Imagine a world without strict regulations for drug manufacturing – a world where anyone could produce medications without quality control or safety measures. Scary, right? Fortunately, the US FDA (Food and Drug Administration) stands as a guardian, setting forth comprehensive compliance requirements that pharmaceutical manufacturers must follow to maintain the highest standards of drug safety and efficacy.

It’s time to dive into a topic that might not sound all that glamorous but is absolutely crucial for the industry’s success and patient safety: FDA Compliance. 🌐💊

FDA Compliance Requirements: A Pillar of Patient Safety

Picture this: You’re a US-based pharmaceutical company with big dreams of delivering top-notch medications to improve countless lives. But guess what?

The road to success isn’t just about scientific breakthroughs and cutting-edge formulations. It’s also about ensuring that the innovation aligns with the regulations and requirements set by the authorities.

Shall we dive into some of the critical requirements?

  • Pre-Market Approvals: Whether introducing your new drugs or generic versions of existing ones, you must undergo rigorous scrutiny through either a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) to ensure that only safe and effective medications find their way into the hands of patients. Drugs that are sold without appropriate approval can face serious repercussions.

💡Between 1969 and 2006, the FDA received 665 adverse event reports linked to quinine sulfate use, including 93 deaths. While approved for specific malaria treatment, unapproved quinine sulfate was marketed for leg cramp relief, resulting in adverse events like cardiac arrhythmia, renal failure, and Myasthenia Gravis. Unlike approved versions, labels of unapproved drugs lacked crucial safety info. The FDA removed the unapproved quinine sulfate from the market.

  • Current Good Manufacturing Practices (cGMPs): You must dance to the tune of the FDA’s cGMPs regulations. This essential symphony orchestrates the consistent production and control of drugs, setting the stage for stringent quality standards.

💡Very recently in July 2023, the FDA issued a warning letter to Intas Pharmaceuticals Limited due to significant violations of cGMPs. One of the observations documented by the FDA inspector is that torn original CGMP documents, including EMS engineering checklists, KF analytical test reports, auto titration curves, and product weight slips, were found discarded in plastic bags.

  • Registration and Product Listing: Transparency takes center stage as you register your facilities with the US FDA, spotlighting the activities performed within your walls. Furthermore, in perfect synchronization with the structured product labeling (SPL) format, you shall list your drugs with the FDA.
  • Labeling Compliance: In the grand performance of pharmaceutical compliance, you take to the spotlight defining the labels with accurate information, including drug usage, dosage, side effects, and contraindications. If a product is not labeled truthfully and per the requirements, it can be considered misbranded.

💡Back in 2021, FDA declared Nurtec ODT as misbranded, due to false or misleading information about the product’s efficacy.

  • Adverse Event Reporting: Amid the symphony of pharmaceutical oversight, a proactive chorus emerges: you reporting adverse events to the FDA. This vigilant ensemble encompasses adverse reactions, product defects, and any safety-related information.

💡In 2022, around 174,475 death were reported to the FDA for drugs and biologics that were approved under EUA for COVID-19.

  • Inspections: The FDA takes up the baton in this pharmaceutical symphony, conducting regular inspections of manufacturing facilities. These inspections represent a critical checkpoint, ensuring the ongoing commitment of you to uphold safety and quality standards.
  • Recall Management: As the curtain draws near on our performance, the crescendo of recall management takes the stage. If your product is found to be defective or poses a risk to public health, you must act swiftly, initiating a product recall in coordination with the FDA.

💡Recently around May 2023, Family Dollar recalled their OTC drugs voluntarily, as it was not stored at the temperature defined in the labeling.

Looking to market your drug in the US and finding it challenging to interpret FDA compliance requirements? No worries, we, the FDA consultant are here to assist you. Drop an email, and we will call you.

Cruising to Compliance: Your Pharma Manufacturing Checklist

As you know, the manufacturing process for pharmaceuticals can vary significantly depending on the type of your drug being produced (e.g., tablets, capsules, injectables, creams) and the specific formulation involved.

That’s where our compliance checklist swoops in to save the day, 🦸‍♀️ and help you ensure that amidst different manufacturing processes, the sight of compliance is not lost.

Whether you’re a seasoned industry player or just dipping your toes into the pharmaceutical pool, this checklist is your trusted guide. We’ve got you covered, from establishing your manufacturing facility to ensuring your quality control measures are airtight.

  1. Current Good Manufacturing Practices (cGMP):
    • Implement and maintain cGMP regulations as per the requirements of 21 CFR Part 210 and 211.
    • Develop and document comprehensive Standard Operating Procedures (SOPs) for all manufacturing processes.
    • Establish a robust Quality Management System (QMS) to ensure consistent compliance with cGMP guidelines.
  2. Personnel Training and Qualification:
    • Provide comprehensive training programs to all employees involved in the manufacturing process.
    • Maintain records of employee training, responsibilities, and qualifications, ensuring these records are up-to-date.
    • Include cGMP, safety, and job-specific training in the training program.
  3. Facility and Equipment:
    • Maintain your facilities that meet cGMP standards, including adequate space, environmental controls, and cleanliness.
    • Regularly calibrate and validate critical equipment used in the manufacturing processes.
    • Implement a preventive maintenance program to ensure equipment remains in optimal working condition.
  4. Raw Material and Supplier Management:
    • Establish a robust system for qualifying and approving raw material suppliers.
    • Perform risk assessments for critical raw materials and implement appropriate control measures.
    • Regularly audit and monitor suppliers to ensure they meet cGMP and your quality requirements.
  5. Testing and Validation:
    • List down the standards to be complied with, define the testing procedure, conduct the appropriate testing, and record the results.
    • Reject the products that do not meet the established acceptance criteria.
    • Retain an appropriate number of samples needed to determine if the product meets the specification
  6. Identification and Traceability:
    • Establish identification and traceability process to ensure rejected, and approved components/products/containers are stored separately.
    • Inspect/reinspect the components/products as appropriate before approving them for usage.
  7. Product Packaging and Labeling:
    • Adhere to FDA regulations regarding the product’s packaging and labeling.
    • Ensure accurate and up-to-date product labeling, including safety information, dosage, and storage instructions, specific to your product type.
  8. Quality Control and Quality Assurance:
    • Conduct thorough in-process testing and final product testing to ensure product quality and compliance with specifications.
    • Launch a Quality Control Unit (QCU) responsible for overseeing quality-related activities and releasing products for distribution.
    • Implement a comprehensive deviation and investigation management system to address any quality-related issues promptly.
  9. Warehousing and Distribution Control:
    • Set up the First In First Out method to make sure the product produced first is dispatched first.
    • Maintain required storage conditions to store the approved components/drug product.
  10. Batch Records and Documentation:
    • Maintain detailed and accurate batch records for each manufacturing process, documenting all critical steps and deviations.
    • Ensure proper and organized documentation of all manufacturing, testing, and quality-related activities.
    • Retain batch records and documents as per regulatory requirements.
  11. Regulatory Compliance Monitoring:
    • Define the salvage process if the drug gets exposed to unacceptable storage conditions.
    • Conduct regular internal audits to assess compliance with cGMP and other regulatory requirements.
    • Stay updated on changes in regulations and guidelines issued by relevant regulatory authorities.

How Elexes can help you?

Elexes can be your backstage pass to the world of pharmaceutical compliance. We’re here to demystify the jargon, break down the complex procedures, and help you navigate the maze of regulations like a seasoned pro. We’ll handle everything from documentation and record-keeping that would make any document controller proud, to audits that might give you a few butterflies.

Give us a call now to help you with your pharma compliance. Let’s talk!

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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