The FDA and ISO guidelines for the pharmaceutical industry make sure new medications are made to the highest standards of quality, safety, and effectiveness. Staying compliant isn’t just about ticking boxes. Falling short can lead to big fines, product recalls, and damage to your reputation. From FDA’s 21 CFR Part 11 to ISO 45001, keeping up with these standards is tough.

And just knowing the rules isn’t enough. Many pharma manufacturers face inefficient manual processes, lack of quality standardization, and poor visibility into operations.

To help you understand what you need to know to make compliant, high-quality, safe, and effective products, we’ll list the key regulations and standards for pharma companies. We’ll also highlight how software like TenForce’s quality management suite can make your compliance journey smoother.

A regulatory roll call

Every step in the pharmaceutical manufacturing process, from sourcing raw materials to disposing of waste, faces strict regulations to ensure products and processes are safe, effective, and environmentally responsible.

Here are some key regulatory standards you’ll need to follow:

FDA Regulations

• 21 CFR Part 11: To comply with this, you’ll need to make sure your electronic records and signatures are accurate and secure.
• 21 CFR Parts 210 and 211: These regulations deal with drug manufacturing, processing, packing, and holding.

ISO Standards

• ISO 9001: Focuses on quality management systems, ensuring your products are consistently high-quality.
• ISO 14001: Centers on environmental management systems, helping you minimize your environmental impact.
• ISO 45001: Covers occupational health and safety management systems, ensuring a safe and healthy workplace.

GMP and GAMP

• GMP (Good Manufacturing Practices): Your EHSQ software should help you ensure that your products are consistently made and controlled to meet quality standards.
• GAMP (Good Automated Manufacturing Processes): Your automated systems should be properly designed, implemented, and operated.

Occupational Safety and Health Administration (OSHA)

• 29 CFR 1910: These general industry standards cover various workplace health and safety requirements. Your EHSQ should help you manage and mitigate workplace hazards effectively. This includes ensuring safe working conditions, identifying potential risks, and implementing safety protocols.

Environmental Protection Agency (EPA) Regulations

• Compliance with the various EPA regulations is crucial for your operations. Your EHSQ software should help you manage waste disposal, monitor emissions, and oversee other environmental issues.

European Medicines Agency (EMA) Regulations

For companies operating in or exporting to the EU, compliance with EMA regulations is essential. Here are key areas to focus on:

• Good Distribution Practice (GDP): Ensures the quality and integrity of medicines throughout the supply chain. Your EHSQ software should help you control storage, transportation, and distribution. It should monitor conditions, manage documentation, and support regular audits.
• Pharmacovigilance: Monitors the safety of medicines after they hit the market. Your EHSQ software should help collect, analyze, and report adverse drug reactions (ADRs). It should track patient safety data, manage risk assessments, and submit required reports to regulatory authorities.

Data Protection Regulations

• GDPR (General Data Protection Regulation): If you operate in the EU or handle the data of EU citizens, your EHSQ software should have robust data protection features, including data encryption, access controls, audit trails, a data breach response, and consent management.

International Council for Harmonization (ICH) Guidelines

ICH Guidelines: ICH guidelines ensure the safety, quality, and efficacy of pharmaceuticals. Your EHSQ software should be able to:

• Implement and maintain a Quality Management System that aligns with ICH Q10.
• Conduct risk assessments per ICH Q9.
• Manage clinical trial data and processes per ICH E6 (R2) Good Clinical Practice guidelines.
• Ensure stability data and protocols comply with ICH Q1A(R2) requirements.

Chemical Regulations

• REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals): For handling chemicals in the EU, your EHSQ software should facilitate chemical inventory management, safety data sheets management, exposure scenarios, and reporting to ECHA (European Chemicals Agency).
• TSCA (Toxic Substances Control Act): For handling chemicals in the US, your EHSQ software should support chemical data management, risk evaluations, and compliance with TSCA reporting and record-keeping.

10 ways TenForce helps simplify compliance

Our EHSQ software simplifies compliance, so you can focus on what you do best: researching, developing, and delivering life-saving medications. Here’s how we do it:

1. Centralized data management: Compliance means handling lots of documentation, but with TenForce, everything’s in one centralized, secure spot. You can quickly access audit reports, training records, and incident reports with just a few clicks.
2. Proactive risk management: Spotting risks before they cause issues is crucial. TenForce helps you identify and fix potential problems early on with integrated risk assessments.
3. Stress-free audits: Audits don’t have to be stressful. TenForce automates scheduling, tracking, and reporting, whilst automated reminders ensure you’re always ready for internal or external reviews.
4. Notifications and alerts: Stay on top of things with alerts for important deadlines, upcoming audits, regulatory changes, or tasks that require immediate attention. Automating these reminders helps you avoid oversights and stay compliant.
5. Automated workflows: Our customizable workflows automate the entire compliance process, from initiating a document review to escalating unresolved issues. These workflows ensure that every step is followed and documented, reducing delays and human errors to create a seamless compliance process.
6. Electronic signature capabilities: To comply with FDA 21 CFR Part 11, TenForce supports electronic signatures. This adds a layer of security to document approvals and ensures that electronic records are accepted by regulators, streamlining the approval process and reducing paperwork.
7. Detailed audit trails: For every document, process, or data entry, TenForce keeps a comprehensive audit trail, providing transparency and proof of compliance.
8. Regulatory intelligence tools: TenForce integrates regulatory intelligence tools that track and interpret regulatory changes across global markets. This helps companies operating in multiple regions to quickly adapt to local compliance requirements.
9. Continuous compliance: Compliance is an ongoing journey. TenForce analyzes data from incident reports, near-misses, and quality checks to create targeted corrective actions. This helps you fix root causes, prevent recurrences, and keep improving.
10. Collaboration and engagement: Our user-friendly interface and collaborative tools make it easy for your team to communicate and work together towards compliance goals.

TenForce in action: reducing the burden of compliance

By implementing TenForce’s quality management suite, Douglas Pharmaceuticals streamlined processes and reduced manual workloads, saving 10% of the Quality Department’s time within months of implementation.

Having TenForce in place limits the number of administrative mistakes. This immediately reduces non-compliance risks. It’s creating efficiency and transparency. It’s taking away the administrative burden and creating time to perform meaningful tasks to focus on quality.

Beatrijs Van Liederkerke

GENERAL MANAGER OF QUALITY
DOUGLAS PHARMACEUTICALS, NZ

Take the next step in compliance

Ready to follow in the footsteps of Douglas Pharmaceuticals and simplify your compliance journey?

Get in touch with us today to learn more about how TenForce can help you meet industry standards with confidence and ease. Or see our quality management suite in action with a live demo:

Watch Taking Quality Management from Compliance to Competitive Edge webinar for free

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