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Taab Biostudy Services

The List of Standard Operating Procedures at TAAB Biostudy Services

HR Department

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SOP No.

Title of the SOP

1 TAAB/BSC/HR/01 Standard operating procedure for staff screening and recruitment

Quality Assurance Department

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SOP No.

Title of the SOP

1 TAAB/QA/CPU/1 Standard operating procedure for use and maintenance of standard operating procedure
2 TAAB/QA/CPU/2 Standard operating procedure for quality assurance unit and its functions
3 TAAB/QA/CPU/3 Standard operating procedure for documentation of training and qualification of employees
4 TAAB/QA/CPU/4 Preparation, approval, distribution, amendment, storage and archival of standard operating procedures
5 TAAB/QA/CPU/05 Standard operating procedure for record keeping, reporting, storage and retrieval of data

Clinical Pharmacology Department

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SOP No.

Title of the SOP

1 TAAB/BSC/CPU/01 Standard operating procedure for volunteer screening and recruitment and management of ineligible volunteers
2 TAAB/BSC/CPU/02 Standard operating procedure for bringing volunteers in the clinical unit and recycling the volunteers
3 TAAB/BSC/CPU/03 Standard operating procedure for pre-study physical and clinical examination of volunteers
4 TAAB/BSC/CPU/04 Standard operating procedure for collection and handling of biological samples
5 TAAB/BSC/CPU/05 Standard operating procedure for transportation of biological samples from clinical laboratory to analytical laboratory
6 TAAB/BSC/CPU/06 Standard operating procedure for administration of oral dosage forms of the drug to human subjects during BA/BE study
7 TAAB/BSC/CPU/07 Standard operating procedure for handling of subject check-in and check-out
8 TAAB/BSC/CPU/08 Standard operating procedure for adverse event monitoring ,recording and reporting
9 TAAB/BSC/CPU/09 Standard operating procedure for distribution of meals to the study subjects
10 TAAB/BSC/CPU/10 Standard operating procedure for obtaining written informed consent
11 TAAB/BSC/CPU/11 Standard operating procedure for study approval process by ethical committee
12 TAAB/BSC/CPU/12 Standard operating procedure for control of outsourcing process
13 TAAB/BSC/CPU/13 Standard operating procedure for cannulation of the study subjects
14 TAAB/BSC/CPU/14 Standard operating procedure for recording of vital signs of subjects
15 TAAB/BSC/CPU/15 Standard operating procedure for recording temperature and relative humidity
16 TAAB/BSC/CPU/16 Standard operating procedure for disposal of biological waste materials
17 TAAB/BSC/CPU/17 Standard operating procedure for operation of high speed (Elektrocraft) cold centrifuge machine
18 TAAB/BSC/CPU/18 Standard operating procedure for operation of 12 lead electrocardiograph (Cardiart 108T) machine
19 TAAB/BSC/CPU/19 Standard operating procedure for operation of 12 lead electrocardiograph (Vega 3 Channel ECG Machine)
20 TAAB/BSC/CPU/20 Standard operating procedure for drug sample handling and accountability
21 TAAB/BSC/CPU/21 Standard operating procedure for operation of low temperature freezer (-20ºC)
22 TAAB/BSC/CPU/22 Standard operating procedure for compensation of injury or serious adverse event for subjects participating in the bioequivalence study
23 TAAB/BSC/CPU/23 Standard operating procedure for subject withdrawal or dropout from the BA/BE study
24 TAAB/BSC/CPU/24 Standard operating procedure for coding and decoding of the biological samples
25 TAAB/BSC/CPU/25 Standard Operating Procedure for Recording of Video for the Informed Consent Procedure During Inclusion of Volunteers in the BA/BE Study
26 TAAB/BSC/CPU/26 Signal Detection & Risk Management in Pharmacovigilance

Analytical Department

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SOP No.

Title of the SOP

1 TAAB/BSC/AU/01 SOP for receipt of biological samples from Clinical Unit
2 TAAB/BSC/AU/02 SOP for operation of high speed (Eltek) cold centrifuge machine
3 TAAB/BSC/AU/03 SOP for operation of Eltek centrifuge machine
4 TAAB/BSC/AU/04 SOP for operating the high performance liquid chromatography (Jasco, Japan)
5 TAAB/BSC/AU/05 SOP for operating and maintenance of precision weighing balance
6 TAAB/BSC/AU/06 SOP for operating the automatic off line tablet dissolution apparatus with auto sampler
7 TAAB/BSC/AU/07 SOP for operating and calibration of pH meter
8 TAAB/BSC/AU/08 SOP for operating the high performance liquid chromatography (Knaur, Germany)
9 TAAB/BSC/AU/09 SOP for operation of Deep (low temperature) freezer (-20ºC)
10 TAAB/BSC/AU/10 SOP for recording temperature and relative humidity at different areas in the analytical laboratory
11 TAAB/BSC/AU/11 SOP for method validation and analysis of volunteer plasma samples
12 TAAB/BSC/AU/12 SOP for operating the UV-Visible Spectrophotometer (Jasco, Japan)
13 TAAB/BSC/AU/13 SOP for operating the high performance liquid chromatography (Schimadzu, Japan)
14 TAAB/BSC/AU/14 SOP For Liquid Chromatography -Mass Spectrometry / Mass Spectrometry (API-2000) (LC-MS/MS-I)
15 TAAB/BSC/AU/15 SOP For Liquid Chromatography -Mass Spectrometry / Mass Spectrometry (API-2000) (LC-MS/MS-II)