Q: What is the best way to perform batch recovery procedures for the manufacturing of pharmaceutical products?

A: Pharmaceutical batch recovery is a critical process in the manufacture of medicines. The batch recovery process is performed when there is a deviation during manufacturing, and the situation is such that there may be a potential to “recover” the batch while still ensuring the final product meets quality, safety, and compliance standards. Batch recovery involves identifying and rectifying any deviations or issues that occurred during the production of the specific batch in question by conducting a thorough investigation resulting in definitively identifying the root cause of the deviation. The investigation should involve collaboration between quality assurance, production teams, and regulatory authorities. The batch recovery process should define the details of the root cause analysis as well as any future corrective and preventive actions to prevent recurrence. This will help determine if the batch is suitable for recovery.

The main challenge in batch recovery is quickly identifying the root cause of the deviation. Investigations can sometimes be complex and may take more time to come to root cause. This impacts the ability to be able to recover the batch especially when dealing with time sensitive products that may degrade while awaiting the outcome of the investigation. Regardless of the product involved and the criticality of the situation, care must be taken to maintain consistent, thorough documentation, and timely communication with management and regulatory authorities to guarantee the recovered product meets all quality, safety, and regulatory standards, thereby ensuring patient safety.

One of the most important elements in considering batch recovery steps is making sure that a robust quality control system has been implemented across the company. The culture of the organization must be mature enough before undertaking batch recovery operations. This includes, but is not limited to, having appropriate risk analysis procedures, robust documentation and change control procedures, a highly trained staff, a comprehensive investigation process, and adherence to data integrity requirements. Continuous improvement and regular facility audits will help prevent the issue from recurring in the future.

The decision to perform a batch recovery is a difficult one. It is important to understand when a batch recovery procedure can be utilized and when it would be inappropriate to try to and recover a batch. The determination to perform a batch recovery will depend on the severity of the deviation and if the root cause that prompted the deviation was successfully identified with documented supporting evidence. Batches that have more than one deviation during that manufacturing process should not be considered suitable for batch recovery.

The ideal situation is to try and avoid batch recovery situations by having a robust quality system that values continuous process improvement based on identifying root causes for deviations and proactively implementing changes. It is essential to follow best practices and proactively address manufacturing challenges upfront. Identifying the true root cause of the deviation not only helps minimize cost, especially when expensive active ingredients are involved, but helps maintain product integrity that meets regulatory commitments. Even if you have all the necessary elements imbedded into the quality system, unexpected occurrences may lead to a scenario where the company needs to determine whether a batch can be recovered. By following best practices and employing continuous process improvements based on robust investigations and corrective and preventative actions, manufacturers can potentially recover a batch that might otherwise be rejected.

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, and a member of the 

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Vol. 49, No. 9
November/December 2025
Page: 26

When referring to this article, please cite it as Schniepp, S.J. Fundamentals of Batch Recovery Procedures. 

Articles

Batch recovery in pharmaceutical manufacturing is crucial when deviations occur, ensuring the final product meets quality, safety, and compliance standards. The process involves identifying and rectifying deviations through thorough investigation, collaboration, and root cause analysis. A robust quality control system, mature organizational culture, and continuous improvement are essential for effective batch recovery. The decision to recover a batch depends on the severity of the deviation and successful root cause identification. Proactive measures and best practices can minimize the need for batch recovery, maintaining product integrity and regulatory compliance.

Ask the Expert

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing.

Fundamentals of Batch Recovery Procedures

Pharmaceutical manufacturers must comply with good manufacturing practices (GMPs) set by regulators in 

 (3). Pharmaceutical manufacturing buildings and equipment are governed by these regulations (4,5) and usually must comply with these rules in the form of risk-based maintenance programs.

The path to following these requirements is defined by regulators or created by the pharmaceutical company itself, according to Pranav Vengsarkar, PhD, director, process R&D and site head at Avantor. Routine inspections along with equipment calibration and cleaning must be performed and documented to demonstrate facilities and equipment are being maintained to meet regulations, Dr. Vengsarkar says. “Beyond regulatory expectations, proactive maintenance also drives operational efficiency and strengthens credibility with regulators. This enables companies to stay competitive while protecting patient safety.”

To assist in these maintenance tasks, Dr. Vengsarkar recommends the utilization of digital monitoring and artificial intelligence (AI) tools to predict when updates may be needed and to anticipate calibration problems. “This approach supports GMP compliance and minimizes downtime. It also reflects smart manufacturing—leveraging data to maintain equipment performance, improve efficiency, and scale to new modalities without compromising product quality or patient safety,” Dr. Vengsarkar says.

