SOPs

Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store

ABHA

Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store

Objective

  • To lay down a procedure for Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store to prevent them from drying and embattlement or the absorption of moisture.

Scope

  • This Standard Operating Procedure is applicable in Raw Material Store for the proper storage of Empty Hard Gelatin Capsule Shells at formulation plant
  • Responsibility
  • Raw Material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Raw Material Store In-charge shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

  • Raw Material Store In-charge & 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
  • PVC                            :            Poly Vinyl Chloride

Procedure

Capsule Shells

  • Empty Hard Gelatin Capsules Shells are transported under controlled conditions of temperature and humidity i.e. in ‘REFRIGERATED CARGO’. Capsule shells are tightly air sealed in PVC air tight bags. These bags are put into Corrugated Boxes. Adhesive tape is put on all the sides of Corrugated Boxes to seal the joints and to make the box airtight. After the receipt of empty hard gelatin capsule shells the following steps are followed:
      • Shift these corrugated boxes to Quarantine Area having controlled conditions that is humidity and temperature.
      • Let the Empty Hard Gelatin Capsule Shells to be sampled out by Quality Control for testing.
      • After sampling seal the bags and corrugated boxes airtight.
      • Wait for the testing report of Quality Control Department.
  • If the results of the empty hard gelatin capsule shells ‘Passed’ then transfer them to approved area in Raw Material Store with controlled temperature and humidity conditions.
  • Otherwise shift the rejected capsules to the rejected Raw Material Store also affix red colored “Rejected” Status Label.
  • The Empty Hard Gelatin Capsule Shell shall be stored at a temperature 25 ± 2˚C.
  • The empty hard gelatin capsule shells shall be stored at relative humidity 55% ± 5 %.
  • Maintain the controlled conditions that is temperature and humidity for storage of empty Hard Gelatin capsules shell in Raw Material Quarantine and Raw Material dispensing and storage areas because of the factors ahead:
      • At high moisture levels the capsules absorb moisture, become soften, tacky and deform under their own weight.
      • At low moisture levels, capsules become brittle and suffer dimensional changes.

Forms and Records (Annexures)

  • Not Applicable

Distribution

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

 History

 

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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