Not going to invest in your own new equipment or building a new manufacturing line? Engineering trials and CMOs are here to help!
So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking to partner up with a contract manufacturing organization (CMO) for your commercial needs. What should you expect from your CMO/CDMO partner? Better quality, fewer product failures, and stronger expertise are some skills that probably come up immediately in your mind.
Working with your CMO partner to invest in new equipment or build a whole new line for Oral Solid Dosage (OSD), semi-solid, or liquid manufacturing and packaging, you will need to collaborate with your contract manufacturing partner to target solutions to achieve outstanding results. Before producing that first batch, the equipment or the whole line needs to be qualified under cGMP requirements and that includes purchasing, construction, installation qualification, operational qualification, performance qualification, and process performance qualification (IQ/OQ/PQ/PPQ). These all require engineering expertise which a good contract manufacturing partner will provide because they have a strong background in manufacturing and quality systems.
What is an Engineering Batch?
An Engineering Batch can also be called an engineering trial run, engineering lot or practice runs. It’s a non-cGMP run that is used for developing specifications, demonstrating manufacturing process steps, or identifying and resolving any potential issues before the formal cGMP documentation and activities. It may have certain restrictions according to the facility’s SOPs or policy. An engineering trial run is mainly to ensure that the equipment can be operated in good condition according to the facility’s/utilities’ conditions, limitations, and capacity.
Timing and type of Engineering Batch
Challenges will inevitably be encountered before or during manufacturing. However, to minimize the cost, time, and smooth the process before commercial production, an engineering batch run can help avoid many predictable and unpredictable issues.
After installation of new equipment or installation of a new manufacturing line, Site Acceptance Testing (SAT), commissioning, and/or qualification are required to be applied under good manufacturing procedure (GMP). During these activities, an engineering trial can be involved in certain testing and training. An engineering batch can also be applied for improvement purposes after the product has been launched.
The scale of an engineering trial could vary according to the purpose and complexity of the trial; which is from testing an equipment function to a study batch runs as part of technology transfer projects.
Advantages of doing an Engineering Batch
There are many benefits of doing an engineering run, such as:
Acceptance testing
Acceptance testing is the first stage after installation to ensure the new line was built based on User Requirement Specification (URS). URS is a list of all requirements prepared by the user, also the acceptance criteria after receiving equipment. Engineering testing could identify the possible deviation and resolved issues in the early stage.
Training in operation and maintenance
The client and their CMO partner always seek a smooth and high-quality manufacturing process without preventable deviations. To accomplish these trials, operators must be familiar with specific equipment operations and batch production. In addition, experience in troubleshooting is also critical for future operations. If the line is newly built, maintenance engineers may not fully understand all the kinds of equipment failures that may occur from the new mechanical structure and automation systems. Through engineering testing, equipment issues could be identified and resolved quickly by adding routine inspections or improving the design before releasing the process for its intended use.
Efficiency in material usage
Engineering trials are an unofficial test that is not required to follow all cGMP requirements. Clients and their CMOs expect that pharmaceutical ingredients or excipients will be handled efficiently and used in formal production batches. Unfortunately, this doesn’t always occur and engineering trial runs are a way to seek greater efficiency. It is important to remember that sometimes batches of ingredients are rejected for being past expiration dates or appearance failure. It is always best to evaluate these first before doing an implementation.
Reference data
Engineering batches provide insight and flexibility into the operation using the cGMP process at the facility to help figure out the best operation modes and adjust parameters in a wider range without formal documentation. Some of the equipment may have complicated designs and operations; thus, a trial run could be implemented to determine optimum (or greater) setting parameters and data before equipment qualification or successful process validation, thus saving time and cost later on.
As you can see, there are many benefits of conducting engineering trials. It is best to speak with your CMO partner early on to make sure you are both aligned and have well-defined tech transfer plans. The right contract manufacturing partner will have many solutions and plenty of experience in conducting these.
What happens after equipment qualification is completed?
The summary report will determine if the equipment passes the qualification or not. Only equipment which passed qualification can be used for manufacturing. After a piece of equipment is “qualified,” the qualification status of that qualified equipment should be reviewed and the results can be used to determine if and when requalification is needed. Such review includes, at a minimum, calibration, preventive maintenance, deviations, and change history of the equipment. This review task will need to be maintained during the time the equipment is in use, and can only be finally completed when the equipment is inactivated or decommissioned.
Conclusion
Equipment qualification/validation is an absolute must to ensure that the equipment is installed, operates, and consistently performs what it is purposed to do. The qualification documents provide evidence to an auditor so they can review and ensure the equipment is well-maintained to ensure compliance, reduces the risk of misuse and helps prevent future problems. Equipment qualification is key to ensure that the piece of equipment performs consistently and produces high-quality products throughout production.
