Part 4: Life Sciences Quality, Regulatory & Manufacturing Acronyms
New to this series? Click on the links below to catch up.
Part 1: Project Management & Business Acronyms
Part 2: Contract & Legal Acronyms
Part 3: Supply Chain& Finance Acronyms
The first three articles in this series focused on acronyms we believe any project manager (PM) should know – regardless of the industry in which they work. Today, we shift gears a bit, highlighting manufacturing, quality, and regulatory acronyms a PM working within the life sciences industry is likely to encounter. While many of these terms are not unique to the life sciences industry, we are choosing to highlight them here because of the pivotal role manufacturing, quality, and regulatory concerns play in the successful delivery of life-saving products and therapies.
These three areas – manufacturing, quality, and regulatory – are inextricably linked, which is why we’ve chosen to cluster them in a single article. Manufacturing, the heart of this triad, is where the process of producing pharmaceuticals, medical devices, and biotechnological products actually unfolds in real time. When it comes to manufacturing, PMs work with production teams to optimize schedules, manage resources effectively, and maintain the highest standards of product quality throughout the manufacturing process. This is where quality comes in.
In the life sciences industry, quality has a much more stringent and precise definition than the definition of quality we typically think of in project management. As PMs, we are taught to think of quality as meeting (or exceeding!) the expectations and requirements of project stakeholders. In the life sciences, quality typically refers to the degree to which a product or process conforms to established standards, specifications, or regulatory requirements, particularly in fields such as pharmaceuticals, biotechnology, and healthcare. Quality control measures are highly regulated and enforced to ensure safety, efficacy, and compliance with various regulatory standards, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Thus, to successfully deliver a life sciences project, a PM must understand both quality and regulatory considerations.
Today represents the final article in our series “From CCB to WBS: Acronyms for Project Managers.” It’s our longest list of acronyms yet, but it’s an incredibly important one for PMs working in the life sciences industry. Project managers familiar with key manufacturing, quality, and regulatory concepts are better able to orchestrate successful projects, delivering high-quality, compliant products. Ultimately, this expertise helps advance science and technology and enhance global healthcare outcomes, improving the lives of countless individuals worldwide.
API (Active Pharmaceutical Ingredient): The biologically active component of a pharmaceutical drug.
AQL (Acceptable Quality Level): The maximum number of defects or non-conformities that are considered acceptable in a particular sample size of a product batch.
ATP (Acceptance Test Protocol): A document outlining the procedures and criteria for acceptance testing of equipment or systems.
BMR (Batch Manufacturing Record): A detailed instructional document recording all steps and procedures to be followed during the manufacturing of a specific batch of a product, ensuring consistency and traceability.
BPR (Batch Production Record): Documentation that records the manufacturing processes and controls used for a specific batch of a pharmaceutical product.
CAPA (Corrective Action Preventative Action): A systematic process for investigating and addressing the root causes of quality issues to prevent recurrence.
CAR (Corrective Action Request): A formal request to address and resolve a non-conformance or quality issue within a process or product.
CDMO (Contract Development Manufacturing Organization): A company that provides manufacturing services to other companies under contract, often specializing in specific production processes or capabilities.
CFM (Continuous-Flow Manufacturing): A production method characterized by a continuous, uninterrupted flow of materials and components through the manufacturing process.
DCR (Document Change Request): A formal request to modify or update a document, such as a technical specification or standard operating procedure.
DCO (Document Change Order): A formal request and authorization to modify or update a specific document within an organization, such as a technical specification or standard operating procedure, typically initiated to reflect changes in processes, requirements, or regulations.
DHR (Device History Record): A comprehensive record that documents the production history and quality control information for each manufactured medical device.
DFM (Digital Asset Management): The management and organization of digital files, such as images, videos, and documents, to facilitate efficient storage, retrieval, and distribution.
DMR (Device Master Record): A compilation of documents and specifications that define the design, manufacturing processes, and quality requirements for a medical device.
DP (Drug Product): Refers to the finished pharmaceutical product in the form that will be administered to patients (i.e., tablets, capsules, injections, etc.).
ECO (Engineering Change Order): A formal document that authorizes and documents changes to a product's design, engineering specifications, or manufacturing processes.
ECR (Engineering Change Request): A formal request to initiate a change to a product's design, engineering specifications, or manufacturing processes.
eIFU (Electronic Instructions for Use): Digital versions of instructions or manuals provided with a product, typically accessed electronically.
FAR (Floor Access Report): A document that records the access of individuals to the manufacturing floor or restricted areas within a facility.
FDA (Food & Drug Administration): Regulatory agency responsible for protecting public health by ensuring the safety, efficacy, and security of foods, drugs, medical devices, cosmetics, and other products.
FAT (Factory Acceptance Testing): A type of testing conducted at the manufacturer's facility to verify that equipment or systems meet specified requirements and perform as intended before being shipped to the customer's site.
GLP (Good Laboratory Practices): Regulatory guidelines and standards for the conduct of non-clinical laboratory studies to ensure data integrity, reliability, and traceability.
GMP (Good Manufacturing Practices): Regulatory guidelines and standards for the manufacturing, testing, and quality control of pharmaceuticals, medical devices, and food products.
IND (Investigational New Drug): A formal application submitted to the FDA containing preclinical and clinical data, allowing for human clinical trials to be conducted on a new pharmaceutical compound.
IQ (Installation Qualification): A process verifying and documenting that equipment or systems have been correctly installed according to manufacturer specifications and requirements.
MCO (Manufacturing Change Order): A formal document that authorizes and documents changes to a product's manufacturing processes or procedures, ensuring that modifications are properly reviewed, approved, and implemented to maintain product quality and compliance.
MTBF (Mean Time Between Failure): A metric used to measure the reliability of a product or system, representing the average time between failures.
NCMR (Non-Conformance Material Report): A document that records and addresses instances of non-conforming materials or products, documenting the deviation from quality standards and corrective actions taken.
MDR (Medical Device Reporting): Regulatory requirements for manufacturers to report adverse events and product-related incidents to regulatory authorities.
NPD (New Product Development): The process of bringing a new product from concept to market, including research, design, prototyping, testing, and commercialization.
NPI (New Product Introduction): The phase of product development that focuses on preparing for the launch and commercialization of a new product.
OQ (Operational Qualification): A process of verifying and documenting that equipment or systems operate effectively within defined operational parameters and performance specifications.
PLM (Product Lifecycle Management): A systematic approach to managing the entire lifecycle of a product, from its initial conception, through design and manufacturing, to service and disposal.
PQ (Performance Qualification): A process verifying and documenting that equipment or systems consistently produce results that meet predetermined criteria and requirements when operated in their intended environment.
Quality Assurance (QA): QA involves implementing systematic processes and activities to ensure that products or services meet specified quality standards and requirements, focusing on continuous improvement and adherence to quality management systems.
Quality Control (QC): QC encompasses operational techniques and activities to verify that products or services meet predefined quality standards and requirements through inspection, testing, and monitoring processes, aiming to detect and correct defects before release to customers.
SAT (Site Acceptance Testing): A type of testing conducted at the customer's site to verify that installed equipment or systems meet specified requirements and perform as intended within the intended operational environment.
SCAR (Supplier Corrective Action Request): A formal request for a supplier to investigate and address quality issues or non-conformances related to supplied materials or products.
SOP (Standard Operating Procedure): A documented set of step-by-step instructions or guidelines that outline how to perform routine tasks or processes consistently and safely within an organization.
TPP (Target Product Profile): A comprehensive document outlining the desired characteristics, attributes, and specifications of a potential product, serving as a guide for product development and regulatory submissions in the pharmaceutical industry.