m03[1]sanitation and hygiene
TRANSCRIPT
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 1/26
Module 3 Slide 1 of 26WHO - EDM
Sanitation and
Hygiene
Basic Principles of GMP
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 2/26
Module 3 Slide 2 of 26WHO - EDM
Sanitation and Hygiene
Objectives
Review measures to ensure good sanitation in:
premises
equipment
processes
To review measures to ensure good personnelhygiene
Group session - to discuss the situation in yourcountry and to look at some bad sanitation andhygiene practices in some photographs.
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 3/26
Module 3 Slide 3 of 26WHO - EDM
Part One 4
Sanitation and Hygiene
Scope
All aspects of manufacturing
Personnel
Premises !uipment
Apparatus
Production materials and container
Products for cleaning and disinfection
All potential sources of cross-contamination
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 4/26
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 5/26Module 3 Slide 5 of 26WHO - EDM
Part Two 15.1 – 15.34
Sanitation and Hygiene
Avoidance of Cross-Contamination I
%egregated areas
&entilation systems and airlocks
'lothing
'losed processing systems
'leaning and decontamination
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 6/26Module 3 Slide 6 of 26WHO - EDM
Part Two 15.1 – 15.34
Sanitation and Hygiene
Avoidance of Cross-Contamination II
%egregated areas and separate facilities for
lie accines and other "iological materials penicillin products
campaign processing
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 7/26
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 8/26Module 3 Slide 8 of 26WHO - EDM
Part Two 15.1 – 15.34
Sanitation and Hygiene
Avoidance of Cross-Contamination IV
'lothing
protection of operator and product
highly potent products or those of particular ris% )need for special protectie clothing
personnel should not moe "et!een areas
producing di$erent products
garments need to "e cleaned
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 9/26Module 3 Slide 9 of 26WHO - EDM
Part Two 15.1 – 15.34
Sanitation and Hygiene
Avoidance of Cross-Contamination -V
'losed processing systems
*or example+ totally enclosed !ater puri#cationsystems
tan%s #tted !ith appropriate #ltration ) !ithout
remoa"le lids
present special cleaning diculties, sometimes
use
clean)in)place -C.P/
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 10/26Module 3 Slide 10 of 26WHO - EDM
Part Two 15.1 – 15.34
Sanitation and Hygiene
Avoidance of Cross-Contamination VI
'leaning and decontamination
procedure for remoing soil and dirt remoe all cleaning chemical residues or disinfectant
residues
must remoe or reduce micro)organisms
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 11/26Module 3 Slide 11 of 26
WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – I
(ork-)ow
designed to aoid potential contamination0
Access
to production areas restricted to authori1ed
personnel
direct operators, 2C sta$, !arehouse sta$,
maintenance personnel, cleaners
the more critical the area ) fe!er num"er of
persons there
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 12/26Module 3 Slide 12 of 26
WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – II
%imultaneous operations
not permissible to process di#erent products in di#erent
areas with a common ventilation system
permissible to carry out secondary packaging activities
for di#erent products within a packing hall with
ade!uate physical separation
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 13/26Module 3 Slide 13 of 26
WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – III
Area clearance checks
Process of checking
all materials and documentation from the preious"atch remoed
all plant and equipment thoroughly cleaned and
appropriate status la"elling
chec%list useful
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 14/26
Module 3 Slide 14 of 26WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – IV
Area clearance checks
The area clearance check should be carried out bytwo people
"et!een "atches of same product, accepta"le for
"oth chec%s to "e carried out "y production
personnel
for product changeoer, second chec% carried out "y
2C sta$
all chec%s carried out in accordance !ith !ritten S3Pand results recorded on the "atch documentation0
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 15/26
Module 3 Slide 15 of 26WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – V 'leaning and cleaning validation
degree of cleaning depends on !hether consecutie
