Policy vs Standard Operating Proceedure vs Operator Instruction

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.

  • 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.
Tables  Informational
  • Overview only – Section/Description.
  • Stage/Description.
Step/Action
Flow Charts  Informational

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.
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.
In General
  • 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).
  • Chunk the information 7±2

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

The Validation Master Plan

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

Writing Technical Reports

What is technical writing?

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

The Importance of Trending

What is Trending?

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

Viable Environmental Monitoring

What Is Viable Environmental Monitoring (VEM)?

Viable environmental monitoring is the monitoring of factors within a production environment that may have an impact on the quality of goods produced within the environment. Typically this is any physical object than could support or introduce microbial contamination to a manufacturing environment: air, surfaces (as in introduced equipment), liquids, people.

Why Is VEM Needed?

Microbial monitoring is used to determine if the controlled environmental being monitored is within an adequate state of microbiological control (i.e whether or not the area meets the specifications as described in the site quality manual, product registration dossiers and associated documents) . It may also be used to confirm that cleaning and sanitation is effective (and being conducted as specified) and that personnel within the production environment are not carrying an unacceptable bioload or inadvertently causing contamination. This is required information as it ensures that products produced are unadulterated and are fit for their intended purpose. Continue reading

What Makes An Objectionable Organism?

What is a specified organism?

A specified organism is one that according to the pharmacopeia, cannot be present in a sample (usually 10g). These microbes are specified either as they may be an indicator organism (a microbe where its presence may indicate a pathogenic micobe could be present) or they may actually pose product safety concerns (whether by reducing the efficacy or posing a risk to the end user). Continue reading