PV Inspection Readiness

Medicines Quality Assurance: EU Legal Basis

The guidelines governing manufacturing of medicinal products in Europe are explained in Eudralex Volume 4 Good Manufacturing Practices (GMP) for human and veterinary medical products as laid down in Commission Directives 91/356/EEC.

European Union’s pharmaceutical industry keeps high standards for Quality Assurance in the manufacture and development of medicinal products. Marketing Authorisation Holders make sure that medicines they produce and place on the market comply with quality and safety requirements.

Part 1 of the Volume 4 Good Manufacturing Practices (GMP) has principles on basic requirements for the concept of Quality Assurance during the manufacture of medicines. It tells about the main objectives and details regarding the essential matters.

Some basic requirements of Good Manufacturing Practices (GMP):

  • All manufacturing techniques should be defined and reviewed to show the capability for making medicines of the required quality levels.
  • Staff should be qualified and trained with suitable equipment and machinery.
  • Use the right materials, labels, and storage and transport facilities.
  • Procedures and instructions should be written and be clear & concise.
  • A system should be in place to recall any medicines from previous sales or supplies.

Quality Control part is mainly concerned with sampling and testing. It makes sure no medicines are released for sale without adequate tests and documentation.

Some basic requirements for Quality Control:

  • Trained staff and approved procedures for sampling and testing of raw materials, packaging supplies, all intermediate and finished products.
  • Records should be made using qualified recording instruments. Any deviations should be thoroughly investigated and documented.
  • Medicines should be composed of ingredients complying with the composition of Marketing Authorisation and should be of the required priority.

No medicinal products can be sold before proper certification by a Qualified Person that shows that the products are produced conform to the GMP and Marketing Authorization requirements.

Any European company selling medicinal products either inside or outside the European Union needs to comply with the regulations under the rules governing medicinal products in the European Union.

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.

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