What follows will form part of a post tentatively titled “GMP Technical Writing”. The larger post will incorporate aspects of Writing Technical Reports and The Need for Documentation and detail the hierarchy of documents within a Quality Management System, what information goes where and how to conduct business process mapping. I’m tossing up on whether to present this as a series of posts or as some sort of presentation style document (pdf or Powerpoint). Continue reading
Author Archives: P Yeatman
What is the Internal Audit?
The purpose of an internal audit is to ensure the compliance of the process or processes being audited. That the documented procedure is followed, justified, validated. That the operators carrying out the process are trained and have a strong understanding of the process.
Why do we need to audit?
Notes on the FDA’s Draft Data Integrity and Compliance With CGMP Guidance for Industry
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
Why You Need an INTJ Working With You
Introduction
When I take the Myers-Brigs personality test, I without fail placed in the INTJ box. What does this mean?
(I)??? (N) Intuitive (T) ??? (J)Judging
It means I am a rare breed – just 2% of the population are said to fall into this group. Whether or not that’s an unsubstantiated “fact”, I’ll not go into.
INTJ’s can be summarised (if that is possible) as: Continue reading
Notes on ISO 13408-2 (2003) – Aseptic processing of health care products – Part 2 : Filtration
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
TGA Inspection Trends
My reply to a post on LinkedIn.
Current TGA Inspection trends: This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.
Comment 1 stated “…there are patterns that seem to repeat year after year. Poor QMS, inadequate investigations, lack of training.”
My reply to this was:
“The PIC’S guide to GMP stresses the need for a robust QMS and repeats over and over again the need for documentation, solid investigations and adequate training and retraining. It is a wonder why citations regarding a lack of these keep being given.” Continue reading
Notes on International Standard ISO 13408-1: 2008
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.
INTRODUCTION
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
Notes on USP36-NF31 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>
The USP is the United State’s Pharmacopeia.
If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation. For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.
The latest iteration of this section of the USP is 39-NF34, The last version I managed to get my hands on was USP36 NF31. I’ve compared the two and noted the changes from the NF I reviewed initially. The identified changes are in blue. Continue reading
Notes on PIC/S Guide for Good Manufacturing Practice for Medicinal Products (2009)
When I was working in the sterile pharmaceutical industry, I reviewed the The Australian Code of Good Manufacturing Practice for Medicinal Products (2002) as part of my self-development. This code was revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. Here’s the original review.
I have now reviewed the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, from the stand point of a microbiologist working collaboratively in a sterile pharma plant. What my review does is make note of the salient points and I add comments to some.
Both the revoked 2002 Australian GMP code and the 2009 PICs guide are based on ICH Q&A Good Manufacturing practice Guide for Active Pharmaceutical Ingredients which was last modified in 2000. In 2015 21 pages worth of clarifications were published to clear up some technical questions and to remove ambiguities. Looking at them, I’m not sure why clarification was needed as they all seem straight forward and answerable by anyone experienced working within a pharmaceutical manufacturing environment. This means that despite having “no recent experience” as deemed by some potential employers, my knowledge is still bang up to date. Combine that with my fantastic memory and impressive technical skills and I’d be an asset to your company. Continue reading
Project Management
Over the years I have been a member of various project teams. These were great experiences as I gleaned how to manage projects as well as developed new skills. Also, contributing to the success of a project is pleasing.
Not having access to MS Project until recently, I created and coded my own Gannt Chart using Microsoft Excel. This allowed me to manage small projects within the laboratory such as:
- media expiry date validation
- Total Microbial Count validation
- implementation of electronic worksheets