SOPs

Stock Rotation of Raw Materials, Packing Materials and Finished Goods on the “First-in, First-out” basis

Objective

  • To lay down a procedure to ensure proper stock rotation of Raw materials, Packing Materials, and Finished Goods so that the stock rotation of the materials may be on the “First-in, First-out” basis.

Scope

  • This Standard Operating Procedure is applicable in Store for Stock Rotation of Raw Materials, Packing Materials, and Finished Goods on the “First-in, First-out” basis at the formulation plant.

Responsibility

  • Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Store in charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability

  • Store Incharge & 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.
  • QA:            Quality Assurance
  • FIFO:            First In First Out
  • Finished Goods

Procedure

  • The persons holding charges of the stores of Raw Materials, Packing Materials and Finished Goods shall maintain their stores adopting a system to avoid the materials brought earlier may not remain in the store without disposal for a long time by dispatching the later ones.
  • The persons holding charges of stores shall adopt the procedure of the proper stock rotation of the materials stored by them on the basis of “First-in, First-out” (FIFO).
  • The materials shall be stored in such a way to enable quick identification and stock movement.
  • The stocks should be racked and stored in a manner that earlier stocks are more easily accessible than the later ones.
  • The stock received should be with proper documents detailing the name of material, the batch number, quantity received and date of expiry, if any.
  • The stock control system must be such that only passed lots (released) are issued.
  • The materials should be stored on shelves at convenient heights and with proper labels which clearly identify the materials and with status labels of “Released” on each packing.
  • List of materials giving details such as their names, batch numbers, date of manufacture and date of Expiry, if any, and quantities in stock, should be prepared.
  • The stock rotation shall be such that the materials are disposed of on the “First-in, First-out” basis, i.e. in sequence of their receipt to avoid disposal of any material received later than the one received earlier.

Forms and Records (Annexures)

  • Not Applicable

Distribution

  • Master copy         –   Quality Assurance
  • Controlled copies        –  Quality Assurance, Store

History

DateRevision Number Reason for Revision
0New SOP

 

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