Quality Assurance System:

Quality Assurance Unit ensures that studies are performed in accordance with Good Laboratory Practice (GLP)-Good Clinical Practices (GCP) regulations and through in house procedures. Also, it is responsible for document controlling of study protocols, analysis plans, SOPs & policies; and ensuring the updated versions of these controlled documents are effective and in place or accessible to relevant staff. QA unit is responsible for regular auditng which include:
• Study source documentation, procedures, and reports; and provides regulatory advice and support to the operational staff.
• Facility & system, to check adequacy & eligibility of resources and proper utilization of provisions.

Staff:

1. Center Manager: Dr.Muhamad Gamal Eldean Hassan.
2. Technical Manager:Dr.May Amin.
3. Quality Assurance Manager: Dr. Aya Badr.
4. Chief Analyst.
5. Analysts.
6. Physician.
7. Nurse.

1. Bioanalytical Part:

Facilities: a. LC-MC/MS systems. {(UP) LC-MS – Waters}
b. HPLC Systems:
  - Agilent
  - Shimadzu
   i. UV detector.
   ii. Flourscence detector. c. Microbalance.
d. All study samples are stored in controlled freezers (-20°C and -70°C).
e. UPS (Uninterrupted Power Supply) and generator back-up.
  - Services
   i. Method Development.
   ii. Method Validation.
   iii. Bio-Waiver / Bioequivalence.

2. Data Management Part:

• Non-compartmental pharmacokinetic analysis using validated KineticaTM software.
• Assessments of Bioequivalence.
• Tabulation, graphical display, analysis and interpretation of study data.
• Study design and development of Protocol and Informed Consent Form (ICF).
• Designing of Case Report Form (CRF) as per protocol requirements.
• Preparation of Bioequivalence Report, Clinical Report, Analytical Report and Statistical Report.
• Sample Size Estimation and Randomization.

3. Clinical Part:

• Screening area for physical examination.
• Sample collection rooms.
• Complete examination of volunteers with close monitoring during two study phase for the expected AE/SE.
• Notify the drop-out volunteers with a copy from his analysis report, and follow them up.
• The BE Center contracted with El-Safwa Hospital for emergency cases.
• First Aid cupboard.
• Dining room.
• Storage freezers ( -70 and -20º C).
• Archives for secure document storage.

4. Quality Assurance System:

Quality Assurance Unit ensures that studies are performed in accordance with Good Laboratory Practice (GLP)-Good Clinical Practices (GCP) regulations and through in house procedures.
Also, it is responsible for document controlling of study protocols, analysis plans, SOPs & policies; and ensuring the updated versions of these controlled documents are effective and in place or accessible to relevant staff. QA unit is responsible for regular auditng which include:
• Study source documentation, procedures, and reports; and provides regulatory advice and support to the operational staff.
• Facility & system, to check adequacy & eligibility of resources and proper utilization of provisions.

Download: Bioequivelence Center - List of Facilities

1. Bioequivalence and Bio-weivar study:

- Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. - A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. - MSA bioequivalence center have all facilities and equipment required to undergo steps of Biowaiver and Bioequivalence study

2. Analytical Research:

- Research Service support and enhance the research, education, and public service missions of the University by providing access to characterization and process instrumentation. - Staff provides the assistance and guidance necessary so that students, faculty, and industry get the most effective and appropriate use of the center's facilities.

3. Fromualition:

 Is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product.