1
Q
Totality features or conformance to specifications of a product
A
QUALITY
2
Q
A list of detailed requirements or standards with which a product has to conform (tests, references of procedures, and
acceptance criteria)
A
Specifications
3
Q
Quality is everybody business
A
TOTAL QUALITY MANAGEMENT (TQM)
4
Q
Sum total of the organized activities made with the objective of ensuring that products are of quality required for intended use
A
QUALITY ASSURANCE
5
Q
- AO _____ (old)
- AO _____ (new)
- Part of QA which ensures that products are consistently produced & controlled to quality standards appropriate to intended use
- PIC/S: Pharmaceutical Inspection Cooperation Scheme
A
Current Good Manufacturing Practice (cGMP);
220 s. 1974;
2012 - 0008
6
Q
Administrative Order of Old Good Manufacturing Practice
A
AO 220 s. 1974
7
Q
Administrative Order Current Good Manufacturing Practice (cGMP)
A
AO 2012 - 0008
8
Q
Part of cGMP concerned with sampling, specification, testing, organization, documentation, and release procedures
A
QUALITY CONTROL
9
Q
“If its not written, it never happened.”
A
DOCUMENTATION
10
Q
- It is the linkage between written records of action taken and the quality operation
- All the tests to be conducted on a product and raw materials and/or appropriate references containing DETAILS OF PROCEDURE and EXPECTED RESULTS vs ACTUAL RESULTS
A
DOCUMENTATION
11
Q
regular periodic quality review of all registered drug products to verify & consistency of existing processes and to identify improvement
A
PRODUCT QUALITY REVIEW (PQR)
12
Q
systematic process for the assessment, control, communication, and review of risks to the quality of the product
A
QUALITY RISK MANAGEMENT (QRM)
13
Q
combination of probability of the occurrence of harm and the severity of harm
A
Risk
14
Q
CAPA
A
PRODUCT QUALITY REVIEW;
Corrective and Preventive Action
15
Q
Aim to improve its performance by learning about good practices through looking at those processes in other, better-performing organizations, building on evaluation of relevant performance in own and other organizations.
A
BENCHMARKING
16
Q
Specific amount produced in a unit time or according to a single manufacturing order during the same cycle of manufacture, sharing the same production conditions and date.
A
BATCH
17
Q
Portion of a batch
A
LOT
18
Q
An organizational unit independent of Production which fulfills both QA and QC responsibilities.
A
QUALITY UNIT
19
Q
A set of activities that ensures quality in the processes by which the products are developed.
A
Quality Assurance
20
Q
A set of activities that ensures quality in the product.
A
Quality Control
21
Q
Aims to present defects in the process used to make the products
A
Quality Assurance
22
Q
Aims to identify and correct defects in the finished product
A
Quality Control
23
Q
- Audit and monitoring
- Primary contact with regulatory agencies
- Prepares SOPs
A
Quality Assurance
24
Q
Process oriented
A
Quality Assurance
25
* Conducts sampling and testing of Raw Material & Finish Product
* Inspects PM components
* Performs environmental monitoring
Quality Control
26
Product oriented
Quality Control
27
testing the quality of bulk ingredients and containers
Raw Material QC (RMQC)
28
testing the quality of intermediate products (e.g. granules prior
tablet compression)
In-process Material QC (IPQC)
29
testing the final dosage form in its container
Finished Product QC (FPQC)
30
* Written standard published in compendium (USP/BP/Eur/PP) that describes an article
* Quality attributes approved by a regulatory body (identify strength, purity, performance)
Monograph
31
* Name of substance, definition, packaging & storage requirements
* Information on all tasks & expected results needed to ensure its quality
Monograph
32
Step-by-step instruction for doing a particular task or activity
SOP by QA
33
* Shows the actual results of all tests conducted to show compliance with standards
* Describes the tests conducted on a particular material, along with the acceptable criteria, results, and disposition
Certificate of Analysis
34
* Information on potential health effects of exposure and safe working procedures when handling
* Properties of a particular hazardous substance or chemical.
