TGA to adopt the new PIC/S guide to GMP
What does this mean for an Australian GMP manufacturer?
- GMP inspectors will use the new guide to GMP during inspections
- Compliance with the new requirements will be expected from this adoption date
- GMP inspectors, will however take a pragmatic approach to discussing and reporting deficiencies
- A 12 month graduated adoption plan has been developed to highlight the increasing expectations for compliance through this period
So what is different? Here is a flavour of the changes:
- Chapters 1, 2 and 7 have been revised to align with the current version of ICH Q10
- Chapter 2 (Personnel) has a new section on consultants, specifically stating that they have adequate education, training and experience.
- Chapter 2 (Personnel) includes more detail on Senior Management being ultimately responsible and ensuring they are involved through management review.
- Chapter 4 (Documentation) provides more clarity on the retention of documents
- In Chapter 6 (Quality Control), all the sections have been revised.
British Pharmacopoeia 2018 – what’s changed?
This edition incorporates all the monographs of the 9th Edition of the European Pharmacopoeia, as amended by Supplements 9.1 and 9.2.
A snapshot of the changes are listed below:
- 35 new monographs of national origin.
- 39 new monographs from the European Pharmacopoeia.
- 102 technical and a further 83 editorial revisions to monographs.
- There are a number of herbal additions including Horse-chestnut Fruit and Liquorice Liquid Extract
Keep up to date with the changes at pharmacopoeia.com
To check the upcoming changes and its effect on your materials and products, click here to email us.
TGA: Complementary medicine reforms – commencing in 2018
The implementation of this new framework will:
- Introduce a new product assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways.
- Include a list of permitted indications
- Reward innovation with exclusivity for newly approved ingredients
In preparation for the changes the TGA are running information sessions throughout Australia. Click here for more information from the TGA.