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Investigational Medicinal Products

Basic Pharma Manufacturing runs GMP-certified clean room facilities at the Brightlands Chemelot Campus in Geleen, the Netherlands. These facilities are supported by a well-equipped, certified laboratory. We have a profound knowledge of the CMC guidances for Drug Substances and Drug Products, as directed by the relevant guidelines and regulatory requirements.

Basic Pharma Manufacturing runs GMP-certified clean room facilities at the Brightlands Chemelot Campus in Geleen, the Netherlands. These facilities are supported by a well-equipped, certified laboratory. We have a profound knowledge of the CMC guidances for Drug Substances and Drug Products, as directed by the relevant guidelines and regulatory requirements.

With respect to investigational medicinal products (IMPs), Basic Pharma Manufacturing can offer the following services in its GMP-controlled clean rooms:

  • Aseptic fill and finish of solutions for injection, including cytotoxic compounds
  • Study medication blinding
  • Preparation of placebo capsules
  • Randomisation, packing and labelling of clinical trial medications
  • Authorised use of narcotic drugs
  • Autoclave sterilisation

In addition to the clean room activities mentioned above, we offer the following processional services:

  • Drafting and compiling IMPDs and PSFs
  • QP release of the Drug Product
  • Import of study medication from outside the EU
  • Wet chemical analysis of DSs & DPs

Additional information about our IMP services can be found below, or you can contact us by email or telephone:
Basic Pharma Manufacturing
Burgemeester Lemmensstraat 352
6163 JT Geleen
The Netherlands
T: +31 (0)88 255 40 10

Introduction
The manufacture, testing and distribution of investigational medicinal products (IMPs) is strongly regulated by the relevant authorities to assure high quality in any medicinal products administered to patients in clinical trials. Full transparency and traceability, from the origin of the starting materials to dosing and the ultimate destruction of the study medication, is mandatory. In addition, compliance with Good Manufacturing Practices (GMPs) is meant to ensure that all the requirements are met. Maintaining a GMP-certified status for clean rooms requires continuous investment in equipment, facilities and well-trained people.

Aseptic fill and finish of solutions for injection, including cytotoxic compounds
In our certified clean rooms, we have the necessary environmental controls and filters in place to ensure the aseptic fill and finish of solutions for injection in a large range of vial sizes. We can handle batch sizes of up to several thousand units per day in our facilities. In addition, we have a dedicated clean room where we can process cytotoxic compounds. In recent years we have gained expertise in producing sterile injectables of sensitive nanoparticles and the liposomes containing these highly toxic drug loads. With our flexibility and amassed expertise, we can support you in finding the right solution for your promising products.

Study medication blinding
Many clinical studies require blinding of the trial medication. We have access to a wide range of differently sized capsules for masking the trial medication, thereby making it impossible to distinguish the medication being tested from the placebo.

Preparation of placebo capsules
Using different types of non-transparent capsules, Basic Pharma Manufacturing can swiftly produce placebo capsules filled with harmless excipients such as starch or microcrystalline cellulose. Due to their colour, shape and variable weight, these capsules cannot be distinguished from the capsules containing the active study medication.

Randomisation, packaging and labelling of clinical trial medication
GMP requires clear protocols for all activities concerning the manufacture of medicinal products. Packaging and labelling are both activities that need to be performed with great accuracy and built-in controls in order to avoid product mix-ups. Basic Pharma Manufacturing has skilled, well-trained staff to perform these activities and execute randomisation for both single- and double-blinded placebo-controlled clinical trials.

Authorised use of narcotic drugs
Narcotic drugs are notorious for their addictive properties. Their strong biological activity also makes them very interesting for use in clinical studies. Obviously, though, their use, handling and destruction should be subject to even more stringent regulation than non-controlled substances. Basic Pharma Manufacturing has the required licenses in place to support you with IMP activities using such controlled medications.

Autoclave sterilisation
Basic Pharma Manufacturing has recently installed a new state-of-the-art autoclave for the sterilisation of IMPs and medical devices under the required quality system. This autoclave can be used stand-alone or as an integral part of a more complex project.

Drafting and compiling IMPDs and PSFs
Before a developer starts a clinical trial, they must obtain approval from the relevant authorities. One of the documents required for such approval is the Investigational Medicinal Product Dossier (IMPD). The IMPD is a document that describes the purity, safety and quality of the Drug Substance and Drug Product to be used in the clinical trial. The document has to be prepared in a predefined format to facilitate review. It must therefore contain sufficiently detailed information on the production process, analytical testing and substance stability. The Product Specification File (PSF) is a document comprehensively described in Annex 13 of Eudralex, Volume 4. The PSF lists (and refers to) the quality documentation of the IMP, such as production records, analytical method validation reports and stability reports.

QP release of the Drug Product
One of the most critical aspects of the GMP-based quality system is the final batch release of the IMP before it can be used in a clinical trial. To ensure the IMP has the required quality, the product and the documentation must be reviewed by an independent Qualified Person (QP). Basic Pharma Manufacturing’s QPs are experienced in both commercial and non-commercial batch release.

Import of study medication from outside the EU
The import of any study medication registered outside the EU requires an import license. In addition, the product needs to be relabelled and released by a Qualified Person (QP) to assure its quality. Basic Pharma has the relevant import license and a Qualified Person to review and release the imported study material. Our team can perform any and all assessments of the quality of non-EU medications.

Wet chemical analysis of DSs & DPs
Our certified laboratory offers a plethora of the analytical tests required for starting materials and finished products. High-level analytical support is crucial for guaranteeing the quality of IMPs. This includes full ICH-compliant stability studies on DSs or DPs.

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Basic Pharma
Contact us via email or phone or come by our office!
phone+31 (0)88 255 40 10
phoneinfo@basicpharma.nl

Burgemeester Lemmensstraat 352
P.O. Box 1124
6160 BC Geleen
The Netherlands

For navigation systems, use the following address: Koestraat 1, 6167 RA, Geleen.

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