tugas revika r - qa.ppt

8/10/2019 Tugas Revika R - QA.ppt

1/53

Quality Assurance

Revika Rachmaniar

260120130007

Program Pascasarjana

Magister Teknologi Farmasi dan Kosmetika

Fakultas Farmasi

Universitas Padjadjaran

Bandung2013 1


2/53


3/53

DEFINITIONS

QUALITY

The totality of features and characteristics of a

medicinal product and its ability to satisfy

stated and/or implied needs QUALITY ASSURANCE

The sum totalof the organized

arrangements made with the object of

ensuring that medicinal products are of thequality requiredfor their intended use.

3


4/53

DEFINITIONS

GOOD MANUFACTURING PRACTICE

(GMP)

That part of QAwhich ensures that products

are consistently producedand controlled tothe quality standardsappropriateto their

intended use.

QUALITY CONTROL

That part of GMPwhich is concerned withsampling, specificationsand testing.

4


5/53

Quality relationships

5

QA

GMP

QC


6/53

Quality relationships

Quality Management

Quality Assurance

GMP

Quality Control

6


7/53

FACTORS IN DRUG QUALITY ASSURANCE

7

DRUG

PRODUCT

QUALITY

LABELLING &

PRODUCT

INFROMATION

IMPORT

& EXPORT

CONTROL

RAW

MATERIALS-

ACTIVE &

INACTIVE

MANUFACURING

PROCESSES

& PROCEDURESSTORAGE

TRANSPORT

DISTRIBUTION

DISPENSING

& USE

QC &

ANALYSIS

HUMAN

RESOURCES-

PROFESSIONALS

LEGISLATIVE

FRAMEWORK

-REGULATIONS PACKAGING


8/53

Quality AssurancePrimary Functions

Quality Control Analytical testing of products

Active and Non active material control Sampling, inspecting and testing of incoming raw materials

Packaging and labeling components Bottles, caps, foils, labels, measures, cartons

Physical inspection of product and operations atcritical intermediate stages

In-process controls, HHACCP

Control of product through its distribution GSP, GDP ETC

8


9/53

Quality Must Be Designed Into A

Product Quality is not an add-on: it begins with

research and development

Product quality criteria must be established Detailed specifications provide quantitative

parameters for measurement

Written procedures document how quality is

attained and maintained Continuous monitoring (sampling, testing) to

confirm quality is being built-into product

9


10/53

Quality Assurance: Essential At

All Stages

Quality Assurance Cycle

Research

Development

Raw Materials

Facilities

Documentation

Equipment

Personnel

10

f Q


11/53

Elements of the Quality Assurance

Cycle in Pharmaceutical

Manufacturing Research

Development

Prototyping Documentation

Raw Materials

Facilities

Equipment

Personnel and Supervision

Monitoring, Feedback, Follow-up

11


12/53

Analytical Control Laboratory

Academically trained and certified staff

Experienced supervision/management

Capable of performing complex analyses

Able to report honestly and in a timely manner

Equipment and instrumentation must be suitable forperforming testing

Access to reliable power, water and other stable

infrastructure

12

Heart of Quality Management inPharmaceuticals


13/53

Quality Control & Analysis

Qualification Design, Installation, Process and Operational

Calibration Daily and periodic

Validation Equipment, Method and process

SOPs Authorized, used and updated

Documentation Systematic and well kept

Quality Manual Quality manager, staff trained and motivated to comply.

Safety measures

13


14/53

Quality Assurance Throughout

the Manufacturing Process

Monitoring environmental conditions underwhich products are manufactured/stored

Monitoring of air and water systems to preventcontaminationAir Handling Units

Monitoring of humidity

Monitoring of personnel

Feedback and follow-up

14


15/53

Manufacturing Process and Procedures

Dispensing / Weighing

Mixing / Granulation / Preparation

Compression / Encapsulation / Filling

Equipment, Operational & ProcessQualification

Validation & calibration

Documentation and record keeping Yield Reconciliation

15


16/53

A Guiding Philosophy for Quality Assurance in

the Pharmaceutical Industry

Poor Quality Medicines:

