Well-written documentation and a comprehensive and well-designed Pharmaceutical Quality System (PQS) can be a manager’s best friend.

Pharmaceutical Quality System (PQS) documents:

provide guidance and instructions for employees to complete the day-to-day activities
are the ‘go-to’ during an audit or inspection
are the first reference point when inducting new employees.

But designing a good PQS can be a challenge.

As required by PIC/S guidelines ‘a Pharmaceutical Quality System (PQS) should be defined and documented’ (Clause 1.7, PIC/S Guide to GMP). Good documentation (and well-written procedures) is key to achieving compliance with GMP requirements.

The below sections detail some things you should consider before you even start writing your PQS (proper planning prevents poor performance, right?).

Define documents types

‘All types of document should be defined….’ (Clause 4.1 PIC/S Guide to GMP)

To demonstrate compliance, you must establish, document, implement and maintain your PQS, as well as maintain its effectiveness, in accordance with the required compliance standard (e.g. PIC/S Guide to GMP).

Your PQS should include:

A Site Master File
A Quality Manual
Quality policy and objectives
Documented procedures
Records required by the compliance standard to provide evidence of conformity to requirements and the effective operation of the PQS.

Some documents that may form part of your PQS should include, but are not limited to:

Procedures (SOPs)
Work instructions
Forms
Registers
Lists
Training assessments
Test methods
Specifications
Master manufacturing formula
Batch records, etc.

Pharmaceutical Quality System Document hierarchy

PQS documents are typically organised and written according to a document hierarchy. The hierarchy indicates the relationship between each document in your PQS which can be described as a ‘parent/child’ relationship. A typical document hierarchy is provided below:

Create document templates

‘Documents containing instructions should be laid out in an orderly fashion and be easy to check.’ (Clause 4.4, PIC/S Guide to GMP).

Well-designed templates make the contents of a document clear and reduce the opportunity for document authors to change the formatting to suit their personal preferences. You should create templates for each document type that you intend to use in your PQS.

Document templates should:

Have consistent styles and formats so that the documents are easy to navigate and read; your document writers should get familiar with using built-in styles. It is also recommended to develop a company ‘Style Guide’ which details the expected formats, styles, fonts, use of bullets, tables, language, etc.
Meet controlled document requirements (unique identifier, version control, etc).

A company logo can be included with the document header (or footer), although this is not mandatory.

The table below details some common headings that you would expect to see in a procedure (SOP) and work instructions template:

When designing templates, where (and in which order) you put each heading is also important. Locating references, abbreviations and change history sections at the start of a document can be distracting and cause your user to lose interest before they even get to the content – so remember to consider your audience (and what they need to know) when designing your document templates.

Document numbering conventions

‘Documents should have unambiguous contents and be uniquely identifiable.’ (Clause 4.3, PIC/S Guide to GMP).

There is no right or wrong document numbering convention for a PQS. Below is some general guidance for you to consider when developing your document numbering convention:

Documents should be uniquely identifiable i.e. they should have unique document numbers.
Typically, a letter code for the document type is included in the document number so that the user recognises the document type (e.g. SOP-001, POL-023).
You may like to include a department identifier in the document number (e.g. QA-SOP-001, OPS-POL-023). This may be more suitable for larger organisations to show document ownership or where documents are controlled across different departments; however, it should not be considered mandatory.
The document numbering system should be developed so that it can grow with your business.
It is advised not to assign specific ‘blocks’ of numbers to a certain department or area as this can cause problems if your PQS grows e.g. If Quality documents are assigned 000-100 and Production documents are assigned 101-200, what do you do if you have more than 100 Quality documents?
It is recommended to show the parent/child document (hierarchy) relationship in your document numbering. This shows how documents are related and prevents the creation of orphan documents (e.g. SOP-001, FORM-001-01).
Develop a document register to list all your documents and their status.

Then what?

Now that you’ve got the foundations sorted, you can start to the scope of your PQS. This will be driven by the compliance standard (e.g. GMP requirements), and the documents needed by your company to ensure effective planning, operation and control of your operations. This may change as you start to document your PQS; and that’s OK.

Once this scope has been established, then we’d recommend that you map your processes and develop a QMS structure for each process (see example below).

From here, you are ready to start drafting your documentation! Have a read through our Top Tips for Writing User-friendly GMP Documentation for further guidance.

You can also use professional technical writers to improve the quality of your PQS documents. This will also free up your technical experts so they can provide input. Sometimes our SMEs are technical geniuses but not great with writing in plain language, and that’s OK as we are here to help.

What if I have an existing PQS?

If you already have some documentation as part of your PQS, list these down and include their status (such as current, out of date, inaccurate, etc.). From this list determine which documents and processes should be included in the PQS scope.

There may be some areas of the business which you decide are out of the PQS scope (such as finance, billing or business strategy documents) however be careful when assigning documents as out of scope to avoid creating two document systems.

You can also request one of PharmOut’s experienced quality system specialists to conduct a gap assessment and review your existing documentation and systems to assist you with this exercise.

Need help?

PharmOut’s experienced technical writers can help you:

Scope your PQS
Develop your document templates and document numbering conventions
Conduct a gap assessment of your existing PQS
Help you write and implement your PQS.

Read more about implementing a PQS here: PharmOut White Paper: How to Implement a Quality Management System

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