Preparing your BCP for Trump’s Attacks on Immigration

Time (maybe past-time) to evaluate your organization’s business continuity plan and anticipate the potential actions against immigrants, in particular the potential impact of Trump’s proposed immigration policies on the facility cleaning industry, particularly cleanrooms, which could be significant.

Labor Shortage

The cleaning industry, including cleanroom maintenance, heavily relies on immigrant labor. A mass deportation policy could lead to:

Significant workforce reduction: Many cleaning companies employ immigrant workers, both documented and undocumented. A large-scale deportation could severely reduce the available workforce.
Increased labor costs: With fewer workers available, companies may need to offer higher wages to attract and retain employees, potentially increasing operational costs.

Industry Disruption

The cleanroom industry, which requires specialized skills and training, could face particular challenges:

Loss of experienced workers: Cleanroom maintenance requires specific knowledge and expertise. Deporting experienced workers could lead to a skills gap in the industry.
Reduced productivity: As companies struggle to replace deported workers, there might be a temporary decrease in productivity and quality.
Increased costs for clients: Higher labor costs in the cleaning industry could be passed on to clients, potentially affecting industries that rely on cleanroom facilities, such as pharmaceuticals and electronics manufacturing.

Actions to Evaluate

Time to evaluate internal training programs to quickly upskill current and new workers, particularly for specialized cleanroom maintenance. Be prepared for the need to have your staff step in and clean, on the moment’s notice. This is a key action to have in the business continuity plan, and frankly should already be there.

Compliance and Legal Challenges

Beyond that, companies should be evaluating their other plans with broad stakeholders like HR and legal for when law enforcement comes calling as a result of heightened enforcement and audits of cleaning companies to ensure compliance with immigration laws. Remember these cleaners work side-by-side with your staff and quite frankly, are really hard to tell the difference. Are you prepared to side with law enforcement, or delay law enforcement? What is your risk tolerance for navigating the complex legal situations, particularly if long-term employees are suddenly subject to deportation?

While the full extent of the impact remains uncertain, Trump’s proposed immigration policies could significantly disrupt the facility cleaning industry, which will greatly impact every manufacturing site I know. The industry may need to adapt quickly to potential labor shortages, increased costs, and changing regulatory landscapes, while navigating the thorny ethical considerations.

No time like the present to start.

What do I need a Toxicologist for in the GMPs

Working on a job description for a toxicologist. Here’s what I have so far: what am I missing on the GMP side (not the GCP, GVP, or GLP sides).

A toxicologist plays several important roles in GMP activities, including in cleaning validation and extractable/leachable (E&L) studies for pharmaceutical manufacturing:

For cleaning validation:

Establishing safety thresholds: Toxicologists help determine the Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) limits for residual substances. These limits are crucial for setting acceptance criteria in cleaning validation.
Risk assessment: They evaluate the potential health risks associated with residual substances that may remain after cleaning processes.
Determining safety factors: Toxicologists apply appropriate safety factors when calculating acceptable residue limits, considering factors like route of administration and patient population.
Reviewing toxicological data: They analyze available toxicity data on active ingredients, excipients, and cleaning agents to inform safety assessments.

For extractable and leachable studies:

Toxicological evaluation: Toxicologists assess the potential health impacts of identified extractables and leachables from packaging materials or manufacturing equipment.
Setting thresholds: They help establish Safety Concern Thresholds (SCT) and Analytical Evaluation Thresholds (AET) for E&L studies.
Risk characterization: Toxicologists evaluate the toxicological significance of detected leachables in relation to patient exposure.
Providing expertise on regulatory guidelines: They ensure studies comply with regulatory expectations regarding toxicological risk assessment.
Interpreting study results: Toxicologists help interpret the significance of E&L findings in the context of patient safety.

Toxicologists provide critical expertise in assessing the potential health impacts of trace contaminants or leached substances. They also ensure that cleaning processes and packaging materials do not introduce unacceptable risks to patient safety. Their input is essential for developing scientifically sound and regulatorily compliant approaches to these critical pharmaceutical quality and safety aspects.

