1. Drug application relevant:
IND (Investigational new drug application):
Current federal law requires drug sponsors to obtain New Drug Application (NDA) approvals before they transport or distribute a drug across state lines. Because the sponsoring company, academic organization, or individual will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The Investigational New Drug application (IND) is the means through which the sponsor technically obtains this exemption from the FDA.
NDA (New Drug Application):
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. Since 1938, every new drug has been the subject of an NDA before approval for shipment in interstate commerce. The chemistry, manufacturing, and controls section of the NDA describe the composition, manufacture, and specification of the proposed drug substance and product. Data gathered during animal studies and human clinical trials of an IND become part of the NDA. One of the goals of the NDA is to provide enough information to permit the FDA to determine whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.
ANDA (Abbreviated New Drug Application):
An ANDA is an application used specifically to obtain marketing approval for generic drugs. Its genesis is the Waxman-Hatch Amendments (Drug Price Competition and Patent Term Restoration Act of 1984).
API (Active pharmaceutical ingredient):
Any substance or mixture of substances used in manufacturing that becomes an active ingredient in the drug product. APIs furnish pharmacological action or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affect the structure and function of the body.
RM (Raw material):
“Raw material” means any ingredient intended for use in the manufacture of a drug substance or drug product, including those that may not appear in that product. An RM can be either an active or inactive ingredient.
BLA (Biologics license application):
The BLA is a request for permission to put a biologic product into interstate commerce. As with any other drug, a biological product’s clinical trials are conducted under an Investigational New Drug application (IND), and the Form FDA 356h is used to seek marketing approval. The Center for Biologics Evaluation and Research (CBER) regulates these products.
CMC(Chemistry, manufacturing, and controls):
The section of an Investigational New Drug application (IND) describing the composition, manufacture, and control of the drug substance and product, including placebo, labeling, and
environmental analysis. The FDA requires that the CMC contain sufficient information to ensure the proper identification, quality, purity, and strength of the investigational drug. The amount of information needed to make that assurance will vary with the phase of the investigation, the proposed duration of the investigation, the dosage form, and the amount of information otherwise available.
DMF (Drug master file):
A DMF is a submission to the FDA that the holder may use to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing,
packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF can also support other applications (such as an IND, an NDA, or an ANDA), or another DMF.
NCE (New chemical entity):
An NCE is a drug that contains no active moiety already approved by the FDA. An active moiety is the molecule or ion (excluding those appended portions of the molecule that cause the drug to be an ester, salt, or other noncovalent derivative of the molecule) responsible for the physiological or pharmacological action of the drug substance.
NME (New molecular entity):
A NME is an active ingredient never before marketed in the United States in any form.
2. Device applications relevant:
510(k) Premarket notification:
Any company wanting to market a Class I, II, or III device intended for human use, and not requiring a Premarket Approval (PMA), must submit a 510(k) to the FDA unless the device is exempt from 510(k) requirements of the Food, Drug, and Cosmetic Act.
IDE (Investigational Device Exemption):
An IDE allows an investigational device to be used in a clinical study to collect safety and effectiveness data required to support a PMA or a 510(k) submission to the FDA. Clinical studies with devices of significant risk must be approved by the FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk require only the IRB’s approval before the study can begin. An IDE, similar to the Investigational New Drug (IND) application, allows for an unapproved (uncleared) medical device to be shipped for interstate commerce.
PMA (Premarket Approval):
PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of causing illness or injury. The PMA application is the most stringent type of device marketing application required by the FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device.
3. Inspection forms and related items:
UL (Untitled letter):
An untitled letter is an initial correspondence from the FDA to a regulated industry that cites violations that do not yet meet the threshold of regulatory significance of a warning letter. An untitled letter does not include the warning letter’s mandate to promptly correct a violation that could result in enforcement action.
WL (Warning letter):
An FDA notification that a manufacturer has significantly violated a federal regulation. The warning letter identifies the violation, such as poor manufacturing practices, false claims of product performance, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction. The FDA then checks to ensure that the company’s solutions are adequate.
