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2 September 2024

Pharmaceutical manufacturing of drugs: explanations

Medications play a major public health role by treating and preventing various diseases. Their production involves pharmaceutical manufacturing processes that drug manufacturers must adhere to. This is essential to ensure the effectiveness and safety of medications.

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Pharmaceutical drug manufacturing processes.
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Medications play a major public health role by treating and preventing various diseases. Their production involves pharmaceutical manufacturing processes that drug manufacturers must adhere to. This is essential to ensure the effectiveness and safety of medications.

In this article, find out what you need to know about the pharmaceutical manufacturing process of drugs.

1. What is medicine ?

a. Definition of medicines

A medicine is defined by the Public Health Code (article L.5111-1) as “Any substance or composition presented as having curative or preventive properties with respect to human or animal diseases, as well as any substance or composition that can be used in humans or animals or that can be administered to them, with the aim of establishing a medical diagnosis or of restoring, correcting, or modifying their physiological functions by exerting a pharmacological, immunological, or metabolic action“.

b. Role of medicines

Medicines play a threefold role by enabling the treatment of acute and chronic diseases, preventing the onset of certain illnesses, and improving the quality and life expectancy of patients by helping to manage disease symptoms.

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    c. Types of medicines

    There are two main types of medicines based on their pharmaceutical manufacturing principle :

    • Chemical or “conventional” medicines: These traditional medicines are manufactured using industrial processes that utilize active substances of chemical origin. Chemical medicines emerged with the rise of chemistry in the 19th century, marked by the identification and isolation of therapeutic substances known as active ingredients, which are often derived from plants.
    • Biological medicines: These drugs are produced using active substances derived from living organisms, such as living cells or tissues.

    2. The manufacturing process of a medicine

    The main steps in the pharmaceutical manufacturing of drugs are:

    • Formulation: This involves developing the chemical composition of the medicine with its active ingredients and excipients.
    • Production: Pharmaceutical manufacturers begin by producing pilot batches that validate the reliability of larger-scale production.
    • Quality control: Compliance with quality and safety standards for each batch produced is verified through rigorous testing, including tests for purity, potency, dissolution, stability, and contamination).
    • Primary packaging: After quality controls, the medicine is ready for packaging. Primary packaging protects the medicine from contamination, light, moisture, etc., and ensures its stability and effectiveness until use. Double-point glass ampoules are one type of primary pharmaceutical packaging.
    • Labeling: After packaging, each container is labeled to provide all the necessary regulatory information (name, concentration, usage instructions, expiration date, batch number, etc.) required for the proper use of the medicine.
    • Distribution: The process of distributing medicines to pharmacies, hospitals, and other health facilities must ensure optimal storage and transport conditions to maintain the quality and effectiveness of the medications.

    To learn more about primary pharmaceutical packaging, discover our complete guide.

    ampoules for primary pharmaceutical packaging

    Although the production of dietary supplements does not directly fall under pharmaceutical manufacturing, some dietary supplement manufacturers draw inspiration from pharmaceutical processes to ensure safety and efficacy.

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      3. The other stages in the development of medications include:

      a. The preliminary research

      To develop effective medications that address new diseases or emerging needs, pharmaceutical manufacturers must dedicate a portion of their efforts to research.

      Thanks to preclinical studies evaluating the efficacy and safety of drug candidates, research enables the identification of new active molecules and the understanding of their mechanisms of action.

      b. Clinical trials

      Clinical trials are studies conducted in humans with the aim of evaluating the safety and efficacy of medications.

      This process occurs in several stages:

      • Phase I: safety tests on a small group of healthy volunteers.
      • Phase II: evaluation of efficacy and side effects on a larger group.
      • Phase III: confirmation of efficacy on a large group of patients.
      drugs clinical trials process example

      c. MA

      The Marketing Authorization (MA) is an official approval granted by regulatory authorities to any pharmaceutical manufacturer, allowing the commercialization of a medication. It ensures that the medication has been rigorously tested and meets safety and efficacy standards.

      To find out more on MA, discover our complete MA guide.

      4. Importance of pharmaceutical manufacturing for our business

      Pharmaceutical manufacturing of medicines and dietary supplements is a complex and rigorous process, essential in guaranteeing the safety and efficacy of our products.

      Thus, to offer its partners, manufacturers of dietary supplements and pharmaceuticals, high-quality double-pointed glass ampoules, SFAM favors manufacturing processes in line with pharmaceutical drug manufacturing standards, such as:

      • The use of ILLAX® (Type III) and FIOLAX® (Type I) glass from Schott, ensuring high resistance and minimal interaction with formulations.
      • Automatic visual quality control of each bulb.
      • The ISO 15378 standard, ensuring optimum quality and safety for pharmaceutical manufacturers.

      To learn everything about ISO standards in pharmaceuticals, discover our guide.

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