Cleaning Solution and a Disinfectant Solution

To the average person on the floor, there are just things to clean with. However, cleaning and sanitization are very different, and it’s important to recognize this and ensure folks are properly educated. I can’t count how many audits I’ve had where this became a tripping point.

The primary difference between a cleaning solution and a disinfectant solution lies in their purposes and the outcomes they achieve.

Cleaning Solutions

Purpose: Cleaning solutions are designed to remove dirt, dust, grime, and impurities from surfaces. This process involves using soap, detergents, or other cleaning agents combined with water and physical action (e.g., scrubbing) to lift and wash away contaminants.

Effectiveness: Cleaning physically removes germs from surfaces but does not necessarily kill them. It reduces the number of germs and prepares the surface for further treatment, such as sanitizing or disinfecting.

Examples: Common cleaning agents include all-purpose cleaners, dish soap, and glass cleaners.

Disinfectant Solutions

Purpose: Disinfectant solutions are specifically formulated to kill or inactivate harmful microorganisms on surfaces, including bacteria and viruses. They contain chemical agents that are effective against a wide range of pathogens.

Effectiveness: When used correctly, disinfectants are designed to kill nearly 100% of the germs listed on their labels. They are regulated by the Environmental Protection Agency (EPA) and must meet stringent efficacy standards.

Examples: Common disinfectants include bleach solutions, alcohol-based solutions, and products containing quaternary ammonium compounds (QUATS).

Here is a table comparing the key differences between cleaning solutions and disinfectant solutions:

Aspect	Cleaning Solutions	Disinfectant Solutions
Purpose	Remove dirt, dust, grime, and impurities	Kill or inactivate harmful microorganisms
Effectiveness	Physically removes germs but does not necessarily kill them	Kills nearly 100% of germs listed on their labels when used correctly
Examples	All-purpose cleaners, dish soap, glass cleaners	Bleach solutions, alcohol-based solutions, QUATS
Function	Reduces the number of germs	Kills or inactivates germs
Usage	First step in the cleaning process	Applied after cleaning to kill remaining germs
Regulation	Not always regulated by the EPA unless they have sanitizing or disinfecting claims	Must be registered with the EPA and meet specific efficacy standards
Contact Time	Not applicable	Requires specific contact time (usually 5-10 minutes)
Safety	Generally safer, fewer precautions needed	May require precautions such as gloves or ventilation
Impact on Equipment	Less likely to cause wear and tear on equipment	Can be harsh on surfaces and equipment, potentially causing damage over time

Comparison of the key differences between cleaning solutions and disinfectant solutions

Cleaning Validation Checklist

I’m reviewing the status of cleaning validation. Here is the list I’m currently going through, just in case it helps others.

Develop a comprehensive cleaning validation master plan that outlines your overall approach, policies, and procedures for cleaning validation at your facility. This should cover all aspects of the cleaning validation lifecycle.
Ensure you have written standard operating procedures (SOPs) for equipment cleaning processes that address different scenarios (e.g., cleaning between batches, between product changes, etc.).
Have written cleaning validation protocols for each piece of equipment that cover common issues like sampling procedures and analytical methods.
Maintain thorough documentation of your cleaning validation studies, including the protocols, results, and final reports stating whether the cleaning process for each piece of equipment is valid.
Implement a continuous verification program for routine residue monitoring after initial cleaning validation.
Be prepared to demonstrate that your cleaning procedures can consistently clean equipment to predetermined standards using scientifically sound sampling and analytical test methods.
Have data available to support your rationale for residue limits, which should be logical, practical, achievable, and verifiable.
Be ready to explain your approach for different types of equipment (dedicated vs. multi-use) and how you handle potent compounds or other high-risk materials.
Review your cleaning agent selection process and be able to justify the cleaning methods and agents used.
Ensure you have a system in place for equipment maintenance and cleaning records.
Be prepared to discuss how you handle manual vs. automated cleaning processes and any associated validation differences.
Review past audits or inspections and ensure any previous findings related to cleaning validation have been addressed.

Let me know if I’ve missed anything.