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Quality is an integral part of any product and more so when products are designed for consumption. Quality control plays an important role in ensuring the consistency of quality in medicinal products. It is present at each stage of the product life cycle and even continues once the finish good hits the market.

So what tests are carried out to assess the quality of a product?

Physical Tests

These tests evaluate the appearance of the tablet. Size, shape, thickness and weight between all tablets should be consistent, any deviation may signal a variation in ingredient amounts between tablets. Hardness and disintegration times are also assessed. The structural integrity of a tablet depends on its hardness and must be strong enough to withstand the handling of the manufacturing and transportation process. However, if the tablet is too hard the tablet will take longer to disintegrate and the contents will not be release as intended; negatively impacting the dissolution time.

Chemical Tests

Chemical testing involves quantifying and/or identifying different materials in the product. For example, the identity of an herb in a tablet may be established by TLC and comparing the resulting chromatogram against the chromatogram of a known standard. To quantify a component in the product, an assay is performed, and the right equipment or technique selected.
A problem presents when a range of ingredients are used in the product which can interfere with the assay of a specific component giving a false quantifiable result. Similarly, the task of identifying herbs and their components becomes increasingly difficult as more and more herbs are present in the product. During these times ingredients are “quantified by input” and a statement written to explain why a specific test cannot be undertaken.

Microbiology testing

Microbiology tests are carried out to ensure that the product is free from microbial contaminants and is safe to consume. Products are tested for a range of bacteria that may enter the product during the manufacturing process. Yeast, mould and fungi are also tested to ensure that any colony forming units are not present or are well below the acceptable limits.

Stability Studies

All products undergo a grade of decomposition. The aim of stability studies is to determine the time it takes for components in the product to fall below the label claim and determine the storage conditions that will minimise the decay. If the product is brand new, stability is carried out concurrently with the product launch and monitored at different time intervals. At the end of the trial the stability results are reviewed and the shelf life maintained, increased or overages in the material adjusted if needed.

All products are analysed against specific tests based on official guidelines and standards, these include:

  • The British Pharmacopoeia (BP)
  • The United State Pharmacopoeia (USP)
  • The European Pharmacopoeia (EP)
  • International standards (ICH, ISO, FCC and others)

Chemical Techniques and Equipment used at Vitex include:

  • High/Ultra Performance Liquid Chromatography (HPLC/UPLC)
  • Gas Chromatography (GC)
  • Inductively Coupled Plasma (ICP) – OES
  • Dissolution Testing
  • Fourier Transform Infra-Red (IR)
  • Karl Fischer Auto Titrator
  • Ultraviolet- Visible (UV/VIS) spectrophotometer
  • Refractive Index Polarimeter

All products are tested by QC before being release for supply. A good product will receive extensive testing before receiving the green tick of approval.

 

Author: Freddy Macias
December 2017
Vitex Pharmaceuticals Pty Ltd www.vitexpharma.com