pmd education
cGMP
Current Good Manufacturing Practices in Manufacturing of Finished Drug Products
ORGANIZED BY; Dr. Sumera Latif
Department of Pharmaceutics
Lahore College for Women University Lahore
SPEAKER
Muhammad Farooq Saleem
M.Phil.
Pharmaceutical Tech.
(Pb)
Plant Manager
Medipak Ltd
Lahore-Pakistan
Brand Owner
PMD Group
What is cGMP?
Definition
Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
Why GMP?
- Primary Aim
Diminishing the risks of
- Cross-contamination/mix-ups
- False labelling
- To Ensure Drug Product
- Safety
- Quality
- Efficacy
- Risk Assessment to achieve above mentioned GMP objectives has become central subject of Quality Assurance guidelines world wide.
cGMP Regulations and Guidelines
U.S. Food & Administration
US Federal Food, Drug and Cosmetic Act Title 21 CFR (Code of Federal Regulations), includes sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.
Regulations for cGMP of Finished Pharmaceuticals are described in Part 211 of 21 CFR.
Eudralex
Collection of rules and regulations governing medicinal products in European Union.
EudraLex consists of 10 volumes:
World Health Organization (WHO)
WHO provides detailed GMP guidelines covering different aspects like R&D, Technology Transfer, Validations, HVAC etc. But main principles of Pharmaceutical GMP are enlisted in TRS 986-Annex-2
International Council for Harmonisation (ICH)
The ICH topics are divided into the four categories.
- Quality Guidelines
- Safety Guidelines
- Efficacy Guidelines
- Multidisciplinary Guidelines
WAREHOUSING & DISTRIBUTION
cGMP Overview
US FDA Title 21 CFR part 211 regulations describe minimum current good manufacturing requirements to which a pharmaceutical manufacturing unit shall comply in order to get marketing authorization for its finished drug products.
Similarly Eudralex Volume-4 provides a complete GMP guidelines to EU pharma manufacturer to comply with regulations as set forth is Eudralex Volume 1 and 5.