SOP on handling scrap and disposal in pharmaceutical

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 management of Scrap generated in different departments of the Organisation to ensure correct handling & disposal.

2) Scope: It provides an overview for the generation of reject/scrap, its collection, and accounting, 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) Correct Handling Scrap And Disposal of Scrap in the department, transfer Scrap to scrap yard –officer and Housekeeping Person

b) Periodic inspection of Scrap in the scrap yard. – Q.A. Officer

c) Final disposal of Scrap. – Manager Stores

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 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, inspection stages 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 packing operation defaced/shredded and sent to scrap yard.

f) Excess or used stereos after complete 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, remaining after the testing, is to be destroyed in the laboratory.

i) Control samples in the custody of Quality Assurance after the mandatory storage period 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 too 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.

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.

Handling Scrap And Disposal

8) Inspection of Processed Scrap By Quality Assurance before Final disposal:

a) Processed Scrap should keep in the scrap yard for periodic Q.A. inspection.

b) Check and ensure that the identity of all printed /overprinted materials, 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.

9) 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.

a) Place the Scrap separately based on the following classification:

  • Glass scrap
  • Plastic Scrap
  • Paper scrap
  • Blister /strip scrap

b) Lock the scrapyard after keeping the Scrap inside.

11) 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.