Archives by Month: July 2025
When choosing a company to manufacture your pharmaceuticals, there are so many different aspects to consider. Aside from the bottom-line pricing, product safety and quality are the biggest drivers of deciding whether to contract with a manufacturing company.
The FDA’s regulations offer a systematic framework for companies to follow to ensure that their products are of the highest quality and safety. The FDA warning letters companies might receive are then a result of inspections and any noncompliance with established standards. Over the years, more warning letters have been issued because an aging American population and an increasing need to address chronic diseases has prompted growth in research and development in pharmaceuticals and medical technologies.
Before the addition of the Quality System Regulations in 1997, the FDA found that about 44% of quality issues leading to voluntary recall actions were attributed to deficiencies in product design that would have been prevented with better controls. The general trend has been an increase in violations in design control which shows increasing FDA’s emphasis on it. The quality systems fall in five categories:
- Production and process controls – Production and process controls relate to establishing and maintaining procedures to document, monitor, and verify compliance of the manufacture of the product. These processes are applied to all phases of production beginning with initial purchase and receipt of raw materials and/or parts and extending to the sale, distribution, installation, and servicing of the finished product.
- Corrective and preventive actions – CAPAs relate to establishing and maintaining procedures for investigating non-conformances, identifying actions to address these, and verifying that these actions are effective.
- Design controls – Design controls involve the establishment and maintenance of procedures to control the design of the device to ensure that the specified design requirements are met.
- Management controls – Management controls refer to policies, organizational structure, resources, personnel, and internal review of the quality system.
- Document controls – Document controls relate to procedures for documenting device and batch-/lot-specific specifications and production processes, as well as those for document approval, distribution, and changes.
The Difference Between Form 483 and a Warning Letter
After an inspection, the FDA usually issues Form 483, which details inspectional observations. The form is used as a guide for voluntary corrective action with a response from the company required within 15 working days.
It is not a final determination of whether the business is in violation of any regulations. On the other hand, a warning letter states the exact regulation of which the company is in violation. The warning letter has the potential to have an impact on requests by the company for certain licenses or applications. The FDA can also take legal action if the concerns in the letter are not addressed.
The Most Common Warning Letter – Failure to Follow Standard Operating Procedures (SOPs)
Just like any other organization, the FDA has limited resources. This means that when they inspect a company, one of the biggest aspects they focus on is the standard operating procedures because the foundation of the quality system is a set of SOPs that are meant to be followed to ensure compliance with regulations. The consensus is that if a company does not take compliance with SOPs seriously, they will not take other regulatory compliance seriously either.
Why Oakwood Labs Is the Best Choice for a CDMO Partner
Oakwood Labs maintains rigorous in-house quality systems, including Quality Assurance and Validation, QC Microbiology, and QC Chemistry. Our team is highly committed to quality and has a long history of compliance.
Quality Assurance/Validation
We have a documented Quality Management System (QMS) designed and implemented to fulfill the following regulatory requirements:
- FDA 21 CFR Part 210 and 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals
- FDA 21 CFR Part 4, Regulation of Combination Products
- FDA 21 CFR Part 11 Electronic Records and Electronic Signatures
- ICH Q10 Pharmaceutical Quality System
Need a Trusted Partner for FDA Compliance? Contact Us
If you want to ensure that your operations avoid running afoul of the FDA, let the experts at Oakwood Labs help. Reach out to our team today to discuss project details and we can get to work developing workable solutions.
Because of opioids’ abilities at treating moderate to severe pain, acute pain, and chronic pain, as well as their use in other roles, many doctors and medical facilities rely on them to provide patients with the best care possible for a range of conditions. While there are several ways to distribute opioids, one viable approach is using long-acting injectables, or LAIs, to achieve reliable and precise results.
At Oakwood Labs, we’re experts at long-acting injectable development for an array of medicine types, including opioids. Read on to learn about everything we can provide and why we’re the right choice for opioid medication development.
Uses and Forms of Long-Acting Injectable Opioids
Medical professionals may opt for long-acting injectables for opioid administration due to the many benefits the approach provides, or in some cases they may rely on LAIs when other methods are nonviable or unable to treat ongoing conditions effectively.
Specific applications can include distribution of:
- Medications for moderate to severe pain
- Medications for acute pain
- Medications for chronic pain
- Sedatives
- Anesthesia
Some of the opioids that have been successfully produced as extended-release medications include:
- Avinza
- Kadian
- MS Contin
- Exalgo
- Duragesic
- Dolophine
- Butrans
- Embeda
- Nucynta ER
- OxyContin
- Palladone
- Opana ER
- Fentanyl (generic)
- Methadone hydrochloride (generic)
- Morphine sulfate (generic)
- Oxymorphone hydrochloride (generic)
Benefits of Using LAIs for Opioid Administration
There are a variety of advantages to using long-acting injectables for opioids and other drugs, including:
- Reduced injections and less frequent doses – Patients need to receive injections only every few weeks or months, depending on the circumstances, compared to other application methods that may require daily use
- Prevention of drug abuse – Since opioids have the potential for abuse and addiction, using long-acting injectables for administration over other methods keeps the control in health professionals’ hands, preventing intentional or accidental abuse
- Improved adherence – With a regular injection schedule, patients will be less inclined to miss or forget doses, allowing them to stay on track and fully benefit from their treatment plan
- Consistent dosing – LAIs provide a steady dose of a drug over time, minimizing the peaks and valleys that can come about from daily oral medications
Long-Acting Injectable Development at Oakwood Labs
The Oakwood Labs long-acting injectable development process uses our technology platform Chroniject™. Some of the benefits of the Chroniject™ system and our overall LAI approach include:
- Medication release durations of 1 week to 1 year
- Formulations that are easy to scale
- Rapid development of formulations via small-scale batches
- Excellent stability characteristics
- Proven content uniformity
- Molecule compatibility with small molecules, proteins, and peptides
- Absence of foreign particulate matter
- Immediate reconstitution with WFI, and no special diluents are required
- Well-controlled process parameters
- Proven lot-to-lot reproducibility
- Ease of syringe administration with 18- to 23-gauge needles
Other Long-Acting Injectable Opportunities for Opioids
In addition to supplying LAIs for opioid drugs, our team is also adept at providing extended-release solutions for treating opioid use disorder. Though opioids have many uses for patient care, they can obviously be abused or lead to accidental addiction.
Just as LAIs excel at controlling opioid distribution, they can also help healthcare providers and patients treat addiction. If your organization is interested in this additional long-acting injectable application, know that you can benefit by way of:
- Removing the need for daily dosing, reducing the chance of missed doses and patient relapses
- Targeting specific areas of the body, particularly the brain, which affects withdrawal symptoms, cravings, and euphoric effects
- Ensuring consistent medication levels that can lead to improved patient outcomes
Contact Us for Opioid Long-Acting Injectables
The Oakwood Labs team is ready to provide your organization with the long-acting injection solutions you need to supply first-rate medical care. Reach out to our team today to discuss options.