SeerPharma Blog

GMP Facility Design, Services and Equipment Qualification

March 16, 2017
by SeerPharma

Need expert help in the requirements for the design of GMP facilities, services and equipment in the pharmaceutical and related industries?  SeerPharma has helped many companies in the Asia-Pacific region and we can help you too.

You might need help from ground-zero to understand what licensing and facility requirements will apply to your proposed operation or you may be more advanced with a live project and require expert consulting or training to help get your project over some hurdles.  Whatever your needs in the Good Manufacturing Practices (GMP) facility space, SeerPharma can support you. We have helped companies dealing with products such as pharmaceutical, complementary, traditional Chinese medicine (TCM) and cosmetics with:

  • Facilities
    • Reviewing options for GMP facility design and layout of a manufacturing facility under Good Engineering Practices (GEP) including the more challenging elements such as cleanrooms.
    • Discussing various approaches to design development and project management for GMP facilities and determing the most appropriate.
    • Detereming suitable surface finishes from a range of options.
    • Developing and implementing Environmental Monitoring programs and supporting other GMP facility validation activities.
  • Services
    • Applying GMP guidelines, standards and requirements for design, validation (IQ, OQ & PQ) and control (including microbiological) of pharmaceutical water systems.
    • Applying GMP standards & requirements for other engineering & maintenance services including pharmaceutical gases and Heating Ventilation and Air Conditioning (HVAC).
    • Supporting these and other GMP facility qualification activities.
  • Equipment
    • Performing and formalising risk-assessment in the classification of critical and non-critical equipment and determining the level of qualification required.
    • Developing practical equipment qualification protocols and supporting the execution of IQ, OQ and PQ.
    • Preparing equipment support, maintenance and documentation packages.

Contact us to discuss your particular project needs and learn about how we can help you achieve your goals in a time- and cost-effective manner.

You may also be interested in the case study linked below of how we supported the design, commissioning, qualification, validation and licensing of a new GMP facility for an Australian pharmaceutical contract manufacturer.

Filed Under: Facility Validation, GMP Facility, GMP License, GMP Equipment, Equipment Qualification