SOPs

Handling of Spillage of Materials

ABHA

Spillage of Materials

Objective :To lay down a procedure for Handling of Spillage of Materials to prevent contamination in surrounding areas and to avoid environmental hazards by any hazardous material.

Scope : This Standard Operating Procedure is applicable in the facility for the handling of spillage of Material in the pharma industry.

Responsibility

  • Concerned Department personnel shall be responsible to follow the procedure mentioned in this SOP.
  • The concerned Department in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability : Concerned Department Head & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

SOP:  Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

Spillage of material: It denotes an occurrence in which material is lost/scattered by spilling accidentally.

Procedure

Spillage of any material shall be handled immediately when observed and effectively as per the procedure mentioned below:

The personnel working in the concerned department shall immediately inform the In-charge of the concerned department about the spillage of material.

Concerned department In-charge shall inform to QA about complete details of spilled materials.

The personnel who shall handle the spillage wear proper protective dress such as aprons, hand gloves, masks, and safety glasses to prevent if the material is volatile or irritating to the nose and eyes.

If the material is a solid one, then the same shall be collected with the help of a plastic scoop and a soft broom into a container for disposal as waste. In case of very fine powder being spread over a large area of the floor, then the floor may be cleaned with a vacuum cleaner. The floor shall be thoroughly cleaned first with a wet mop and then dried with a dry mop.

If the material is a liquid one, the same shall be collected, with the help of a plastic scoop and a sponge, into a container for disposal as waste. The floor shall be cleaned first with a wet mop and then dried with a dry mop.

If the material is sticky or greasy, the same shall be collected with the help of a plastic scoop and soft broom, into a container for disposal as waste. Thoroughly clean the floor first with a mop dipped in hot water and then dries with a dry mop.

If the spilled material is corrosive (acidic or alkali) the same shall be neutralized with acid or alkali, as the case may be, before collecting with the help of a plastic scoop and soft broom into a container for disposal as waste. Thoroughly clean the floor first with a wet mop and then dry with a dry mop.

If the spilled material is a controlled substance, then the spilled material shall be collected in a polythene bag, which shall be closed tightly with a thread/rubber band and the same shall be weighed and labeled as under

  • Name of the material
  • Batch No.
  • Name of the Manufacturer
  • date and Exp. Date
  • Weight of Material
  • This polythene bag containing spilled material shall be kept near the container from which it has fallen off for inspection by QA. The details regarding spilled material shall be entered in the “Spilled Material Logbook” as per Annexure-I.

Spilled material shall neither be used in manufacturing/testing of products nor shall it be disposed of as a waste material without the permission of QA. After getting the approval of QA, the material shall be disposed of as per SOP “Disposal and Destruction of Material” and details of disposing of materials shall be recorded in the respective Logbook.

Concerned department personnel must get proper training for handling of spillage of Material.

Forms and Records (Annexures)

Spilled Material Logbook – Annexure-I

Distribution

Master copy –   Quality Assurance

Controlled copies –  Quality Assurance, Production, Quality Control, Stores

History

Annexure-I

Spilled Material Logbook Contents

  • Sr. No.
  • Date
  • Spilled Product Name
  • Batch No.
  • Quantity of material Spilled
  • Status of material
  • Done By
  •  Checked By
  • Verified By

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube