WHO GMP Standards for Production & Quality Control of Pharmaceutical Products:
Good Manufacturing Practices:
Good Manufacturing Practices (GMP, also
referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect
of quality assurance that ensures that medicinal products are consistently
produced and controlled to the quality standards appropriate to their intended
use and as required by the product specification.
GMP
defines quality measures for both production and quality control and defines
general measures to ensure that processes necessary for production and testing
are clearly defined, validated, reviewed, and documented, and that the
personnel, premises and materials are suitable for the production of
pharmaceuticals and biologicals including vaccines. GMP also has legal components,
covering responsibilities for distribution, contract manufacturing and testing,
and responses to product defects and complaints. Specific GMP requirements.
This article contains the list of GMP Guidelines applicable for the Production and Quality Control of the Pharmaceutical Products such as Active Pharmaceutical Ingredients; Pharmaceutical Excipients & Pharmaceutical Products Containing Hazardous Substances.
GMP Guidelines:
Production:
Production covers all operations
involved in the preparation of a pharmaceutical product, from receipt of
materials, through processing, packaging and repackaging, labeling and relabeling,
to completion of the finished product.
Guidelines: Production
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WHO good manufacturing practices for pharmaceutical products: Main
principles |
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WHO
good manufacturing practices for active pharmaceutical ingredients (bulk drug substances) |
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WHO
good manufacturing practices for the manufacture of pharmaceutical excipients |
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WHO
good manufacturing practices for pharmaceutical products containing hazardous substances
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Quality Control GMP Guidelines:
The
term “quality control” refers to the sum of all procedures undertaken to ensure
the identity and purity of a particular pharmaceutical. Such procedures may
range from the performance of simple chemical experiments which determine the
identity and screening for the presence of particular pharmaceutical substances
(e.g. thin layer chromatography, infrared spectroscopy, and so on), to more
complicated requirements of pharmacopoeial monographs. Activities extend to the
area of quality control laboratories (e.g. good laboratory management
practices, models, for example for certificates of analysis and lists of
laboratory equipment, and an external assessment scheme).
Quality control guidelines
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Pharmacopoeias
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WHO
good pharmacopoeial practices: Chapter on compounding - TRS 1010 - Annex 6 |
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WHO
good pharmacopoeial practices: Chapter on herbal medicines - TRS 1010 - Annex
7
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WHO
good pharmacopoeial practices |
https://www.who.int/publications/m/item/who-good-pharmacopoeial-practices
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Analysis of samples
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WHO
considerations for requesting analysis of medicines samples - TRS 1010 -
Annex 3 |
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WHO
model certificate of analysis - TRS 1010 - Annex 4
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https://www.who.int/publications/m/item/who-model-certificate-of-analysis---trs-1010---annex-4
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Laboratory guidelines
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WHO
good practices for pharmaceutical quality control laboratories - TRS 957 -
Annex 1
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WHO
good practices for pharmaceutical microbiology laboratories - TRS 961 - Annex
2
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WHO
good chromatography practices - TRS 1025 - Annex 4
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https://www.who.int/publications/m/item/trs-1025---annex-4-who-good-chromatography-practices
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Plant materials
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Quality control methods for medicinal plant materials
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https://www.who.int/publications/m/item/quality-control-methods-for-medicinal-plant-materials
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WHO guidelines for selecting marker substances of herbal
origin for quality control of herbal medicines - TRS 1003 - Annex 1
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Screening tests
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Basic tests for drugs: pharmaceutical substances,
medicinal plant materials and dosage forms
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International Pharmacopoeia and International Reference Standards |
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The International Pharmacopoeia
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WHO International Chemical Reference Substances (ICRS): Purposes
& Use |
https://www.edqm.eu/en/WHO-ICRS-Reference-Substances-1393.html
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WHO general guidelines for the establishment,
maintenance and distribution of chemical reference substances - TRS 943 -
Annex 3 |
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The International Pharmacopoeia: Updating
mechanism for the section on radiopharmaceuticals - TRS 992 - Annex 2
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The International Pharmacopoeia: Related
substances tests - dosage form monographs guidance notes - TRS 943 - Annex 1
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Testing of
suspect samples
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WHO
guidance on testing of “suspect” falsified medicines - TRS 1010 – Annex 5
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WHO
recommendations for quality requirements when plant‑derived artemisinin is
used as a starting material in the production of antimalarial active
pharmaceutical ingredients - TRS 992 – Annex 6
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UNFPA-WHO
technical specifications for male latex condoms - TRS 1025 - Annex 10
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UNFPA-WHO
specifications for plain lubricants - TRS 1025 - Annex 11
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WHO
guidelines for sampling of pharmaceutical products and related materials -
TRS 1025 - Annex 4
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Procurement
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WHO
model certificate of analysis - TRS 1010 - Annex 4 |
https://www.who.int/publications/m/item/who-model-certificate-of-analysis---trs-1010---annex-4 |
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