A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
other
accelerated condition, storage
accelerated data, retest period
accelerated data, showing change
accelerated stability study
accelerated stability test
accelerated storage condition
accelerated storage condition, no significant change
accelerated storage condition, significant change
accelerated testing
acceptable daily exposure
acceptable daily intake
acceptance activity
acceptance activity, receiving
acceptance criteria
acceptance criteria, biotechnological/biological products
acceptance criteria, chemical substance, Q6A
acceptance criteria, definition
acceptance criteria, degradation product
acceptance criteria, dissolution
acceptance criteria, drug product dissolution
acceptance criteria, extractables
acceptance criteria, filing
acceptance criteria, for granulation dose uniformity testing
acceptance criteria, ICH Q4B annex 2
acceptance criteria, ICH Q4B annex 3
acceptance criteria, ICH Q4B annex 4C
acceptance criteria, ICH Q4B annex 5
acceptance criteria, ICH Q4B annex 6
acceptance criteria, ICH Q4B annex 8
acceptance criteria, ICH Q4B annex 9
acceptance criteria, impurity
acceptance criteria, in-process
acceptance criteria, new drug product
acceptance criteria, new drug substance
acceptance criteria, oral liquid
acceptance criteria, particle size distribution
acceptance criteria, PAT
acceptance criteria, phase 1 investigational drug
acceptance criteria, polymorphy
acceptance criteria, pre-determined
acceptance criteria, Q6A
acceptance criteria, release vs. shelf-life
acceptance criteria, validation of high purity water system
acceptance criteria, widening
acceptance criterion, assay
acceptance criterion, definition
acceptance criterion, determination of purity
acceptance criterion, establishment
acceptance criterion, numerical
acceptance level, outlier test
acceptance limit, IPC
acceptance limit, new drug product
acceptance rule
acceptance testing
acceptance, activities
acceptance, record
accuracy check, computerised system
accuracy, analytical procedure
accuracy, definition
acetonitrile, residual solvent, limit
acetonitrile, solvent limit, example
achieving quality
achiral assay
acive substance, quality management
act
actinometry, quinine chemical
action level
action limit
action limit, antacid
action limit, definition
action limit, in-process control
action limit, microbial
action limit, purified water system
action limit, Water for Injections systems
active ingredient, definition
active pharmaceutical ingredient
Active pharmaceutical ingredient manufacturer, Questionnaire
active pharmaceutical ingredient, highly toxic
active pharmaceutical ingredient, ICH Q7
active pharmaceutical ingredient, trade
active substance gas
active substance import, third country
active substance import, written confirmation
active substance manufacturer audit, audit findings
active substance manufacturer audit, closing discussion
active substance manufacturer audit, conducting
active substance manufacturer audit, directive 2011/62/EU
active substance manufacturer audit, document review
active substance manufacturer audit, observations
active substance manufacturer audit, on-site audit
active substance manufacturer audit, opening discussion
active substance manufacturer audit, preparing
active substance manufacturer audit, regulatory requirements
active substance manufacturer, audit
active substance manufacturer, audit checklist
active substance manufacturer, GDP certificate
active substance manufacturer, GMP certificate
active substance manufacturer, official supervision
active substance manufacturer, third party audit
active substance manufacturing, buildings and facilities
active substance manufacturing, cleaning validation
active substance manufacturing, differences to drug product manufacturing
active substance manufacturing, documentation
active substance manufacturing, GMP deficiencies
active substance manufacturing, GMP starting point, EU GMP Guide
active substance manufacturing, GMP starting point, ICH Q11
active substance manufacturing, laboratory controls
active substance manufacturing, process equipment
active substance manufacturing, quality management
active substance manufacturing, scope of GMP regulations
active substance manufacturing, special risks
active substance manufacturing, supplier qualification
active substance release, test result
active substance starting material
active substance starting material, residual solvent
active substance, APIC guidelines
active substance, authorisations
active substance, biological
active substance, biotechnological
active substance, CEP
active substance, change control
active substance, chemical
active substance, compulsory registration
active substance, contract manufacturing
active substance, definition
active substance, documentation
active substance, EC delegated regulation (EU) No. 1252/2014
active substance, equipment
active substance, EU GMP Part II/APIC "how to do"
active substance, EU-GDP
active substance, facility
active substance, GMP certificate
active substance, ICH Q11
