All the guidance - in one* place

* -  To make this navigable the list of guidance documents have been broken down into sub sectional pages - which I will make live over the next few weeks. Actually deciding how to order these is pretty challenging given the sheer variety of guidance out there. 

Loosely the grouping of guidance areas is based on the standard chapter structure featured in Part 1 of EU/UK GMP Guidance as a starting point.  To accommodate the areas that are usually scattered through the annexes I have altered this somewhat.   

The chapters depart slightly from the common EU annex structure for convenience of grouping relevant guidance together.

If you think the guidance documents linked below are too thrilling you can also check our the primary legislation using our all the regulations in one place page.

1. Foundation Areas

  • Pharmaceutical Quality System

  • Personnel and Training

  • Premises, Utilities and Equipment

  • Data Integrity, Documentation and Computerised Systems

  • Qualification and Validation

  • QP Batch Certification and Release

  • Good Distribution Practise

  • Importation

2. GMP Activities - Preclinical and Clinical Development

  • Pharmaceutical Development and Quality by Design

  • CTD / PSF / Ethics

  • IMP Production and Manufacture

3. GMP Activities - Routine

  • Production and Manufacture

  • Quality Control and Testing

  • Auditing and Self inspection

  • Outsourced Activities

  • Complaints, Quality Defects and Product Recalls

  • Stability, Reference and Retention Samples

  • Sampling and Inspection

4. Product Type Specific Guidance

If you think something is missing please contact me.

Disclaimer

This document is not a legal document not should it be interpreted in any fashion as a guide. This is a set of notes compiled as part of a personal CPD program.  It is not complete or authoritative. I hope it gives you some value.

This is a personal effort and is not affiliated with my current role or employer.

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. If you use it to train someone else, fantastic, but give the QP Notebook a plug. Thanks