January 2024
TGA Presentation into PIC/s Annex 1 – Manufacture of Sterile Medicinal Goods
The PIC/s (Pharmaceutical Inspection Co-operation Scheme) has updated Annex 1 for sterile medicinal products.
The TGA have given a good presentation on their understanding and expectations for when this Annex comes into play in Australia.
Annex 1 still doesn’t apply to non-sterile goods.
However there are parts that are relevant to all manufacturing plants, especially when it gives guidance on environmental monitoring. So a lot of non-sterile companies in New Zealand and Australia refer to the guidance in the PIC/s code.
In the future you need to specify which portions of Annex 1 are specifically applicable so that you are clear you are not following all of this Annex.
If you need a Gap Assessment for Annex 1, we can help you with that. Just click on the Contact link and drop us a line.
Which Version of PIC/s should I be looking at?
As of today (January 2024) Australia uses PIC/s PE009-15, and New Zealand uses PIC/s PE009-14.
But… A lot of the time the versions are not really that different. PIC/s has a good introduction document which details the differences between each of the versions so you don’t need to go through everything when looking at updating.
When you are doing a gap assessment it pays to look at the newer versions of the PIC/s so that when they come into play you are already prepared.
To give an example the current PIC/s version is PE009-17. When you look at the introduction you can see that between version 14 and 17 there is no change to Part I or Part II, but there are changes to the Annexes.
Who is Responsible for Compliance and Quality?
I was reading a LinkedIn post about how the Compliance people in Company X really need to start being held accountable for when something goes wrong, which I thought was a rather interesting view-point.
What does the PIC/s say about this? Well under PE009-17, Part I, Section 2.4 it reads “Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation“. And if you are thinking about the version… it has been there for quite some time.
Your quality and compliance people are not everywhere just remember that. If you want a great quality system, as a company you need to work on building a good quality culture. One where:
– Everyone understands that quality and compliance is part of the job, not additional to the job.
– You work on the issues and actually find the root cause and good corrective and preventive actions.
– Staff are given good training before starting a job, and at routine intervals afterward.
– SOPs match the process and people understand the SOPs are not ‘follow them if you want’ documents.
– Staff are given time and encouragement to look at the latest regulations.
– Staff are encouraged and rewarded for stopping work when needed and bringing up quality issues.
– Staff are encouraged to continually challenge and improve the processes so they are streamlined and simple.
Quality and Compliance is EVERYONE’s responsibility – whether you are cleaning the floor, making the product, managing the process or as the owner of the company.
Upcoming Events
Researchfora is organizing ICMHS, a conference that aims to provide a platform for sharing knowledge and ideas among Students, Doctors, Researchers, and Academicians in the field of Medical & Health Science.
06-07 March 2024