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

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 the formulation plant.

Responsibility

Raw Material Store personnel shall be responsible for following the procedure mentioned in this SOP.

The raw Material Store in charge shall be responsible for the 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

Ltd.: Limited

PVC: Poly Vinyl Chloride

Procedure

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 a Quarantine Area that has controlled conditions that is humidity and temperature.

  • Let the Empty Hard Gelatin Capsule Shells 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 an 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 a red colored “Rejected” Status Label.

The Empty Hard Gelatin Capsule Shell shall be stored at a temperature of 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 capsule shells 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

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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