Material Safety Data Sheet
35
Process of removal of an appropriate number of items (n) from a population (N) in order to make an inference to
the entire population
SAMPLING
36
Most common (Old) Military Standards
MIL-STD-105E
37
By variables (new) Military Standards
MIL-STD-144
38
Most common (new) Sampling Plans
ANSI/ASQ ZI.4-2008
39
Easiest Sampling Plan
Square Root System
40
100% inspection may be allowed for ______________ medications
Sampling;
High risks
41
A definite working rule regarding size and frequency of sample and the basis for acceptance and rejection. It requires
3 numbers.
SAMPLING PLAN
42
identify what 3 numbers sampling plan:
number of items in the lot or batch
N
43
identify what 3 numbers sampling plan:
number of items in the random sample drawn from the lot
n
44
identify what 3 numbers sampling plan:
acceptance number
c
45
Graphs on which the quality of product is plotted as manufacturing is actually proceeding
CONTROL CHARTS
46
Proportional or % defectives; versatile, most used in control charts where n is not always constant
p-Chart
47
non-proportion, number of defectives in control charts where n is always constant
np-Chart
48
used for measurable characteristics in control charts
X Bar Chart
49
alerts the operator to closely monitor the process
2 standard deviation / 2 sigma
warning limit
50
stop the process and do corrective actions
3 standard deviation
Action & Control Limit
51
proving & documenting that any process, procedure, or method actually leads to the expected results.
Validation
52
proving that premises, systems, or equipment work correctly and actually lead to expected results.
Qualification
53
Types of Data:
Continuation
Variable
54
Types of Data:
Whole
Attribute
55
Sources of Variations:
The quality between supplier 1 and 2 are not the same
Material
56
Sources of Variations:
Some parts of the equipment are not well-maintained
Machine
57
Sources of Variations:
The working instruction is written in jargon
Method
58
Sources of Variations:
Overfatigue, lacking PPE
Man
59
Non-conformance to a standard or requirement
PRODUCT DEFECTS
60
PRODUCT DEFECT CLASS:
May endanger the life of patient and render the product non-functional
According to Magnitude;
Critical Defect
61
PRODUCT DEFECT CLASS:
May affect the function of product and render it useless
According to Magnitude;
Major Defect
62
PRODUCT DEFECT CLASS:
Neither; discoloration, labels
According to Magnitude;
Minor Defect
63
PRODUCT DEFECT CLASS:
Measured by instrument
According to Measurability;
Variable Defect
64
PRODUCT DEFECT CLASS:
By inspection (senses)
According to Measurability;
Attributive Defect
65
PRODUCT DEFECT CLASS:
Seen by naked eye
According to Nature;
Occular Defect
66
PRODUCT DEFECT CLASS:
Cannot be seen by naked eye (eg. Concentration)
According to Nature;
Internal Defect
67
PRODUCT DEFECT CLASS:
Function is incorrect (MDI, dissol.)
According to Nature;
Performance Defect
68
Classify the following defects:
The actuator of the MDI is stuck (no function)
Major
69
Classify the following defects:
Metal particles inside a parenteral vial
Critical
70
Classify the following defects:
The sticker label was lighter in color when printed out
Minor
71
Classify the following defects:
Scratches on the amber bottle surface of an oral syrup
Minor
72
Removal from market; either defective/ potentially harmful
PRODUCT RECALL
73
PRODUCT RECALL CLASS:
death or series ADR
ex. chemical involved
Class I
74
PRODUCT RECALL CLASS:
temporary/ medically reversible ADR
Ex. Salmonella
Class ll
75
PRODUCT RECALL CLASS:
not likely to cause any serious ADR.
Ex. Neozep (visible color/packaging)
Class lll
76
Capacity of a drug to remain within specification
Minimum acceptable potency: ___%
Stability;
90%
77
* Physical
* Therapeutic
* Chemical
* Microbiologic
* Toxicologic
STABILITY
78
Stability Mainly Decomposed:
Prevented by using light-resistant containers
Photolysis
79
Stability Mainly Decomposed:
Prevented by antioxidants
Ex. Vit. E & C
Vit. E: ___
Vit. C: ___
Oxidation;
True
Dosing
80
Stability Mainly Decomposed:
Prevented by reduction/elimination of water from preparation
Hydrolysis
81
* Period of time during a product remains within specification
* Estimated using __________ equation
SHELF-LIFE (t90);
Arrhenius
82
* Time or date prior to which a product is expected to remain stable & after which it must not be used
EXPIRATION DATE
83
Mfg Date + Shelf-life = _____
Expiration Date
84
EXPIRATION DATE ERROR:
* Risk of rejecting a true null hypothesis (correct results)
* An inspection/test may indicate that a product or process is defective when it is actually acceptable.
