Science & Technology in Action

16th Edition

The importance of Quality Control in pharmaceutical industry

MSD

Biology
Chemistry
Technology
Qualitative methods determine precisely what substances are present in a product. Quantitative methods assess the concentration of the active ingredient. It is not enough to rely solely on testing to maintain the quality of a product, i.e. ‘quality by testing’. Today ‘Quality by Design’ is a key feature of the pharmaceutical industry.

Available downloads

The full lessons along with a supporting toolkit are available in three different formats, A4, A3 and as a Powerpoint deck.

Lesson excerpt

What does the ‘quality’ of a pharmaceutical product mean?

A high quality pharmaceutical product is one that is both safe and effective. It should therefore be of consistent composition and be free of unwanted by-products and contaminants. Medical practitioners and consumers will then have confidence in the product and will be more likely to choose it. If the quality of a product drops:
    • Patients’ health may be compromised which could have long lasting effects.
    • The manufacturer’s reputation may be damaged, lowering confidence in other products and decreasing sales.
    • In the case of a ‘Flagship product’ reputational damage can endanger the whole company and put jobs at risk.
A high-quality pharmaceutical product is one that is produced from high quality ingredients, using consistent processes that prevent contamination and is in compliance with relevant legal requirements. It benefits both the producer and the consumer. In the long term, quality costs less and is more beneficial to both companies and patients.

Can you measure quality?

The quality of pharmaceutical products can be checked by regular testing of samples, to ensure they are up to the required standards. For example, a product such as paracetamol is typically produced in tablet or capsule form. The tablets are commonly sold in packs of 12 and each tablet is individually sealed. Random samples are taken from each batch of product and tested for composition, weight, packaging, labelling, etc.

Quality by Design — not just by testing

It is not enough to rely solely on testing to maintain the quality of a product, i.e. ‘quality by testing’. Quality should be ‘built in’ to the whole manufacturing process and be based on a fundamental understanding of what happens at every stage, i.e. ‘quality by design’.

True or False?

  1. A high quality pharmaceutical product is one that is both safe and effective. true
  2. High quality products benefit the consumer but not the producer. false
  3. Quality is subjective and so cannot be measured. false
  4. ’Quality by Design’ eliminates the need for testing. false
  5. Quantitative tests involve some measurement of quantities such as mass, volume, concentration, etc. true
  6. Mass spectrometry, chromatography and electrophoresis are instrumental methods of analysis. true
  7. In a ‘double-blind trial’ the patients don’t know if they have received the real product or not, but their doctors do. false
  8. The potency of a pharmaceutical product is the minimum amount of it that is effective, for 50% of recipients. true
  9. School chemistry practicals involve both qualitative tests and quantitative measurements. true
  10. Litmus paper gives quantitative results. false