Facility & Equipment sub-system of the Quality System approach - a very brief introduction

1. Joseph T. Busfield Pharmaceutical Technical Services [email_address] www.PTSGMP.com A very brief outline of the Facility & Equipment System component of the GMP Quality System Seminar offered by PTS Note: This presentation has been distilled from the complete session and is less than 25% of the material Materials System Laboratory Control System Production System Quality System Facilities & Equipment System Packaging and Labeling System

10. The Project Engineering Program Materials System Laboratory Control System Production System Quality System Facilities & Equipment System Packaging and Labeling System

22. Joseph T. Busfield Pharmaceutical Technical Services [email_address] www.PTSGMP.com The Calibration & Maintenance Programs Materials System Laboratory Control System Production System Quality System Facilities & Equipment System Packaging and Labeling System

24. Bases Maintenance (and Calibration) 21 CFR § 211.67 Equipment cleaning and maintenance. (b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following: . . . (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance; Procedures Compliance Compliance

34. Example – WFI Multi-effect Still House Steam 1 st Effect 2nd Effect 3d Effect PI PI 2 PI PI 3 PI 1 Utility Non-critical Condenser AIT 1 Critical Conductivity

36. Process Tolerances Process Calibration Tolerances True Value The Importance of Relationships! Calibration Limits Manufacturer’s Stated Accuracy

38. Joseph T. Busfield Pharmaceutical Technical Services [email_address] www.PTSGMP.com Auxiliary Facility Programs Materials System Laboratory Control System Production System Quality System Facilities & Equipment System Packaging and Labeling System

55. Qualification & Training of Maintenance Technicians You must be able to demonstrate that the folks working on GMP equipment are qualified by training, education, and experience or some combination thereof to do the tasks assigned. In-house or out-house technicians. You do not dodge or fulfill your compliance responsibilities by signing a Purchase Order!

57. Qualification of Outside Contractors Outside contractor organizations require qualification, the level of which depends on the level of support of field personnel. Example. A general tin-knocker company does not support field personnel technically and requires less rigor than a HEPA testing company providing test instruments and equipment and specialized training.