"atches are of same or di$erent product
'heck cleaning agent is fully removed *f possible hot water alone used for cleaning
all cleaning and disinfecting solutions carefully
prepared and expiry dated
+inal rinse with puri,ed water$ or water for inection
for sterile products/ +ull records kept
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 16/26
Module 3 Slide 16 of 26WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – VI
(ater systems
(ater - maor constituent of most products
%0P for cleaning and sanitisation of the waterpuri,cation system should include distributionpipework
&alidation and removal of disinfectant before reuse
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 17/26
Module 3 Slide 17 of 26WHO - EDM
Sanitation and Hygiene
Production Operations – Sanitation – VII
1aintenance and repair
actiities ineita"le in manufacturing area0
Should present no ris% to product
(henever possible$ all planned maintenanceoutside normal operating hours
mergency work in working area followed bythorough clean down and disinfection before
manufacturing recommences Area clearance by 2'
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 18/26
Module 3 Slide 18 of 26WHO - EDM
Part One 10.16 – 10.23
Sanitation and Hygiene
Personne Hygiene – I
3ealth e4aminations
3n recruitment for direct operators , repeated on
regular "asis
Training - check
induction training for ne! operators includes "asic
personal hygiene training
!ritten procedures ) to !ash hands "efore entering
a manufacturing area
signs in changing rooms to reinforce hand !ashing
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 19/26
Module 3 Slide 19 of 26WHO - EDM
Part One 10.16 – 10.23
Sanitation and Hygiene
Personne Hygiene – II
*llness
sta$ !ith illness or open lesions should not handle
starting materials, intermediates or #nished products
Adverse conditions
operators trained to recogni1e ris%s
!illingness to report illness to the area superisor
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 20/26
Module 3 Slide 20 of 26WHO - EDM
Sanitation and Hygiene
Personne Hygiene – III
'ontact between product and operator
aoid direct contact
if direct handling unaoida"le, gloes should "e !orn
chec% gloe disinfection -for sterile production/ anddisposal
Part One 10.20 – 10.23, 11.7 – 11.8
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 21/26
Module 3 Slide 21 of 26WHO - EDM
Sanitation and Hygiene
Personne Hygiene – IV
'lothing and changing facilities
chec% changing rooms -hand!ashing, to!els or hot
air hand dryers/
chec% if used clothing stored in separate closedcontainers !hile a!aiting cleaning
laundering of clean area clothing must "e to S3P and
in appropriate facility
chec% for procedure for sterili1ing and storing
clothing for use in sterile area
Part One 10.20 – 10.23, 11.7 – 11.8
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 22/26
Module 3 Slide 22 of 26WHO - EDM
Sanitation and Hygiene
Personne Hygiene – V
%moking$ eating and drinking should not be allowedin any manufacturing area$ including laboratories andstorage rooms.
'hewing of gum should be banned. There should be no plants kept inside any factory
areas.
Rest and refreshment areas should be separate frommanufacturing areas.
Toilets should not open directly into production orstorage areas. Part One 10.20 – 10.23, 11.7 – 11.8
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 23/26
Module 3 Slide 23 of 26WHO - EDM
Sanitation and Hygiene
!roup Session - Option "
5ook at the photographs in the handout andrecord
as many sanitation and hygiene issues as youcan
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 24/26
Module 3 Slide 24 of 26WHO - EDM
Sanitation and Hygiene
!roup Session - Option #
6ou are inspecting a new factory. (hat are the key
issues for sanitation and the key issues for
personnel hygiene that the company should havein place7
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 25/26
Module 3 Slide 25 of 26WHO - EDM
Sanitation and Hygiene
Possible Issues – I
Sanitation
1i4ed production
Penicillins
Product versus batch changeovers
(ater systems
3ow long should a 8cleaned9 status last for7
(hat should happen if a clearance check is re!uired
when no 2' personnel are on duty7
Procedures and records
8/18/2019 m03[1]Sanitation and Hygiene
http://slidepdf.com/reader/full/m031sanitation-and-hygiene 26/26
Module 3 Slide 26 of 26WHO - EDM
Sanitation and Hygiene
Possible Issues – II
Hygiene
Personal hygiene
3ealth checks
"ealing with health problems
Personal responsibility
Training records
+re!uency of handwashing