Acronyms and Terminology Flashcards
GAMP
Good Automated Manufacturing Practice
ISPE
International Society for Pharmaceutical Engineering
SOP
Standard Operating Procedure
COP
community of practice
As in GAMP COP
GMP
Good manufacturing practices
validation
a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages
cGMP
Current good manufacturing practices
GxP
General term for Good (Anything…) Practice quality guidelines and regulations
DQ
Design Qualification
CQ
Component Qualification
IQ
Installation Qualification
confirms complete documentation, which includes checking purchase orders, proper hardware installation, and software verification according to the manufacturer’s specifications; both user and supplier share primary testing responsibility
OQ
Operational Qualification
confirms the system operations by testing the design requirements that are traced back to the function specifications, including software and hardware functions under normal load, and under realistic stress conditions to assess whether equipment and systems are working correctly; both user and supplier share primary testing responsibility.
PQ
Performance Qualification
confirms that a system is capable of performing or controlling the activities of the process, while operating in a specific environment – namely, a series of checks by the user against the original requirement specifications of the system; responsibility falls solely on the user.
URS
User Requirements Specification
The URS describes the equipment or system as it is intended to function, and it is typically written by the system user. The original version should contain the essential requirements and the desirable requirements. As part of the validation process, the organization checks the software system before launch. Clear documentation of a properly functioning system is typically found in the URS to detail what the system should do and what it could do.
VP
Validation Plan
VRA
Validation Risk Assessment
VP
Validation Plan
VMP
Validation Master Plan
outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects
FRS
Functional Requirement Specification
GLP
Good Laboratory Practice for experimental (non-clinical) research areas
QMS
Quality Management System
CAPA
Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.[1] CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
SIG
special interest group
SDLC
System development lifecycle
GAMP examines the systems development lifecycle (SDLC) – a conceptual model that lays out the deliverable documents required by GAMP – of an automated system to identify issues of validation, compliance and documentation.
V Model
GAMP recommends an SDLC called the V-model (see graphic) because it is a commonly used design, but there are others that can be followed. The V-model shows how the three main qualification activities (installation, operation and performance) are linked back to the design process. These main steps correspond to deliverables within a computerized validation framework. The left side of the V represents the specification stream – user requirements, functional specifications, hardware and software design, and module specifications. The right side of the V represents the system testing stream against the specifications. The bottom of the V indicates the code modules.
With the V-model, which document that initiates the validation process?
URS
User Requirements Specification
What are the steps in the specification stream in the V model?
User requirements, functional specifications, hardware and software design and module specifications.
What is 21 CFR 11
This refers to Title 21 CFR (Code of Federal Regulations) Part 11 of the FDA regulations. defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
ERES
electronic records and electronic signatures
Predicate rule
A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. They are the underlying rules. Although the FDA is revising its rules on electronic records and signatures “the ‘predicate rules’ that required organizations to keep records the first place are still in effect. If electronic records are illegible, inaccessible, or corrupted, manufacturers are still subject to those requirements.”
“Although predicate rules were originally meant to apply to paper records (which required handwritten signatures), these rules remain applicable even when you use electronic records and signatures. In this case, 21 CFR 11 then becomes an additional requirement for e-records and signatures. Part 11 requirements are not meant to replace or override other FDA (GxP, GLP, GCP, CGMP) regulations pertaining to signatures and records. “
What is PDCR?
The GAMP 5 version of PDCA. PDCR stands for Plan>Do>Check>Record Plan= Planning Specifications Check = Design Review Do= Protocol Change management Record = Document Handover
PDCA
Plan-Do-Check-Act
Also called the PDCA cycle and the Deming cycle
It is a four step model for carrying out change. It is a circle and should be repeated again and again for continuous improvement
Explain the steps of PDCA
Plan - recognize an opportunity and plan a change
Do - Test the change. Carry out a small-scale study.
Check - Review the test, analyze the results and identify what you learned
Act - Take action based on what you learned in the study step. If the change did not work, go through the cycle again with a different plan. If you were successful, incorporate what you learned from the test into wider changes. Use what you learned to plan new improvements, beginning the cycle again.
What are standard elements of QMS?
Planning Specification Risk-based approach Verification Documentation Change management Continuous improvement
What do we need to know to effectively validate systems?
- Why we want them
- What they do
- How they do it
- Where the risks are
- How the risks are controlled
Name 12 Good Validation Practices
- Policies and procedures
- Good project management practices
- Validation planning
- Validation strategy
- Specifications and design review
- Protocols
- Documentation
- Change management practices
- Training
- Handover
- Maintaining control in operation
- Post-project reviews
What is Lean Validation?
Delivery of validation services with as little “waste” as possible.
Waste can include
Waiting: Inactive players, long lead times for meetings, priority conflicts
Over-production: Unclear purpose, implementation of optional features
Too many people, too many documents, late detection of defects, wrong skills mix, staff turnover, etc. (see slide)
FEL
Front-End Loading
Early cross-functional involvement, understanding, consensus and commitment
Verification Forms
Verification forms instead of/with protocols
- Driven by SOP
- Individual forms are pre-approved
- Installation and Functional Verification forms
- Forms can be created by leveraging existing protocols
- Forms can be created from requirements and design documents
- Forms can be used for the validation of changes to existing systems
- Examples of verification forms : Security verification, audit trail verification, parameter verification, loop check verification
What is E2500?