active substance, ICH Q7
active substance, import
active substance, import authorisation
active substance, importation
active substance, importation into EU, Q+A
active substance, impurity
active substance, in-process control
active substance, mandatory auditing
active substance, manufacturing authorisation
active substance, marketing authorisation documentation
active substance, metallic impurity
active substance, packaging and labelling
active substance, personnel
active substance, PIC/S guidelines
active substance, quality management
active substance, quality risk management
active substance, recall
active substance, registration
active substance, regulations, Europe
active substance, regulations, global
active substance, regulations, USA
active substance, rejection and return
active substance, release
active substance, repackaging
active substance, third country
active substance, transfer
active substance, used as starting material
active substance, validation
active substance, WHO guidelines
activity, therapeutic
additive weighing, advantages
additive weighing, disadvantages
additive, stability
adhesive floor mats
adjustment, definition
adjustment, equipment
advanced electronic signature
advanced therapy medicinal product
advanced therapy medicinal product, definition
advanced therapy medicinal product, product groups
adventitious agent
adventitious agent, phase 1 investigational drug
adventitious agent, primary cell substrate
adventitious cellular contaminant
adventitious virus
adventitious virus contamination
adventitious virus contamination, unprocessed bulk
adventitious virus, definition
adventitious virus, in vitro cell age
adverse effect, hazard identification
advertising, for the purposes of directive 2001/83/EC
aerobic microorganism
Aerosol
aerosol product, for inhalation
affinity chromatography, impurity
agar
agency
agent
agent, virus tests
aggregation
Aide-Mémoire, inspections of pharmaceutical quality control laboratories, Annex
Aide-Mémoire, PI 009-3, inspection of utilities
Aide-Mémoire, PI 030-1
Aide-Mémoire, PIC/S PI 021-2
Aide-Mémoire, PIC/S PI 023
Aide-Mémoire, PIC/S PI 024-2
Aide-Mémoire, PIC/S PI 025-2
Aide-Mémoire, PIC/S PI 028
Aide-Mémoire, PIC/S PI 038-1
air borne microbial particle, monitoring
air borne particulate classification
air break
air change rate
air change rate, isolator system
air classification
air cleanliness class, particle air filters
air cleanliness grade, aseptic preparation
air cleanliness grade, isolator
air cleanliness grade, terminally sterilized product
air cleanliness, differences EU/US/ISO
air cleanliness, EU Annex 1
air cleanliness, EU requirements, microbiological
air cleanliness, EU requirements, particles
air cleanliness, FDA Aseptic Guide
air cleanliness, FDA requirements
air cleanliness, HEPA filter
air exchange rate
air exchange rate, cleanroom class
air filtration
air flow rate
air flow rate, calculation
air handling
air handling system, central re-circulation/mixed air
air handling system, clean-up phase
air handling system, de-central re-circulation/mixed air
air handling system, humidity control
air handling system, layout
air handling system, logbook
air handling system, maintenance
air handling system, maintenance plan
air handling system, maintenance, actions
air handling system, maintenance, forms
air handling system, maintenance, goals
air handling system, operation
air handling system, performance table
air handling system, planning
air handling system, re-circulation system
air handling system, recovery time
air handling system, requirements
air handling system, requirements, layout
air handling system, requirements, room
air handling system, requirements, usage
air handling system, room data sheet
air handling system, room pressure differential control
air handling technology
air handling technology, air displacement concept
air handling technology, air exchange rates
air handling technology, air flow control
air handling technology, air flow rate
air handling technology, air temperature
air handling technology, controls technology
air handling technology, degree of turbulence
air handling technology, dehumidification
air handling technology, design criteria
air handling technology, differential pressure concept
air handling technology, dilution of particles
air handling technology, energy and media
air handling technology, heat recovery
air handling technology, hierarchy
air handling technology, humidification of air
air handling technology, humidity
air handling technology, legal requirement documents
air handling technology, particle filters for air
air handling technology, temperature control
air handling technology, volumetric flow control
air handling unit, classification
air handling unit, fresh air unit
air handling unit, structure
air heating
air lock
air lock system, for the passage of equipment
air lock, aseptic processing
air lock, definition
air monitoring, active
air monitoring, filtration method
air monitoring, impaction method
air monitoring, Impinger method
air monitoring, method validation
air monitoring, methods
