Quality GMP

A successful supply chain is only as good as its quality systems.  Quality is not simply a support service but rather an integral component of the supply chain. This is true whether the manufacturing is to fuel your clinical trials or your sales force.  Robust quality systems must be fine-tuned to maintain the assurance of the quality of the products for the customers (patients) but also be attentive to the needs of the other customers (sales, clinical development and regulatory agencies).  As products move through the pipeline, our knowledge increases along with our experience.  Our quality requirements must adjust in harmony to the changing environment.

Calcott Consulting staff has many years experience developing, implementing and fine tuning quality systems to meet all these critical steps in the product life cycle. We have developed systems from scratch and modified pre-existing systems to meet business and regulatory needs.

Our services are very broad and include the following:

Quality Strategy

  • Development of a Quality Vision and Mission
  • Development and implementation of Quality Policies and
  • Quality Manuals to meet the spirit of GMPs,  ISO, ICH Q8, 9 & 10 and Quality by Design

Quality Systems

  • Development de novo or optimisation of pre-existing systems
  • Our speciality is change control, deviations and investigations, CAPA, training, lot disposition, RM systems, documentation, complaints, method validation and specification setting
  • Development and implementation of independent audit systems
  • Development of training, certification and learning management systems.
  • Audits of suppliers, systems and operations
  • Gap analysis
  • Total QMS to meet ICH Q10 principles
  • Culture change to aid in a modern quality approach

Enterprise E-Solutions

  • Translation of business processes into robust e-systems, using this opportunity to optimise and fine tune your business process
  • Managing change in the organisation as processes change in response to business needs

Supply Chain Strategies

  • Integrating quality into the supply chain
  • Development and implementation of working relationships with vendors including quality agreements and persons in the plant

Regulatory Compliance

  • Preparation for PAI and PLI and conducting mock inspections
  • Preparation for routine inspections
  • Responding to inspectional observations including warning letters and other stronger actions
  • Filing Field Alerts, Biological Deviation Reports and conducting Recalls.

We look forward to working with you to meet your business challenges.