MINUTES OF THE MEETING TO  FINALISE THE STUDY PROTOCOL FOR PREPARATION OF INSULIN  HUMAN  NATIONAL REFERENCE STANDARD

.A meeting on the Inter Laboratory Collaboration for preparation of Insulin Human National Reference Standard was held under the Chairpersonship of Dr. Jotna Sokhey, Addl. DGHS & Director, NIB on 27.10.2009 at 10.00 a.m.  The representatives of leading manufacturers of Insulin, Indian Pharmacopoeia Commission, Directorate General of Health Services, NABL expert and concerned officers of NIB participated in the meeting.No representative from CDSCO attended.

Dr Sokhey welcomed the participants and said that the preparation of the reference standard for insulin was truly participatory as it involved all concerned in the manufacture, formulating guidelines by Indian Pharmacopoeia Commission and in quality assessment of Insulin. She said that care had been taken to follow accepted international guidelines and to ensure that the ISO standards were met.She said that the protocols of study design had been discussed earlier at the meeting held in March 2009.The purpose of this meeting was to finalize the study protocols, the material details of the coded Insulin Human-API and the time schedule for the collaborative study.The documentation to be maintained in the “Data Recording Forms” for study would also be discussed and finalized. The revised study protocol with a number assigned to it will be communicated to all the labs.

.Dr Renu Jain, Scientist Grade II and Head of the Recombinant Laboratory gave a brief presentation of the salient points of the protocols and the time schedule of activities.She said that API had been procured by NIB and would be sent to the collaborating laboratories in the first or second week of November by courier in dry ice.

Four out the five collaborating laboratories, which had agreed to collaborate in the study, attended the meeting.  Consent forms were signed by the representatives of these laboratories. NIB would write to the fifth laboratory to seek their consent before coded material is shipped.The participating laboratories are :

*did not attend the meeting

The document (ILC-01) for collaborative testing program prepared by NIB   as per NABL guidelines and requirements of ISO standards was finalized.It was decided that for calculation of measurement of uncertainty ISO standard 98-3 Part 1, Part 3 and for inter laboratory comparisons NABL guideline 163 and ISO Guide 43 will be consulted and communicated to the collaborators.The revised document ILC-01 will be communicated to all the labs.

After discussions, the following decisions were taken:

The Certified Reference Standard of Insulin (Human) used for the Potency assay shall be from the traceable sources of EDQM which will be arranged by the Collaborating labs at their end.  The value reported for human Insulin standard of highest metrological order is in %, the sample which is calibrated against it will be finally reported in IU/mg.

The calculation of estimated Potency values will be on the dried basis for which the test for Loss- on-Drying (LOD) will be determined on the coded sample. Six repeatability performances will be done.  Once the value of insulin human API is established the LOD need  not be performed subsequently.

Characterization study on coded sample need not to be performed by all the collaborating labs. The data for characterization on human insulin –API will be obtained from the laboratory from where the API is sourced and also be generated by NIB and tests carried out shall be: a) protein identification by peptide mapping, b) purity for related proteins and c) purity for higher molecular weight proteins (HMWP). All the three tests will be performed by HPLC.