David Basile, VP Technical Operations, Americas at Hovione recommends a comprehensive approach that starts with specification, design, and installation and then moves through to the decommissioning of the equipment. He also suggests using modular and scalable processes to accelerate product deployment.

How much is risk mitigation involved in facility design?

Designing quality from the beginning of a facility’s creation or in the modification of an existing facility may be imperative (6). A robust quality design approach provides a blueprint for continuous improvement. A design review process should be defined in a project execution plan that includes quality reviews (6).

Mark O’Brien, Process Equipment Procurement Leader, DPR Construction, says that understanding the GMP requirements before the early facility design decisions are made can help achieve compliance. Items such as personnel flow and zoning identification can protect people and product from potential contamination. Airflow is also an important concern; therefore, HVAC system design should be taken into consideration.

Pharmaceutical facilities need reliable utility systems to purify water and have backup power supplies, O’Brien says, and a waste system should be designed to properly dispose of waste. “By making key decisions in the infancy of a project, you can deliver a facility that has been designed and built to ensure GMP regulatory compliance with minimal risk and maximum future success,” he stresses.

Risk mitigation identifies potential future problems before they arise so management strategies can be planned ahead of time. For facility design, common problems may be contamination, improper zoning, or faulty equipment. “Gaining early engagement with regulatory bodies to understand expectations and guidelines helps adherence from the start, as well as successfully commissioning, qualifying, and validating the facility at the end,” O’Brien explains. “Risk identification and mitigation isn’t just a starting process. It is an ongoing activity throughout the life of a project. Recurring GMP reviews and audits will be necessary to ensure that correct design decisions are made to allow for the successful and compliant construction of the GMP facility.”

How often should facilities and equipment be evaluated?

Pharmaceutical companies should be using a quality management system (QMS) that includes a review of the GMP facility and the equipment within that is used for GMP-regulated processes. A risk-based approach should be used to determine at what time intervals equipment should be evaluated.

According to Dr. Vengsarkar, pharmaceutical companies are expected to perform internal audits and risk assessments to ensure their operations are current. “Drivers include new technologies, scaling across modalities, or updated compliance requirements,” Dr. Vengsarkar notes. “These upgrades safeguard product quality and patient safety while also improving efficiency, flexibility, and adoption of innovative processes. A periodic review of a GMP facility is a critical process to ensure it remains in a validated state and compliant with current regulations.”

While the quality control and quality assurance departments usually oversee GMP compliance, Dr. Vengsarkar stresses it is a “cross-functional responsibility” that relies on collaboration with engineering and manufacturing departments. “This integrated approach ensures equipment is properly maintained, calibrated, and qualified while aligning facility operations with regulatory standards,” he says. “This approach reflects a culture of shared accountability that regulators expect to see across the organization.”

A dedicated reliability engineer and maintenance planner can assist in facility and equipment evaluation, according to Basile. “This is critical to shorten the mean time to repair and ensure that all tools and supplies needed for the job are available and kitted to support fast first-time-right work order execution,” he adds. “These roles are game changers to the operation and take you from walking to sprinting, especially when candidates bring hands-on experience. In fact, the best planners are usually seasoned mechanics.”

Basile also suggests having a shutdown cycle to identify potential problems with equipment as well as performing internal audits. For long-term updates in response to market demands or new products, more substantial planning may be needed.

“For example, we might have a client that has a pipeline of potent products, in which case we would evaluate the implementation of, say, airlocks, or isolators or misting stations in the relevant processing areas in the GMP facility,” Basile explains.

A site’s validation master plan includes requalification and/or assessment of GMP equipment, says Basile, and each type of equipment may need its own evaluation timeline based on a risk assessment. This can also include a review of the equipment’s historical changes, failure trends analysis, and any corrective and preventive actions performed.

“GMP manufacturing and lab equipment also require regular calibration with critical instrumentation being performed more frequently,” says Basile. “[One should take] a life cycle approach to maintaining equipment, where the equipment master serves as a birth certificate when a machine comes in, all the way through to decommissioning. This is a fundamental part of good asset management.”

How do manufacturers assure regulators that their facilities and equipment are well-maintained?

Possibly more important than setting up a maintenance schedule and having a QMS is proving to a regulatory body that these tasks are indeed being performed. Regulators insist on pharmaceutical manufacturers backing up their claims with data and proof.

“Proof of maintenance is a routine request during GMP inspections,” Dr. Vengsarkar explains. “These records should be complete, organized, and easily accessible, ideally in electronic form. They should detail the date, personnel, service performed, and verification that equipment was returned to a compliant state. A lot of companies tend to outsource their calibration and maintenance needs, which makes clear stakeholder review of these documents necessary to support compliance requirements. Strong documentation not only satisfies inspectors but also demonstrates a robust quality system—reinforcing both regulatory compliance and an organization’s commitment to operational excellence.”

