Cgmp For Biologics
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This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.
FDA evaluates prescription drugs, including biologics, and some over-the-counter drugs, before they can be distributed in the United States to help ensure those products are safe and effective. Manufacturers and product sponsors that produce drugs, including active pharmaceutical ingredients (API), and biologics are subject to certain laws and regulations that ensure these products are manufactured in compliance with appropriate quality standards.
FDA reviews human drugs, including biologics, for safety, effectiveness and quality. Manufacturers and product sponsors are subject to FDA laws and regulations. See the links below for specific information on each type of product application:
Current good manufacturing practice (CGMP) regulations outline the minimum quality standards for manufacturing of drugs, including biologics, and are established to ensure that products are safe and effective for human use. See CGMP regulations for drugs and chemistry, manufacturing and controls (CMC) and CGMP guidances for biologics. Relevant regulations governing quality can be found in 21 Code of Federal Regulations (CFR) parts 210, 211, and 212 (drugs, including biologics), and the applicable requirements in parts 600-680 (biologics only).
Many drugs are required to have FDA approval prior to marketing. If FDA agrees to file an application for marketing, the agency performs a multi-disciplinary assessment of the facilities identified in the application and their manufacturing processes and related controls, including testing, to assess whether the drug substance and drug product are of sufficient quality and conform to the quality and purity characteristics that the drug purports or is represented to possess.
Manufacturing facilities are required to electronically register their establishment and list the drugs, including biologics, they produce with the agency. See Drug Registration and Listing System for more information.
Imported products must meet the same FDA standards for quality, safety, and effectiveness as drugs, including biologics, manufactured in the United States. See Human Drug Imports and CBER-Regulated Products (biologic imports) for more information.
Applicants are required to submit postmarket safety reports of adverse events to FDA. Other entities (e.g., manufacturers, packers and distributors named on the product label) are required under certain circumstances to submit postmarket safety reports of adverse events to the agency or to the applicant. See FDA Adverse Event Reporting System and Vaccine Adverse Event Reporting System for more information on how to submit adverse events.
Applicants and manufacturers are also required to notify FDA about a permanent discontinuance or interruption in manufacturing of certain drugs and biological products under section 506C of the Federal Food, Drug, and Cosmetic Act. These timely notifications help our efforts to prevent or mitigate shortages of drugs, including biologics.
Additionally, applicants holding an approved NDA, ANDA or BLA are required to submit reports to FDA in certain circumstances under 21 CFR parts 314 and 600. See Field Alert Reports for reporting quality defects about drugs and Biological Product Deviations for reporting about biologics.
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Small and medium-sized biotech companies often must make difficult decisions regarding whether the quality level of materials and processes should be for research use only (RUO) or compliant with good manufacturing practice (GMP). The numerous challenges and pitfalls to navigate when developing biologics manufacturing processes for therapeutic or diagnostic products range from sourcing of raw and starting materials to implementing quality management systems.
At Thermo Fisher Scientific, our aim is to be a reliable partner to biotech firms as you plan your strategy for usage of RUO and GMP materials and products in your biologics process development and seek to understand how your choices may have downstream impacts. Here we suggest considerations to help you make decisions that improve your downstream outcomes.
GMP stands for Good Manufacturing Practices. In general, it is a system of ensuring that any product is made in a way that ensures quality and traceability. For biotech companies, it refers to the set of guidelines and regulations that govern the way that drugs and other therapeutic modalities are manufactured in a way that is controlled, reproducible, and meets quality standards. GMP defines best practices for a company to follow in product development and manufacturing.
Each country or region has its own sets of GMP guidelines. For example, companies operating in America have different GMP guidelines than companies operating in Europe. The diverse range of guidelines has led to the formation of global organizations like the International Council for Harmonisation (ICH) and International Organization for Standardization (ISO) to drive harmonization. In practice, a company must follow general ICH guidelines in addition to specific, regional GMP guidelines.
The first draft of the international GMP guidelines for pharmaceuticals was submitted to the World Health Organization in 1967 and published with some amendments into the international pharmacopoeia in 1971. Since then, more and more countries have adopted these guidelines into national law, which has led to an internationally recognized quality standard for the manufacturing of medicine and medical equipment.
Before the implementation of GMP for example, in a 1937 incident, cough medicine containing impure sulfanilamide led to over 100 deaths in the United States. Another example is the early polio vaccine, which was insufficiently processed and gave many children polio.
The first draft of the international GMP guidelines was submitted to the World Health Organization in 1967 and published with some amendments into the international pharmacopoeia in 1971. Since then, more and more countries have adopted these guidelines into national law, which has led to an internationally recognized quality standard for the manufacturing of medicine and medical equipment.
There are numerous quality techniques that focus on one or more segments of the PDCA cycle. Such techniques include Kaizen improvement events, GEMBA reviews of work areas, 5 Why questioning, error-proofing practices, and implementation of computer-controlled error detection systems.
Producers of biotherapeutics must make sure that every component in the manufacture, processing, and storage of the product is supplied by a qualified vendor. To that end, the vendor selection and qualification process requires:
In addition to the broader GMP guidelines, there are also more specific rules when dealing with products made from biological sources. The WHO defines a list of biological substances to which different GMP quality criteria should be applied. These biologicals differ by their source and include:
For biotech companies developing pharmaceutical or diagnostic products, it is important to understand some key terms. Both the ICH Guideline for Common Technical Document (CTD) Quality Sections and the FDA Guidance for Industry M4Q distinguish between raw materials, source or starting materials, and excipients.
Guidelines that apply to source or starting materials may be straightforward, but their application is often complicated. Raw materials require qualification and assessment of risk with respect to safety and performance.
One of the key questions related to source is whether it is acceptable to use raw materials that may contain human or animal-origin components. These could be present at the product level or at the production level. Companies should aim to avoid animal-origin components when possible. If avoidance is not possible, a risk-based approach for the selection of raw materials is important. It pays off to give some consideration to the country of origin, source of material, viral testing and inactivation, grade of material, upstream vs. downstream use, possible alternatives, and supplier traceability.
When assessing risk associated with the use of a material of animal origin, it is often important to investigate multiple levels of processing. Most vendors who provide such materials to the cell and gene therapy industry have an animal policy statement. By having a certified animal origin-free product, the need to prove viral safety of biologically derived components is removed.
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