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SOP For Handling Scrap and Disposal in Pharmaceutical

The document provides a standard operating procedure for handling scrap and disposal in the pharmaceutical industry. It outlines responsibilities for quality assurance and stores department staff. The SOP describes receiving scrap from production, generating scrap from manufacturing stages, inspection and disposal procedures. Rejects must be securely stored and records maintained. All scrap must be destroyed and disposed of according to regulatory standards to prevent misuse and protect the environment.

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270 views

SOP For Handling Scrap and Disposal in Pharmaceutical

The document provides a standard operating procedure for handling scrap and disposal in the pharmaceutical industry. It outlines responsibilities for quality assurance and stores department staff. The SOP describes receiving scrap from production, generating scrap from manufacturing stages, inspection and disposal procedures. Rejects must be securely stored and records maintained. All scrap must be destroyed and disposed of according to regulatory standards to prevent misuse and protect the environment.

Uploaded by

王仁宏
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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SOP for Handling Scrap and Disposal in Pharmaceutical


Last Updated on: January 20, 2023 by Naresh Bhakar

1) Objective
Handling Scrap And Disposal coming from any regular production run assumes great
significance in the pharmaceutical industry. Improper destruction procedures
followed can lead to a problematic situation if such material finds its way into the
wrong hands.
To lay down instructions for the management of Scrap generated in different
departments of the Organization to ensure correct handling & disposal.
2) Scope
It provides an overview of the generation of reject/scrap, its collection, and
accounting, and recommends guidelines for dealing with the rejects/scrap and its
disposal thereof.

3) Responsibility
The responsibility for dealing with rejects/scrap rests on the representatives of
Quality Assurance and the store’s department for its final disposal in such a manner
that it cannot be misused.
a) Officer and Housekeeping Person: Correct Handling Scrap and Disposal of Scrap in
the Department, transfer scrap to the scrap yard
b) Q.A. Officer: Periodic inspection of Scrap in the scrap yard.
c) Manager Stores: Final disposal of Scrap.

4) Receipt of Scrap/Reject
a) Receive the Scrap generated by the concerned production department.
b) Place specified Scrap in a designated area of the scrap yard.
c) Inform the concerned department in charge in case of any discrepancy.
d) Ensure that there is no spillage of scrap/reject on the floor or road during
transfer.
5) Reject/Scrap Generation
Rejects generated at various stages of the manufacturing site of pharmaceutical
products should be systematically collected, accounted for, and disposed of
correctly to prevent misuse.
a) Product rejects generated during material processing and transfer operations are
destroyed on the shop floor.
b) Product residues extracted into dust extraction system at various stages of
manufacture or leftover in various processing equipment and machinery destroyed
on the shop floor.
c) Rejects generated during compression, encapsulation, coating, filling, and
inspection stages were destroyed on the shop floor.
d) Rejects generated from in-process checks such as weight variation, volume
checks, leak testing of the strip, etc. Product to be destroyed on the shop floor and
packing material sent to scrap yard.
e) Excess or rejected printed packing materials coded or non-coded, like labels,
leaflets, foils, tubes, etc., at the end of the packing operation were
defaced/shredded and sent to the scrap yard.
f) Excess or used stereos after completion of batch coding to be destroyed by doing
small pieces.
g) Obsolete printed packing materials in the stores defaced/shredded in a
scrapyard.
h) Excess sample that remains after the testing, is to be destroyed in the
laboratory.
i) Control samples in the custody of IPQA after the mandatory storage period was
destroyed in the laboratory.

6) General Principles
a) There shall be written authorized procedures for:
i) Differentiating recoverable residues from non-recoverable rejects.
ii) Scrap which is disposed of solid on a commercial basis. The person must take
precautions, e.g., defacing labels on empty bulk containers, corrugated boards ,
cartons (un-printed), etc.
b) There shall be a written, authorized procedure for handling the destruction and
disposal of rejects generated during the production/handling of pharmaceutical
products and printed packing components.
c) All rejects should be collected in suitable closed containers, labeled appropriately,
and held in a secured segregated space until taken for destruction.
d) Destruction must be carried out by authorized persons under the supervision of a
responsible person.
e) Quantities rejected and destroyed must be recorded and reconciled in the
relevant batch documents as per the “reconciliation and destruction of materials ”
SOP.
f) Rejected printed packing materials shall not be returned to suppliers.
g) Appropriate safety precautions must be taken while carrying out destruction.
h) Final disposal of residual solids/liquids shall be consistent with local regulatory
requirements, including its effect on the environment.
7) Inspection of Processed Scrap by Quality Assurance before final disposal:
a) Processed Scrap should keep in the scrap yard for periodic QA inspection.
b) Check and ensure that the identity of all printed/overprinted materials is
destroyed by shredding them into small pieces.
c) Check and ensure that the labels on all the containers are correctly defaced.
d) Checked and ensure that all the containers of Injectables/drops were crushed.
e)After complying with all the above checks, clear the Scrap for final disposal after
noting all entries.

8) Final Disposal of Scrap from Scrap holding area to scrap yard:


a) After obtaining the Q.A. clearance, properly close the containers/poly bags
holding the Scrap on a pallet in the designated area.
b) Place the Scrap separately based on the following classification:
 Glass scrap
 Plastic Scrap
 Paper scrap
 Blister/strip scrap
c) Lock the scrapyard after keeping the Scrap inside.

9) Disposal of Scrap from Scrap Yard


a) Weigh each container of the Scrap and enter the item’s details and the weight in
the register maintained for the purpose.
b) Load each item into the vehicle. Ensure that the details are checked and
countersigned by a security officer and the representative of the scrap contractor.
c) Prepare gate pass mentioning all the items being dispatched.
d) Counter-check the details in the gate pass with the scrap yard register. If found
correct, allow the vehicle to pass.

10) Abbreviations
IPQA: in-process Quality Assurance
QA: Quality Assurance
SOP: Standard Operating Procedure

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