SOP on Preparation & Handling of Un-blinding Envelopes

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1.0 Objective

To lay down a procedure for preparation and handling of un-blinding envelopes meant for un-blinding of patient kits of Clinical Trial Study.

2.0 Scope

This standard operating procedure is applicable for formulation plants of Panacea Biotec Limited. Preparation of un-blinding envelopes shall involve the following

  • Procurement of packaging material required for preparation of un-blinding envelopes.
  • Preparation of un-blinding envelopes.
  • Dispatch of un-blinding envelopes to CRO
  • Recall and destruction of un-blinding envelopes.

3.0 Responsibility

3.1 Head, Clinical Research or his/her designee shall be responsible for

  • Preparation of randomization codes.
  • Review and support in preparation of the protocol.
  • Recall, reconciliation and destruction of un-blinding envelopes.

3.2 Head, Materials Management or his/her designee shall be responsible for procurement of packaging material and providing related documents to Stores.

3.3 Head, Stores or his/her designee shall be responsible for storage and issuance of materials.

3.4 Head, Production or his/her designee shall be responsible for preparation of un-blinding envelopes in conjunction with QA.

3.5 Head, QA shall be responsible for the release of un-blinding envelopes and compliance of this SOP.

4.0 Abbreviations and Definitions

QA                              :           Quality Assurance

CRO                            :           Contract Research Organization; CRO shall carry clinical trial for pharmaceuticals formulation unit.

CRD                            :           Clinical Research DepartmentDP                               :           Designated Person.

DP                               :           Designated Person.

SOPs                           :           Standard Operating Procedures

IOM                             :           Inter Office Memo

Randomization            :           The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Un-blinding                 :           Un-blinding means the disclosure of the identity of a blinded

product.

5.0 Procedure

5.1 QA in conjunction with Clinical Research Department shall prepare a protocol on carrying out preparation of blinding envelopes activity under following heads, but not limited to:

5.1.1 Objective

5.1.2 Scope

5.1.3 Responsibility

5.1.4 Abbreviations & Definitions

5.1.5 Pre-requisites

5.1.6 Procedure on preparation of un-blinding envelopes

5.2 QA shall evaluate the packaging, un-blinding leaflets and envelopes requirement along with CRD.

5.2.1 Printed leaflets, patient ID stickers and printed envelopes shall be evaluated by QA and CRD.

5.3 CRD shall intimate QA to plan for preparation of un-blinding envelopes.

5.4 Upon receipt of request from the CRD, QA shall intimate DP for preparation of un-blinding envelopes.

5.5 Un-blinding envelope preparation shall be undertaken by Designated Person as per the procedures laid down by Clinical Research Department.

5.6 Requisition shall be addressed through IOMs or other suitable means to the concerned departments.

5.7 The activity of preparation of un-blinding envelopes shall be undertaken by authorized and trained persons. Head QA shall constitute a team who shall support DP in the activity.

5.7.1 Head-QA shall plan for training of the team participating in the un-blinding activities.

5.7.2 The entry to the activity area shall be restricted. The entry and exit from the activity area shall be under discretion of DP.

5.7.3 The necessary arrangements for carrying out the preparation of un-blinding envelopes activity shall be thoroughly explored towards the correct and error-free activity.

5.8 Packaging material and un-blinding envelopes shall be reconciled by QA and DP and the reconciliation shall be recorded accordingly.

5.9 Signed and sealed copy of randomization list shall be obtained from CRD by Head-QA.

5.9.1 Head-QA shall forward the sealed copy to DP for execution of activity as per the treatment assignment(s)/ groups, based on the information given by CRD.

5.10 Randomization list shall be the same list earlier used for blinding activity of Clinical Trial Samples.

5.11 DP shall supervise the activity and shall handover un-blinding envelopes to plant QA for dispatch to CRO with necessary documents.

5.12 All the documents and records shall be reconciled and verified before dispatching the un-blinding envelopes to CRO by Head QA.

5.13 Details of reconciliation and dispatch shall be given to CRD.

5.14 The un-blinding envelopes shall be transported through courier. The courier details shall be filed with the respective Protocol.

5.15 Returned used/unused un-blinding envelopes shall be accounted and destroyed by CRD as per the Clinical Trial plan.

5.16 In case of clinical trial supply to Regulatory markets, Qualified Person shall release the envelopes based upon the understanding of facility audit and compliance statement of Designated Person.

Forms and Records

Nil

Distribution

Master Copy –           Documentation Cell (Quality Assurance)

Controlled Copies –  Quality Assurance, Production, Quality Control, Stores, Materials Management, Clinical Research, Research and Development, Regulatory Affairs

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

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