Training notes

These present a quick summary of the basics of a distinct pharmaceutical process, practise or product. The summaries are not exhaustive but are some of the elements that I feel are important to consider when getting stared in understanding the area.

They are written to help fellow trainees with no prior experience in the area as a starting point in their learning. The summaries primarily relate to aspects of knowledge sought in the QP study guide.

Reference material, when available on the internet and of interest but not fitting into either the study guide outline or the notes themselves will be linked below.

All the regulations in one place

Legal basis of the QP

QP Legal Duties

Role of the QP

The MHRA

Process Control Charts

Basic PQS

PQS as Process Control

PQS Guidance Compared

Basic autoclave validation

Basic HEPA

BCC risks

Sampling statistics and the sterility test

Basic Cleanroom Layout

PUPSIT