ASTM E2500
“Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”
Approved in 2007
C’&Q
Commissioning and Qualification
ICH
International Conference of Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use.
A project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration
QbD
Quality by Design
principles originally developed for the automotive industry, adopted by the FDA for discovery, development and manufacture of drugs.
The focus of this concept is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. This is a successor to the “quality by QC” (or “quality after design”) approach that the companies have taken up until the 1990s.[13]
The QbD initiative, which originated from the Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products and processes that maximizes the product’s efficacy and safety profile while enhancing product manufacturability.
OBP
Office of Biotechnology Products (FDA)
PQAS
pharmaceutical quality assessment system
ONDQA
Office of New Drug Quality Assessment
QbR
Question Based Review process
BLA
Biologic License Application
DoE
Design of Experiment
ICH guideline Q8
Pharmaceutical Development
ICH guideline Q9
Quality Risk Management
ICH guideline Q10
Pharmaceutical Quality System
When beginning the testing environment, the test author should understand the testing environment in terms of:
- Correct hardware (peripherals and interfaces)
- Software (validated tools, software configuration)
- Data units (inputs, outputs, quality and quantity of data)
- Procedures (especially for user acceptance testing)
- People (training and experience)
Benefits of GAMP
- Improved understand of the subject with the introduction of common terminology
- Reduced cost and time to achieve compliant systems
- Reduced time and resources for revalidation or regression testing and remediation
- Reduced cost of qualification
- Enhanced compliance with regulatory expectations
- Established responsibility for all involved parties
CDER
Center for Drug Evaluation and Research
CBER
Center for Biologics Evaluation and Research
APIs
active pharmaceutical ingredients
also, application programming interface
ORA
Office of regulatory affairs
Narrow Interpretation
A narrow interpretation means a reduced number of records will be subjected to the authority of Part 11. Everyone would like to know exactly which records will and will not be held accountable to the standards of Part 11 before an inspection. The guidance document specifically states when records that must be maintained under predicate rules or submitted to FDA are maintained in electronic format, Part 11 applies. On the other hand, when computers are used in the generation of a permanent paper record, Part 11 does not apply. This is also known as the ‘typewriter clause’ because just as a typewriter would not be subject to inspection, the computer that generated a document will not be inspected as long as the document itself is the true and official record.
Hybrid systems — systems in which records exist in electronic form as well as in traditional paper format — may or may not be subject to Part 11. If you use the electronic portion of the system for any GxP function, then the electronic system would fall under Part 11’s jurisdiction. However, if you are keeping records in both formats, but use the paper form as sole means for making any regulated decisions, then Part 11 does not apply. Before an inspection, it makes sense to decide whether Part 11 applies to specific records and to have this decision fully justified and documented. An inspector may accept your reasoning if you show — in writing — that you have thought it through ahead of time versus spontaneously explaining your thoughts on why Part 11 does not apply to a given system during an inspection.
GAP Analysis
comparison of actual performance with potential or desired performance
Horizontal Gap Analysis
Assessment of one system/process across several functional groups
Vertical Gap Analysis
Assessment of each function (department) and conduct gap analysis of all processes in each function
Pareto
Pareto Analysis is a statistical technique in decision-making used for the selection of a limited number of tasks that produce significant overall effect. It uses the Pareto Principle (also known as the 80/20 rule) the idea that by doing 20% of the work you can generate 80% of the benefit of doing the entire job.
Histogram
a graphical display of data using bars of different heights.
It is similar to a Bar Chart, but a histogram groups numbers into ranges
excellent explanation at https://plot.ly/histogram/
ALARP
As Low As Reasonably Practable
SCORM
sharable content object reference model
Allows sharing data between applications
SCAR
Supplier Corrective Action Request
don’t know if they use this term
CAR
Corrective Action Request
CFR
Code of Federal Regulations
What is referred to as “the Act”?
Federal Food, Drug, and Cosmetic Act
What 11 items did the FDA say the intended to continue to enforce during the re-examination period of 21CFR11?
- limiting system access to authorized individuals
- use of operational system checks
- use of authority checks
- use of device checks
- determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
- establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
- appropriate controls over systems documentation
- controls for open systems corresponding to controls for closed systems bulleted above (§ 11.30)
- requirements related to electronic signatures (e.g., §§ 11.50, 11.70, 11.100, 11.200, and 11.300)
SGML
Standard Generalized Markup Language
One of the formats that the FDA considers acceptable to use for archiving electronic files along with PDF and XML (but not limited to these formats).
RTM
Requirements Traceability Matrix
Likely will contain columns for the
- Requirement including its location in the requirements document (e.g. 3.1.1)
- Design Specification where it is captured in the design specification document
- Test Case Step, which test case and which step tests this specific requirement
