Choosing the right contract manufacturing organization (CMO) for sterile injectables is challenging.
Sterile injectables involve highly complex manufacturing processes and are heavily regulated. Finding a CMO that understands the processes, complies with the stringent regulations, and maintains high-quality standards isn’t easy. The tens of available options make it more overwhelming as CMOs have unique strengths, capabilities, and approaches.
To simplify the selection process, start by reducing the pool of potential CMOs, then shortlist those that align with your specific outsourcing needs and criteria. It’ll save valuable time, effort, and resources because you will conduct a more in-depth evaluation only on CMOs that are likely to be the best fit.
But how do you identify and narrow down potential CMOs to work with? Through a technical and quality assessment.
Defining Technical Expertise and Quality
Technical expertise refers to the specialized knowledge and skills required to produce sterile injectable products. It requires understanding the complex processes, technologies, equipment, and facilities required to safely and effectively manufacture the products.
You should consider the technical expertise of CMOs before shortlisting them for the following reasons.
- Understanding and following the intricate manufacturing processes while maintaining aseptic conditions requires technical expertise.
- CMOs with technical expertise can understand the stringent regulatory requirements on sterile injection product manufacturing and keep up with their updates to ensure compliance.
Quality control is the process of verifying that the raw materials, manufacturing process, and final product meet all quality standards. Quality assurance is the systematic efforts taken to ensure that the manufactured sterile injectable products meet specified quality requirements.
You should consider the quality control and assurance of CMOs because:
- Companies with good quality control and assurance can guarantee the safety and well-being of patients by ensuring their sterile injectables are of excellent quality.
- You can be denied approval to market and distribute your sterile injectable products if your CMO’s quality control and assurance don’t comply with regulations.
- Quality control helps identify and mitigate risks that could compromise product quality or harm your patients.
Eliminating potential CMOs based on their technical expertise and quality (or lack thereof) will leave you with a shortlist of competent and reliable potential partners that meet the stringent standards of manufacturing sterile injectables.
Conducting technical and quality assessments involves:
- Prioritizing technical expertise and proficiency
- Ensuring regulatory compliance
- Assessing quality control and assurance
- Checking flexibility and scalability in production
- Assessing manufacturing infrastructure.
Prioritizing Technical Experience and Proficiency
To reduce your pool of potential CMO candidates, you should first check whether they have the technical experience and proficiency to handle your sterile injectable manufacturing needs. This involves assessing each CMO’s track record of handling similar pharmaceutical products and their expertise and knowledge.
Examining the CMO’s Track Record With Comparable Products
A CMO’s history with sterile injectables or comparable products can give you insights into their proficiency and reliability. You can get the details of their past projects by:
- Asking them for a list of past projects
- Contacting previous clients directly for feedback
- Requesting any available performance metrics, such as audit results
Assessing Technical Capabilities and Specialized Knowledge
Assess each CMO’s technical capabilities and specialized knowledge to ensure they can handle intricate formulations, aseptic processes, and other aspects critical for product safety and quality.
You can assess the ability to handle the complex processes and meet the high standards by:
- Reviewing the CMO’s team qualifications and experience
- Evaluating each CMO’s track record
- Checking for adoption of advanced technologies
CMOs with the right technical experience and proficiency can deliver high-quality, precise, and compliant sterile injectables that meet industry standards.
Ensuring Regulatory Compliance
After the first round of eliminations, evaluate whether the remaining CMOs comply with the regulatory requirements in sterile injectable manufacturing. It involves the following two steps.
Understanding and Meeting Regulatory Requirements (FDA, EMA, Etc.)
Ensure the CMO understands and meets all regulatory requirements set by different authorities. Because regulations are subject to change, the CMO should also be proactive in staying updated and adjusting their processes. Compliant CMOs produce safe and high-quality sterile injectables.
You can ensure they understand and meet regulatory requirements by:
- Confirming their history of successful regulatory approvals and compliance with audits and inspections
- Checking if they have a dedicated regulatory affairs team
- Requesting documented proof of regular training and updates on relevant regulations
You should also analyze compliance issues, warning letters, and observations to understand their regulatory approval and compliance history.
Adherence to cGMP (Current Good Manufacturing Practice) Standards
cGMP is a set of standards that ensure the production of safe, high-quality pharmaceuticals, medical devices, and other related products.
CMOs that adhere to cGMP demonstrate a commitment to produce pharmaceuticals that meet rigorous quality and safety standards. Eliminate the shortlisted CMOs that don’t apply cGMP standards throughout the contract manufacturing process. They can’t guarantee product quality, safety, and efficacy.
