Smooth startups start with good commissioning practices

From a strategic perspective, you could say that a pharmaceutical processor’s skill at quickly expanding facilities in response to changing product, market and regulatory needs ranks right alongside research and scientific prowess.

A key factor in bringing new facilities online is commissioning, a function often misunderstood and poorly managed. Commissioning plays an invaluable role in the plant startup process by ensuring that all equipment and systems are designed, installed, tested, and fully operational in accordance with the owner’s design intent.

Commissioning covers all planning, documentation, equipment balancing, calibration and control, performance qualification and other procedures leading up to startup and turnover. Other key elements include operator training and spare parts programs.

A well planned commissioning program will:

• Accelerate project startup


• Produce superior documentation


• Improve online time


• Create a positive commercial impact


• Reduce validation effort


• Ensure a GMP-compliant facility

Though actual practices sometimes vary by project, the Commissioning Master Plan (CMP) is the nexus of an effective commissioning program. It coordinates interaction between contractors, material and equipment suppliers, and internal personnel.

In addition to road-mapping a project, the Commissioning Master Plan assigns team responsibilities and expectations to vendors, monitors performance, and establishes a basis for corrective actions needed to ensure the integrity and success of the project.

In pharmaceutical operations requiring cGMP-compliance, critical utilities and process systems must also undergo validation to satisfy FDA requirements. Occasionally, confusion arises over these terms. But, in a nutshell, all facilities must be commissioned, while only those with cGMP-critical systems undergo validation.

For GMP-compliant plants, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) steps are prerequisites for validation, and monitor the following functions:

• IQ ensures installation of the proper equipment


• OQ ensures that equipment and systems operate as required, producing consistent outputs


• PQ ensures that equipment and systems perform to spec and meet process requirements

Risk management-based qualification, espoused by the FDA and incorporated into the ISPE Baseline Commissioning and Qualification Guide, empowers owners to focus primary quality and regulatory efforts on those critical design features and processes that directly impact product and patient safety. This approach ensures that all functions performed by design/contractor teams and vendors meet prescribed quality standards without overlapping or duplicating efforts. By effectively leveraging commissioning practices, owners minimize documentation and redundancy, while reducing qualification/validation time and startup costs.

From a budgetary standpoint, commissioning costs add up to a significant capital outlay, and are frequently underestimated or overlooked. Costs vary greatly according to a project’s scope, complexity and regulatory compliance factors. But it’s important for owners to properly plan and budget for all commissioning-related functions, including: planning, administration, analysis, progress monitoring and reporting.

Another decisive factor in minimizing problems during commissioning and start-up is knowing when and how to work effectively with outside vendors. Pharmaceutical plants comprise a vast network of complex equipment and infrastructure, with few owners experienced in managing renovation and expansion projects of such magnitude. As a result, many are out of their element when faced with such challenges.

To further complicate matters, cost-saving measures, like outsourcing plant engineering, maintenance and operations functions, have drained specialized technical skills from many companies.

As a result, owners could be forced to rely on untested outside contractors to manage critical commissioning and startup operations. In the absence of knowledgeable and experienced oversight, such a massive coordination effort could easily lead to planning and construction errors and delays that eat up capital, delay startup and ultimately slow a product’s speed-to-market.

For best results when establishing design/build partnerships for facility commissioning and startup, it’s important to consider a vendor’s overall project management expertise in conjunction with a high degree of technical know-how.

Finally, by integrating good commissioning practices early in the planning and design process, owners make an investment that pays dividends in time and capital savings, and supports the strategic objectives of the enterprise.