SOP for Handling of Waste Paper in Pharmaceutical Industry

Purpose

To provide a standard operating procedure for the management of waste paper generated during the documentation in the pharmaceuticals.

Scope

The scope of this procedure applies to the management of waste paper generated during the documentation in all the departments at PharmaceuticalSky Ltd.

Responsibility

All employees:

• To put waste paper in a waste paper box with a lock and key arrangement.

An authorized person from the user department:

• Review the papers available in the waste paper box, record the number of documents and types of documents to be discarded, and access the waste paper disposal room.

Department head:

Verify the document disposal request before any document is discarded.

Definitions

Waste Paper:

Waste papers are the papers generated during documentation, drafting, reviewing, etc., which are not controlled or approved documents.

Authorized person (under the scope of this SOP):

The person who has access to the wastepaper box lock and key and waste paper disposal room.

Procedure

• No paper shall be discarded or shredded without authorized request.
• In the absence of an authorized individual, the department head can allocate the task to another individual for that day.
• The waste paper generated at all working areas shall be put by an individual in the wastepaper bin/box provided in the respective department.

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• The number of waste paper bins/boxes shall be identified with the unique identification numbering system.
• The numbers and locations of bins/boxes shall be maintained and controlled through the authorized list.
• Authorized personnel of individual departments shall collect the waste paper from the waste paper bin/ box.
• The collected papers shall be checked to ensure that it is fit for destruction.
• The authorized person needs to ensure that the document is not a master copy, an original copy, a control copy, a weight print, a machine or instrument printout, or any other GMP document.
• If such a document is noted, inform the department head to get confirmation before it is discarded.
• The authorized person also shall ensure that no document is within the retention period of the record.
• Once the documents are verified, record the type of paper and the number of pages to be discarded.

• The record shall be approved by the department head/designee.
• While transferring the waste paper from the department to the paper disposal area, it should be kept in a sealed bag with a label for paper disposal. An authorized person should duly sign the label. The purpose of labeling the sealed bag is to identify the bag while moving from the department to the waste paper disposal area. Because of any reason, if the papers could not be discarded, they can be identified and justified at any given point in time.
• An authorized person shall access the paper disposal area. The area designated for the paper disposal shall remain in lock and key or under an access control system so that no unauthorized person can discard any document.
• Waster papers shall be discarded using a paper shredding machine.
• Adequate safety measures shall be ensured while handling the paper shredding machine.
• Shredded papers shall be handled by authorized housekeeping staff only.

Annexure

Nil

Revision History

Nil

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