Best Practices to Managing Investigational Medicinal Product

In a clinical trial, the drug itself is the protagonist. It is the potential cure, the scientific question, and the most valuable asset in the study. Therefore, the way this drug—technically known as the Investigational Medicinal Product (IMP)—is handled can make or break a trial.

Implementing the Best Practices for Managing Investigational Medicinal Products is not just about logistics; it is about patient safety and regulatory compliance. One missing vial or one unrecorded temperature excursion can invalidate data from dozens of patients, costing millions of dollars and delaying life-saving treatments.

At the Clinical Trial Unit (CTU) of Premium Medical Complex (PMC), we treat IMP management with the same rigor as surgery. As a DRAP-approved site, we adhere to the strictest International Conference on Harmonisation (ICH-GCP) guidelines. Below, we share the gold-standard protocols that every top-tier research site must follow.

1. The “Chain of Custody” Begins at Receipt

The journey of an IMP is documented from the moment it leaves the manufacturer until the moment it is swallowed or destroyed. This “Chain of Custody” is the backbone of Best Practices for Managing Investigational Medicinal Products.

• Verification: Upon arrival at PMC, our pharmacists do not just sign the courier slip. They physically inspect the shipment against the “Packing List.”
• Condition Check: Was the box damaged? Did the temperature logger show any spikes during transit? If the “Cold Chain” was broken (e.g., the ice packs melted), the shipment is immediately quarantined.
• Acknowledgment: A formal receipt of acknowledgement is sent to the sponsor within 24 hours. This creates an audit trail proving the drug arrived safely at the site.

2. Storage: Temperature, Security, and Segregation

You cannot store a million-dollar experimental drug in a standard kitchen fridge. Professional storage is non-negotiable.

• Temperature Monitoring: At PMC, we utilize calibrated pharmaceutical-grade refrigerators (2°C to 8°C) and ambient storage units (15°C to 25°C). These are equipped with 24/7 continuous digital data loggers.
• The “Excursion” Plan: What happens if the power goes out? One of the critical Best Practices for Managing Investigational Medicinal Products is having a backup. Our facility is backed by industrial generators and UPS systems. If a temperature excursion occurs (e.g., the temperature rises to 9°C), an automated alarm alerts our staff immediately.
• Segregation: IMPs must never be mixed with regular hospital stock. We maintain a dedicated, restricted-access pharmacy zone specifically for clinical trials to prevent dispensing errors.

3. Accurate Accountability Logs

“If it isn’t written down, it didn’t happen.” This GCP mantra is the law in IMP management.

• Subject Accountability: Every time a pill is dispensed to a patient, it is recorded on a “Subject Dispensing Log.” We record the date, the kit number, and the lot number.
• Returns: We ask patients to bring back their empty or partially used blister packs. Why? To prove compliance. Counting the leftover pills tells us if the patient actually took the medicine. This “pill count” is a vital data point for the study’s validity.

4. Blinded vs. Unblinded Management

In many high-quality studies, the doctor and patient must not know if the treatment is the real drug or a placebo (double-blind).

• The Unblinded Pharmacist: To maintain this blind, PMC often employs an “Unblinded Pharmacist.” This person is the only one who knows the truth. They prepare the medication behind closed doors and hand it to the nurse in a generic syringe or bag.
• Risk Mitigation: This separation of duties is one of the most sophisticated Best Practices for Managing Investigational Medicinal Products, ensuring that the study results remain unbiased.

5. Handling Temperature Excursions

Even with the best equipment, things can go wrong. How a site reacts defines its quality. If an IMP is exposed to temperatures outside its safe range, we follow a strict protocol:

1. Quarantine: The affected drug is physically marked “DO NOT USE” and moved to a separate quarantine area (while maintaining its required temperature).
2. Report: We immediately notify the Sponsor or Contract Research Organization (CRO).
3. Adjudicate: The Sponsor’s quality team reviews the stability data. Only if they issue a written “Memo for Release” do we move the drug back to active stock. If not, it is marked for destruction.

6. Destruction and Disposal

The lifecycle of an IMP ends with its destruction. This is a sensitive area in Pakistan due to environmental and safety regulations.

• Sponsor Authorization: We never destroy a drug without written permission from the sponsor.
• DRAP Compliance: Destruction is carried out according to local hospital waste management policies and DRAP rules, often involving incineration.
• Certificates: A “Certificate of Destruction” is generated, listing exactly how many vials were destroyed. This closes the loop on the Chain of Custody.

7. Digital Inventory Management

Paper logs are good; digital logs are better. At PMC, we are moving toward Inventory Management Systems (IMS). These digital tools allow for:

• Auto-Alerts: Notifying us when stock is running low so we can re-order before we run out.
• Expiry Tracking: Alerting the team if a batch is approaching its expiration date, ensuring no patient is ever given expired medication.

Why PMC is the Leader in IMP Management

Implementing these Best Practices for Managing Investigational Medicinal Products requires investment. It requires backup generators, calibrated thermometers, secure access doors, and highly trained pharmacists.

Premium Medical Complex has made these investments because we know that a trial is only as good as its data. By securing the drug, we secure the result.

Are you a Sponsor looking for a safe harbor for your research? Trust your IMPs to a facility that understands the stakes. Contact the Clinical Trial Unit at PMC to inspect our pharmacy capabilities today.

Visit https://ctu.pmcpk.com/ and experience the difference of professional research management.