air monitoring, passive
air monitoring, sedimentation method
air pattern analysis
air sampling, active
air sampling, frequency
air separation
air shower
air supply
air testing, sterile test isolator
air, blow-fill-seal technology
air, microbiological quality
air, microbiological testing
air, radioactive product
air, recycling
air, sampling frequency
air, source of contamination
airborne microbial count, methods
airborne particle count
airborne particle, monitoring system
airflow, clean area
airflow, critical area
airflow, isolator
airflow, turbulence
airlock concepts
airlock, bin
airlock, bubble-airlock
airlock, cascade airlock
airlock, furnishings
airlock, interlocking doors
airlock, pressure differential
airlock, sink-airlock
airlock, sit-over bench
airlock, wardrobe locker
airlock, washbasin
airlocks, requirements
ALCOA plus
ALCOA principle
ALCOA, good data and record management practice
ALCOA, WHO TRS 996
alcohol, oral liquid
alert level
alert limit, environmental monitoring
alert limit, media fill
allergen product, biological active substance
allergen, definition
allergenic product, GMP regulations
allergenic product, manufacture
alloys
ambient air monitoring, microbial spectrum
amino acid composition, characterization
amino acid sequence, characterization
ampoule product
analyse phase, DMAIC
analysis method, during development
analysis, averaging results
analysis, covariance
analysis, data
analysis, expression construct in cells
analysis, risk
analysis, stability data
analyst, laboratory error
analyst, laboratory management
analyst, responsibility for test results
analyst, second, for retesting
analytical development
analytical method validation
analytical method, cleaning process
analytical method, cleaning validation
analytical method, definition
analytical method, validation
analytical methodology, process validation
analytical parameter, method validation
analytical procedure, accuracy
analytical procedure, change
analytical procedure, definition
analytical procedure, ICH Q4B annex 1
analytical procedure, ICH Q4B annex 10
analytical procedure, ICH Q4B annex 2
analytical procedure, ICH Q4B annex 3
analytical procedure, ICH Q4B annex 4A
analytical procedure, ICH Q4B annex 4B
analytical procedure, ICH Q4B annex 5
analytical procedure, ICH Q4B annex 6
analytical procedure, ICH Q4B annex 7
analytical procedure, ICH Q4B annex 8
analytical procedure, ICH Q4B annex 9
analytical procedure, impurity
analytical procedure, linearity
analytical procedure, methodology
analytical procedure, new drug product
analytical procedure, pre-change product
analytical procedure, range
analytical procedure, residual solvent
analytical procedure, specifity
analytical procedure, system suitability testing
analytical procedure, types
analytical procedure, validation
analytical techniques, comparability exercise
analytical technology, Q6A
analytical worksheet, pre-approval inspection
ANCOVA, see analysis of covariance
ANDA
ANDA, methods validation
ANDA, pre-approval inspection
ANDA/ANADA product, manufacturing procedures
animal cell line, description
animal house
animal house, immunological veterinary medicinal product
animal immunosera product, biological active substance
animal source product, biological active substance
animal toxicity, N-Methylpyrrolidone
animal toxicity, residual solvent
animal toxicity, tetrahydrofuran
animal, biological active substance
animal, biological product
animal, biotechnology
animal, immunological veterinary medicinal product
animal, maintenance
animal, tissue donor
Annex 16, EU GMP Guide
annual product review
annual product review, actions
annual product review, CAPA system
annual product review, change
annual product review, compared to PQR
annual product review, complaints, returns, recalls
annual product review, content
annual product review, creating
annual product review, data collection
annual product review, data evaluation
annual product review, data evaluation, examples
annual product review, data sources
annual product review, deviation
annual product review, evaluation and results
annual product review, number of batches
annual product review, outline template
annual product review, product groups
annual product review, product quality vs. marketing authorization
annual product review, rejected batches
annual review
antacid, action limit
antibody production test
antibody production test, virus
antibody, definition
antibody, immunochemical properties
anticounterfeiting, guidance for industry
anticounterfeiting, physical-chemical identifiers
antigen, definition
antimicrobial preservative
antimicrobial preservative, oral liquid
antimicrobial preservative, parenteral drug product
antioxidant preservative, oral liquid
antioxidant preservative, parenteral drug product
antitoxin, biological product
ANVISA
API
API manufacturer, inspection
API production, single-use technology
API starting material, definition
API, blending batch
API, building and facility
API, cell culture/fermentation
API, cellculture
API, change control
API, clinical trial
API, clinical trials
