by Jhong Andaya
Good Manufacturing Practice
2:01 pm in Pharmacy Guide by Jhong Andaya
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. Good manufacturing practices (gmp) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous. Up until now, however, there was no applicable guideline or rule for primary packaging materials, which contain, seal or are used for dose application and have direct contact with the medicinal product. GMP is also sometimes referred to as “cGMP.” The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, errors and mix-ups, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.
List below are the sites that are gathered related to Good Manufacturing Practice
- Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (FDA)
- Good Manufacturing Practices Guidelines (Canada)
- WHO – GMP Good manufacturing practices and inspection for pharmaceuticals
- Good Manufacturing Practice Guide for Active Pharmaceutical ingredients (ICH)
- PIC/S GMP Guide for Active Pharmaceutical Ingredients (PIC/S)
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
- PIC/S GMP Guide for Blood Establishments
- Guide to Good Manufacturing Practice for Medicinal Products (PH 1/97 (Rev.3) – 01/ 2002) (PIC/S)
- European GMP Guide (Eudralex Volume 4)
- ET Drug ProductsCurrent Good Manufacturing Practice (CGMP) guidance (PDF)
WHO GOOD MANUFACTURING PRACTICES
- Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
- Good Manufacturing Practices for Pharmaceutical Products: Main Principle
- Good manufacturing practices: requirement for the sampling of starting materials (amendment)
- Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
- Active pharmaceutical ingredients (bulk drug substances)
- Pharmaceutical excipients
- Sterile pharmaceutical products
TRAINING MATERIALS
VIDEOS
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