sop for disposal of residual sample  

 

sop for disposal of residual sample  

 

1.0. OBJECTIVE :
1.1 To lay down a procedure for disposal of Residual sample of Quality Control Department.

2.0. SCOPE:
2.1 This procedure is applicable for disposal of Residual sample of Quality Control Department
.

3.0. RESPONSIBILITY :
3.1 Officer/ Executive shall be responsible for disposal of Residual sample of Q C

4.0. ACCOUNTABILITY:
Head-Quality Control Department



5.0. PROCEDURE:
5.1. At every weekend collect residual samples from chemical, instrumentation and Microbiology section into a plastic container.
5.2 Disposal of Residual sample of finish product:

5.2.1 Dispose the collected samples of finished product at Every weekend under supervision of Officer / Executive of Quality Control .
5.2.2 Disperse the solid dosage forms in bucket containing water and then discard at disposal point.
5.2.3 Transfer the liquid dosage forms in bucket containing water and then discard at disposal point.
5.2.4 Transfer injectable product from vials/ampoules in bucket containing water and then discard at disposal point.
5.2.5 Crush the bottles, ampoules and vials and cut other packing materials into small pieces then discarded in common garbage.
5.3 Disposal of residual sample of Raw material /working standard /reference standard:
5.3.1 Dispose residual raw materials /working standard /reference standard in bucket containing water under the supervision of Officer/Executive of Quality Control and discard at the disposal point.
5.4 Disposal of residual sample of Packaging material:
5.4.1 Crush the bottles, ampoules and vials and cut other packing materials into small pieces and then discard in common garbage.
5.5 Disposal of Used/Expired Lab Chemicals:
5.5.1 Neutralize the used expired lab chemicals by suitable neutralizing agent and discard at the disposal point.
5.6 Disposal of Used Mobile phase and waste solvents:
5.6.1 Collect the used mobile phase and waste solvents in bucket containing water and then discard at disposal point.
5.7 Disposal of Used Dissolution medium and DT Medium:

5.7.1 Collect the used dissolution medium and DT medium in bucket containing water and then discard at disposal point.
5.8 Disposal of waste solvent/medium from Total Organic Carbon Analyzer and Liquid Particle Counter:
5.8.1 Collect the waste solvent/medium from TOC Analyzer and LPC in bucket containing water and then discard at disposal point.
5.9 Disposal of discard material:
5.9.1 Collect the empty solvent bottle/acid bottle and other extra bottles , poly bags, corrugated boxes and plastic bottles and keep in the designated place in QC.



5.9.2 Lab assistant should take necessary precaution (like safety goggle, Hand gloves and mask and other PPE) when handling such type of materials.
5.9.3 At the end of the day collect all discard material from Quality Control in a suitable size of poly bag and send to scrap area for disposal.

6.0. ABBREVIATION:

Abbreviation Full form of abbreviation used
Ltd. Limited
SOP        Standard Operating Procedure
No.         Number
QC        Quality Control
QA       Quality Assurance

TOC      Total Organic Carbon
LPC      Liquid Particle Counter
Sr.          Senior
PPE      Personal Protective Equipment

 

7.0 DISTRIBUTION:

    Controlled Copy

Controlled Copy

Master Copy

Quality Assurance

Quality Control

Quality Assurance Department

 

8.0REFERENCES:

In House

9.0 REVISION HISTORY:

Revision No. Change Control No. Details of Changes Reason of Changes Effective Date Done By
Nill Not Applicable Not Applicable New SOP

 

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Disposal of Residual Sample or Left Over Material

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sop for preparation of mobile phase