“In our industry, you didn’t do it if you didn’t document it,” Basile stresses. “We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we’ve seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they’d like to reference them at their convenience.”

Basile also recommends using a computerized maintenance management system (CMMS) as a central repository for maintenance-related activities. “This is a key system in the efficient execution of any strong, compliant maintenance program,” he insists. “It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data, and spare parts inventory, so we can see trends and pick up instrument drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation.”

Do different stages of manufacturing have different GMP maintenance requirements?

Equipment used later in the lifecycle of a drug product carries higher risk, according to Dr. Vengsarkar; therefore, it requires more stringent maintenance requirements. Different equipment types also can have different rules for maintenance.

“Typically, analytical equipment, which is usually the last line of defense against a contaminated product, is held to a high standard from an accuracy and data integrity standpoint. Analytical instruments must be regularly calibrated and qualified to ensure accuracy and data integrity,” Dr. Vengsarkar explains. He also says that tableting and packaging equipment need preventive maintenance and rigorous cleaning to maintain consistent performance and prevent contamination.

What mistakes do manufacturers often make?

Being reactive instead of proactive when it comes to equipment maintenance is a common mistake seen by Dr. Vengsarkar, along with incomplete records. He also points to poor personnel training and inadequate cleaning procedures that can cause risk. These risks should be prevented by implementing robust cleaning practices that are consistent and by updating procedures when processes evolve.

Not performing comprehensive criticality assessments using a risk-based approach can lead to over- or under-maintenance of equipment, according to Basile. Relying only on time-based maintenance instead of a proactive approach, such as precision alignment or lubrication, can result in subpar maintenance.

“Today’s teams need to incorporate conditions-based maintenance using technologies, such as vibration analysis,” Basile advises. “They can no longer just fix things that break. They need to diagnose equipment, looking for early signs of failure before they fully develop. Other examples of this are ultrasound or infrared scanning to ensure motors and electrical systems are wired and operating properly.”

Not designing for maintainability is also a common mistake, says Basile. “During the design phase, [having] adequate space and access to equipment, standardized tools, and having the right pickups on equipment for condition-based maintenance is important. I can’t tell you how many times I’ve seen a filter housing or an instrument placed in the interstitial space above a ceiling with no way to safely access it.”

Not allowing enough time for commissioning is also a problem seen by Basile. “The lifespan of equipment can be greatly influenced during the commissioning phase; this is where maintenance reliability starts,” he says. “Too often, commissioning is rushed through, and equipment, preventive maintenance plans, and required spare parts are not thoroughly assessed. In many cases, due to limited time, the CMMS system is not fully populated with key information to perform comprehensive root cause analysis.”

How can facility and equipment problems be avoided?

Anticipating future problems using risk-based approaches can prevent facility and equipment problems. Often in pharmaceutical manufacturing, contamination control is key. Designing facilities that take into account requirements for cleanrooms and separate manufacturing areas for different types of products can keep costly contamination errors from happening…and help prevent drug shortages.

Being proactive and not reactive with equipment maintenance is key to successfully complying with regulations in a GMP environment. GMPs are there to keep patients safe, but they can also keep pharma companies from finding themselves offline.

FDA. Current Good Manufacturing Practice (CGMP) Regulations. 

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice

WHO. Health Products Policy and Standards. WHO.int. 

https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/gmp

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Penko, A. Design Quality in Pharmaceutical Design: A Primer for Facility Executives. 

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Vol. 49, No. 9
November/December 2025
Pages: 10–12

When referring to this article, please cite it as Haigney, S. How a “Plan, Prevent, Prove” Approach Helps Avoid Facility and Equipment Problems. 

Pharmaceutical manufacturers must adhere to GMPs, which are crucial for maintaining compliance and ensuring patient safety. Proactive maintenance, supported by digital tools and AI, enhances operational efficiency and regulatory credibility. Facility design should incorporate risk mitigation strategies from the outset, focusing on contamination prevention and reliable utility systems. Regular evaluations and audits, guided by a QMS, are essential for maintaining compliance. Documentation and data are critical for demonstrating maintenance activities to regulators. A proactive, risk-based approach to equipment maintenance, incorporating condition-based technologies, is vital for preventing issues and ensuring GMP compliance.

Cover Story

Starting with risk mitigation, GMP facility and equipment maintenance is all about anticipating problems before they happen and showing regulators a controlled environment.

Pharmaceutical Technology November December 2025

Fundamentals of Batch Recovery Procedures

How a “Plan, Prevent, Prove” Approach Helps Avoid Facility and Equipment Problems