Clinical GMP Production

Clinical Trial Capsule Production and Over-Encapsulation / Blinding
The requirements for comparative clinical studies are growing. Creapharm has the answer to this problem through its clinical GMP production services.

Creapharm can help you to find the more adapted solutions to your needs thanks to its wide experience in capsules production and in blinding.

In fact, multiple parameters have to be taken into account when considering over-encapsulation solutions:

• Clinical trial study distinctiveness :

 The clinical protocol
 The treatment schemes

• Products characteristics :

 Size and shape of IMP and comparator(s)
 Choice and blending of the excipients to safeguard dissolution and bioavailability
 Volumes to choose between manual or automatic blinding

• The pharmaceutical environment

 GMP compliance
 Safeguarding 100% count and fill accuracy
 Establishing suitable IPCs and reconciliation procedures

• The control capabilities

 Dissolution tests
 Stability studies to determine expiry date definition
 Pharmaceutical control and release

Creapharm can also propose capsule production services including placebo production would you be needing it.

Creapharm has expanded its capacities by constructing and qualifying a new GMP zone of 520m2. This zone is devoted to:

– Bulk production and capsule filling (actives and placebos)
– Semi-automated capsules filling and over-encapsulation
– All sizes of capsules (coni-snap and DB cap capsules)
– Automated or manual deblisterization
– Over encapsulation of ½ or 1 tablet or multiple units or capsules

ISO8 is a new area that contains a sampling and weighing room as well as 4 suites with independent airlocks and air treatment systems. There is also a suite that possesses 100% air renewal and individual protections to deal with sensitive hipo products.

For more information or to discuss clinical GMP production please contact us directly.