Guidance on Common Regulations and Standards

Whether a company is in the life science industry, or providing products in the pharmaceutical, biological, medical devices, cosmetics, veterinary products, there are many regulations and standards developed by regulatory agencies such as US Federal Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use (ICH), World Health Organization (WHO) that need to be considered for regulatory and quality compliance. These common regulations and standards are developed and need to be followed by companies in order to ensure the quality, safety and efficacy of products and services, as well as accurate and clear document management systems for the same. 

Common Federal Regulations (CFRs)

The infamous Thalidomide tragedy that took place in July 1962 triggered the development of the first Federal Food, Drug and Cosmetic Act (21 USC), requiring that all drugs conform to current Good Manufacturing Practices (cGMP), codified in Title 21 Code of Federal Regulations (21CFR). Since then, there have been multiple guidelines and regulations approved to ensure the safety of the patient. 

A) Common 21 CFR Regluations: Some key 21 CFR regulations that are applicable for regulated product industry , be it a pharmaceutical product, animal drugs, biologic, medical device or any other product that can impact a patient and are extremely critical, are listed as below: 

1.  21CFR 11: This regulation is pertaining to the rules for electronic records and electronic signatures set by the FDA. This requirement is to ensure companies electronic records & signatures are as authentic as physical records & signatures. In other words, this regulation is automatically applicable for any company that is dealing with electronic documents that are approved within a system and ensures integrity within the system. For more details and applicability of this regulation, visit website to learn more.

2.  21 CFR 210/211: This regulation is related to cGMP in manufacturing, processing, packaging or holding of drugs. These regulations contain the minimum requirements for the methods, facilities and controls for any drugs. This is a significant regulation that can be used to ensure quality and regulatory compliance and can be applicable for any regulated product. Check the website for more details.

    

3. 21 CFR Part 807, Part 814, Part 812, Part 801, Part 803: These are fundamental regulations pertaining to medical devices and device manufacturing, testing, and marketing. These are basic regulations that need to be followed by companies that are looking to manufacture and distribute medical devices of Class I, II or III in the US market.
   a) 21 CFR Part 807 covers Establishment Registration and Medical Device Listing. If your company is intending to manufacture, package, repackage, label or salvage devices, you need to register your establishment and list all the devices that will be manufactured in each facility with the FDA. Part 807 also lists regulations for submitting Pre-market Notification (510k), a pre-market approval application submitted to FDA to prove that your device is safe and effective.
   b) Part 814 emphasizes regulations for submitting Pre-market approval (PMA) for Class III devices (which are high risk devices and require preapprovals).
   c) Part 812 focuses on regulations on using a device for investigational study in clinical trials.
   d) Part 803 which lists regulations for medical device reporting and Part 801 describes labeling requirements for medical devices. 
   e) Part 820 lists all the cGMP requirements for medical device manufacturing listed within this Part. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacturing, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

    

4. 21 CFR 314: This regulation is developed to facilitate approval process for drug products and ensuring the quality, safety and effectiveness of drug products. This regulation includes significant terms such as 180-day exclusivity, 505 (b) (1) or the New Drug Application (NDA), 505 (b) (2), 505 (j) or the Abbreviated New Drug Application (ANDA), Priority Review, Orphan Drug designation. These terms are important to be considered for registering new drugs or generic drugs in the US market.

    

5. 21 CFR 600: This regulation covers general regulation for biological products or products obtained from biological sources such as vaccines, blood products, tissue products, gene therapy products, proteins, etc. It consists of sub parts such as establishment standards, inspections, adverse experience reporting, reporting of biological deviations that are critical for biological product registration in the US market.

    

6. 21 CFR 225/226: These regulations are related to cGMP)for Medicated feeds and is targeted for veterinary drug industry.

    

B) Common ICH Guidelines: The ICH Guidelines are significant and harmonized guidelines developed by a council consisting of regulatory agencies such as USFDA, EMA and Pharmaceuticals and Medical Devices Agency of Japan. There are many guidelines related to quality, safety, efficacy as well as documentation or submission. More details can be found on their website.

ICH Q7: This is one of the most followed guideline that is related to Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (APIs). Although this guideline specifically applies to API, this guideline can also be applied to finished pharmaceutical products. 

C) International Organization for Standardization (ISO) Guidelines: Some key ISO guidelines that are critical include: 

1. ISO 13485: This is a standard specific to the design and manufacture of medical devices. This standard ensures that medical device manufacturers design quality management systems that establish and maintain the effectiveness of their process. It helps ensure consistency in the design, development, production, installation and delivery of medical devices that are safe for their intended purpose.

    

2. ISO 14971: This standard specifies terminology, principles and a process for risk management of medical devices. This standard helps manufacturers identify hazards associated with medical devices, as well as control risks and monitor the effectiveness of the controls.

3. ISO 14644: This standard specifies the classification of air cleanliness in terms of air particles in cleanrooms and clean zones. This standard applies to manufacturing of drugs, biological products as well as medical devices (Class III). This guideline only provides guidance on the threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm for classification purposes; this does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. 

PSC Biotech provides expertise in various quality, regulatory compliance-related activities and common regulations and guidelines. We provide gap assessments, risk identification, assessment and management, mock audits, and inspections in addition, we also provide services like change control, deviation, and OOS investigations, and management as well as regulatory affairs to help ensure your company stays compliant throughout the life cycle of a regulated product.  

Contact us today to help ensure that your company complies with all quality standards! 

References to common guidelines and regulation  

• ICH Guidelines
• USFDA (US Food and Drug Administration) 
• USDA (US Department of Agriculture)
• FDA-CVM (Center for Veterinary Medicines)
• WHO Guidelines
• ISO Guidelines
• ICH Q10 Pharmaceutical Quality system
• 21 CFR 11
• 21 CFR 210
• 21 CFR 211
• 21 CFR 800
• 21 CFR 314
• 21 CFR 600
• 21 CFR 225
• ISO 13485:2016
• ISO 14971:2019
• ISO 14644:2015