faculty of pharmacy

Pharmaceutical Consultation & Research Unit


In order to conduct bio-equivalence studies to assure high level of confidence and meet with time-lines has created the bio-equivalence study center. It strives to ensure high quality clinical, bio-analytical, statistical and pharmacokinetic data necessary to create international harmonization in bioequivalence testing. The harmonization in the requirements and standards for bioequivalence testing would be achieved by conducting all the studies as per the GCP and GLP regulations and other regulatory guidelines.

The center has developed bio-analytical section with state of art equipments such as LC /MS MS, HPLC, Low Temperature Freezers and Centrifuges. The facility is well enabled with IT systems such as ………. for statistical computation, bio-enable software for volunteer registration and access control system for prevention of unauthorized movement of personnel.

The Bioequivalence Unit performs the following activities:

  • Performs and achieves bioequivalence.
  • Performs experimental studies for the availability and bioequivalence of drugs.
  • Performs complementary studies for availability and bioequivalence of drugs.
  • Performs the studies required to determine the degree of drugs' stability in their different pharmaceutical forms.
  • Measures metabolism and pharmacokinetics of certain kinds.
  • States the required opinion and scientific consultation to help in solving the control problems and the related safety and effectiveness ofpharmaceutical preparations.
  • Presents technical consultations and performs different environmental analyses such as water, soil and air analysis to help in discovering and controlling toxins and pollution.
  • Delivers courses on different instruments of measurement.

 


Mission

Our mission is to provide clients with expertise and technically advanced CLINICAL RESEARCH services in a timely manner in compliance with local and international regulations and through a process of continuous communication.


Vission

Our vision is to make BPRO one of the most reliable and most versatile clinical RESEARCH organizations worldwide.


Core Values

Quality Assurance:

The bioequivalence department of Bio-Scientific Research Laboratories (i) Pvt. Ltd shall ensure that the Quality Assurance (QA) shall subject all Bioequivalence studies to regular quality assurance monitoring and auditing. All monitoring and auditing will be followed by issuance of audit reports by the QA to the concerned person and assuring appropriate amendments.

Documentation Practices:

Bioanalytical method development, validation, report and standard test procedure is prepared as per the relevant SOPs. The statistical activities are carried out as per the respective SOPs of the statistics section The observations are recorded in the controlled copies of the forms which are the part of the SOPs MASTER documents are controlled and archived by the quality assurance section as per the SOP The archival time of the documents is defined in the SOP Quality Manual, Training Manual, Safety Manual, Quality System Procedures (QSP) and the Site Master File (SMF) are prepared and updated by the quality assurance section.


Conformance to International Standards

 

  • All studies are carried out as per the international regulatory guidelines for GCP and GLP.
  • Generation of the experimental raw data, their documentation and archiving is done as per international regulatory guidelines.
  • All SOPs shall be readily accessible to all users at the designated section.
  • All deviations from the SOPs shall be documented and authorised by the study director, principal investigator or section head.
  • A historical file of SOPs and all revisions thereof, including the dates of such revision, shall be maintained.
  • All projects shall have an approved written protocol, indicating the objectives and methods for the conduct of the study.
  • All protocol amendments and reasons thereof shall be documented, signed and maintained.
  • SOP and Protocol deviations shall be documented and described in the final report.
  • A final report shall be prepared for each project conducted in the bioequivalence department of BPRO.

International Standards& Work Plan

Conformance to International Standards

  • All studies are carried out as per the international regulatory guidelines for GCP and GLP.
  • Generation of the experimental raw data, their documentation and archiving is done as per international regulatory guidelines.
  • All SOPs shall be readily accessible to all users at the designated section.
  • All deviations from the SOPs shall be documented and authorised by the study director, principal investigator or section head.
  • A historical file of SOPs and all revisions thereof, including the dates of such revision, shall be maintained.
  • All projects shall have an approved written protocol, indicating the objectives and methods for the conduct of the study.
  • All protocol amendments and reasons thereof shall be documented, signed and maintained.
  • SOP and Protocol deviations shall be documented and described in the final report.
  • A final report shall be prepared for each project conducted in the bioequivalence department of BPRO

 


Description of Work Plan:

  • The training records of all employees in BPRO are maintained and updated regularly. 'Training of Personnel'.
  • These records document the employee's attendance of in-house or external training programmers, safety training, GLP and GCP training etc. All the training records of the ex-employees are then archived.
  • BPRO shall endeavour to promote continuous improvement amongst its technical staff in areas of technical expertise, quality systems, procedures and general skills. Continuous improvement shall be achieved by means of documented in-house or external training programs conducted periodically.
  • BPRO shall ensure that all its staff members are adequately trained for their assigned duties and that job descriptions are documented and periodically updated.

 

Equipments:

  • All the equipments in the Bioequivalence department are of appropriate design and adequate capacity to function according to the protocol and are suitably located for operation, cleaning, calibration and maintenance. All measuring equipments (e.g., HPLC, LC/MS/MS, Balances, etc.) are calibrated at regular time intervals, depending on manufacturer's recommendations, laboratory experience and extent of use. All the equipment have written standard operating procedures (SOPs) or working instructions describing in detail the method, material, and schedules to be used in the routine inspection, cleaning, maintenance and calibration of equipment. The SOPs also describe appropriate action to be taken in the event of failure or malfunction of equipment.
  • The records of all equipment are maintained for calibration and maintenance operations. The record documents the date of calibration or maintenance operation (routine or non-routine) in case of equipment failure or malfunction. Records also document the nature of defect, how and when the defect was discovered, and any remedial action taken in response to the defect.
  • Equipment operation, calibration and maintenance and repair records are also recorded in the logbook or respective equipment especially designed for the purpose.

 
Last Update
5/1/2017 12:26:46 AM