Quality covers two areas - Quality Assurance and Quality Control.
Pharmaceutical products are designed and developed with the following requirements -
  1. GMP (Good Manufacturing Practices)
  2. GLP (Good Laboratory Practice)
  3. GCP (Good Clinical Practice)
GMP (Good Manufacturing Practices) for pharmaceuticals include assessment of quality, safety & efficacy:
  1. Crude plant material - pharmacognosy
  2. Plant preparation - analytical
  3. Finished product - formulation and development
  4. 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
  1. Toxicological studies - acute, subchronic, chronic, and teratogenicity
Efficacy assessment
  1. Activity - pharmacological
  2. Clinical studies - phases I, II, & III
Formulation of products
  1. Identification (Literature surveys of ancient classical texts and scientific literature)
  2. Pharmacognosy - microspical identification, macroscopical identification, maceration and cultivation
  3. Preclinical pharmacology
  4. Standardization - Certificate of analysis, quality assessment, purity
  5. Formulation and Development - development of dosage forms, stability studies
  6. Clinical studies - Phases I, II & III, and Phase I V (post-marketing surveillance)
The Quality Management System at Himalaya
  1. QA holds prime responsibility for generating systems and procedures, handling product complaints, audit, process stabilization and validation
  2. Regulatory Affairs prepares QA-related documents for product registration, GMP documentation and answering technical queries
  3. QA regulates sourcing, site approval, GMP maintenance, transfer of technical documents, training support, product technology transfer, daily reviews and audits
  4. For GMP - documentation of critical steps in the manufacturing process and any significant changes made to the process are validated
Good Laboratory Practices (GLP)
  1. Organizational process; includes the conditions under which laboratory studies are planned, performed, monitored, recorded and reported
  2. 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
  3. GLP principles - Standard Operating Procedures, test facilities, personnel and test systems
Good Clinical Practices (GCP)
  1. An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects
  2. 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
  3. 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