Contract GMP Auditing, GMP Systems, Management of Regular Inspections

Ulverston GMP Consulting Ltd

Ulverston GMP Consulting Ltd specialises in the design, assessment and improvement of GMP and Quality Management Systems in pharmaceutical manufacturing and consumer healthcare. Dr. David Inglis has more than three decades of experience in the development of effective GMP and quality assurance procedures, auditing of manufacturing facilities, provision of GMP training courses and detailed preparations for regulatory inspections.  David also has in-depth experience of plant cleaning and decontamination, particularly for bulk intermediates and active pharmaceutical ingredients.more

Contract GMP AuditingDavid is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for regulatory inspections (FDA/MHRA/IMB).  He is an international consultant in cGMP training and design/development of Quality Management Systems, including documentation, change control, internal auditing and routine compliance to cGMP.  David is also a Qualified Person, available for part-time contract QP roles.

Ulverston GMP Consulting Ltd offers a complete contract GMP auditing service, from first contact to report and follow up.  Alternatively, a partial service can be designed to fit your requirements. 

GMP audits conducted of your contractor’s site, processes, systems and procedures, to applicable cGMP standards:

  • raw materials, excipients, contracted intermediates and APIs
  • product intermediates, bulk products, finished products
  • Quality Risk Assessment through the supply chain

QA Auditor Training

Ulverston GMP Consulting Ltd offers a two- or three-day QA Auditor Training course to improve standards and gain business advantage from your Self Inspections, QA-led audits and contractor/supplier audits.  Targeted at QA auditors, production/engineering managers and supervisors, plus auditors of suppliers and contractors, training may be in-house, at Ulverston or at your chosen location.  (See website for course outline.)

Practical Auditor Training – your auditor(s) / inspector(s) trained, assisted or mentored:

  • at your own site (internal audits)
  • during audits at your supplier’s site (contractor audits)

GMP Training Courses

Ulverston GMP Consulting Ltd offers customized GMP training courses for GMP compliance:

  • Practical Compliance with ICH Q7 / EU GMP Guide, Part II
  • Critical Parameter Management
    • Knowledge-based GMP compliance
    • Responsive control within the QMS
    • Improved process flow
  • Secure Batch Release
  • CAPA in the Pharma Industry
  • Certification by a QP
  • Product Specification File (for IMPs)

(See website for course outlines.)

Assessment of GMP Systems for Active Substances (APIs)

Ulverston GMP Consulting Ltd offers GMP Systems / Quality Systems assessment and improvement services for active substances (APIs) contract intermediates and related processes.

  • Application of EU GMP Guide Part II / ICH Q7
  • Application of ICH Q7 / Part II GMP standards for business benefit.
  • Process flow for APIs
  • Secure systems to meet requirements of EU and FDA GMP-compliance
  • Secure systems for Batch Release within the QMS
  • Product Quality Reviews to regulatory standards
  • Effective management of process deviations
  • Requirements and controls for plant cleaning or full decontamination (including sensitizing materials)

Management of Regulatory Inspections

Ulverston GMP Consulting Ltd offers in-depth training in practical preparation for and management of regulatory inspections.  This training is most effective when combined with a mock inspection to assess current standards and test actual responses. 

The key to effective management of regulatory inspections lies in effective preparation and staff training.  Being well organized during the inspection builds confidence and means that your company or site gives the best possible performance.

  • Getting Ready – Preparation and Expectation:
  • Organization – Inspection Room and Control (War) Room
  • Staff Training – How to Face the Inspector

Survival Kit for Regulatory Inspections: A pre-packaged version of this comprehensive training package for survival of regulatory inspections is available through our North America partners, GMP Training Systems Inc.  To purchase, please visit the website.

Practical Preparation for Regulatory Inspections: – Invite us to challenge the inspection readiness of your site, processes, systems and procedures to assess your cGMP compliance.  Use a mock inspection to improve inspection readiness, identify weaknesses, establish required standards, practice audit technique, practice documentation retrieval and generally test your company responses.less

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Ulverston GMP Consulting Ltd
6 Beechlands
LA12 9SQ, Barrow-in-Furness
United Kingdom

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