The traditional role of a compounding pharmacy is to make specific drugs prescribed by medical doctors to meet the needs of an individual patient.
Prescription compounding has seen a resurgence in recent years because of the many benefits offering formulas tailored to patient needs. Many patients have found mass-produced drugs difficult to stomach, or are sensitive or allergic to dyes and preservatives in commercially produced medications. Although this is great for patient care, regulatory scrutiny is increasing to ensure the safety of these same patients.
What is a Compounding Pharmacy?
The FDA’s compounding program “aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.”
There are around 7,500 compounding pharmacies that are producing batches in the US, at both the state and federal levels. With that increase comes an additional rise in audits where pharmacies are required to produce evidence that they have appropriate quality controls in place. The FDA requires proof that components of the compounded drug and the final drug product must “conform to appropriate standards of identity, strength, quality, and purity.”
In 2013, the federal Drug Quality and Security Act (DQSA) was signed into law and established provisions to create two different kinds of drug compounding facilities:
- 503A Compounding Pharmacies: The FDA designated 503A for compounding pharmacies that compound medications according to prescriptions specific to a particular patient’s needs. Facilities are no longer allowed to compound large batches; instead, the FDA has placed limits on their abilities to dispense medication beyond home use. They are required by state boards of pharmacy to comply with USP guidelines.
- 503B Compounding Pharmacies: The FDA designated 503B to compounding pharmacies with outsourcing facilities that manufacture large batches, with or without prescriptions, to be sold to healthcare providers.
Compounding pharmacies must comply with USP standards for preparing compounded sterile medications to reduce risks such as contamination, infection, or incorrect dosing. All compounding pharmacies must have a system for monitoring environmental conditions, and provide stability information, pyrogen and/or sterility and environmental monitoring. They may also be required to test for potency, identity, and concentration ensuring the safety of the drug before it is released to the patient.
3 Reasons Why Compounding Pharmacies Need Cloud-Based LIMS
Regulators and consumers want to reduce the amount of adverse medical events from taking compounded medications. With increased concern, compounding pharmacies need to show their quality control, especially when compounding sterile products. When questionable results are found that are not compliant with regulatory requirements, these pharmacies must have a way to track the results along with putting in place mitigation strategies.
Here are three reasons why using a cloud-based LIMS solution can help compounding pharmacies keep up with regulations and produce safe medications for consumers.
Data Tracking Capabilities
Cloud-based LIMS technology will log, track, record, and report on samples and scientific data in a structured, consistent manner ensuring a reliable chain of custody. The processing of samples will produce accurate results every time because samples required to be tested, comply with an established schedule ensuring correct testing is performed on a consistent basis. This demonstrates to auditors, that pharmacies not only have control of their processes, but they can also demonstrate an accurate timeline of testing along with their results leading up to producing a certificate of compliance.
Reduced Human Errors
LIMS technology provides built-in quality control and assurance measures because of automated workflows and assignments of specification tests. During a process, if any abnormalities are uncovered or if a test fails, the LIMS technology can automatically launch an investigation.
Without LIMS technology, there is greater opportunity for human error when it comes to sampling and data collection along with the maintenance of a chain of custody. Manual processes are often outdated and error-prone, providing a much more cumbersome operation than working through a quality LIMS system.
With LIMS technology you not only eliminate inherent human error, but it is also a more strategic approach to ensure testing is both consistent and compliant. Results are stored in an ultra-secure cloud-based system reducing the potential loss of paperwork that can’t be retrieved.
Easy Access to Data
When data is stored in the cloud, it is easy for multiple laboratories to gain access from various locations and simultaneously the system preserves the integrity of the data in a safe and secure environment. When audited, pharmacy personnel can retrieve the data to prove quality controls and compliance with ease.
Even with investigations, pharmacy personnel can put additional information into a LIMS system at the time of manufacture. Having an internal investigation tool in your cloud-based LIMS means you can perform an investigation and monitor the completion. This way, compounding pharmacies can take the lead in developing their quality control processes automated with internal controls, instead of being driven by external regulations. Procedural testing releases rigorous environmental controls around quality which are provable when audited because you can demonstrate your consistency of approach with all documentation readily available in the cloud.
LIMS vs. QMS Differences
There is a big difference between a LIMS system and a quality control management system (QMS). LIMS is part of a QMS that incorporates software, procedures and training. This approach means you can ensure the quality in your environment will pass an audit because it goes beyond a QMS as it includes management accountability at the front end.
It is always better to be in a position where you are proactive when it comes to lab compliance - catching possible issues before they arise. LIMS manages your space avoiding potential problems in the first instance, not after the fact. By being proactive and strategic allows you to address quality procedures bringing them to the surface before they occur. This allows you to extend what you’ve captured based on your learnings from the quality checks. LIMS puts in place procedures such as testing and release along with environmental management controls resulting in provable controls around quality.
Benefits of Cloud-Based LIMS for Compounding Pharmacies
One of the keys when it comes to an audit is the ability to show cleanroom sterility, which is a common reason for failing an audit. LIMS technology documents every lab process and highlights any inconsistencies when it comes to sterilization. Any testing samples for a batch are recorded, documenting both the cleaning of the equipment and the room, to ensure there is no cross-contamination. If any anomalies arise, LIMS can show how the issue was resolved by keeping comprehensive records demonstrating what remedial action was taken. These records can be retrieved from the cloud and shown to an auditor on- demand.
LIMS solutions can demonstrate your compounding pharmacy is in complete control, that you are tracing your samples along with the manufacturing environment so you can confidently show and recall that information in case of an audit. The manufacturing process maintains consistency throughout therefore preserving the integrity of the data. As a result, this gives both the compound pharmacy and the auditors added confidence because the technology proves compliance.
Anytime processes are automated with a LIMS system, it removes inherent human error prevalent in manual paper-based systems. Automation enforces consistent processes for releasing a batch, which gives you absolute confidence that it is safe to do so and will not put the patient at risk. You know each batch was processed the same way every time culminating with a certificate of analysis that is stored securely in the cloud. These documents are easily accessible without locating stacks of paper in a cabinet. This makes your documentation easier to find supported by a higher quality controlled process.
A LIMS system helps with procedures and quality checks throughout giving your customers peace of mind and confidence in the data and medicinal products that they are receiving. LIMS ensures the same checks are carried out the same way every time ensuring these checks are never forgotten, missed, or inconsistently applied from batch to batch.
For smaller compounding pharmacies, validation is already carried out for workflows, which will support any audits. A cloud-based LIMS is a cost-effective solution and quick to implement because you don’t have to worry about significant start-up costs and ongoing maintenance to deliver industry-leading functionality.
The biggest advantage of a LIMS system is it proactively looks at all aspects of compounding pharmacy testing processes, not just investigations. Deploying a stand-alone quality control system for managing quality incidents is a reactive approach to compliance that can still leave you compromised when it comes to an audit because when used in isolation, you may be left with residual issues post-implementation of a corrective action as a result of an investigation. With a fully-functional cloud-based LIMS, you are assured your metadata, workflows, samples, results, and instruments are completely organized at all times giving you increased visibility of all processes including taking corrective action after an issue arises.
A trusted LIMS provider helps your lab implement a quality management system, underpinning the implementation of quality improvements that keep you in full control of your operations at every level. It reassures your internal stakeholders and external regulators that any compliance issues are being addressed in a timely manner.