Unit 2: Quality assurance in herbal drug industry
Introduction:
Herbal drugs have been used since earliest times as medicines for the treatment of a range of
diseases. Medicinal plants have played an important role in world health.
As per WHO, traditional system of medicines includes diverse health practices, approaches,
knowledge and beliefs based on plants, animals and minerals, spiritual therapies, manual techniques
and exercises which are used to maintain well-being, as well as to treat, diagnose or prevent illness
of human.
The herbals are converted into phytopharmaceuticals by multiple processing and hence in each step
quality matters which ensures identity, quality, purity and safety of the herbal materials and their
products.
National Drug regulatory authorities have to establish guidelines on overall quality assurance and
also data submitted by the producers and the specifications set by the producers as well as
compliance with GMP.
Several tests require to perform to establish quality of the herbal products which are under quality
control and quality assurance.
The manufacturers also have to follow the Good Agricultural and Collection Practices (GACP), GMP
and Good Laboratory Practices (GLP) specifications and standards for their products.
Quality assurance:
Quality assurance (QA) is a wide-ranging concept covering all matters that individually or collectively
influence the quality of a product, development, manufacturing, and sales phases. It is essential for
ensuring safety and maintaining consistent standard of manufactured pharmaceutical products and
also quality required for their intended use.
Elements of Quality assurance are:
(a) Adherence of GACP, GMP and GLP guidelines
(b) Setting specifications
(c) Quality control measures
QA=QC + GMP (Good Manufacturing Practice)/Other quality systems
cGMP:
cGMP refers to the Current Good Manufacturing Practice regulations imposed by the FDA.
cGMP assures proper design, monitoring and control of manufacturing processes and facilities in the
herbal drug industry.
This regulation assures the identity, strength, quality, and purity of drug products by requiring that
manufacturers of medications adequately control manufacturing operations.
cGMP helps to assure the safety and efficacy of drug products.
Objectives of cGMP:
a) cGMP regulations assure that quality is built into the design and manufacturing process at every
step.
b) Manufacturing facilities are in good condition.
c) Equipment's are properly maintained and calibrated.
d) Employees are qualified and fully trained.
e) Processes that are reliable and reproducible.
General guidelines on cGMP for medicinal plants:
In India Drug & Cosmetics Act, schedule T covers the minimum requirements for the manufacture &
quality control of herbal medicinal products.
cGMP is basic common manufacturing sense formalized into an
International pharmaceutical convention covering every aspect of 'current Good Manufacturing
Practise' and its consequent 'quality assurance'.
The main plan of cGMP is an inspection by the national body responsible for enforcement of quality
standards in medicines.
cGMP controls starting materials, intermediates, and finished goods.
Quality System:
Every pharmaceutical product has to establish identity, strength, purity and other quality
characteristics to ensure the required levels of safety and effectiveness.
Quality System
Facilities & Equipment System
Production System
Laboratory Control System
Packaging and Labelling System
Materials System
Production System:
This system includes measures and activities to control the manufacture of drugs and drug products.
Including; batch compounding, dosage form production, in-process sampling and testing and process
validation.
Also includes; establishing, following and documenting the Performance of approved manufacturing
procedures
Cleaning and validation of cleaning processes:
Utilities that are not intended to be incorporated into the product such as; heating, ventilation and
air conditioning (HVAC), compressed gases, steam and water systems.
Laboratory Control System:
This system includes; measures and activities related to laboratory procedures, testing, analytical
methods development and validation or verification, and the stability program.
Materials System:
It includes measures and activities to control finished products, components including; water or
gases that are incorporated into the product, containers and closures. It also includes; validation of
computerized inventory control processes, drug storage, distribution controls and records.
Packaging and Labelling System:
This system includes; measures and activities that control the packaging and labelling of drugs and
drug products.
It includes; written procedures, label examination and usage, label storage and issuance, packaging
and labelling operations controls and validation of these operations.
GMP
In 1996, WHO issued guidelines for the manufacture of herbal medicinal products i.e. good
manufacturing practice (GMP).
It covered several issues relevant to the production and quality control of herbals.
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products
are regularly produced and controlled according to the quality standards suitable for their use.
GMP standards are the only guidelines, alternative processes and control mechanisms that can be
used as an essential tool to assure quality
Objectives of GMP:
a) Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free
from contamination.
b) The manufacturing process has been prescribed to maintain the standards.
c) Adequate quality control measures are adopted.
d) The manufactured drug which is released for sale is of acceptable quality.