To gauge consistency in compliance, evaluate the frequency and outcomes of regulatory audits and assess how they addressed the observations and citations raised in the audits.
Stringent Quality Control and Assurance
Stringent quality controls and assurance in sterile injectable manufacturing ensure the products meet the highest quality standards. They guarantee the effectiveness of the injectables and the safety and well-being of patients who use them.
You can assess the CMOs’ quality control and assurance through scrutinizing quality control processes and checking the availability of analytical and testing methods.
Scrutinizing Quality Control Processes
You can scrutinize the CMO’s quality control processes by:
- Examining their methodologies for ensuring product quality at every stage of manufacturing
- Checking how they monitor compliance throughout the manufacturing process
- Ensuring they can track each component and process for accountability and transparency
- Assessing how they handle deviations from standard procedures and protocols
Availability of Advanced Analytical and Testing Methods
Verify if the CMO possesses advanced analytical instruments and technologies for comprehensive testing of raw materials, intermediates, and final products. They should utilize the instruments and technology to conduct thorough testing for purity, potency, sterility, etc., to ensure the injectables meet the required specifications. It can lead to higher product quality and safety.
They should also continuously monitor and verify the testing processes to maintain precision and consistency in results.
Flexibility and Scalability in Production
The pharmaceutical market experiences significant fluctuations in demand due to changing market trends and business growth. To ensure business continuity in this dynamic environment, only consider flexible and scalable CMOs. That means they should accommodate fluctuating volumes and batch sizes and facilitate future growth.
Accommodating Fluctuating Volumes and Batch Sizes
The CMO should be able to adjust production levels and batch sizes based on market demand without compromising quality or timelines. It’ll help you meet the varying demands of your clients without disrupting operations.
It also allows you to respond to changing market trends and allocate resources efficiently. To help you meet the diverse needs of your clients, the CMO should also be able to accommodate specific requirements of different clients or products.
CMO’s Capacity to Facilitate Future Growth
An adaptable and scalable CMO can accommodate and facilitate future business growth. That means they can support and enable your expansion, development, or increase of operations, capacity, capabilities, or market presence.
Evaluating their capacity to facilitate future growth involves assessing their ability to accommodate additional volumes, adopt advanced technologies, invest in infrastructure, and manage resources efficiently to facilitate and support your growth.
Assessing Manufacturing Infrastructure for Sterile Injectables
The manufacturing infrastructure directly impacts the products’ quality, safety, and efficiency. Assessing every CMO’s infrastructure ensures product quality and safety, compliance with regulatory standards, aseptic processing and containment, and risk mitigation.
You can assess the manufacturing infrastructure by checking for an environment conducive to aseptic filling and robust environmental controls.
Facility Design for Aseptic Processing and Containment
Sterile injectable CMOs must adhere to stringent aseptic filling and processing techniques to ensure the products are free from contamination.
To confirm adherence, evaluate the CMO’s facility design to ensure it provides a sterile and controlled environment necessary for aseptic processing. You can also assess the containment measures in place to prevent cross-contamination and ensure product integrity during manufacturing.
Monitoring and Controls
Verify that the facility maintains precise control over temperature, humidity, and pressure to meet the specific requirements of sterile injectable manufacturing. Check for advanced air filtration systems that can maintain a high level of air quality and minimize the risk of airborne contaminants.
To keep the temperature, humidity, and pressure at a safe level, your CMO should use state-of-the-art monitoring systems that provide real-time data on critical parameters. It allows for prompt adjustments and interventions if needed.
Approach CMO Selection Strategically
Selecting a sterile injectable CMO can be challenging if you don’t approach it strategically. To simplify it, you should first filter out CMOs that don’t meet your technical and quality requirements and shortlist those that do. With the narrowed-down list, it’ll be easier to conduct a more in-depth analysis of each CMO’s offering to pick the best fit for your sterile injectable manufacturing needs.
You can filter out CMOs that can’t meet your needs through a technical and quality assessment. Passing the assessment means the CMOs are experienced and committed to compliance and quality and can scale operations effectively to meet changing demands. These are the CMOs you should work with.
One such CMO is Afton Scientific. Afton is a pharmaceutical CMO in Virginia specializing in sterile-filling small-volume injectable drugs. We have provided reliable pharmaceutical services and lasting relationships within the industry for over 30 years and currently serve clients in 18 countries. For more information on sterile injectable CMOs and our lab services, visit the Afton Scientific website or contact us today. For more on this topic, check out Choosing The Right CMO for Sterile Processing.