Handling of Spillage of Materials

Handling of 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 hazardness by any hazardous material.

Scope

  • This Standard Operating Procedure is applicable in facility for handling of spillage of Material

Responsibility

  • Concerned Department personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Concerned Department in-charge shall be responsible for 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 to an occurrence in which material is lost/scattered by spilling accidently.
  • QA                              :             Quality Assurance
  • Ltd.                             :             Limited
  • Mfg.                            :             Manufacturing
  • Exp.                            :             Expiry

Spillage of Materials

Procedure

Procedure for Handling of Spillage of Materials

  • Spillage of any material shall be handled immediately when observed and effectively as per the procedure mentioned below  :
  • The personnel working in concerned department shall immediately inform the Incharge of the concerned department about the spillage of material.
  • Concerned department Incharge 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, mask 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 a 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 a 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 plastic scoop and soft broom, into a container for disposal as a waste. Thoroughly clean the floor first with mop dipped in hot water and then dries with a dry mop.
  • If the spilled material is corrosive one (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 a waste. Thoroughly clean the floor first with 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, material shall be disposed of as per SOP “Disposal and Destruction of Material” and details of disposed materials shall be recorded in the respective Logbook.

Concerned department personnels 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

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                  Next Review Date:
Sr. No.DateSpilled Product NameBatch No.Quantity of          material SpilledStatus of materialDone ByChecked ByVerified By

 

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                         Next Review Date:
 

 

 

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 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, Panacea Biotec Ltd, and Nectar life Science 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

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