m02[1] Quality Management and QC
-
Upload
zakx24x7bd -
Category
Documents
-
view
216 -
download
0
Transcript of m02[1] Quality Management and QC
-
8/18/2019 m02[1] Quality Management and QC
1/26
Module 2 Slide 1 of 26 WHO - EDM
QualityManagement
Basic Principles of GMP
Part One
-
8/18/2019 m02[1] Quality Management and QC
2/26
Module 2 Slide 2 of 26 WHO - EDM
Quality Management
Objectives
To understand key issues in qualityassurance/quality control.
To understand specifc requirements onorganization, procedures, processes andresources.
To develop actions to resolve your currentproblems.
-
8/18/2019 m02[1] Quality Management and QC
3/26
Module 2 Slide 3 of 26 WHO - EDM
Part One
Quality Management
Quality Management
Determines and implements the “quality policy”
The basic elements are
an appropriate infrastructure or “quality system”encompassing the Procedures, Processes, andResources
the systematic actions necessary to ensureadequate condence that a product (or serice!
"ill satisfy gien requirements for “Quality”
The totality o! these actions is termed “"uality#ssurance”
-
8/18/2019 m02[1] Quality Management and QC
4/26
Module 2 Slide 4 of 26 WHO - EDM
Part One
Quality Management
Quality Management
Terminology may di$er
“Quality #ystem” is said to $e rarely used in
drug manufacturing The concepts o! "#, %&' and "uality (ontrol
are interrelated aspects o! "uality&anagement.
%hey are descri$ed on the follo"ing slides inorder to emphasi&e their relationship and theirfundamental importance to the production
and control of pharmaceutical products
-
8/18/2019 m02[1] Quality Management and QC
5/26
Module 2 Slide 5 of 26 WHO - EDM
Part One 1.1
Quality Management
Principles of Quality Assurance
)ide*ranging concept
coers all matters that indiidually or
collectiely in'uence the quality of a product
Totality o! the arrangements
to ensure that the drug is of the right quality
for the intended use
"uality #ssurance incorporates %&'
and also product design and deelopment"hich is outside the scope of this module
-
8/18/2019 m02[1] Quality Management and QC
6/26
Module 2 Slide 6 of 26 WHO - EDM
Part One 1.2 a-j
Quality Management
Requirements for QA Systems – I
+.nsure products are developed correctly
-.denti!y managerial responsibilities
.'rovide 01's !or production and control
2.1rganize supply and use o! correct startingmaterials
3.Defne controls !or all stages o!manu!acture and packaging
-
8/18/2019 m02[1] Quality Management and QC
7/26
Module 2 Slide 7 of 26 WHO - EDM
Quality Management
Requirements for QA Systems – II
4. nsure fnished product correctlyprocessed and checked be!ore release
5. nsure products are released a!ter revie6by authorized person
7. 'rovide storage and distribution
8. 1rganize sel!*inspection
Part One 1.2 a-j
-
8/18/2019 m02[1] Quality Management and QC
8/26
Module 2 Slide 8 of 26 WHO - EDM
Part One 2.1 a-j
Quality Management
GMP
nsure that products are consistentlyproduced and controlled
Diminishes risks that cannot be controlledby testing o! product
ross)contamination
Mi*)ups
-
8/18/2019 m02[1] Quality Management and QC
9/26
Module 2 Slide 9 of 26 WHO - EDM
Part One 2.1 a-j
Quality Management
asic Requirements for GMP – I
+. (learly defned and systematicallyrevie6ed processes
-. (ritical steps validated
. #ppropriate resources personnel,buildings, equipment, materials
2. (learly 6ritten procedures3. Trained operators
-
8/18/2019 m02[1] Quality Management and QC
10/26
Module 2 Slide 10 of 26 WHO - EDM
Part One 2.1 a-j
Quality Management
asic Requirements for GMP – II
4. (omplete records, !ailure investigations
5. 'roper storage and distribution
7. 9ecall system
8. (omplaint handling
-
8/18/2019 m02[1] Quality Management and QC
11/26
Module 2 Slide 11 of 26 WHO - EDM
Quality Management
Group session ! I
:o6 many %&' defciencies can you fnd inthe photographs in the handout;
-
8/18/2019 m02[1] Quality Management and QC
12/26
Module 2 Slide 12 of 26 WHO - EDM
Part One 1, 2 and 3
Quality Management
Quality relations"ips
"uality &anagement
"uality #ssurance
%&'
"uality (ontrol
-
8/18/2019 m02[1] Quality Management and QC
