As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of sterility assurance. Another 27 were due to impurities with 5 more due to mislabeling. Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination.
It is vitally important that your products are fit for purpose. What is on the label must be in the product. Nothing more. Nothing less. Quality assurance goes a long way and with the correct processes in place, the number of potential batch recalls should be zero.
With regards to microbial contamination, I am updating my “Microbiology for Non-Microbiologists” presentation and will shortly be providing an abridged version online. Stay tuned.
I am a microbiologist with over 15 years’ experience in the pharmaceutical realm. I have a strong interest in regulatory compliance and developing others. Recently I have been working closely with data security. I have an arty streak, have been a work place trainer and have an affinity for computers.
Lately I’ve been thinking of ways to share my knowledge with others outside of my cycling and science blogs and have decided to write 12 LinkedIn posts over 12 months. I will limit the post size to between 500 and 1000 words (1-2 A4 pages). Continue reading →
My work called for presenters on a wide range of topics, both work and non work related. I put my hand up to deliver a talk on something drawn from my background as a scientist. After some thinking I came up with “Quality Assurance – How to Apply Scientific Principles to Troubleshooting”. I thought that would be a good topic as that’s the main thing I do in my current role and I did a lot of it in my old roles. I thought I would be able to impart knowledge to help others examine and solve their problems. Project mangers might find it useful. Software developers might find it useful. Athletes might find it useful.
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 buisiness 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).
Course of action adopted due to one or more considerations such as legal or regulatory requirements
Contains regulatory, corporate or scientific policies, rules or principles. Explains why these are considerations.
generally affect multiple SOPs. If affects one SOP, should include detail in SOP after Additional Information section.
If information >1 page and affects >1 SOP
or >3 pages and affects 1 SOP, write a separate policy document
Who, what, when where and why.
A series of stages describing the sequence of tasks performed
Describes processes lasting an extended time (hours, days, weeks).
Tends to encompass multiple users.
Written with the overall goal of achieving the outcome via a number of specified outcomes.
Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:
≤4 steps -SOP content.
>4 steps – place in an OI.
How to do something.
Step wise instructions.
Takes place in the now.
Tends to involve single user.
Written to achieve a specified outcome.
Overview only – Section/Description.
Must not exceed 1 page.
Used a process overview.
If ≥5 sections, a flow chart can be used.
If <5 sections, a Section/Description table use used.
Must not exceed 1 page.
Suitable only where instructions are straightforward.
Must not exceed 1 page.
Use present continuous. eg. Sampling of Water for Injection
!!”ing” in the title.
Use the present simple. Daily Check of Equipment Calibration
!!If the proposed title includes “How to…” the it’s likely an OI.
Section headings do not include full stops
For all nouns and verbs in document titles, use capitals. Does not apply to section headings.
-Title: Using The Autoclave
-Section Heading: Load the autoclave
Be consistent in the use of bullets and font.
Be consistent with capitalisation and use of punctuation.
Read your work out loud. If you stumble, the reader will too.
Plan. Talk to SME’s. Before you begin writing, identify the information type(s).
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.
I have experience developing training and presenting it to small to medium sized groups. Part of this process involves determining the way in which to present the training. Once such way to use some form of visuals in support of speaking. For my Microbiology for Non Microbiologists course, I used Microsoft Powerpoint.
Duration of Session:
60 minutes x1, followed by 10 minutes x1 (display style)
The quantitative use of zones of agar made inhibitory to the growth of one microorganisms by diffusing substances produced by another organism was in use at least as early as 1885 (Analytical Microbiology, Kavanagh, 1963). The first official assays of penicillin were carried out in 1943. Publication of the theoretical aspects involved was published by Cooper and Woodman in 1946 in Pathological Bacteriology. The antibiotic assay used by pharmaceutical companies is primarily the agar plate diffusion assay. Some products that are a mixture of polymers may have a specific monograph stating that they must be assayed by a turbidimetric method. Such an example is Gramicidin. Continue reading →
Technical writing is a style of writing used when preparing protocols, reports, investigations and other laboratory documentation.
What are some examples of technical documents?
In general, any regulated manufacturing site will use the following technical documents: validation documents, reports, Standard (Operating) Procedures, SOP’s and Work/Operator Instructions (OI’s), standard forms and overriding policies and a Site Quality Manual all within the framework of a Quality Management System (QMS), Continue reading →
Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading →