136

قائمة المحتويات

• APA
• MLA
• AMA

لغة النص

الإنجليزية

نوع البيانات

رسائل جامعية

رقم السجل

BIM-363702