Are a health hazard

Waste money for governments and consumers

May contain toxic substances that have unpredictable,

unintended consequences

Will not have a desired therapeutic effect

Does not save anyone any money in the long term

Hurt everyonepatients, health care workers, policy

makers, regulators, manufacturers16


17/53

CONSEQUENCES OF QA BREACHES

Poor Treatment outcomes

High Health Bills

Treatment Failures & Deaths

Loss of Confidence in the HealthServices

Enormous Economic Losses National Security Issue

17


18/53

What is GMP? (WHO)

Comprehensive system for ensuring

products are consistently produced and

controlled according to quality standards

Designed to minimize risks involved in any

pharmaceutical production that cannot be

eliminated through testing of final product

alone Cross-contamination

18


19/53

Major Risks in Pharmaceutical

Production

Contamination of products (microbial,

particulate or other) Incorrect labels on containers

Insufficient active ingredient

Excess active ingredient Poor quality raw materials

Poor formulation practices

19


20/53

The Breadth of GMP

Covers all aspects of production including Raw or starting materials

Finished products

Premises and environment

Equipment

personnel

Training

Hygiene

20


21/53

GMP Principles

Must be built into manufacturing process

Prevents errors that cannot be eliminatedthrough quality control of finished product

Ensures all units of a medicine are of the same(within specified parameters) quality

Poor medicines leads to loss of credibility for

everyone: manufacturers, health care workersand governments

WHO Guidelines for GMP

21


22/53

WHO Technical Guide to GMP

First prepared in 1967

Updated and revised regularly

Quality Management in the Drug Industryoutlines general concepts and principlecomponents of GMP

Good practices in production and quality

controldescribes implementation

22


23/53


General Consideration

Licensed pharmaceutical products should be

manufactured only by licensed manufacturers

whose activities are regularly inspected by

competent national authorities

23


24/53


Key Concepts

Validation

Action of proving (in accordance with

principles of GMP) that any procedure,

process, equipment, material, activity, or

system actually leads to expected results

24


25/53


Key Concepts

Qualification

Action of proving that any premises,system, and items of equipment work

correctly and actually lead to expected

results

25


26/53

Associated Concepts

Good Laboratory Practice (GLP)

Good Clinical Practice (GCP)

Clear language use

Effective record keeping Design, installation, operational and

process qualification (DQ, IQ, OQ and PQ)

Self-inspection and self-regulation

Good Distribution Practice (GDP)

26


27/53

Key Elements of GMP

(WHO Technical Guide)

Sanitation and hygiene

Qualification and validation

Complaints

Product recalls

Contract Production and Analysis

Self-Inspection and Quality Audits

27


28/53

Key Elements of GMP

(WHO Technical Guide)

Personnel

(Training, Hygiene)

Documentation Premises(Equipment)

Materials(Supplies, Ingredients)

28


29/53

29

Quality Assurance Before Start-

Up Environmental and microbiologic control

and sanitation

To assure that finished dosage forms meet highstandards of quality and purity, an effective

sanitation program is required at all facilitieswhere such products are manufactured.

A successful extermination program must beenforced within and outside the plant to control

insects and rodents.


30/53

30

Personal cleanliness and proper hair

covering and clothing should be required.

Floors, walls, and ceilings should be

resistant to external forces, capable ofbeing easily cleaned, and in good repair.

Adequate ventilation, proper temperature,

and proper humidity are other important

factors.


31/53

31

The water supply may be potable, distilled,or deionized, and must be under adequatepressure to keep the water flowing.

Deionization units should be monitored,

and the resins changed or regeneratedfrequently.

to deliver water of consistently highchemical and microbial quality as per

written compendia or in housespecifications.


32/53

32

Quality assurance should review and

monitor the programs based on written

procedures that specify the details of

Sanitation, Cleaning, Ventilation andWater.


33/53


34/53

34

Only released raw materials with proper

reassay date should be allowed to enter theproduction department.

Raw material intended for used in specific

products should be stored together in an

area with proper identification (name, dosage

form, item number, lot number, weight, and

signatures).


35/53

35

Manufacturing Equipment

Quality assurance personnel must ensure that

manufacturing equipment is designed, located,

and maintained so that it facilitates thorough

cleaning, is suitable for its intended use, and

minimizes potential for contamination duringmanufacture.

Manufacturing equipment should be thoroughly

cleansed and maintained in accordance with

specific written directions.


36/53

36

Prior to the start of any production operation,

the quality assurance personnel should

ascertain that the proper equipment andtooling for each manufacturing stage are

being used.

