Services

Commissioning, Qualification and Validation

Commissioning, Qualification and Validation Ensuring that your utilities, process equipment and production lines consistently function and operate as intended to produce materials of the desired quality requires a multi-stage process. The three main activities that accomplish this are: Commissioning Qualification, and Validation These three activities, often grouped together and termed ‘CQV’, are usually performed in sequence. Commissioning is required before undertaking qualification activities, and qualification of equipment must be completed prior to validation activities.

Documentation

Documentation Clear and accurate documents are a key part of efficient manufacturing. Some of the most common documents in the pharmaceutical and food processing industries include: Standard Operating Procedures Batch Records Equipment instructions Validation documents Training documents and much more Standard Operating Procedures Standard Operating Procedures (SOPs) are documents that contain instructions on how to perform a particular task. SOPs can include procedures for control of documents; how to deal with deviations; dress codes; equipment operation, cleaning and maintenance; qualification and validation procedures; cleaning of premises and environmental control; sampling of materials; training and inspections.

Process Design and Development

Process Design and Development Pharmaceutical process design and development refers to the systematic approach used to create and improve the manufacturing processes of pharmaceutical products. It starts with identifying the current process and determining areas for improvement. Then, a new process is designed and implemented, taking into consideration factors such as efficiency, effectiveness, and compliance with regulatory standards. The process also includes testing and validation to ensure the product quality and safety.

Process Improvement and Optimisation

Process Improvement and Optimisation Process improvement and optimisation encompasses several techniques to ensure that a process performs as efficiently as possible while minimising waste. Some of the main aims of optimisation include maximising yields and product quality, minimising processing costs, and minimising defects. Different techniques can be used at different stages of the process lifecycle, from design and development to mature processes. Process improvement and optimisation techniques and methodologies that we are experienced in include:

Safety & Risk Management

Safety and Risk Management “Safety and risk management” is an overarching term that covers the safety of manufacturing processes, safety within a manufacturing facility and job site, and managing risks to ensure hazards are minimised. Effective safety and risk management protocols help to reduce workplace hazards, process failures and operational downtime. There are a number of methodologies and tools that are used in the pharmaceutical and food processing industries to identify, analyse and manage risk.