Rudiments of Good Laboratory Practices (GLP)
Quality Product testing is the backbone for promotion of global trade. A
product tested and approved to meet defined specifications should yield the same result when
tested
in any other laboratory.
Good laboratory practices (GLP) are an essential ingredient of a quality
system that ensures uniformity, consistency, reliability and reproducibility of
data.
In other words the data generated using GLP practices is a true
reflection on work or study and is traceable to internationally accepted
standards.
ISO has evolved several standards that strengthen GLP practices. ISO
17025:2005 in particular lays down the guidelines for accreditation of
calibration and testing laboratories.
The Drugs
and Cosmetics Rules laid down by government of India refer to GLP
guidelines in schedule L – 1.
Organization for Economic Co-operation and Development (OECD) national guidelines promote the quality and validity of test data used for chemicals and chemical products.
GLP Requirements
GLP requirements fall under different heads and the essentials of each
are briefly outlined below:
General requirements
These relate to planning process which involves :
- Developing
policy and quality plan to achieve organization objectives
- Designing
organization structure to carry out plans
- Dividing
the total work in logical pattern and assigning responsibility for each
activity
- Defining
relationship and coordination of work of internal departments and
interaction with outside agencies to achieve company mission
- Design
system for quality evaluation, audits and surveillance of products
Premises
- Laboratory
should be located in area free from noise, dust and vibrations
- Layout
planning for different sections to avoid cross contamination
- Test
and Storage area should be separate and restricted to authorized persons
only
- Sufficient
space should be provided for carrying out testing procedures
- An
effluent treatment plant is necessary if laboratory waste contains harmful
pollutants
- Centralised
air-conditioning is recommended to reduce cross contamination and to
control moisture levels
- Floors
should be impervious and washable
Animal house facilities
Under this all the rules relating to prevention of cruelty to animals
should be taken into consideration
Manpower
Personnel are the most important resource in any organization. Laboratory
should have sufficient staff with the required educational background and with
the ability to perform all the responsibilities laid down by the quality
manager. Proficiency test and various training programs should be conducted to
improve the personal knowledge and skills.
Equipment
- Testing laboratory should provide and maintain suitable equipment required for testing procedures.
- Maintenance,
calibration and validation of equipment is necessary to keep equipment in
good working condition and improve both the efficiency and accuracy of
results
- Installation
qualification IQ, operational qualification (OÓ) and performance
qualification (PQ) should be performed for all new instruments and when
major accessories are added.
- Analytical
instruments should be kept in clean environment with controlled
temperature and humidity. Records of temperature and humidity should be
maintained and made available whenever required.
- Instrument
should be calibrated throughout and defective instruments should be
labeled ‘out of order ‘till they are repaired
Chemicals and reagents
Chemicals and reagents should be stored and labeled according to their
physicochemical properties. The label should clearly indicate date of expiry.
SOP should be there for preparation of solutions and standardization
Reference Materials
Reference materials use is recommended due to their high
purity, critical characteristics and suitability.
Reference standards can be used to prepare secondary standards or
working standards with the trace-ability to primary reference standard
Quality Systems
Quality manual is the main document which helps to maintain the product
quality and is the permanent reference for the implementation and maintenance
of quality system which describes both the management requirements as well as
customer requirements.
Standard operating procedures
Standard operating procedures are documented procedures in chronological
order listing established procedures and processes essential for upkeep of
established quality management systems.
Good housekeeping and safety
Written instructions for good housekeeping and should be communicated to
the staff through handouts, audio visuals or other methods.
Audits
Both internal and external audits should not be considered additional
burden but on the contrary help maintain and improve quality standards.
The outlined requirements are touched upon in brief. GLP in itself is a
vast area and there can be variations leaving scope for innovation by
individual laboratories in defining their own quality policies..
Please do leave your comments based on your specialization and
experience.
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