Relevant topic:
4. Contract organization:
CMO (Contract Manufacturing Organization):
An organization that serves the pharmaceutical, biotechnology, and medical device industries and provides clients with comprehensive services from product development through manufacturing.
CRO (Contract Research Organization):
CROs that provide support services to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research (for both drugs and medical devices). CROs range from large, international full-service organizations to small, niche specialty groups and can move a new drug or device from its conception to FDA marketing approval, freeing the sponsor from staffing for these services.
5. Quality related:
ALCOA (Attributable, Legible, Contemporaneous,Original, Accurate):
For data to be accepted as reliable, valid, and usable by the researcher, it should meet certain fundamental elements of quality, whether collected or recorded electronically or on paper. Data should be attributable, legible, contemporaneous, original, and accurate.
CAPA:
Corrective action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
Preventive action: Action taken to eliminate the cause of a potential nonconformity or other
undesirable potential situation.
NOTE: Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence. (ISO 9000:2005)
OOS (Out of specification):
OOS results include all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.
QA (Quality Assurance):
The planned and systematic activities that ensure a food, drug, or device will be processed and produced with consistency, meeting all analytical and performance specifications within and between batches. QA primarily involves (1) review and approval of all procedures related to production and maintenance; (2) review of associated records; and (3) auditing, performing, and evaluating trend analyses.
QC (Quality Control):
The steps taken during the generation of a product or service to ensure it meets requirements and the product or service is reproducible. QC usually involves (1) assessing the suitability of incoming components, containers, closures, labeling, in-process materials, and the finished products; (2) evaluating the performance of the manufacturing process to ensure adherence to proper specifications and limits; and (3) determining the acceptability of each batch for release.
QS (Quality system):
Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product and service requirements, customer satisfaction, and continual improvement. Under a quality system, it’s normally expected that the product and process development units, the manufacturing units, and the QU will remain independent.
QU (Quality Unit):
A group organized within an organization to promote quality in general practice by ensuring the various operations associated with all systems are appropriately planned, approved, conducted, and monitored. The QU has the authority to create, monitor, and implement a quality system.
VMP (Validation master plan):
The VMP is the foundation of a company’s Good Manufacturing Practice validation program. It’s a comprehensive plan that should include process validation; facility and utility qualification and validation; equipment qualification; cleaning; and computer validation.
PV (Process Validation):
Collection and evaluation of data from the process design stage to commercial production, which establishes with scientific evidence that a process is capable of consistently delivering quality products.
DQ (Design Qualification):
Documented verification that the proposed design of the facilities, equipment, or systems are suitable for the intended purpose.
IQ (Installation Qualification):
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendation, and/or user requirements.
OQ (Operational Qualification):
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges.
PQ (Performance Qualification):
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.
SOP (Standard operating procedure):
An SOP is a detailed written instruction aimed explicitly at achieving uniformity in the performance of a specific function.
Source: FDA site
Source: FDA site
About the Author:
Dhansukh Viradiya is a highly accomplished expert in the pharmaceutical and biopharmaceutical industries. With over 10 years of experience in the field, he has gained comprehensive knowledge and expertise in various areas, including Process Validation, Cleaning Validation, Quality Management System, In-process quality assurance, Qualification etc.
Mr. Dhansukh holds a Master's degree in Pharmacy from a renowned University, where he specialized in Quality Assurance.
As a thought leader, Mr. Dhansukh has published numerous articles and white papers on various topics related to pharmaceutical and biopharmaceutical industries. His research work focuses on emerging trends, current regulatory expectations, advancements in technology, personalized medicine, and the intersection of healthcare and technology.
With his passion for improving patient care and dedication to advancing the field, Dhansukh Viradiya continues to make significant contributions to the pharmaceutical and biopharmaceutical industries. His insights and expertise make him a valuable resource in understanding the dynamic landscape of these sectors and their impact on global healthcare.
Disclaimer:
The author's biography is provided for informational purposes only and does not imply any endorsement or affiliation with the article or its content.
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