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GMP Services for the Biopharmaceutical Industry

KNAUER provides equipment for downstream processing in the biopharmaceutical industry such as skids for the formulation of lipid nanoparticles, or chromatographic systems for mRNA purification or continuous chromatography. KNAUER provides a wide range of services to support our customers and to ensure that GMP requirements are met. 

GMP describes a quality control process that enforces and ensures the correct design, monitoring, and control of manufacturing processes and facilities. Pharmaceutical quality is of vital importance as the goods produced are made for human consumption – consequently, failures in pharmaceutical quality control can cause harm and, in a worst-case scenario, cost lives. A GMP controlled production process ensures a high product quality and reduces the risk of harm towards consumers or the general public. The Food and Drug Administration (FDA) is one of the world’s leading pharmaceuticals regulatory bodies, with the main regulatory standard for pharmaceutical quality being the Current Good Manufacturing Practice.

How does KNAUER support GMP compliance for pharmaceutical manufacturers? 

Pharmaceutical manufacturers have an important responsibility to implement GMP compliant pharmaceutical production. Our Customers often have specific requirements for the KNAUER hardware that they are interested in, these are usually defined in their specific User Requirement Specifications (URS). The URS defines the specifications of the product as well as GMP relevant topics, such as product safety, personnel training and quality control.  
 

Experts in GMP Compliance


KNAUER provides expertise and resources to pharmaceutical manufacturers. We discuss the URS with our customers and help to ensure that their regulations remain up to date; helping manufacturers deliver products that meet their end user’s requirements.  

KNAUER’s GMP services are based on our hardware- and software-solutions; encompassing product safety, quality control and the training of personnel. Risk management, in relation to GMP, is covered by the user.

 

Factory Acceptance Testing and Site Acceptance Testing (FAT & SAT)

The factory acceptance test (FAT) is a functional test that is performed upon completion of the manufacturing process to prove that the equipment has the same specification and functionality as indicated in the datasheet, specification and purchase order. KNAUER are experienced in establishing such test procedures together with our customers prior to the delivery of our equipment.

A test carried out on reception of the equipment at your site (known as a site acceptance test, SAT) can also be undertaken: Here, a KNAUER technician visits your site to ensure that your new KNAUER system works to your utmost satisfaction. In addition, we can also integrate the system into our customer’s existing production environment when required.

Engineering Support is a Standard

At KNAUER we love to work alongside our partners in biopharma to design the right system solution for their needs. In most instances our customers already know their process well and can provide us with the required specification for their desired system. 

KNAUER provides engineering services to develop the tools that match the needs and requirements of our end users. 

Full GMP Compliance for Wetted Parts

Documentation on the compliance of materials used for wetted parts is an important requirement for product safety: In the bio-pharmaceutical industry, potentially harmful substances must be avoided in liquids for clinical, cosmetic or food applications. Therefore, any materials of the liquid flowpath that come into contact with the final product must meet certain criteria.

According to our end user’s requirements KNAUER can provide compliance with the order (EN 10204-2.1), certificates of compliance on the materials used for wetted parts, and further documentation from the supplier such as 2.1 certificates.  

 

Type of Certificate / Statement Unit of Quantity Article Number
Declaration of Compliance with the order (EN 10204-2.1) for 1 order A0000TDCOO
Declaration of Compliance (EN 10204-2.1) with Certificate and compliance of material of wetted parts for 1 article with less than 5 components A0000COMS
Declaration of Compliance (EN 10204-2.1) with Certificate and compliance of material of wetted parts for 1 article with 5 or more components A0000COM
Declaration of Compliance (EN 10204-2.1) with Certificate and compliance of material of wetted parts for one pump for 1 article A0000COMP
Declaration of Compliance (EN 10204-2.1) with Certificate and compliance of material of wetted parts for one pump head for 1 article A0000COMPK
Declaration of Compliance (EN 10204-2.1) with Certificate and compliance of material of wetted parts for one valve for 1 article A0000COMV
Declaration of Compliance (EN 10204-2.1) with Certificate and compliance of material of wetted parts for one detector for 1 article A0000COMD
TSE/BSE*-free Statement: Customized order- and article related
*) Transmissible Spongiform Encephalopathy (TSE) und Bovine Spongiform Encephalopathy (BSE)
for 1 order A0000TDTSE
STEP** file per device without functional groups
**) Standard for the Exchange of Product Data in 3D-CAD software
for 1 article A0000IDSTE
Documentation on compliance of material of wetted parts: Compliance with the order (EN 10204-2.1); Certificate of compliance on material of wetted parts; Documentation on references (supplier information of material) and wetted parts (certificates such as 2.1) customized A0000TD

 

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