Waste treatment procedure for medicinal products which must be utilized/destructed

OBJECTIVE

To provide waste treatment procedure for medicines which must be utilized/destructed.

SCOPE

This SOP is applicable to waste treatment compliance of medicines which must be utilized/ destructed.

RESPONSIBILITY

Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP.

ACCOUNTABILITY

ATTACHMENTS

List of available medicinal products which are not subject for the further use – Attachment-I

PROCEDURE

The rest of the raw material, in-process samples, finished products after completion of analysis, expired control samples, samples used for stability test which are not subject for the further use, obtain «waste» status and are to be utilized/destructed.

Utilization and destruction of solid waste (tablets, capsules, granules, etc)

After analysis and achievement of the result, remove sample remains (in-process, finished products samples and samples after stability test) from secondary packaging. Remove tablets, capsules and granules, which must be utilized/ destructed, from primary packaging and place in a special container for «waste».
Remove expired control samples (finished products) from secondary packaging .Remove tablets, capsules and granules, which must be utilized/ destructed, from primary packaging and place in a special container for «waste».
Deface primary and secondary packaging by scissors and throw it to the waste container.

Utilization and destruction of liquid waste (suspension, syrups, solution, etc.)

After analysis and achievement of the result, remove sample remains from secondary packaging. Deface the label on the bottle of suspension/ syrup/solution by making cross lines with black tip marker. Place suspension/syrup/solution bottles, which must be utilized/ destructed, in a special container «for waste».
Remove expired control samples (finished products) from secondary packaging.Deface suspension/syrup/solution label on bottle by making cross lines with black tip marker. Place suspension/syrup/solution bottles, which must be utilized/ destructed, to the «waste» container.
Deface secondary packaging with scissors and throw it to the waste container.

Raw material (API, excipients)

Remove from secondary package (additional package) raw material expired control samples, and the rest of the raw material samples after testing and receiving results. Deface the label on primary packaging of raw material by making cross lines with black tip marker. Place polyethylene package with raw material, which must be utilized/ destructed, to the waste container.
Deface secondary packaging (additional package) with scissors and throw it to the waste container.

Remarks

If finished product control sample is expired , prepare information sheet of medicinal products which are not subjected for the further use (AttachmentI).
Once the container is filled, label it as «Waste» and transfer to a responsible person (Technical Supervision Engineer) with the official note for storage and subsequent submission/utilization/destruction to the enterprise that has appropriate licenses for hazardous waste activities (as per agreement).
Keep the «waste» sample containers in the designated area outside of the laboratory, for waste storage, collection, utilization and further disposal.

REFERENCES

ABREVIATIONS

DISTRIBUTUON LIST

HISTORY OF REVISION

Attachment-I

List of available medicinal products which are not subject for the further use

LIST

of available medicinal products which are not subject for the further use

dated

Sr. No. of Medicinal Product Registration certificate	Name of Medicinal Product	Dosage form	Dosing	Manufacturer	Country of Manufacturer	Batch number	Available quantity	Reason

Members of commission sign Surname, first and patr. Name

The Head of commission: sign Surname, first and patr. Name

sign Surname, first and patr. Name