API, complaint and recall
API, contract manufacturer
API, definition
API, distribution
API, documentation
API, EU-GDP
API, fermentation
API, holding
API, import into the EU
API, in-process control
API, labelling
API, laboratory control
API, material management
API, non-sterile product
API, packaging
API, packaging and labelling
API, personnel
API, PIC/S PS/INF 20
API, pre-approval inspection
API, process equipment
API, quality management
API, rejection and material reuse
API, relabelling
API, repackaging
API, Six Sigma
API, stability monitoring
API, starting material
API, testing
API, traceability
API, validation
API, WHO TRS No. 957, Annex 2, 2010
API, written confirmation
APIC "how to do", combined with EU GMP Guide Part II
apparatus
application file, for marketing authorization
application, definition
approval
APR, see annual product review
AQL value
aqueous-based product
archiving periods, research and development
archiving, concept
archiving, data
archiving, definition
archiving, documents
archiving, electronic batch documentation
archiving, laboratory documentation
archiving, raw data
archiving, technical documentation
asepsis, definition
asepsis, monitoring program
aseptic filling
aseptic filling, vial
aseptic manufacturing area
aseptic operation
aseptic preparation
aseptic process
aseptic process, recontamination
aseptic processing
aseptic processing facility
aseptic processing room
aseptic processing, application
aseptic processing, checklist for media fill
aseptic processing, clean room clothing
aseptic processing, components and container/closures
aseptic processing, definition
aseptic processing, from early manufacturing steps
aseptic processing, gowning qualification
aseptic processing, isolator
aseptic processing, isolators
aseptic processing, monitoring
aseptic processing, of cellular therapy products and cell-derived products
aseptic processing, personnel
aseptic processing, prior to filling and sealing operations
aseptic processing, process simulation
aseptic processing, room requirements
aseptic processing, sterile drug product
aseptic processing, sterile filtration
aseptic processing, sterility assurance
aseptic processing, time limitation
aseptic processing, training
aseptic processing, validation, see media fill
aseptic, gowning
aseptic, phase 1 investigational drug
aseptic, workstation
ASMF, see EDMF
assay limit, for finished product
assay procedure
assay test
assay, accuracy
assay, antibody binding
assay, definition
assay, new drug product
assay, new drug substance
assay, potency
assessment activities, quality risk management
at rest condition, crimp capping
atomic absorption (AA), qualification
ATP Agreement, certificate of compliance
ATP Agreement, classification
ATP Agreement, distinguishing marks
ATP Agreement, transport temperatures
ATP-Agreement, certificate
attribute, control
audit data, computerised laboratory system
audit program, computerised laboratory system
audit program, supplier
audit report, third party
audit trail
Audit trail review
audit trail, changes to data
audit trail, computerised system
audit trail, data integrity
audit trail, electronic documentation system
audit trail, good data and record management practice
audit trail, Part 11
audit trail, records
audit trail, spreadsheet
audit, active substance manufacturer
audit, carrier
audit, classification of findings
audit, clinical investigation
audit, contract laboratory
audit, contractor
audit, coverage
audit, data integrity
audit, definition
audit, excipient
audit, medical device QMS
audit, outsourced activity
audit, qualified person
audit, quality risk management
audit, quality system
audit, strategy
audit, supplier inspection
audit, suppliers
authenticity, computerised systems
authority check, 21 CFR Part 11
autoclave
autoclave, GMP inspection
automated system
automatic cleaning
automatic cleaning, cleaning media
automatic cleaning, critical parameters
automatic cleaning, design aspects
automatic cleaning, ICT systems
automatic cleaning, pumps
automatic cleaning, qualification tests
automatic cleaning, requirements
automatic process control
averaging
averaging, appropriate use
averaging, inappropriate use
averaging, OOS test result
averaging, result
as of 2019 - 05 - 07
21 Active Pharmaceutical Ingredients
21.A Introduction
Summary
21.A.1 Differences between active substance manufacturing and medicinal product manufacturing
21.A.2 Definitions
21.A.2.1 Active substances
21.A.2.2 Starting materials
21.B Regulatory principles
Summary
21.B.1 General GMP regulatory works
21.B.1.1 Global
21.B.1.2 USA
21.B.1.3 Europe
21.B.2 Regulatory works for biotechnological active substances
21.B.2.1 Global
21.B.2.2 USA
21.B.2.3 Europe
21.B.3 Compulsory registration
21.B.4 Required authorisations
21.B.4.1 Manufacturing authorisation
21.B.4.2 Import authorisation
21.B.5 Import
21.B.5.1 Written Confirmation
21.B.6 Release
21.B.7 Official supervision
21.C Marketing authorisation documentation for active substances
Summary
21.C.1 Information on marketing authorisation for active substances
21.C.2 What is an EDMF/ASMF?
