GMP: What is it? The U.S. Food and Drug Administration (FDA) has established Good Manufacturing Practices (GMP) as a collection of guidelines to guarantee that drugs are produced and controlled consistently with quality standards while minimizing patient hazards. Federal laws protecting the public from dangerous goods and technologies were absent for a long time. There have been numerous food and medication safety-related tragedies, many of which have claimed the lives of adults and children. The FDA created the GMP regulation1 to safeguard consumers, which was formally adopted in 1978. The FDA then began inspecting companies to ascertain if they adhered to GMP guidelines.

Federal Register Code (CFR) Title 21, which interprets the Federal Food, Drug, and Cosmetic Act and associated acts, such as the Public Health Service Act, is where the FDA’s section of the CFR is located. The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections 1-99, 200-299, 300-499, 600-799, and 800-1299.

The regulations outline the standards that drug producers, applicants, and the FDA must adhere to in order to create a shared understanding of the regulatory process.

• 21 CFR Part 314 – This is for FDA approval to market a new drug.
• 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals.
• 21 CFR Part 212 – Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
• 21 CFR Part 600 – Biological Products: General.

The following pages provide more information concerning regulations for particular product types and manufacturing considerations:

• Field Alert Reports (for NDAs and ANDAs)
• Biological Product Deviation Reports (for BLAs)

What is the U.S. and E.U.’s GMP Guidelines?

Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110) contains the GMP guidelines, which the United States Food and Drug Administration enforces. Eudralex2 fully describes the additional pertinent GMP legislative standards that apply to Europe. Furthermore, pharmaceutical medicines created for use in Europe must undergo scientific examination and have their safety monitored by the European Medicines Agency (EMA). Aside from Europe and the U.S., there are other distinct GMP systems; Japan is one example. Nevertheless, they both have incredibly comparable criteria.

What constitutes GMP’s core components?

Goods, personnel, locations, operations, and protocols. GMP Guidelines focus on five essential elements: people, goods, premises (facility/equipment), processes, and procedures. They provide regulations to guarantee consistent quality and safety of products. Only the minimal requirements for each of the five parts must be fulfilled to ensure that the produced medication is of the highest quality and purity and satisfies applicable standards of identity and strength. Moreover, adherence to GMP guidelines is necessary for both clinical trial permission and a full marketing license. Therefore, by guaranteeing the proper quality of each product batch, GMP aims to safeguard patients and lower the risks connected with the production of pharmaceutical products.

Which tasks are covered under the GMP guidelines?

Record-keeping and documentation. Maintaining records and documentation is a crucial aspect of GMP. Documentation guarantees the traceability of all development, production, and testing processes. Appropriate GMP documentation is required to assess the general quality of the various operations and procedures that make up an organization.

Systems for managing quality: Establishing quality management systems, putting standard operating procedures into practice, looking for deviations in product quality, and keeping trustworthy testing facilities are additional crucial GMP tasks. Ensuring the facilities are in good shape, the equipment is qualified and maintained, the staff is thoroughly trained, and the remaining procedures are repeatable and dependable requires a robust quality management system

Why is adhering to GMPs so crucial? Pharmaceutical product development is a complicated process that typically takes ten to fifteen years to finish all clinical trial phases before commercialization. Numerous steps are involved in the drug development process, including regulatory registration, animal studies, clinical trials, and laboratory testing. Regulatory bodies demand adherence to GMP guidelines in addition to these phases to guarantee that the manufactured medication is secure, stable, and free of contaminants before it is sold. When adequately implemented, GMP helps avoid contamination, confusion, deviations, failures, and errors. Strict adherence to GMP laws ensures that pharmaceutical products are safe for consumption and satisfy all quality requirements. GMP was created to guarantee patient-safe and efficient medication manufacture. It also aids in making sure patients receive the appropriate medication in the proper dosage.

Since the US FDA does not issue GMP certificates, applicants for U.S. manufacturing locations that have undergone prior FDA inspections should provide all available documentation attesting to GMP compliance, as follows:

• The most recent applicable FDA Establishment Inspection Report;
• A screen grab from the FDA Inspection Classification Database;
• The FDA’s 90-day facility classification decisional letter: If the production facility is also listed in the U.S. dossier, a Certificate of Pharmaceutical Drugs (CPP) must be presented for drugs the US FDA has approved.
• These export certificates follow the format suggested by the World Health Organization’s (WHO) Certificate of Pharmaceutical Product program and are valid for two years after they are granted. The applicant must ensure that the supplied CPP discusses the production site(s) mentioned in the E.U. application’s GMP compliance.

Conclusion – Adherence to Good Manufacturing Practices (GMP) is a regulatory requirement and a fundamental aspect of ensuring the safety, efficacy, and quality of pharmaceutical products. Compliance with GMP mitigates risks associated with product contamination or deviations, fostering trust among regulatory agencies and consumers. Ultimately, prioritizing GMP principles underscores a commitment to patient safety and the delivery of high-quality medications, thus upholding the integrity of the pharmaceutical industry.

How ND Global can help – As a customer interested in ensuring the safety, efficacy, and quality of pharmaceutical products, understanding and adhering to Good Manufacturing Practices (GMP) is paramount. ND Global, as a regulatory consultant, can play a crucial role in helping you navigate the complexities of GMP compliance and ensuring that your pharmaceutical products meet the necessary standards.

• Compliance Support: ND Global assists you in ensuring that your manufacturing processes, facilities, and documentation meet GMP standards. This includes helping you establish quality management systems, develop standard operating procedures, and implement robust record-keeping practices.
• Preparation for Inspections: ND Global helps prepare your manufacturing facilities for regulatory inspections by conducting mock inspections, identifying potential areas of non-compliance, and providing remediation strategies to address any deficiencies.
• Documentation Assistance: ND Global supports you in creating and maintaining accurate and comprehensive documentation required for GMP compliance. This includes batch records, validation reports, SOPs, and other essential documents necessary for regulatory submissions and inspections.
• Continuous Monitoring and Improvement: ND Global assists you in establishing systems for ongoing monitoring and continuous improvement of your manufacturing processes to ensure sustained GMP compliance and product quality.
• Global Reach: With their expertise in international regulatory requirements, ND Global helps you navigate the nuances of GMP compliance across different regions and markets, including the U.S., Europe, and beyond.