INSPECTION OF UTILITIES
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Leading the international development, implementation, and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products,
PIC/S has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021, (Geneva),
PI 009-4 Aide-Memoire on INSPECTION OF UTILITIES The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021.
The purpose of PI 009-4 Aide-Memoire is to provide guidance for GMP inspectors to use for training purposes and in preparation for inspections. The Aide-Memoire is the direct result of the 2001 PIC/S Seminar and was drafted with the aim of facilitating the effective planning and conduct of GMP inspections of utilities. The Aide-Memoire should enable the inspector to make both an optimal use of the inspection time and an optimal evaluation of GMP compliance.
The PI 009-4 Aide-Memoire on INSPECTION OF UTILITIES describes different areas that could be evaluated during the GMP inspection of HVAC systems, pharmaceutical water, steam, and medicinal gases. However, the Aide-Memoire should be considered as a non-exhaustive list of areas to be looked at during an inspection. The document is describing the following points;
HVAC Key design parameters Qualification of HVAC System Walk round tour Confront differences between design specifications, drawings (in SMF) and reality, unplanned maintenance, and change control and etc. Monitoring of HVAC systems Maintenance and calibration of HVAC systems Documentation for HVAC systems Pharmaceutical water system Key design parameters Qualification Walk round inspection Is water for injection produced and used according to requirements of Note for Guidance on Quality of Water for Pharmaceutical Purposes and Ph Eur? Confront differences between drawings and reality, unplanned maintenance, and change control. Follow the system from pre-treatment to user points: in each part, check leaks, sampling points (access), who does what, start-up and shutdown, cleaning/disinfection/sterilization), quantities produced. Quality control testing Monitoring Maintenance and calibration of water systems Documentation Pharmaceutical steam systems Key design parameters Qualification Walk round tour What kind of steam is used for the manufacture of pharmaceutical products – factory, clean steam generator)? What kind of source water is used for the production of steam? Confront differences between drawings and reality, unplanned maintenance, and change control. Follow the system in a logical order. Pay attention to leaks, sampling points (access), who does what, start-up and shutdown, cleaning/disinfection/sterilization), quantities produced. Monitoring Quality control testing Maintenance and calibration of the system Documentation Pharmaceutical gases Key design criteria (compressed air) Qualification Walk round inspection Identify all used gases with the risk for medicinal products. Confront differences between drawings and reality, unplanned maintenance and change control Follow the system in a logical order Operating the system Monitoring of the system Quality control Maintenance and calibration of the system Documentation To read the entire Aide-Memoire published by PIC/S Click here
This Short Note is published as a news update only; however, the detailed article on INSPECTION OF UTILITIES will be available shortly.
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