Medicines Quality Assurance

Medicines Quality Assurance

When it comes to sustaining and improving the well-being of individuals, medicines play a vital role in it. Quality, Safety and Efficacy are the three primary characteristics that each medicine should have.  Quality is very important as it covers all the aspects. It assures that each medicine that completes production and is available for patients, is effective, safe, and of acceptable quality.

Different Phases of Quality Assurance

Quality Assurance is a wide-concept and covers all the aspects that collectively or individually influence medicine quality. The major areas to which it is divided are:

  • Development
  • Quality control
  • Production
  • Distribution
  • Self-inspections, Audits and Inspections

Consequences of lack of Quality Standards

If the quality standards are not met, or medicines are used when the expiry date is passed or stored at not the required conditions, it leads to possible consequences, for example:

  • Lack of therapeutic effect that may lead to prolonged illness or death
  • Adverse reactions
  • Or could lead to waste of financial resources

What Should Quality Assurance Ensure?

The comprehensive Quality Assurance should fulfill the following:

  • The selected suppliers of active substance, excipients and medicines should have acceptable quality standards.
  • Medicines received from suppliers and donors should fulfill the set quality standards at the delivery time.
  • Packaging of the medicinal products must meet the Marketing Authorization as well as usage requirements.
  • Not only packaging but repackaging and dispensing should also maintain required quality.
  • The conditions under which the pharmaceuticals are stored and transported should not compromise on quality strictly.
  • Medicine prepared should show the safety and effectiveness of its use.
  • The packaging of the medicines should present an appropriate dosage.

Identity, strength, purity, packaging, labeling, and performance are the key characteristics that evaluate the quality of medicine.

Inspection of shipments, laboratory testing, product specifications, batch certification, and periodic product quality review, stability monitoring are critical aspects that contributes to the quality of products. Checking of appropriate storage, dispensing, transport, and use procedures also part of Quality Assurance.

All the pharmaceutical products must undergo required quality control testing and pass them.


Quality Assurance can reach its goal through well-established and properly implemented procedures and work instructions. Quality Assurance is the responsibility of many different departments. A coordinated effort is required to ensure that all departments work together in dealing with Quality Assurance. Thus, Quality Assurance is often defined as the sum of all activities and responsibilities which are necessary to ensure that the commercialized medicines are of the acceptable quality. This contributes to Safety and Effectiveness of the medicines for patients.

Kristina Bindus

• Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality & Regulatory Affairs.
• Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
• Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
• Kristina is specialized in online medical communication: webcast, webinar and e-learning.
• She has developed universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
• Kristina has an extensive experience in Quality & Pharmacovigilance.