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


2/26


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.


3/26


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”


4/26


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


5/26


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


6/26


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


7/26


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


8/26


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


9/26


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


10/26


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


11/26


Quality Management

Group session ! I

:o6 many %&' defciencies can you fnd inthe photographs in the handout;


12/26


Part One 1, 2 and 3

Quality Management

Quality relations"ips

"uality &anagement

"uality #ssurance

%&'

"uality (ontrol


13/26


Quality Management

Quality #ontrol $Q#%

"( is part o! %&'


14/26


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


15/26


Part One 3.2

Quality Management

asic Requirements for Quality#ontrol

Resources #dequate !acilities

Trained personnel

#pproved procedures


16/26


Part One 3.2

Quality Management

asic Requirements for Quality#ontrol

Tasks

0ampling

nspecting

Testing

&onitoring

9eleasing/re>ecting


17/26


Part One 3.2

Quality Management

asic Requirements for Quality#ontrol ! I

Objects

0tarting materials

'ackaging materials

ntermediates

?ulk products

@inished products

nvironmental conditions


18/26


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


19/26


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


20/26


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


21/26


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


22/26


Part One 3.5

Quality Management

Q# Access

"( 'ersonnel &


23/26


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


24/26


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


25/26


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


26/26


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

m02[1] quality management and qc

Documents