Stamping of 'Uncontrolled copy' stamp on documents submission to DCA/CDSCO

Quality Assurance
1

Is it required stamping of ‘Uncontrolled copy’ stamp on documents which are going to be submitted to DCA/CDSCO as part of compliance report attachments. (site inspection)

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If the copies of the documents you are sending to the DCA/CDSCO are originally Controlled, then yes, you should make those “Uncontrolled” copies by stamping and submit to DCA/CDSCO.

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4

Yes — stamping “Uncontrolled copy” is generally considered good documentation practice when submitting to DCA/CDSCO during inspections or for compliance reports.

Here’s why:

  • Your controlled documents are maintained within your site’s quality management system (QMS).
  • When you share copies with external authorities (DCA/CDSCO), those are outside your control system, so stamping them as “Uncontrolled” prevents any confusion that they’re part of your live QMS.
  • It also demonstrates compliance with GxP documentation requirements and avoids audit observations around document control.

In short: yes, stamp them Uncontrolled copy before submission — unless your SOPs explicitly state otherwise.