Science & Technology in Action

2nd Edition

Manufacture and Analytical Testing of Pharmaceutical Products

Teva Ireland

This lesson looks at a general manufacturing process and analytical testing of a pharmaceutical product. It outlines the key objectives in developing high quality pharmaceutical products and the importance of rigorous quality and stability testing.
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Lesson excerpt

When you are sick and you reach for that box of tablets, how do you know that what you are about to take is safe? All pharmaceuticals are manufactured to rigorous regulatory standards to ensure that the products reaching patients are safe, effective and of a high quality. 

What is Good Manufacturing Practice?
Good manufacturing practice (GMP) is just one of theregulatory requirements that ensure quality standards are maintained and are used to control the suitability of raw materials, manufacturing premises, equipment, product sampling, specifications,  stability testing , determination of product shelf life, testing and the release of products to the marketplace.

The key objective for any pharmaceutical company is to develop a high-quality therapeutic product that fulfils the following criteria:

  • Therapeutic effect : The drug (the active pharmaceutical ingredient , API), identified to treat a particular condition must be proven to be effective at the specified dose level.
  • Bioavailability : The manufacturers must ensure that the API is released within the body and is available at the site of action. In the case of a product in tablet form, the tablet must disintegrate and the active ingredient should rapidly dissolve in the stomach and intestine where it is absorbed.
  • Manufacturability : The product can be reliably and reproducibly prepared to the required productspecification using pharmaceutical processing equipment.
  • Stability: The product must have a proven shelf-life (usually 3 to 5 years) with minimal levels of decomposition of the active ingredient that would reduce the potency or ‘label claim ’ (amount of drug available) or cause the formation of impurities that might be harmful to the patient.

Who develops pharmaceutical products?
Developing a suitable product involves a number of different stages within a pharmaceutical company: formulation, process development, analytical development, regulatory, quality control and clinical . 

True or False?

  1. GMP stands for General Manufacturing Practice.
  2. Development of a pharmaceutical product is the primarily the responsibility of the formulation group.
  3. Fillers and binders are examples of excipients used in tablet production.
  4. Qualitative tests are carried out using chromatographic methods.
  5. Qualitative tests allow concentration of drug substances in tablets to be calculated.
  6. Direct compression is a simple method for manufacturing tablets.
  7. A coloured coating is sometimes used to make tablets taste better.
  8. Once a tablet is produced no more testing is required.
  9. HPLC is a valuable tool for the identifi cation and quantifi cation of any impurities in the tablets.