26/27 January 2021
In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) issued the new document PI 052-1. What is in it?
The PI 052-1 document is entitled "INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL) ASSESSMENTS AND USE IN QUALITY RISK MANAGEMENT". The document is divided into seven chapters:
and comprises 10 pages.
It is intended to help a GMP inspector who does not have specialized toxicology knowledge to evaluate Health Based Exposure Limits (HBEL). In the introduction it is pointed out that HBELs may well differ for the same substance if they have been calculated by different experts. Variations with a factor of 3 are considered normal, variations with a factor > 10 are intended to prompt the inspector to conduct further "investigations"... The introduction also points out that Permitted Daily Exposure (PDE) and similarly Acceptable Daily Exposure (ADE) also refer to health based limits. Finally, the introduction contains a note on the classification of inspection deficiencies with regard to their significance and influence on patient safety. For example, deficiencies should only be classified as critical if they have a direct impact on patient safety.
The actual Aide memoire part (Chapter 5) is divided into three columns in a table: a column with questions ("prompt"), a column with expectations and a reference column regarding GMP regulations and further information. The table is then split into 2 sections by rows. One section deals with the evaluation of health based limits. The other section deals with the quality risk management studies derived from the health based limits, which then lead to organisational and technical measures. For example, Section 1 contains questions or instructions such as
The following questions or instructions are listed in section 2:
The document concludes with references and the revision history.
The topic of cross-contamination from the point of view of cleaning validation will be dealt with during the ECA Live Online Training Cleaning Validation on 3/4 September 2020.
You can find the document on the PIC/S website, see PI 052-1.