GOOD LABORATORY

PRACTICE
Rabu, 26 September 2018
Jam 08.00-09.40 WIB, di Gedung G.106
(THP A)
Jam 12.20-14.00 WIB di Gedung G.106
(THP B)
Oleh
Dr. Ir. Fronthea Swastawati, MSc.
Departemen Teknologi Hasil Perikanan
Fakultas Perikanan dan Ilmu Kelautan
Universitas Diponegoro
2018

.
Semarang, 26 September
 Good Laboratory Practice (GLP)

Good Laboratory Practice didefinisikan sebagai suatu

sistem kualitas yang berkaitan dengan proses organisasional
dan kondisi laboratorium. Dimana suatu penelitian
dirancang dilaksanakan, dipantau, dicatat, diarsip, dan
dilaporkan.
 Pendahuluan
Konsep resmi Cara Berlaboratorium yang Baik (GLP) pertama kali
disusun di Amerika Serikat pada tahun 1970 -an yang disebabkan
adanya keprihatinan terhadap validitas data keamanan praklinik obat
baru yang diserahkan ke Food and Drug Administration (FDA).

Hasil Pemeriksaan menunjukkan bahwa adanya perencanaan uji dan

penelitian yang kurang memadai, dokumentasi metode dan hasil
yang tidak lengkap, serta adanya manipulasi data

FDA lalu mengajukan regulasi GLP pada tahun 1976 dan menjadi
peraturan akhir ( Final Rule) pada 19 Juni 1979
 Tujuan GLP
 Certify that every step of the analysis is
valid
 Meningkatkan kualitas penelitian dan
data.
 Dasar untuk mendapatkan kualitas,
reabilitas, dan integritas penelitian, serta
keterlacakan data.
 Sasaran GLP
 Melindungi manusia dan lingkungan hidup dari
pengaruh bahan kimia berbahaya dan beracun
 Menghindari pengulangan data
 Pengembangan kualitas data uji
GLP di Laboratorium sebagai persyaratan GMP yang
harus dipatuhi

Laboratory
sample Results of Analysis
Processes

Good Laboratory Practices

Raw Materials Manufacturing Finished Product of

Packaging Processes Standard Quality
Materials
Good Manufacturing Practices
 Schedule (GLP)
 General requirements
 Premises
 Personal
 Equipments
 Chemicals & reagents
 Good House Keeping and Safety
 Maintenance, calibration, and validation of euipments
 Reference materials
 Microbiological cultures
 Quality system
 Internal quality system audits
 Management review
 Standard operating procedures
 Protocols and specification archive
 Raw data
 Storage and archival
 Cleanliness
 Control laboratories & equipment should be kept
clean
 All laboratory personel should wear clean
protective clothing appropriate to duties being
performed
 Premises
 Located, designed, constructed or adapted/maintained
to suit the performance of all quality control test &
analysis required before, during, & after manufacture
 Design & construction should prevent entry or
rodents & insects
 Interior surfaces of walls, floors, & ceilings should be
smooth & free from cracks
 Temperature & relative humidity should be
appropriate for desired functions
 Premises
Separate facility for :
 Instrumentalation

 Chemical analysis / wet chemistry

 Micro lab/ sterility/ pyrogen testing lab

 Hot room

 Stability room

 Reference sample/ control samples room

 Personel
 Adequate education, training, & experience
 Head of laboratory shall be responsible for
1. Maintenance of SOPs, protocol & documentation
2. Organising audits & follow up of corrective action
3. Investigation of technical complaints
 Reagents
 The reagents should be dated upon receipt or
preparation & labelled for identification
 Reagenets made up in the laboratory should be
prepared by competent persons according to laid-
down procedures
 The labels on the reagent bottles should indicate the
concentration, standarization factor, shelf life &
storage conditions, date of preparation, date of re-
standardisation & signature of the chemist who has
prepared it.
 Equipments
 Laboratory instruments & equpments should be
serviced & calibrated at suitable intervals
according to written procedures by persons or a
service agency & validated (SOP for operation &
calibration)
 Readly available records must be maintained for
each one of them
 Next servicing or calibration due date should
also be mentioned on them
 Separate room under control temperature &
humidity
 Equipments
 Written operating instructions should be
readly available or preferably be
displayed for each instrument
 Detective instrument should be with
drawn from use until the fault has been
rectified.
 Sampling
 Sample should be a proper presentative of bulk
product
 Written sampling SOP should include :
1. Method of sampling
2. Equipment to be used
3. The amount of sample to be taken
4. Instructions for any required sub division of sample
5. The type & condition of sample container to be used
6. Any special precaution to be observed
7. Cleaning & storage of sampling equipment
 Sampling
 The sample container should have labels
bearing details about Name of material, Batch
no., Mfg. Date, expiry date, Name of
manufacturer & quantity sampled
 Those containers from which samples are
drawn, are marked with sampled stamp with
date & signature of the chemist so that they
are identifiable from bulk containers
 Sampling equipments should be cleaned after
each use & stored separately from other
laboratory equipments
 Documents
 All the departmental systems & procedures,
specifications for all input materials,
intermediates & finished products & all test and
methods of analysis should be documented
 All raw data, formats of analytical reports,
under test, approved & rejected labels, various
inprocess checks, calibration check records
should be documented & available.
 Archives for storage & retrieval of records.
Retention time should be maintained
 Documents
 Documents shall specify the title, nature
& purpose
 They shall be laid out in an orderly
fashion & easy to check
 Documents shall be approved, signed,
regularly reviewed, and dated by
appropriate & authorised person
 Standard Operating Procedures
 To store data in paper format, humidity
conditions shall be maintained
 Data in the form of disc & tape should be
stored with care
 For storage on optical disc, its life shall
be longer than storage time
 Keep photocopy of data on thermal
paper
 Records
Records should have following details
 Analytical report no

 Name of the sample

 Date of receipt of sample

 Batch/ lot no

 Protocols of tests applied

 Signature of the analyst

 Opinion & sign of approved analyst

 Records should also contain the basic data & calculations

from which test result were derived.

 Good house keeping & safety
 People working in the laboratory should
look after safety aspects of their work for
themselves, their colleagues & the
organization
 They should wear appropriate safety
gadgets while working with hazardous,
corrosive chemicals & inflammmable
 Persons in the departement should be
familiar to first-aid techniques in case of
emergency till medical help is available
 Management Review
 At least once in 12 months to cover
 Internal & external audit audit report
 Complaints & customer feedback
received from laboratory customers
 Training records of the staf
 Other laboratory requirements
 Standard operating procedures
Sops required for
 Analysis of drugs

 Sample handling & accountability

 Receipt, identification, storage & sampling of test & control articles

 Cleaning, maintenance and calibration of equipments

 Responsibilities of audit team personel

 Healthy & safety precaution

 Storage & maintenance of microbial cultures

 Maintenance of animal rooms

 Use & storage of reference standards

 Training programs & their frequency

 House keeping

 Document control
 Standar operating procedures
 Retention & disposal of control samples
 SOPs should be reviewed periodically
 SOPs should include designation of the
person responsible for intended activity
 Complaints & product recall procedures
THANK YOU

AND

GOOD LUCK