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not the easy thing

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we seek newer and better ways

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We challenge innovation
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Integrate

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it makes a difference

Quality


Quality is an integral part of our commitment to world class research and customer service.

Ethix Pharma is dedicated to quality and continuous process improvement for both customers and employees. Our responsibility is to ensure that through established standards and measurements, the level of quality at premier matches or exceeds our customers’ expectation. We develop quality awareness through, training, development and measurements improvements of our employees.

Ethix Pharma Quality management system has been certified as standard: ISO 9001:2008 (QMS) for contract research services via JAS-ANZ (JAS/0613T/4029).

Quality Policy at Ethix has been practiced in its most basic form:

Say what you do: have documented procedures for the work affecting product or service quality
Do what you say: carry out the work in accordance with the written procedures
Check your own practices: confirm compliance with procedures and regulations through internal auditing
Implement improvements: immediately correct problems or weaknesses as they are found; then, revise the system to prevent the same problems from recurring
Have the records to prove it: provide documented, objective evidence of quality-related activities as proof of compliance to auditors.

Ethix comprise of an independent QAU (Quality assurance unit) responsible for quality of the study conduct and reporting. For each study QAU runs independent quality audits for protocol compliance.

SOP: Standard operating procedures are an integral part of our QMS. Ethix Pharma has 21 SOP’s for defining and conducting quality procedures.

  • Recent Audits:


    18.07.2013:   Quality assessment for regulatory Pharmacovigilance (UK) for EU project compliance.                 (BKJRMK01)
    11.06.2013:   QMS audit by Elite certification for Standard: ISO 9001:2008 recertification.                                 (JAS/0613T/4029)
    04.04.2013:  Sponsor audit for GCP and clinical protocol compliance.
    (EP/CLN/2009EP001)
  • SOP's List


    Sr. No.

    TITLE OF THE SOP

    DEPARTMENT

    ID

    1

    SOP for SOP

    QA

    SOP01EN01

    2

    Handling Business Enquires

    BD

    SOP02EN01

    3

    Project Team - Role definitions, Responsibilities and task delegation

    PM

    SOP03EN01

    4

    Identifying and Organizing a site for the study

    PM

    SOP04EN01

    5

    Preparing the team for a study

    PM

    SOP05EN01

    6

    Study feasibility assessment

    PM

    SOP06EN01

    7

    Site Research team : Competence, Knowledge and training

    PM

    SOP07EN01

    8

    Protocol preparation, review, approval and submission to Research Ethics Board

    PM

    SOP08EN01

    9

    Consent process and Subject Informed Consent Form

    PM

    SOP09EN01

    10

    Rights and Protection of Study subjects

    PM

    SOP10EN01

    11

    Research Ethics Board (REB): Ongoing communications

    PM

    SOP11EN01

    12

    Management of Communication during a study

    PM

    SOP12EN01

    13

    Subject recruitment

    PM

    SOP13EN01

    14

    Subject follow up

    PM

    SOP14EN01

    15

    Study Site Monitoring Visit

    PM

    SOP15EN01

    16

    Management of AE/SAE and ADR

    PM

    SOP16EN01

    17

    Management of Investigation Product or Biological Specimens

    PM

    SOP17EN01

    18

    Management of Raw Data and Source Document

    PM

    SOP18EN01

    19

    Dealing with Misconduct and Protocol deviation

    PM

    SOP19EN01

    20

    Study Closure

    PM

    SOP20EN01

    21

    Preparation for an Audit or Inspection

    QA

    SOP21EN01

 

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