Aseptic, sterile and non-sterile trial medicines and placebo manufactured on GMP-classed premises
A project manager is appointed for each assignment, who is responsible for coordination of all activities. The project manager is your main contact at APL during the course of the project. We carry out all activities, such as planning, purchase of raw materials and packaging materials, design of specification and preparation for transport.
APL manufactures trial medicines and placebo in most preparation forms. On our GMP-classed manufacturing premises, we carry out aseptic, sterile and non-sterile filling of products. Injection preparations are always filled using a sterile and aseptic method. If the product to be filled is sensitive to temperature, it is always filled
How the product is filled is also determined by what is needed in a clinical trial, how stable the product is and how it will be transported to a trial site.
Differing amounts of filled units are required, depending on how many patients or trial subjects are included in a clinical trial. In most cases, the most cost-effective method is to fill them automatically using a filling line. For a small trial, we can fill products manually.
At a clinical trial, the active trial medicine and corresponding placebo are usually given in a randomised order. We can randomise, label and package for
single-blind or double-blind trials, or alternatively for crossover trials.
The manufactured products are marked with a label that links them to a list where only an independent party knows which trial subject receives which treatment in
The labelled products are placed in secondary and transport packaging for transport to the trial site or to a distribution centre, which in turn transports them to the trial site.
Every product manufactured goes through a pre-defined list of analyses to safeguard the product’s quality and identity. These analyses are carried out at a QC (Quality Control) laboratory that is independent from the manufacturing unit.
When the analysis is completed, our certified QPs (Qualified Person) carry out a detailed review of all documentation associated with the reception of raw
materials, manufacture and analysis of the product. If all has been done according to GMP and corresponds to our SOPs (Standard Operating Procedures) and instructions, the product is released for a clinical trial. We only release
products to be used in clinical trials approved by EMA (European Medicines Agency).
We have one or more QPs at each manufacturing unit.