Quality Policy

Commitment to provide high quality services at par with the internal standards.

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

		Standard operating procedures (SOPs) are available for the procedures for the project and the clinical study.
		The clinical study is carried out as per the respective SOPs of the clinical section.
		The pathological activities are carried out as per protocol.
		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.