21.C.3 What is a CEP?
21.C.4 Additional details on EDMF/ASMF and/or CEP
21.C.4.1 GMP compliance of production
21.C.4.2 Revoking or suspending a CEP
21.D GMP Certificates
Summary
21.D.1 Certificates as documents of proof (ISO, GMP, CEP)
21.D.2 GMP Certificates of the EU, PIC/S and WHO
21.D.2.1 What is the significance of an EU-GMP certificate?
21.D.2.2 What is the significance of GMP certificates from PIC/S and the WHO?
21.D.3 GMP certificates of other national health authorities from third countries (not EU, PIC/S or WHO)
21.E Auditing active substance manufacturers
Summary
21.E.1 Regulatory requirements and professional prerequisites
21.E.2 Active substances from Europe and/or third countries (such as China or India)
21.E.3 Audits
21.E.3.1 Definitions
21.E.3.2 Preparing for an audit
21.E.3.3 Conducting the audit
21.E.3.4 Audit findings
21.E.4 Third Party Audits
21.E.4.1 Mandatory auditing of active substances
21.E.4.2 Requirements for third-party audits
21.E.5 Audit Checklists
21.F Chemical active substances
Summary
21.F.1 What are chemical active substances?
21.F.2 Definition of terms
21.F.3 Scope of GMP regulations
21.F.4 Basic GMP requirements
21.F.5 Special Risks
21.F.5.1 Impurities: Genotoxic or potentially genotoxic substances
21.F.5.2 Impurities: Residual solvents
21.F.5.3 Impurities: Heavy metals or residues from metal catalysts/metal reactants
21.F.5.4 Other impurities
21.F.6 Typical GMP deficiencies in chemical active substance manufacturing
21.F.6.1 Quality management
21.F.6.2 Buildings and facilities
21.F.6.3 Process equipment
21.F.6.4 Documentation and records
21.F.6.5 Materials management
21.F.6.6 Packaging and identification labelling of APIs and intermediates
21.F.6.7 Laboratory controls
21.F.6.8 Validation
21.G Biotechnological active substances
Summary
21.G.1 What are biotechnological active substances?
21.G.2 Types of biotechnological active substances
21.G.3 Definition of terms
21.G.4 Scope of GMP regulations
21.G.5 Special risks
21.G.6 Basic GMP regulations
21.G.6.1 Personnel
21.G.6.2 Premises and equipment
21.G.6.3 Documentation
21.G.6.4 Production and control strategy
21.G.6.5 Starting and raw materials
21.G.6.6 Seed culture and cell bank system
21.G.6.7 Working principles and production
21.G.6.8 Quality Control
21.G.6.9 Animals
21.G.7 Specific GMP regulations
21.G.7.1 Allergenic products
21.G.7.2 Immunosera of animal origin
21.G.7.3 Vaccines
21.G.7.4 Recombinant products
21.G.7.5 Monoclonal antibodies
21.G.7.6 Transgenic plant products
21.G.7.7 Gene therapy medicinal products
21.G.7.8 Somatic and xenogeneic cell therapy medicinal products and tissue engineered products
21.H References
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