disposal of samples chemicals glassware columns

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disposal of samples chemicals glassware columns

1.0 Purpose
1.1 To describe a procedure for disposal of samples, chemicals, glassware, columns etc.

2.0 Scope
2.1 This standard operating procedure is applicable for disposal of samples, chemicals, glassware, columns

etc in Quality Control Department at ABC Pvt. Ltd.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP and follow the procedure as per SOP
Assistant Manager Reviewing and Training of SOP
Manager QC Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 The All left over samples (after testing), expired reference reserve samples, spoiled

and / or expired chemicals (used for testing purpose), broken glassware and non –performing HPLC

columns etc. shall be disposed off as follows.
5.2 Disposal of left over samples after testing
5.2.1 Clean the sink with detergent and plenty of tap water.
5.2.2 All the samples received in Quality control laboratory as granules, tablets, solutions, powder

and raw materials etc. shall be tested and the left over samples shall be collected.
5.2.3 All granules, capsules and Tablets shall be broken into pieces collect in raw water and dilute,

and then they are disposed off in the collection tank of the ETP.
5.2.4 Solutions are disposed off under continuous flow of tap water
5.3 Disposal of Reference standards, working standards and reserve samples
5.3.1 After the expiry of Reference standards, working standards and retention samples of raw materials

active or Excipients, which shall be verified and confirmed by the Manager QC, shall be disposed off in

the collection chamber of ETP. The empty bottles, Polythene and Boxes shall be sent to scrap yard.
5.3.2 Drug products packed in blister packs, strips, sachets and pouches etc. shall be cut open and the

tablets, capsules and powder etc. shall be broken into pieces and be disposed off in the collection

chamber of ETP. Packaging materials of those packs shall be cut into pieces and sent to scrap yard for disposal.
5.3.3 Drug products packed in Glass bottles shall be opened; material shall be drained under continuous

flow of water. Empty bottles and other packing materials shall be collected and sent to scrape yard for disposal.
5.4 Disposal of laboratory chemicals
5.4.1 At the end of month, the expired or spoiled chemicals shall be segregated for disposal and to prevent their further use.
5.4.2 Each spoiled and / or expired laboratory chemical shall be separately disposed off.
5.4.3 All chemicals shall be disposed off after diluting with water, and then the diluted chemical shall be

drained off under continuous flow of tap water.
5.4.4 Hazardous chemicals shall be disposed off as per the recommendations given by the manufacturer.

It shall be done under the fume hood chamber by the recommended procedure.
5.4.5 All the personnel handling of hazardous material must wear hand gloves, safety goggles, nose masks or gas masks.
5.5 Disposal of Glassware
5.5.1 Broken glassware (non-repairable) shall be collected separately and sent to scrap yard of company.
5.6 Disposal of HPLC column
5.6.1 All the non-performing columns of HPLC (Not meeting the system suitability requirements), which

shall be confirmed and approved by the Quality Control-Manager, shall be segregated for disposal purpose.
5.6.2 After due permission from Quality Control-Manager, take out packing of the column, deface it and

cut it into three pieces before sending it to scrap yard for disposal.

6.0 Reference
In House

7.0 Attachments
Annexure I : Disposal record of Sample and chemical

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure
ETP : Effluent Treatment Plant
HPLC : High Performance Liquid Chromatography

10.0 Revision History