Acronyms and Terminology

Question 1

GAMP

Answer 1

Good Automated Manufacturing Practice

Question 2

ISPE

Answer 2

International Society for Pharmaceutical Engineering

Question 3

SOP

Answer 3

Standard Operating Procedure

Question 4

COP

Answer 4

community of practice

As in GAMP COP

Question 5

GMP

Answer 5

Good manufacturing practices

Question 6

validation

Answer 6

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

Question 7

cGMP

Answer 7

Current good manufacturing practices

Question 8

GxP

Answer 8

General term for Good (Anything…) Practice quality guidelines and regulations

Question 9

DQ

Answer 9

Design Qualification

Question 10

CQ

Answer 10

Component Qualification

Question 11

IQ

Answer 11

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

Question 12

OQ

Answer 12

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.

Question 13

PQ

Answer 13

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.

Question 14

URS

Answer 14

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.

Question 15

VP

Answer 15

Validation Plan

Question 16

VRA

Answer 16

Validation Risk Assessment

Question 17

VP

Answer 17

Validation Plan

Question 18

VMP

Answer 18

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

Question 19

FRS

Answer 19

Functional Requirement Specification

Question 20

GLP

Answer 20

Good Laboratory Practice
for experimental (non-clinical) research areas

Question 21

QMS

Answer 21

Quality Management System

Question 22

CAPA

Answer 22

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).

Question 23

SIG

Answer 23

special interest group

Question 24

SDLC

Answer 24

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.

Question 25

V Model

Answer 25

``` 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. ```

Question 26

With the V-model, which document that initiates the validation process?

Answer 26

URS | User Requirements Specification

Question 27

What are the steps in the specification stream in the V model?

Answer 27

User requirements, functional specifications, hardware and software design and module specifications.

Question 28

What is 21 CFR 11

Answer 28

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)).

Question 29

ERES

Answer 29

electronic records and electronic signatures

Question 30

Predicate rule

Answer 30

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. "

Question 31

What is PDCR?

Answer 31

``` 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 ```

Question 32

PDCA

Answer 32

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

Question 33

Explain the steps of PDCA

Answer 33

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.

Question 34

What are standard elements of QMS?

Answer 34

``` Planning Specification Risk-based approach Verification Documentation Change management Continuous improvement ```

Question 35

What do we need to know to effectively validate systems?

Answer 35

- Why we want them - What they do - How they do it - Where the risks are - How the risks are controlled

Question 36

Name 12 Good Validation Practices

Answer 36

1. Policies and procedures 2. Good project management practices 3. Validation planning 4. Validation strategy 5. Specifications and design review 6. Protocols 7. Documentation 8. Change management practices 9. Training 10. Handover 11. Maintaining control in operation 12. Post-project reviews

Question 37

What is Lean Validation?

Answer 37

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)

Question 38

FEL

Answer 38

Front-End Loading | Early cross-functional involvement, understanding, consensus and commitment

Question 39

Verification Forms

Answer 39

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

Question 40

What is E2500?

Answer 40

ASTM E2500 "Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment" Approved in 2007

Question 41

C'&Q

Answer 41

Commissioning and Qualification

Question 42

ICH

Answer 42

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

Question 43

QbD

Answer 43

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.

Question 44

OBP

Answer 44

Office of Biotechnology Products (FDA)

Question 45

PQAS

Answer 45

pharmaceutical quality assessment system

Question 46

ONDQA

Answer 46

Office of New Drug Quality Assessment

Question 47

QbR

Answer 47

Question Based Review process

Question 48

BLA

Answer 48

Biologic License Application

Question 49

DoE

Answer 49

Design of Experiment

Question 50

ICH guideline Q8

Answer 50

Pharmaceutical Development

Question 51

ICH guideline Q9

Answer 51

Quality Risk Management

Question 52

ICH guideline Q10

Answer 52

Pharmaceutical Quality System

Question 53

When beginning the testing environment, the test author should understand the testing environment in terms of:

Answer 53

- 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)

Question 54

Benefits of GAMP

Answer 54

- 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

Question 55

CDER

Answer 55

Center for Drug Evaluation and Research

Question 56

CBER

Answer 56

Center for Biologics Evaluation and Research

Question 57

APIs

Answer 57

active pharmaceutical ingredients | also, application programming interface

Question 58

ORA

Answer 58

Office of regulatory affairs

Question 59

Narrow Interpretation

Answer 59

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.

Question 60

GAP Analysis

Answer 60

comparison of actual performance with potential or desired performance

Question 61

Horizontal Gap Analysis

Answer 61

Assessment of one system/process across several functional groups

Question 62

Vertical Gap Analysis

Answer 62

Assessment of each function (department) and conduct gap analysis of all processes in each function

Question 63

Pareto

Answer 63

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.

Question 64

Histogram

Answer 64

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/

Question 65

ALARP

Answer 65

As Low As Reasonably Practable

Question 66

SCORM

Answer 66

sharable content object reference model | Allows sharing data between applications

Question 67

SCAR

Answer 67

Supplier Corrective Action Request | don't know if they use this term

Question 68

CAR

Answer 68

Corrective Action Request

Question 69

CFR

Answer 69

Code of Federal Regulations

Question 70

What is referred to as "the Act"?

Answer 70

Federal Food, Drug, and Cosmetic Act

Question 71

What 11 items did the FDA say the intended to continue to enforce during the re-examination period of 21CFR11?

Answer 71

* 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)

Question 72

SGML

Answer 72

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).

Question 73

RTM

Answer 73

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