Purchasing Equipment Life Cycle

During the period equipment is being purchased and put into operation, multiple processes are essential for a smooth and timely integration of the equipment in the routine production process. Additionally, all these stages must be documented for written proof and review by the regulatory body at later stages. 

These steps are essential due to reasons such as fulfilling the buyer's requirements and realistic machine design. It becomes more relevant for the pharmaceutical industry due to the product's criticality and regulatory body regulations.

The pharma equipment life cycle is part of a more extensive process, where every aspect, such as environment, company's footprint, and market forecast of equipment, is studied for compatibility and acceptability. 

However, this article will only focus on steps that a pharmaceutical manufacturer must follow, from purchasing equipment to putting it into production, assuming all other factors have been considered and management has decided to procure new equipment..

Life cycle

Let's discuss some common stages of a purchasing equipment in pharmaceutical industry

User requirement specifications

User Requirement Specification - URS is the first stage in the equipment procurement process and acts as a benchmark for the machine manufacturer and all the later-stage activities. 

URS contains all requirements for pharma manufacturers and expectations that a machine buyer has from that particular equipment. Commonly, a URS includes two types of information: technical and commercial.

The technical part consists of all the technical details such as electrical, mechanical, and instrumentation because these details affect the machine working and directly impact the output product.

In the commercial section, all the financial details are added—for example, the procedure of opening LC and releasing payment. 

The URS is created by a team comprising all relevant stakeholders, such as the Quality, Production (User), and Engineering departments. 

The engineering department is responsible for verifying the URS according to the engineering specifications, such as spare parts availability, design, available services, and maintenance. Additionally, it is also responsible for verifying the overall performance and working.

The production department is responsible for ensuring all production requirements have been fully defined and included. Production is responsible for concentrating on a market forecast, existing inventory, and existing facilities.

The quality department ensures that all processes and operations follow acceptable design and meet regulatory regulations. It also focuses on the rule of a target market. For example, if an African country plans to market its product in China, it must concentrate on Chinese regulations.

After the URS is finalized, it is sent to all stakeholders for feedback and review. If there is any feedback, it is again reviewed, and URS is updated. After the final evaluation, the URS is finalized and signed by all the contributing members, and the final authority from the management. The URS is sent to the Pharma machine manufacturer at this stage for their review and feedback. 

The feedback from the machine manufacturer is reviewed, and if necessary, further correspondence is made. This continues until the machine manufacturer and buyer agree on the machine specification. When both parties agree on the URS, it is vetted and becomes part of the agreement. 

After mutual approval from the machine buyer and manufacturer, the buyer informs the manufacturer to start machine manufacturing within the given timeline. 

The manufacturer informs the buyer about machine’s current and final status.

The manufacturer continuously updates the buyer about the machine's status and informs the buyer if any discrepancy occurs during manufacturing.

When the machine has been finally manufactured, the manufacturer informs the buyer to start the commissioning process.

Commissioning

Commissioning activities are performed to verify the equipment's successful manufacturing and operation at the buyer's site. Its main advantage is that a bug or problem can be solved at the manufacturer's location, which can be easily handled and rectified due to the availability of the facility, parts, services, resources, and workforce. It can become difficult at the buyer's location due to the unavailability of these resources. 

Documentation

Before commissioning, every test is documented for regulatory compliance and satisfactory commissioning activity. 

The commissioning activity comprises the Factory Acceptance Test – FAT and Site Acceptance Test - SAT. 

Factory acceptance test

FAT is performed at the manufacturer's location before equipment shipment to the buyer's location. Its primary purpose is to verify the performance at the buyer's location and to make any change or amendment if required. Buyers' representatives perform the FAT to verify the activity. 

In some cases, FAT is abolished, and only SAT is performed due to many reasons, such as difficulty in traveling.

The FAT is performed by connecting all the utility services and other essentials. However, it is often difficult to replicate actual working conditions at the buyer's site, and dummy products are used during the activity.

The machine was shipped to the power location only after it was performed satisfactorily.

Site acceptance test

A site acceptance test is performed at the buyer's site after it has been shipped. The machine is installed correctly with all its requirements and usually operates with all the relevant operating conditions.

Usually, during SAT, representation from the manufacturer is also present, and in some cases, they also install the machine, which depends on the mutual agreement during the procurement stage. 

Report

A report is also generated at the end of both FAT and SAT and includes all the relevant tests, some of which include the following

• Detail activity and test performed

• The outcome of each test and its status, i.e., pass or fail

• Deviation: This is the critical part and helps to solve problems. 

• A further line of action: It outlines a summary of the following action plan

Tests

Some standard tests that include fat and sat are mentioned below

Primary function: Main operation and any deviations

Alarms: verify the working of all alarms in abnormal condition

Safeties: All the required safeties have been installed and are working satisfactorily

Main Controller: Detail of the main controller and its satisfactory working

Utilities: The machine works satisfactorily on the available utilities at the buyer's location

Maintenance: The machine is provided with all the maintenance procedures and required accessories, such as spare parts, lubrication, and tools

Training: Training has been provided for maintenance and operation

Software: The machine is supplied with the relevant software and all the features

Data recording: adequate data recording is provided 

Qualification

After the equipment has been commissioned and is ready for operation, the qualification activities are performed before taking it into routine production. It is a mandatory regulatory requirement and also helps in satisfactory machine performance.

The entire qualification activity is documented, and the record is maintained because it is a critical regulatory requirement, and documentation is reviewed explicitly during their routine inspection.

The qualification activities consist of design qualification, installation qualification, operational qualification, and performance qualification.

Design qualification

Design qualification verifies that the equipment design meets the customer's requirement and that the machine manufacturer has included all the design features the buyer requires. It is performed based on user requirement specification.

Installation qualification

Installation qualification is a process to verify the installation of a machine against the agreed design features. It is critical because an accepted IQ is mandatory and critical for regular machine operation and, subsequently, the operation qualification.

Let's look at some standard tests performed on IQ.

Mechanical structure

• All the utility products and relevant piping and conduits have been installed correctly without any leak

• All relevant connections are intact, accurate, and fixed

• All mechanical components are adequately supported

• All valves are installed and correct according to the sizes

Electrical and electronic

• The electrical panel is complete with relevant safety devices

• Instruments are adequately & safely Installed and connected

• All electrical components outside the electrical panel, such as motors, are adequately and safely installed

Area

• Adequate space for machine piping, accessories, and frames is present

• Proper space for men and material movement is available

HVAC 

• An HVAC system is adequately installed 

• Ducts are firmly connected

• Proper ventilation is provided

• Recording of all process parameters such as temperature, humidity, airflow, and pressure is provided

Documentation

All documentation agreed upon during the design phase, such as the User Manual, Wiring Diagram, Maintenance, and lubrication manual, has been provided.

Operational qualification

The documented evidence shows that the machine's operation is satisfactory and according to the design features. Some tests performed include the following.

Basic machine operation

• The machine operates with all of its relevant functions and accessories

• Machine speed is according to the agreed design specification

• Total output capacity is according to the design face

Safety

All safety devices agreed upon during the design phase are provided and are working satisfactorily.

Data recording

• Data recording for all the critical variables is provided and is according to the requirements

• Data can be stored for a particular period

Performance qualification

The quality department performs the performance qualification by running the machine with the actual product and machine parameters. They then verify the properties of the product against the respective quality parameters.

The quality department is responsible for the validation activities; other departments, such as production and engineering, are also responsible for facilitating and supporting where necessary.