1)What is PGD in pharmaceuticals industry ?
2) who harmonise the specifications?
3)GMPs are derived from (based upon) what?
4) proposed amendment to the GMP regulations are published in?
- Your first question is not clear.
- There is no harmonization of specificationsas such, that is why every pharmacopoeia has specifications in the individual monographs for same raw materials. Harmonization of specifications can be done by pharmaceutical company who utilizes same raw materials having different specifications.
- GMP is a part of Quality Assurance. Based upon basic principles the GMP is derived. Bssic principles are, to avoid cross contamination, to manufacture products of consistent quality (predetermined specifications) and should meet quality, safety and efficiacy requirements, to do what is written (SOPs & procedures) and write what you do (ALCOA principles of data integrity).
- The draft guidelines on GMP aspects are published by different regulatory authoroties from time to time in their respective web sites.