Having worked in the pharmaceutical industry where I’ve dealt with electronic systems, paper based systems, programmed my own access databases and Excel spreadsheet and been on projects such as LIMS system validation, I figured I’d make notes on the FDA’s 2016 guidance for industry document regarding Data Integrity and Compliance With CGMP. This draft is for currently open for comment and the guidance addresses data integrity in:
- drug manufacture
- finished pharmaceuticals
- positron emission tomography drugs
I found the latest ISO online here. As far as I can tell it is legit (in so far as allowing the ISO online for free) – it certainly is the current ISO.
A recent HR rep from a pharmaceutical company contacted me regarding an open role I Sydney. After passing my details along to “senior management”, the response I got was “We have had some discussion with senior quality managers about your profile and unfortunately they feel your relevant experience in Sterile Micro going back 10 years is a little too long for us ideally”.
Such a response show a lack of foresight from the employer as they do not want the best candidate for the job. Do they want someone who knows their stuff? No. Do they have a commitment to training and staff development? No. Continue reading
One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products . Long ago, I reviewed the 1998 edition. More recently, I acquired ISO 13208-1 (2008), so I compared my notes from the 1988 version with what is stated in the 2008 version. The use of italics is my way of emphasising points. Notes on changes are in blue.
When I reviewed the 1998 edition, I did not note down any of the introduction.
- Anything labelled as sterile needs to made under tight control as part of a Quality Management System
- This part of the ISO focusses on the risks to the maintenance of sterility
- All possible sources of contamination need to be controlled and a risk based approach is recommended
- Appropriate validation of the aseptic process is needed and process simulation trials are an essential part of this
Everything related to the production of drugs is based upon a collection of Pharmacopoeia. These contain both guidelines and regulations and are a great source of information (though at times, some interpretation is needed). Continue reading
A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.
The FDA Inspection guides are freely available from here.
For my own reference and review, I’ve saved some of the Guidance for Industry documents below. However, you can get them all from this link.
The Article posed on LinkedIn.
What pharma can learn from Volkswagen’s “defeat device”
Pharma should already be aware of the dangers of misrepresenting the efficacy of a product.
Worse case is the customer dies and the regulators shut you down (or impose sanctions and you fail as a business).
The Question posed on LinkedIn.
“does tga have any guidance on “studies of antioxidant”? ”
If the antioxidant is used as a preservative, then you would need to look at the EP 5.1.3.
One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products . Long ago, I reviewed the 1998 edition. The 2008 edition of the standard was last reviewed and confirmed in 2011 as current. Part 1 details the general requirements. The 2008 edition is edition 2 and is a techncial revision of the 1998 document. The guts of the standard are not dissimilar to version 1.
My review of the 1998 edition follows. When I get my hands on the 2008 edition, I’ll review that with reference to this review.
The use of italics is my way of emphasising points. Continue reading