Equipment must be identified by labelsbearing the name, dosage form, item

number, and lot number of the product to be

processed.


37/53

37

Weighing and measuring equipment used in

production and quality assurance processes,such as thermometer and balances, should

be calibrated and checked at suitable

intervals by appropriate methods. Records of such tests should be maintained

by quality assurance and production

personnel.

Q lit A At


38/53

38

Quality Assurance At

Start-UpRaw Material processing

Only release, properly labeled raw materials areallowed in the in-processing area.

Depending on the nature of the product, quality

assurance personnel should check and verify thatthe temperature and humidity in there are withinthe specified limits required for the product.

If the temperature and/or humidity is beyond thespecified limits, production must be informed andcorrective actions taken.


39/53

39

The specified in-process procedure is to be

checked, at each step in the process,according to written in-process qualityassurance procedures.

Quality assurance personnel should verify

and document the proper equipment

addition of ingredient

mixing time


40/53

40

drying time

filtering

and mesh size of sieves used in screening.

At certain points, samples are to be taken to

the quality control laboratory for assay and

any other testing that is necessary to ensurebatch uniformity and purity.


41/53

41

Containers of in-process raw materials are

labeled with

product name

item number

lot number

and gross, tare, and net weights f the

contents.


42/53

42

Compounding

Quality assurance personnel are responsiblefor ascertaining that all container of raw

materials are properly labeled and staged in

the compounding staging area, that they are

clean, and the manufacturing equipment isproperly identified as to product, strength,

item number, and lot number.


43/53

43

The production process begins with the set-upof the manufacturing equipment to prepare thefinished dosage form within the specified limitsfor the particular product.

At each significant step in the procedure,

quality assurance personnel verify that theprocess is being performed in accordance withthe written directions and is conforming torequired standards.


44/53

44

A variable group of tests that are widely used

for in-process controls measurecharacteristic including physical appearance,color, odor, thickness, diameter, friability,hardness, weight variation, disintegration

time, volume check, viscosity and pH. Such in-process tests are designed to

ensure control of problems that can ariseduring finished dosage form manufacturing.


45/53

45

Packaging Material Control

Packaging materials should not interactphysically or chemically with the finished

product to alter the strength, quality, or purity,

beyond specified requirement.

The compendium provides specifications and

test procedures for light resistance, well-

closed, tightly closed, and different types of

glass containers.


46/53

46

Good Manufacturing Practices require that

stability data be submitted for the finished

dosage form of the drug in the container

closure system in which it is to be marketed.


47/53

47

Labels Control

Production control issue s packaging form that

carries the name of the product, item number,

lot number, number of labels, inserts, and

packaging materials to be used, operations to

be performed, and the quantity to be packed. A copy of this form is sent to the supervisor of

label control, who in turn counts out the required

number of labels.


48/53

48

If the lot number and expiration date of the

product are not going to be printed directlyon the line, the labels are run through a

printing machine, which imprints the lot

number and expiration date.

The labels are recounted and placed in a

separate container with proper identification

for future transfer to the packaging

department.


49/53

49

Quality assurance personnel inspects andverifies all packaging components and

equipment to be used of the packagingoperation to ensure that

it has the proper identification

that the line has been thoroughly cleaned

that all material from the previous packagingoperation have been completely removed.


50/53

50

FINISHED PRODUCT CONTROL

Final testing of finished product is made inthe quality control laboratories.

These tests are designed to determinecompliance with specifications.

Thus, the testing of the finished product forcompliance with predetermined standardsprior to release of the product for packagingand subsequent distribution is a critical factorfor quality assurance.


51/53

51

This testing, along with in-process testing,assures that

each unit contains the amount of drugclaimed on the label,

all of the drug in each unit is available forcomplete absorption,

the drug is stable in the formulation in itsspecific final container closure system for itsexpected shelf-life

the dosage units themselves contain no toxicforeign substances.


52/53

52

Auditing

Good Manufacturing Practice requires thatthe manufacturing process be adequatelydocumented throughout all stages of theoperation.

The history of each task, including thestarting materials, equipment used,personnel involved in production and controluntil completed packaging is complete,

should be recorded.


53/53

Before releasing the product for distribution,quality assuranceshould evaluate the batch

records of all in-process tests and controls

and of all tests of the final product to

determine whether they conform tospecifications.

tugas revika r - qa.ppt

Documents