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• What is 21 CFR part 11?
21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Each title of the CFR addresses a different regulated area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 being applicable to electronic records and electronic signatures.
Read more about 21 CFR part 11:
An Introduction to 21 CFR Part 11
• What is an electronic record?
As defined in 21 CFR Part 11, an electronic record is any combination of text, graphics, data, audio, or pictorial information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer.
• What are ICH guidelines?
The International Conference on Harmonization represents the countries interested in unified standards. ICH developed more than 60 guidelines to eliminate duplication in the development and registration process, so that a single set of studies can be generated to demonstrate the quality, safety and efficacy of a new product. The ICH facilitates international electronic communication through the provision of Electronic Standards for the Transfer of Regulatory Information (ESTRI), giving the Electronic Common Technical Document (eCTD), allowing for the electronic submission of the Common Technical Document from applicant to regulator.
• What is PDUFA VI?
On Aug. 18, 2017, the President signed into law the FDA Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription Drug User Fee Act (PDUFA), intended to provide the FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. Aside from the more visible changes to the fee structure and fees, PDUFA VI also aims to do more to integrate patient perspectives into the development and regulatory review of new medicines.
Read more about PDUFA VI:
• What is the 21st Century Cures Act?
The 21st Century Cures Act, signed into law in December 2016, is intended to provide the FDA with tools aimed at modernizing regulatory programs. In July 2017, the FDA announced a detailed work plan for the steps the agency is taking to implement different aspects of Cures, which included elements that further the goals of the personalized medicines initiative.
Read more about the Cures Act:
• What is PIC/S?
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) aims to harmonize inspection procedures worldwide by developing common GMP standards and providing training opportunities to inspectors. In 2017, the organization published a revised GMP guide, as well as unveiled a new strategic plan with a strong emphasis on training and better communication with heads of regulatory agencies.
Read more about PIC/S:
• What is the DSCSA Pilot Project Program?
Announced by the FDA in February, the DSCSA Pilot Project Program is a 2019 effort to explore business processes and supporting models technologies that will enhance the tracing and verification of pharmaceutical products in the U.S. supply chain.
Read more about the Pilot Project:
FDA DSCSA Pilot Project Program
* What is an IND application?
Before drug sponsors can dive into First in Human (FIH) studies, they first have to demonstrate the safety and efficacy of the proposed drug in their IND application. The application should give a full synopsis of the drug, including all salient data collected from the development and testing phases, along with manufacturing information.
Read more about how to understand, prepare and master the FDA’s IND application
Keys to submitting an successful IND application to the FDA
• What are ATMPs?
Advanced Therapy Medicinal Product (ATMP) is the umbrella term for three drug product classes: Somatic cell therapies, gene therapeutics and tissue engineered products as well as a combination of these technologies with a medicinal product. All ATMP classes contain either living cells or viral vectors and are therefore characterized by a high degree of complexity.
Read more about the vexing issues behind production of gene therapies:
Gene therapies: On the rise
• What is product drift?
Even minor changes in any component of manufacturing or quality control could lead to changes in the biologic product, which may ultimately impact the quality, safety, efficacy, or interchangeability of biologics. This change in the product and its characteristics that can occur over time as a result of manufacturing changes is referred to as “product drift.”
Read more about product drift:
Will product drift cause a rift?
• What is an unproven cellular therapy?
•Unclear scientific rationale to suggest potential efficacy
• Lack of understanding of the mechanism of action and/or the biological function to support clinical use
• Insufficient data from in vitro assays, animal models and clinical studies
• Lack of a standardized approach to confirm product quality and ensure consistency in cell manufacturing
• Inadequate information disclosed to patients to enable proper informed consent
• Uncontrolled experimental procedures in humans
Read more about unproven stem cell therapies:
Bio’s bad apples
• What is aseptic processing in pharmaceutical manufacturing?
According to the FDA’s 2004 “Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice,” in aseptic process: “the drug product, container and closure are first subjected to sterilization methods separately, as appropriate, and then brought together.” It is critical that containers be filled and sealed in an extremely “high-quality” environment.
Read more about aseptic processing:
No Man’s Land
• What are isolators in pharma manufacturing?
Isolators are an arrangement of physical barriers that provide an enclosed working space that is detached from the surrounding environment. This enables manipulation to be undertaken within the space from the outside the enclosure without compromising integrity.
Read more about isolators and sterile processing:
Sizing Up the Benefits of Sterile Drug Manufacturing Techniques
• What is a cleanroom in pharma manufacturing?
In simple terms, a cleanroom is a controlled area within a wider facility that maintains a specific level of air particles and other contaminants.
Read more about cleanroom essentials:
12 essential steps for setting up a pharma cleanroom
• What are the most common tablet production problems?
Although there are quite a few issues that may arise during tablet manufacture, by far the most common tablet production problem is sticking. Sticking is when material adheres to the surface of the punch tip face.
Read more about tablet production:
Q&A: Tablet production
• What is CAPA?
Corrective action, preventive action consists of improvements to an organization’s processes in order to eliminate causes of non-conformities or other undesirable situations.
Read more about CAPA:
• What is glass delamination?
Delamination is a response primarily observed in converted tubing glass vials in which thin flakes release from the interior surface of the vial into the liquid formulation. The propensity for delamination is dependent on multiple factors.
Read more about glass packaging:
Stabilizing the drug supply
Continue at: https://www.pharmamanufacturing.com/fundamentals/pharma-manufacturing-essential-reference-guide/
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