Alpha risk, aka type I error
85
EXPIRATION DATE ERROR:
* Harms the Company
* Accepts Product - reject
* Eg. Too early ED
Alpha risk, aka type I error
86
EXPIRATION DATE ERROR:
* Accepting a false null hypothesis (bad results)
* An inspection/test may indicate that a product or process is acceptable when it is actually defective
Beta risk, aka type II error
87
EXPIRATION DATE ERROR:
* Harms the Patient (unacceptable risk)
* Rejects product - accept
* Eg. Too late ED
* It can be reduced by __________ sample size or improving
the accuracy of the measurement tool.
Beta risk, aka type II error;
Increasing
88
EXPIRATION DATE ERROR:
False Negative
Alpha risk, aka type I error
89
EXPIRATION DATE ERROR:
False Positive
Beta risk, aka type II error
90
* Estimate shelf-life
* Evaluated over time in the same container-closure system in which drug product is marketed.
* Based on ASEAN Guidelines on Stability Studies
STABILITY STUDIES
91
Climatic Zones (Type of Climate):
Temperate
Zone I
92
Climatic Zones (Type of Climate):
Subtropical/Mediterranean
Zone ll
93
Climatic Zones (Type of Climate):
Hot & Dry
Zone lll
94
Climatic Zones (Type of Climate):
Hot & Humid
Zone IVa
95
Climatic Zones (Type of Climate):
Hot & Very Humid
ex. Philippines
Zone IVb
96
Climatic Zones (Temp (°C) :
21 ± 2°C
Zone I
97
Climatic Zones (Temp (°C) :
25 ± 2°C
Zone II
98
Climatic Zones (Temp (°C) :
30 ± 2°C
Zone III, Zone IVa, Zone IVb
99
* Conducted under normal conditions
* Follow __________ kinetics
* Testing Period: _______
Long-term/Real Time Studies;
Zero-Order Kinetics;
0,3,6,9,12,18,24,36
100
* Designed to increase rate of chemical degradation by using exaggerated storage conditions
* Follow __________ kinetics
* Testing Period: ______
Short-term/Accelerated Studies;
First-Order Kinetics;
0,3,6
100
Elucidates intrinsic stability of drug & identify the likely degradation products
Stress Testing
101
Storage Condition: 25 ± 2°C
Relative Humidity: 60% ± 5%
Minimum Time Period: ______
Long Term (Real time);
12 months
102
Storage Condition: 30 ± 2°C
Relative Humidity: 65% or 60 ± 5%
Minimum Time Period: ______
Intermediate;
6 months
103
Storage Condition: 40 ± 2°C
Relative Humidity: 75% ± 5%
Minimum Time Period: ______
Accelerated;
6 months
104
Compensate the loss
Manufacturing Overage
105
Extend shelf-life
Stability Overage
106
Sources of quality variations are as follows, except:
o A. Technician
o B. Inadequate procedure
o C. General manager
o D. Equipment
C. General manager
107
Control chart limit which alerts the operator to closely monitor the process being done:
o A. Acceptable limit
o B. Upper control limit
o C. Action limit
o D. Warning limit
D. Warning limit
108
Samples of vials of Hydrocortisone injection were found to be contaminated with Bacillus subtilis. How will you
classify this type of product defect?
o A. Minor defect
o B. Variable defect
o C. Ocular defect
o D. Critical defect
D. Critical defect
109
Which of the following statements will correctly define the principle of total quality in the manufacture of pharmaceutical products?
o A. Strict adherence to standards combines with quality
o B. Use of state of the art equipment and advance technology
o C. Production department is responsible for quality
o D. Quality is everybody’s business in a pharmaceutical establishment
D. Quality is everybody’s business in a pharmaceutical establishment
MOD 6
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