Annex 4 Supplementary guidelines on good manufacturing practices

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Format for an installation qualifi cation protocol and report a Validation protocol _________ Installation Qualifi cation _________ Page _____ of _____ Title: ______________ Name and address of site: ________________________________ ________________________________________________________________________________ Validation Protocol # __________________________________ IQ Protocol number: ______ Title: ___________________________________________________________________________ Protocol written by: _________________________________ Protocol approved by: ______________________________ Date: _____________________ QA Approval: ______________________________________ Date: _____________________ Objective To ensure that _________________ (system/equipment) installed conforms to the purchase specifi cations and the manufacturer details and literature, and to document the information that ________________________ (system/equipment) meets its specifi cations. Equipment inventory number: _____________________________________________________ Scope To perform installation qualifi cation as described in this IQ protocol at the time of installation, modifi cation and relocation. Responsibility ___________________ (post/person) overseeing the installation will perform the qualifi cation and records results. ___________________ (post/person) will verify results and write the report. Quality Assurance will review and approve the IQ protocol and report. a This format is used for training purposes and refl ects some of the possible contents for an installation qualifi cation protocol. 150
Format for an installation qualifi cation protocol and report (continued) a Validation protocol _________ Installation Qualifi cation _________ Page _____ of _____ Title: ______________ Name and address of site: ________________________________ ________________________________________________________________________________ System/Equipment _______________________________ Code no.: ___________________ a. Description of the system/equipment being installed: general description of the function and the main components. _______________________________________________________________________________ _______________________________________________________________________________ _______________ b. List of the main components: 1. _________________________________ Code no.: _____________________________ 2. _________________________________ Code no.: _____________________________ 3. _________________________________ Code no.: _____________________________ 4. _________________________________ Code no.: _____________________________ c. Description of supporting utilities (e.g. piping, connections, water supply) 1. _________________________________ Code no.: _____________________________ 2. _________________________________ Code no.: _____________________________ 3. _________________________________ Code no.: _____________________________ 4. _________________________________ Code no.: _____________________________ Procedure 1. Prepare a checklist of all components and parts, including spare parts according to the purchase order and manufacturer’s specifi cations. 2. Record the information for each actual part, component, item of auxiliary equipment, supporting facilities, and compare with the manufacturer’s specifi cations. 3. Record any deviations to the system/equipment. 4. Prepare a deviation report including justifi cation of acceptance and impact on the function. 5. Prepare an IQ report. b 6. Submit the report to QA for review and approval. a This format is used for training purposes and refl ects some of the possible contents for an installation qualifi cation protocol. a As a minimum, the IQ report should include the date of initiation of the study, date completed, observations made, problems encountered, completeness of information collected, summary of deviation report, results of any tests, sample data (if appropriate), location of original data, other information relevant to the study, and the conclusion on the validity of the installation. 151
Page 1 and 2: © World Health Organization WHO Te
Page 3 and 4: turers. It is not the intention to
Page 5 and 6: qualifi cation Action of proving an
Page 7 and 8: 5.2.3 There should be proper prepar
Page 9 and 10: — change control — references t
Page 11 and 12: 11.11 Measurements made in accordan
Page 13 and 14: 12.3 Changes should be formally req
Page 15 and 16: 2.6 O & M manuals, schematic drawin
Page 17 and 18: Figure 2 System operating ranges Ac
Page 19 and 20: Appendix 2 Validation of water syst
Page 21 and 22: Appendix 3 Cleaning validation 1. P
Page 23 and 24: 4. Cleaning validation protocols an
Page 25 and 26: 6. Equipment 6.1 Normally only proc
Page 27 and 28: location (e.g. blades, tank walls o
Page 29 and 30: • group products into groups acco
Page 31 and 32: 2.5 The results of analytical proce
Page 33 and 34: 6.1.3.1 Factors that can have an ef
Page 35 and 36: Appendix 5 Validation of computeriz
Page 37 and 38: amending incorrect entries and crea
Page 39 and 40: • that it operates within the ope
Page 41 and 42: Appendix 6 Qualifi cation of system
Page 43: 4. Design qualifi cation Note: see
Page 47 and 48: Format for an installation qualifi
Page 49 and 50: Format for an operational qualifi c
Page 59 and 60: 7. Performance qualifi cation Note:
Page 61 and 62: Format for a performance qualifi ca
Page 67 and 68: 8. Requalifi cation Note: see also
Page 69 and 70: 4. Prospective validation 4.1 Criti
Page 71 and 72: 5.2 The decision to carry out concu

Annex 4 Supplementary guidelines on good manufacturing practices

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