Confidence Beyond Compliance

From the design and development of equipment, systems, and processes, through installation, start-up, commissioning, qualification and validation, PharmaLex offers single-source responsibility and acts as a point of contact to drive and deliver your project-specific needs.

PharmaLex have extensive experience in commissioning and qualification of new and upgraded equipment, automated systems, and software applications. We follow a systematic approach to verify and document that the facility and related systems are properly designed, installed, and tested, and that they are operated and maintained according to the operational requirements established by the client.

 

Our experience includes vast management and execution of Commissioning and Qualification (C&Q) projects following the ASTM E2500 risk-based approach.  We recognize its purpose, know what it takes for an agile and compliant leveraging, and for an accurate and successful C&Q execution. We understand how the C&Q elements relate to the Critical Process Parameters of the manufacturing process, and the Critical Quality Attributes of both the processes and the upcoming products.

We extend our risk-based approaches and methodologies to determine the extent to which each system should be commissioned.  Risk aspects are linked not only to product quality and patient safety, but also to the complexities and novelties of the systems.   Under such conditions, equipment testing can be leveraged at all phases, eliminating redundant activities and inefficiencies.

 

The scope of our services is detailed below:

  • Facilities & Utilities
  • Manufacturing Equipment
  • Inspection and Packaging & Equipment
  • Laboratory Equipment
  • Thermal Studies (e.g. for autoclaves, SIPs, controlled temperature chambers, warehouses)

 

We have successfully applied the above scope of services to the following types of dosage forms:

  • Biotechnology (Parenteral) products  and facilities (Drug Substance and Drug Products)
  • Lyophilized products
  • Traditional (small molecules) products and facilities
  • Oral Solid Dosages
  • Creams and ointments
  • Cell and Gene Therapy products and facilities
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