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sop for disposal of residual sample  

sop for handling of pharmacopoeial changes

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difference between UPLC and HPLC

sop for for Emergency Eyewash and Shower

sop for operation and calibration of total organic carbon analyzers

sop for operation of cobb tester

sop for Operation and calibration of atomic absorption spectrophotometer

sop for Operation and calibration of gas liquid chromatograph

sop for operation of humidity oven

sop for operation and calibration of serological water bath

sop for monitoring of drain trap

sop for destruction of analytical samples after testing and control samples

sop for destruction of used chemicals

Sop for Operation of suction pump

sop for Operation and calibration uv cabinet

sop for Operation and calibration of bulk density apparatus

sop for operation and calibration of shore hardness tester

sop for operation of rub proofness tester

sop for monitoring of purified water

sop for Retesting of packaging materials

sop for Retesting and resampling of raw materials

sop for Control of issuance of record of analysis green sheets

sop for Control of computer passwords

sop for sampling of packaging materials PM

sop for sampling of sterile raw material

sop for sampling of intermediates and finished products

sop for operation and calibration of friability test apparatus

sop for approval and rejection of packaging materials

sop for non conformance of RM PM and finished product

sop for collection storage and disposal of control samples

sop for trend analysis of finished products

sop for Chromatographic practices and system suitability

SOP For Good Laboratory Practices

sop for cleaning and operation of sieve shaker

general specification of packing material cartons

sop for Password for Analytical Instrument and LIMS software

sop for Rounding off numerical analytical results

sop for sampling of bulk and finished product

sop for cleaning of spillage material

sop for Handling of Reference Standard

sop for hplc column maintenance and washing

procedure for sampling and handling of bulk sample

STP for borewell generation point (raw water storage tank)

sop for preparation and standardization of 0.1M Zinc Sulphate

Operation &calibration of analytical balance (dhona)

Operation and Calibration Procedure for Disintegration Test apparatus

sop for preparation and standardization of 1 M Hydrochloric Acid

Preparation and standardization of 0.1 M ceric ammonium sulphate solution

sop for preparation and standardization of 0.05 m iodine solution

validation of volumetric solution 0.1m ammonium thiocyanate

handling of reference standard and preparation of working standard

sop for water sampling and analysis

sop for operation for validation of excel worksheets

sop for laboratory cleaning

sop for stability of volumetric solutions

sop for preparation of raw material in process finish product packing material data sheets

sop for handling of hazardous chemicals

sop for handling of glassware and allocation of identification number

sop for operation cleaning and calibration of bursting strength tester

sop for rounding off the analytical test results

procedure for Analyst Qualification

sop for operation and calibration of dissolution Apparatus

procedure for maintenance of desiccators

sop for for hplc column receipt checking id no and regeneration

safety data sheet for laboratory chemicals

procedure for handling of poisonous chemicals

sop for cleaning of sampling devices

sop for calibration procedure of instruments

sop for specification and standard testing raw material packing material and finished product

procedure for operation and calibration of potentiometric titrator

procedure for operating and calibration of digital hardness tester

procedure for disposal of expired chemicals, reagents and solvents

sop for behavior in quality control department

sop for preparation and standardization 0.1M sodium thiosulphate

sop for preparation and standardization 0.1M Disodium Edetate

preparation and standardization 0.1M Sodium Hydroxide Solution

Preparation and standardization of 0.1M Perchloric acid solution

sop for preparation 0.05M edetate disodium

sop for preparation 0.1M silver nitrate

sop for Operation and Calibration of High Performance Liquid Chromatography

sop for UV & Visible Spectrophotometer

procedure for Cleaning of laboratory glassware

Cleaning of Instrument, Instrument bench and surrounding area of Quality

Safety Precaution in Quality Control Department

Operation & Calibration of Analytical Balance

Calibration of Glassware in Quality Control Department

handling of samples received in Quality Control

Cleaning and Operation of Refrigerator

Operation, Cleaning and Calibration of water bath

Operation & Calibration of Refractometer

Operation and Cleaning of Centrifuge Apparatus

cleaning, operation & calibration of Vernier caliper

Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)

Cleaning and operation of Moisture Analyzer

Cleaning & Operation of Vacuum pump in Quality Control Department

Operation and Calibration of Polarimeter

Cleaning and operation of Magnetic Stirrer

Cleaning Operation and Calibration of Melting Point

Operation Cleaning and Calibration of Muffle Furnance in Quality Control Department

procedure of operation and Cleaning of Sonicator

Operation Cleaning & Calibration of pH meter in Quality Control Department

Entry and Exit in Quality Control Department

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