“Dear Experts, What are the guidelines that clarify the frequency and number of cycles required for re-Validation of equipment? For example, during re-qualification of the autoclave should each cycle be repeated 3 times (empty, minimum and maximum loads)? Or is it based on risk assessment by choosing the maximum loads only? (On initial qualification each cycle was performed 3 times consecutively). Also for depyrogenation tunnels, should the runs be repeated 3 times? Thank you“
“Can we provide the grades of pass box and lafs in on critical area with respect to material movement ? For example if a pass box installed between grade c and grade d environment can be designated as grade b? Similarly laf installed in grade c area can be designated as grade c? If yes what woukd be the viable and non viable limits to be applied?“
“I have been working with an academic team of global R & D partners on TECH DOC, Product Support, Training, and Learning/Development solutions. One item on the hot list is the ability to manage the release of the software/device exactly with the support mechanisms such as the KB, the release notes, and the manual/quick start guide. Across several sectors, this issue seems to exist. How do I save the most time, yet not overwork the team, and remain as precise as possible without creating confusion for the internal teams/external teams? Any product manager, project managers, or other TECH DOC specialists care to share how to provide precision across the different LOBs in a global environment where time zones matter?“
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).
|A Policy||A SOP||An OI|
|What’s What|| 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.
Each stage in a SOP comprises a number of action or steps. Length dictates their placement in a SOP or an OI:
|Flow Charts|| Informational
Must not exceed 1 page.
|Used a process overview.
|Naming Convention||N/A||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.
-Title: Using The Autoclave
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?
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
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
I was recently asked where I would start if I was tasked with developing the Validation Master Plan or VMP for a microbiology laboratory.
That got me thinking. I’ve done my share of validations over the years, encompassing such things as viable particle air samplers, large format incubators, temperature mapping, autoclave validation, sterile media trials, computer system validation and various microbiological test methods. I’ve also written validation documentation in the form of user requirement specifications (URS), installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ) as well as the validation protocols and reports. To take on the task of developing the master plan would be challenging and to my mind, an exciting and fun/rewarding project. I love documentation! Continue reading
The TMC is broken into two parts: a basic look for contamination and a look for more specific forms of contamination. The basic test is described in the USP in section <61> or in the EP in section 2.6.12. The more specific or specified microbe testing is described in USP section <62> or in the EP in section 2.6.13. Continue reading