 |
|
 |
 |
|
|
| |
 |
| Introduction |
| At Himalaya, we pride
ourselves on being a completely research oriented company. Indeed,
it is this emphasis on R&D that allows us to produce safe, efficacious
and consistent remedies using ayurvedic principles.
Our R&D department is focused on product development, quality
control and standardization. All our products are derived through
rigorous research and produced in state-of-the art facilities. They
represent our commitment to continuous investment in the best people,
practices and technology. We do not support "Borrowed Science"
or the practice of using published literature to substantiate efficacy
claims. Each Himalaya product undergoes years of primary research
before it reaches the market.
|
| |
|
|
|
| |
|
|
Recognition |
|
|
 |
In March 2001,
we were granted a "Good Manufacturing Practices (GMP)"
Certificate, issued by the Licensing Authority, Directorate
of Indian Systems of Medicine, Bangalore. Himalaya is the first Ayurvedic
facility to get GMP certification in the country. |
|
|
We are the
only phytopharmaceutical company whose ayurvedic product, Liv.52,
a hepato-protective formula, is registered as a 'pharmaceutical
specialty' in Switzerland. |
|
|
Our R&D
wing has been recognized as a Research Center by the Rajiv Gandhi
University of Health Sciences, Karnataka, India. |
|
|
|
| |
|
|
|
| |
|
| Quality
Assurance |
|
|
|
Quality covers two areas - Quality
Assurance and Quality Control.
Pharmaceutical products are designed and developed with the
following requirements -
GMP (Good Manufacturing Practices)
GLP (Good Laboratory Practice)
GCP (Good Clinical Practice)
|
|
| GMP (Good Manufacturing
Practices) for pharmaceuticals include assessment of quality,
safety & efficacy: |
| |
- Crude plant material - pharmacognosy
- Plant preparation - analytical
- Finished product - formulation and
development
- Stability - stability studies are
conducted on all our products as per ICH (International Conference
for Harmonization) guidelines to ensure quality of the product
throughout its shelf-life
Safety Assessment
- Toxicological studies - acute, subchronic,
chronic, and teratogenicity
Efficacy assessment
- Activity - pharmacological
- Clinical studies - phases I, II,
& III
Formulation of products
- Identification (Literature surveys
of ancient classical texts and scientific literature)
- Pharmacognosy - microspical identification,
macroscopical identification, maceration and cultivation
- Preclinical pharmacology
- Standardization - Certificate of
analysis, quality assessment, purity
- Formulation and Development - development
of dosage forms, stability studies
- Clinical studies - Phases I, II
& III, and Phase I V (post-marketing surveillance)
|
| The Quality Management
System at Himalaya |
| |
- QA holds prime responsibility for
generating systems and procedures, handling product complaints,
audit, process stabilization and validation
- Regulatory Affairs prepares QA-related
documents for product registration, GMP documentation and
answering technical queries
- QA regulates sourcing, site approval,
GMP maintenance, transfer of technical documents, training
support, product technology transfer, daily reviews and
audits
- For GMP - documentation of critical
steps in the manufacturing process and any significant changes
made to the process are validated
|
| Good Laboratory Practices
(GLP) |
| |
- Organizational process; includes
the conditions under which laboratory studies are planned,
performed, monitored, recorded and reported
- Purpose
- to promote development
of quality test data
- comparable for mutual
acceptance in different countries
- to avoid technical
barriers to trade
- to develop standards
for herbal formulations
- to protect human health
and environment
- GLP principles - Standard Operating
Procedures, test facilities, personnel and test systems
|
| Good Clinical Practices
(GCP) |
| |
- An international ethical and scientific
quality standard for designing, conducting, recording and
reporting trials that involve human subjects
- Compliance with this standard provides
public assurance that the rights, safety and well-being
of trial subjects are protected, consistent with principles
in the declaration of Helsinki, and that the clinical trial
data are credible
- Objective - to provide a unified
standard
|
| Good Agricultural Practices
(GAP) |
| |
- |
A benchmark
of acceptable crop production methods |
| |
- |
A prerequisite
to manufacturing pharmaceutical-grade products |
| |
- |
A code
of conduct that lays down how crops must be grown right so quality
of product is not compromised |
| |
- |
Stipulates
that use of pesticides and herbicides, if any, be documented,
synthetic fertilizer be minimized and banning human sewage sludge
in fields |
| |
- |
Introduced
by European Herb Growers Association |
| |
- |
GAP considers
parts of plant used, water availability, temperature during
growing season, time of harvest, and storage and transport of
the raw material as all impact the therapeutic properties of
herbal medicine |
| |
- |
Good
Agricultural Practices are helped by Good Harvesting Practices |
|
| Good Harvesting Practices
(GHP) |
| |
- |
Covers wild crafting
of medicinal plants |
| |
- |
Designed to ensure
that wild material is harvested in a sustainable and environmentally
acceptable way |
|
|
|
| |
|
|
|
| |
|
| Research Activities |
|
|
| |
Pharmacognosy |
|
Establish bona
fides of herbal materials through morphological and microscopic
studies |
|
Maintain herbarium
of phyto-medical materials. |
|
| |
Formulation and
Development |
|
Pre-formulation
studies to check the biochemical action of ingredients. |
|
Trials to
assess safety and efficacy of formulations. |
|
Accelerated
stability trials to check physical, chemical, microbiological
and biological aspects of formulations. |
|
Standardize
processes for uniform quality. |
|
Transfer of
technology to the production department. |
|
| |
Immuno-pharmacology |
|
Study the mechanism
of drug action at a molecular level. |
|
Attempt to
understand the endogenous mediators involved in the activity. |
|
Develop immuno-protective
agents to counter opportunistic infections in AIDS, carcinogenic
malignancy, septic shock, organ transplantation and chronic
infections. |
|
Substitute
work with in vitro (in the laboratory) cell line models for
in vivo
(in the body) experiments. |
|
| |
Veterinary Pharmacology |
|
Study the
safety and efficacy of veterinary formulations in experimental
and clinical trials on different animal species. |
|
Study the
mechanism of action in the formulations. |
|
|
|
| |
|
|
|
| |
|
|
|