13/26
Module 2 Slide 13 of 26 WHO - EDM
Quality Management
Quality #ontrol $Q#%
"( is part o! %&'
-
8/18/2019 m02[1] Quality Management and QC
14/26
Module 2 Slide 14 of 26 WHO - EDM
Part One 3.2
Quality Management
Quality #ontrol $Q#% &epartment
ach holder o! a manu!acturing authorizationshould have a "( Department
ndependence !rom production and otherdepartments is considered to be !undamental
-
8/18/2019 m02[1] Quality Management and QC
15/26
Module 2 Slide 15 of 26 WHO - EDM
Part One 3.2
Quality Management
asic Requirements for Quality#ontrol
Resources #dequate !acilities
Trained personnel
#pproved procedures
-
8/18/2019 m02[1] Quality Management and QC
16/26
Module 2 Slide 16 of 26 WHO - EDM
Part One 3.2
Quality Management
asic Requirements for Quality#ontrol
Tasks
0ampling
nspecting
Testing
&onitoring
9eleasing/re>ecting
-
8/18/2019 m02[1] Quality Management and QC
17/26
Module 2 Slide 17 of 26 WHO - EDM
Part One 3.2
Quality Management
asic Requirements for Quality#ontrol ! I
Objects
0tarting materials
'ackaging materials
ntermediates
?ulk products
@inished products
nvironmental conditions
-
8/18/2019 m02[1] Quality Management and QC
18/26
Module 2 Slide 18 of 26 WHO - EDM
Part One 3.2 b – e
Quality Management
asic Requirements for Quality #ontrol – II
+. 0ampling approved by "( department
-. Aalidated test methods
. 9ecords
2. 9evie6 and evaluation o! productiondocumentation
3. @ailure investigations !or all deviations
4. ngredients comply 6ith the marketingauthorization
-
8/18/2019 m02[1] Quality Management and QC
19/26
Module 2 Slide 19 of 26 WHO - EDM
Part One 3.2 e – h
Quality Management
asic Requirements for Quality#ontrol – III
5. ngredients are o! the required purity
7. 'roper containers
8. (orrect labelling
+B. 9elease o! batches by the authorized
person
++. 9etained samples o! starting materialsand products
-
8/18/2019 m02[1] Quality Management and QC
20/26
Module 2 Slide 20 of 26 WHO - EDM
Part One 3.3
Quality Management
Ot"er &uties of t"e Quality #ontrol&epartment
+. stablish "( procedures
-. 9e!erence standards
. (orrect labelling
2. 0tability testing
3. (omplaint investigations
4. nvironmental monitoring
-
8/18/2019 m02[1] Quality Management and QC
21/26
Module 2 Slide 21 of 26 WHO - EDM
Part One 3.4
Quality Management
Assessment of 'inis"e( Pro(ucts
0hould embrace all relevant !actors. @ore=ample
production conditions
in*process test results
manu!acturing documentation
compliance 6ith fnished productspecifcation
e=amination o! the fnished pack
-
8/18/2019 m02[1] Quality Management and QC
22/26
Module 2 Slide 22 of 26 WHO - EDM
Part One 3.5
Quality Management
Q# Access
"( 'ersonnel &
-
8/18/2019 m02[1] Quality Management and QC
23/26
Module 2 Slide 23 of 26 WHO - EDM
Part One 3.1, 3.2
Quality Management
Quality #ontrol ! summary
"( is part o! %&' * re!er to the handout
sampling
specications
testing
release procedures
recalls and complaintsdecision)ma+ing in all
quality matters
authori&ation
denition of product quality la$oratory operations
release decisions
inestigation and reporting
-
8/18/2019 m02[1] Quality Management and QC
24/26
Module 2 Slide 24 of 26 WHO - EDM
Quality Management
Group session II
magine you are inspecting apharmaceutical company !or compliance
6ith %&'
(onsider the situations in the ne=t slides6hich may impact on a companys qualitymanagement programme.
Describe the action to be taken in eachcase
-
8/18/2019 m02[1] Quality Management and QC
25/26
Module 2 Slide 25 of 26 WHO - EDM
Issues – I
"uality &anagement manual not establishedin 6riting
Eimited human resources
Eack o! qualifed people
'rocesses not properly validated
'oor 01's or standard batch documentation &ore consideration to cost than quality
@amily members in key positions o! authority
Quality Management
-
8/18/2019 m02[1] Quality Management and QC
26/26
Module 2 Slide 26 of 26 WHO - EDM
Issues – II
0ubstandard materials deliberatelypurchased
Technical sta$ not involved in purchasing
nability to re*e=port substandard materials
16ner insists on selling re>ects
(orruption
Fo commitment to training
Quality Management