A pharmaceutical aging facility is termed as a facility that is losing or has lost the capability of producing quality products, The pharma facility fails to produce product of acceptable and regulatory specifications, and is not allowed to market for distribution. If regulatory body finds product of such facility in its area of jurisdiction, it can shut down the plant, until all the requirements have been met by the manufacturer.
This phenomenon is not related to the age of a facility or building, but rather it represents the facility's inability to fulfill the requirements of a quality product. It indicates that pharma facility lacks basic requirements to produce quality and approved products.
Some characteristics that relate to the aging facility include the following.
The facility cannot meet the operational requirements of producing pharmaceutical products.
Production processes and system needs improvement.
Production equipment needs overhaul, maintenance, or replacement.
Manufacturing resources, processes, and testing facilities are becoming absolute. Their spare parts, troubleshooting, and operational support are not readily available from the manufacturer or in the market.
HVAC System suffers frequent failures and breakdowns. It loses or loses the capability to produce the required environmental conditions. Additionally, it suffers frequent breakdowns and requires maintenance on a continuous basis.
Due to maintenance, problems, and capacity issues, the equipment cannot meet production demands.
Processes and products suffer persistent contamination problems, and there remains a continuous need to improve contamination.
An older facility might be fully capable of providing all the quality, process, equipment, and product requirements. While on the other hand, a recently developed facility might be unable to provide the conditions for quality products and processes.
Suppose it has been observed and proven that a facility is becoming aging and losing its capability to produce quality and satisfactory products. In that case, it must be updated and improved concerning all the requirements to make it able to meet all product requirements.
Consider critical factors before deciding to update your aging facility.
Before categorizing your facility as aging and investing in resources, it is critical to consider essential factors and requirements.
The planning helps to make shortlist the essential requirements. It helps in efficient decision-making, such as whether it is feasible to update the existing facility or build a new one.
Let's discuss these factors in detail.
A clear understanding of regulatory requirements helps in curating ways toward better decision-making. It helps to clear confusion regarding new technology and innovation from the regulatory point of view.
This prevents over-expenditure related to facility design, equipment, and quality requirements.
Like other industries, the Pharma industry is also affected by the increased cost rate worldwide. As a result, concerned personnel are under constant pressure from higher management to keep costs down and reduce unnecessary expenditures.
For this season, considering cost factors from the beginning is critical when opting for various options. Try to source as many as possible to make better decisions concerning cost and benefit from multiple options available.
Answers to the following questions can be helpful when considering cost factors
Whether investing in equipment or technology is beneficial or not
Whether the capabilities of the existing facility can be enhanced by design improvement
Whether investing in updating the facility is the only option or the problem can be solved by alternating issues.
Answer the above questions, and like these will enable personnel to better manage the finances from the beginning of the project.
Are existing processes able to tolerate variability?
Real-world Pharma manufacturing processes are prone to variability in various areas, such as raw materials, operating parameters, and environmental conditions. These variations can cause dynamic product properties, quality attributes, and therapeutic effects. Pharma facilities, equipment, and quality parameters must be robust enough to deal with the process variations.
Carefully considering the critical processes increases the ability to handle variations in various components of Pharma manufacturing, raw material, operating conditions, environmental requirements, and quality handling procedures. The study of product and process robustness also gives the necessary information for better decisions related to Pharma aging facilities.
It also allows decision-makers to investigate the current manufacturing status thoroughly, considering the present state of pharma facilities.
Quality in the final product is established from the beginning of pharma product manufacturing, which is the function of various factors such as manufacturing, process, contamination control strategy, and quality assurance & control.
For some Pharma facilities, it might be challenging to implement some processes that ensure quality in the final finished product. It cannot be implemented without measuring the overhaul of process equipment or update in existing facilitated design quality procedures and operational characteristics.
Quality in the final product can be filled by email and amended by slide changes in facility design, operational characteristics, and quality procedures.
