SOP for Destruction of Analytical Samples After Testing

OBJECTIVE

The objective of this SOP is to describe a procedure for the destruction of balanced analytical samples after analysis and control samples.

RESPONSIBILITY

Chemist Quality Control shall be responsible for the Destruction of the remaining unwanted Analytical samples after analysis.

Head - Quality Assurance shall be responsible for ensuring the destruction of samples as per the procedure.

ACCOUNTABILITY

Head – Quality Control

PROCEDURE

NOTE: 2% w/v sodium hydroxide solution shall be used to inactivate samples before Disposal.

Tablets and Capsules:

Blend Analysis

• After analysis, discard the balance sample of the tablets and capsules into a wet bin containing a 2 % w/v solution of sodium hydroxide. Deface the label of the polybag and discard the bag into a waste bin after treating it with 2% w/v solution of sodium hydroxide

Bulk Analysis

• After analysis, discard each and every capsule or tablet into the wet bin containing a 2 % w/v solution of sodium hydroxide. Deface the label of the poly bag and discard the bag into a waste bin after treating it with a 2% w/v solution of sodium hydroxide.

ALSO READ: SOP for Review and Approval of Analytical Raw Data

Finished Product Control Samples:

• Cut the blisters/strip packs and take out the tablets/capsules and discard them into the wet bin containing a 2% w/v solution of sodium hydroxide. Discard the empty blisters/strip packs into the waste bin after treating it with a 2% w/v solution of sodium hydroxide.

Dry syrups/powders and oral liquids.

• Discard the powders/liquids in a wet bin containing a 2% w/v solution of sodium hydroxide. Deface the label on the bottle. Glass bottles shall be treated with a 2 % w/v solution of sodium hydroxide before disposal to the vial/bottle crusher.

Raw Materials

• After analysis, discard a balanced sample of raw material into the wet bin containing a 2 % solution of sodium hydroxide. Deface the label of the polybag and discard it into the waste bin.

Packaging Materials

• After analysis, cut the material into pieces and it to the scrap yard.
• At the end of the day remove the wet bin from the laboratory premises and send it to the ETP to discard the waste.

TRAINING

Trainer -- Head – Quality Control

Trainee -- All departmental heads / Quality Control Personnel

Period -- One day

ANNEXURE

Nil.

REVISION HISTORY

Nil

ALSO READ: SOP for Approval and Release of Finished Goods