Quality Assurance / Regulatory Affairs
Quick Facts:
   ACG Lukaps today is a leading manufacturer of two piece hard capsules in Central Europe and an important supplier for famous pharmaceutical companies. The mission of the company is continuous care of our business partners.
Certificate of Analysis
ACG Lukaps gives COA with each lot of capsules supplied. It gives test results of analysis of the representative sample from each batch.

The COA also serves as a ready reference for colorants / ingredients used in the batch along with their Pharmacopoeial reference.
Regulatory Information
The capsules are manufactured in a GMP facility under the survellance of Croatian Health Ministry. The raw materials used in the manufacture of capsules comply to applicable regulations in the country of use.
Gelatin
  • Gelatin complies to the current Ph. Eur, USP and equivalent internatinal Pharmacopoeia.
  • Bovine gelatin used in the manufacture of capsule shells conforms to the Ph. Eur Monograph (current edition) "Products with risk of transmitting agents of animal spongiform encephalopathies"It is procured from supliers who have certified by the EDQM.
  • Porcine gelatin meets necessary national regulations
Colorants
  • Colorants used in the capsule shells conform to EC Directives.
  • It is ensured that they are permitted for use in drugs in the country where intended to be used. Colorants conforming to CFR standards are used where applicable.
  • Titanium Dioxide conforms to Ph. Eur, USP & Iron Oxides conforms to US/NF & EC Directives.
Quality Management System
Our capsules are manufactured on highly automated state of the art machinary in a controlled environment. The facility operates a QMS in line with ISO 9001:2000 and has been certified by the Lloyd's Register Quality Assurance.

Safety, Health & Environment is of prime concern to ACG Lukaps. The facility is certified for compliance to ISO 14000 standards.

Quality is built into ACG Lukaps capsules through design of system, manufacturing equipments (backed by the Engg. Expertise of its parent company ACG WORLDWIDE) well defined sampling plans & stringent process checks. This ensures optimum performance on the high speed filling machines.
Technical Services
ACG Lukaps has a team of technically competent service personnel who specialize in the area of interface of capsules with the filling machines.

This team works to understand customer filling machine / filling condition requirements & translate them back to design to ensure a snug fit between our product & customer filling machines.
They also provide technical training to filling machine operators to enhance productivity using our capsules.
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