Drug Production & Quality Assurance Competences

Introduction to Drug Production & Quality Assurance Competences

This competence domain is Product Focused. It is designed to ensure that interns understand the critical processes involved in drug manufacturing and the pivotal role of quality assurance in safeguarding public health. The core objective is for the intern to understand drug manufacturing processes and the role of quality assurance in promoting access to genuine medicines.

Even for interns not training in an industrial setting, this knowledge is essential to understand the integrity of the medicines they dispense and to identify substandard products in the supply chain.

Syllabus Outline

The syllabus requires knowledge and application of the following key areas:

• Pharmaceutical Production Processes:

  • Weighing.

  • Mixing / Granulation / Preparation.

  • Compression / Encapsulation / Filling.

  • Packaging & Labeling.

• Quality Management Systems:

  • Concepts of Quality Control (QC), Quality Assurance (QA), Good Manufacturing Practice (cGMP), & Standard Operating Procedures (SOPs).

  • Equipment, Operational & Process Qualification.

  • Validation & Calibration.

• Documentation & Business:

  • Documentation & Record Keeping.

  • Yield Reconciliation.

  • Pharmaceutical Marketing.