2012 Academy Seminar - Thessaloniki, Greece Storage and transportation of pharmacy compounded drugs
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1 2012 Academy Seminar - Thessaloniki, Greece Storage and transportation of pharmacy compounded drugs 21 April 2012, Barbara Wimmer, barbara.wimmer@gespag.at
2 Conflict of interest: nothing to disclose
3 1. Receipt of goods Transportation into storage rooms Storage Compounding of the drugs Transportation to final users/wards
4 1. Receipt of Goods 2. Transportation into storage rooms Storage Compounding of the drugs Transportation to final users/wards
5 1. Receipt of goods (flow of material is defined via SOPs) How can we make sure nothing is transferred into our cleanrooms that is inappropriate?
6 Receipt of goods Delivery of defined material (drugs, solvents and consumables) Inspection for Correctness and Integrity Sterile products: Certificate (batch)... Documentation
7 1. Receipt of goods 2. Transportation into storage rooms Storage Compounding of the drugs Transportation to final users/wards
8 2. Transportation into storage rooms Storage (ensure appropriate storage conditions) Unpacking Flow of material: SOPs
9 1. Receipt of goods 2. Transportation into storage rooms Storage Compounding of the drugs Transportation to final users/wards
10 3. Refrigerator defect or breakdown In-house building control system (surveillance of the refrigerators, temperature, pressure differences...) Deviation (rise out of defined ranges of e.g. refrigerators, cleanroom area): Alarm, doorkeeper of the hospital gets an alert and calls pharmacy If breakdown outside of office hours of the pharmacy: doorkeeper of the hospital alerts engineers, SOPs for emergencies available with the doorkeeper Plan where goods are going to be transferred Documentation of the deviation
11 Displays of pressure differences and temperatures within the different parts of the cleanroom area as pass-throughs, storage rooms and locks.
12 1. Receipt of goods 2. Transportation into storage rooms Storage Compounding of the drugs Transportation to final users/wards
13 4. Compounding of the drugs Transportation protocol Transportation to the wards/final users (in-house or to external hospitals)
14 Implementation of compounding of cytotoxic drugs into pharmacy premises Transportation logistics of in-house pick up and delivery service Analysis of established routes and procedures Analysis of needs of end-user (=supplied wards) Definition of requirements of end-user Definition of new routes and timetables for the pickup and delivery service
15 Transportation Transportation had to be validated External transportation: - Ratified contract with the transportation company and the pharmacy - Time within the span as defined in qualification of transportation boxes...appropriate temperature
16 Equipment On the basis of risk analyses the following documents were generated User requirement specification (to describe the required functions of the device) Design specification Plan and subsequent report of qualification of the refrigerators and the boxes for transportation
17 Qualification of equipment Definition of the number and positions of the measuring equipment Qualification of the refrigerators and the transportation boxes via temperature sensors and data loggers Adherence to appropriate and consistent temperature Worst case scenarios
18 Equipment qualification (refrigerator) Temperature detectors are placed on defined positions
19 Equipment qualification (refrigerator) Temperature graphs were analysed
20 Annual check of the refrigerator Loaded, data loggers
21 Annual check of the refrigerator Without load, data loggers
22 Annual check of the refrigerator Moderately loaded, data loggers
23 Cooling packs used in the transportation boxes Cooling packs with temperature indicators
24 Labelling of the transportation boxes Source: ESOP recommendation for transport of highly potent drugs, the text must be written in the language spoken in the region
25 Transportation box
26 Safe disposal of spilt cytotoxics Figure source: April 2012
27 Figure source: April 2012
28 Figure source: April 2012
29 Figure source: April 2012
30 Figure source: April 2012
31 Figure source: April 2012
32 Figure source: April 2012
33 Figure source: April 2012
34 Figure source: April 2012
35 Figure source: April 2012
36 Figure source: April 2012
37 Pharmacy entrance Transportation boxes are collected here
38 Good distribution practice (GDP) ensures that the level of quality determined by GMP is maintained throughout the distribution network, so that medicines are distributed without any alteration of their properties.
39 References Useful links: ASHP American Society of Health system Pharmacists Guidelines on handling hazardous drugs, Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use, EU Guidelines to Good Manufacturing Practice, Medical Products for Human and Veterinary Use, Volume 4, Annex 1 Manufacture of Sterile Medicinal Products, ESOP recommendation for transport of highly potent drugs, Guidelines on good distribution practice of medicinal products for human use (94/C 63/03), Good distribution practices (GDP): practices as specified in the European Commission. ICH Q9 Quality risk management, QuapoS Quality standard for the oncology pharmacy service, Resolution CM/ResAP on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients, 2011.
40 Thank you very much for your attention! Source photos: Pharmacy LKH Steyr
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