Impact of aging facilities
Let's discuss the impact of the aging facility on Pharma processes and products.
Out-of-date equipment and technology
The most common impact of Pharma's aging facility is outdated equipment and technology. It affects the organization's ability to produce quality products and meet market demands.
Out-of-date equipment and technology also affect the operational goals of an organization, such as a safe production process, less production wastage, efficient workforce utilization, and reduced breakdown.
All these factors contribute to an overall increase in the cost of manufacturing. Additional consequences include improved systems and processes, which also increase expenses related to drug manufacturing.
Aging Pharmaceutical facilities are prone to contamination because older facilities do not contain technologies and resources that effectively prevent contamination. These older technologies are ineffective for dealing with modern-day contamination challenges and are not allowed for dealing with advanced Pharma products.
Another reason for poor contamination control is the material used in the Pharma facility construction. The material used in the construction of aging facilities are inefficient and can cause significant structural deterioration and elevate the contamination rate.
Due to the older use of building materials, aging pharma facilities are also prone to microbial contamination. These older building materials degrade with time and can easily cause microbial contamination to grow on them. It is also possible that the degradation can go undetected during a routine inspection.
Error full processes
Processes in aging pharmaceutical facilities can quickly become errors due to a lack of modern drug Pharma manufacturing techniques and quality procedures. Process errors can become considerable for critical products, such as vaccines and biotech products, where a minor mistake can damage the entire product batch.
The error can be many types, such as
Safety: Errors in manufacturing can compromise personal security due to hazardous products accumulated in the area due to inadequate resources, such as inefficient HVAC systems and ventilation.
Personal safety can also be affected by a lack of protective systems in equipment, for example, safety cover for moving parts.
Machine operation: Error can also be induced in machine operations such as feeding and mixing systems. Errors like these can significantly affect the machine's operation and the final product.
Increase ratio of errors: Pharmaceutical aging facilities can also result in increased errors throughout the manufacturing processes. Errors such as product variation, machine breakdown, quality, and compliance problems can become significant if updated facilities systems are not implemented.
How to reduce the risk of aging pharmaceutical facilities
Let's discuss some ways that pharma professionals used to overcome the risk of aging facilities.
Replacing old and traditional equipment with modern equipment is an effective way to deal with the problem of aging pharmaceutical facilities. It helps plant owners and responsible personnel to rectify problems by
Stabilizing the manufacturing process and preventing variation in the final production output for practical therapeutic effects.
Implementing quality at all stages by preventing contamination and product variation
Safe processes for man, material, and machine.
It provides an effective and efficient way of dealing with regulatory requirements.
Replacing manual equipment and processes with automatic gear and processes provides an effective way for Pharma professionals to remove all the shortcomings and objections related to Pharmaceutical aging facilities. The most significant advantage is reducing manual processes and eliminating human involvement in executing pharma processes. This is the basis for many problems related to Pharma processes and products.
Automatic processes are more efficient and help in accurately executing Pharma processes by controlling factors such as timing, quality, and process requirements. It also provides excellent contamination control throughout the manufacturing processes, compared to manual operations, which can be easily affected by contamination.
Some advantages of automatic processes that significantly help to mitigate problems related to Pharma aging facilities include the following.
Efficient and up-to-date documentation of process which is a critical requirement of regulatory bodies
Ensures process and product safety by preventing cross-contamination, product mix-up, and error in various production parameter
Advanced testing methods
Pharmaceutical aging facilities cannot test the latest and modern drug types, such as Vaccines and biotech products. Updating old and traditional testing methods with advanced and latest significantly contributes to the transition to modern pharma facilities.
Advanced testing methods can also help determine product quality by accurately controlling the deviation in product characteristics. It also ensures quality in the final products from Start to finish without interrupting the production process.
Stability testing is the process of analysing and monitoring the active pharmaceutical ingredients/APIs or the final pharmaceutical products/FPPs stability over time to ensure that it stays safe and effective during its shelf life and under that labelled