Pharmatech offers a full range of services for any type of pharmaceutical plants, covering the following activities:

• GAMP Audits;
• GAP analysis;
• URS preparation;
• Assistance to Site Selection;
• Site Master Planning Feasibility Study;
• Conceptual Design;
• Process simulation;
• Bulk Chemical (API) plants (High Potent APIs, Antibiotics, Herbal/animal sources extracts, Sterile bulk APIs);
• Biotechnology plants (Viral / bacterial vaccines, Recombinant therapeutic proteins, Plasma fractions, Transgenic proteins, Antibiotics);
• Formulation, fill/finish and packaging plants (Sterile injectables (LVP/SVP), Oral solids/liquids, Topical, Freeze dried forms, Inhalations);
• R&D and pilot plants (Research labs, Bio contained Labs, Pilot plants, Animal houses, QA/QC Labs).

We offer maintenance and calibration services to optimize costs and ensure equipment reliability. We employ advanced methodologies such as preventive, condition-based, and predictive maintenance, using diagnostic techniques based on non-destructive testing. In particular, infrared thermography allows us to detect thermal anomalies in electrical and electromechanical systems, preventing failures and reducing repair costs.

Pharmatech provide services in compliance with European EMEA’s GMP and FDA’s cGMP requirements for pharma and biopharma companies. Validation programs management and excution for production and cleaning processes.

All validation activities should be planned. The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent documents”

The Rules Governing Medicinal Products in the European Union – “Good manufacturing practices” – Annex # 15 – Final Version Qualification and Validation – July 2001

“It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.” The Rules Governing Medicinal Products in the European Union – “Good manufacturing practices” – Annex # 15 – Final Version Qualification and Validation – July 2001