Bio-Scientific Research Laboratories Pvt. Ltd.

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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.

In lieu of SOPs, certain instruments and activities may have 'Work Instructions' enumerating the procedure for operation.

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 Bio-Scientific Research Laboratories (i) Pvt. Ltd.


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