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Validation

3P is able to meet the stringent requirements of the world’s most demanding and regulatory bodies.

For example, automation for the medical and pharmaceutical markets not only has to satisfy the efficiency, safety and product quality demands of our clients, but also has to satisfy a variety of regulatory requirements as laid down by various trade associations and government bodies.

We offer a complete validation and qualification service for our equipment, from supporting customers in the generation of User Requirements Specification (URS), Design Qualification (DQ), Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).  We also support customers with on-site validation activities including Installation Qualification (IQ), Operational Qualification (OQ) and Production Qualification (PQ) activities.

We assist with production risk assessments, FMEA’s and validation master plans.

At 3P, we understand the design constraints on equipment which has to be in direct contact with active pharmaceutical ingredients (API’s) or which has to operate in a clean room environment. To ensure that quality is built into every stage of the production process, our equipment is designed to meet the current Good Manufacturing Practices (cGMP’s). Our control systems are designed to Good Automated Manufacturing Practice (GAMP).

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Case Studies

Case Studies

Dual Cartridge Injection

DCI is a reconstitution and mixing technology, suitable for liquid-liquid combination therapies or powder-liquid reconstitution, including lyophilised and spray-dried  powders.  DCI has been designed to reduce the entire reconstitution cycle whilst using    standard...

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