Basic↦Drug or Device↦Medicinal Product↦Manufacturing and Distribution
What is it? Why is it important?
The manufacturing, distribution, and dispensing of Medicinal Products (MP), must follow and comply with given requirements and standards.
Main MP manufacturing standards include the compliance with Good Manufacturing Practice (GMP) guidelines, such as:
- Required technical and operational conditions
- The implementation of a Quality Assurance system
Main MP distribution standards include the compliance with Good Distribution Practice (GDP) to ensure the MP:
- Supply chain is authorised by regulatory authorities (e.g. Swissmedic, EU)
- Is transported and stored according to requirements (e.g. acceptable timelines, temperature, light and humidity exposure, vibration and access protected)
- Is protected against contamination from other products
- Reaches the correct addressee
- Have an adequate turnover
MP dispensing guidelines are based on whether they are subject to a prescription (e.g. MP is handed out in pharmacies on the presentation of a doctor’s prescription), or dispensed without a prescription. The Swiss Federal Council defines the applicable classification criteria.
More
MP distributors should have an effective tracing system in place, enabling them to find / identify faulty MP products, including the implementation of required recall procedures.
In order to ensure compliance, regulatory authorities (e.g. Swissmedic) perform regular inspections and issue mandatory improvement measures. Compliance is crucial in order to keep MP manufacture and distribution licences.
What do I need to do?
As a SP-INV, familiarize yourself with required manufacturing, distribution, and dispensing requirements.
This is especially the case in interventional blinded studies where an applicable placebo (e.g. a MP which looks and tastes like a real MP but has no active pharmaceutical ingredient) is produced for the study.
Investigational Medicinal Products (IMP) used in clinical trials should be manufactured in accordance with Good Manufacturing Practice (GMP) standards. In the event of a collaboration with a hospital pharmacy, know that the pharmacy must hold an applicable GMP manufacturing license.
Note that studies can be inspected by regulatory authorities such as Swissmedic, where compliance with GMP and applicable GDP guidelines will be assessed.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissmedic – see in particular
- About us / publications / Swissmedic videos / about Medicinal Products (MP)
- Guidance Document. GMP compliance by foreign manufacturers ( ZL000_00_036, V.4, 15.04.2024)
References
ICH GCP E6(R3) – see in particular guideline
- 3.15.2. Manufacturing, packaging, labelling and coding of investigational products
- 11 Investigational products used in clinical trials should be manufactures according to GMP
Swiss Law
MPLO – see in particular
- Art. Object and definition of terms
ClinO – see in particular articles
- Art. 2g Investigational Medicinal Product (IMP) definitions
TPA – see in particular articles
- Art. 4 Manufacture definition
- Art. 4 Placing on the market definition
- Art. 5 Mandatory licence
- Art. 6 Conditions
- Art. 7 Manufacturing standards
- Art. 7a Public pharmacies and hospital pharmacies
- Art. 23 Categories of medicinal products
- Art. 24 Dispensing of medicinal products subject to prescription
- Art. 25 Dispensing of non-prescription medicinal products
- Art. 26 Principle of prescription, dispensing and application