MESUTRONIC Metal Detection made in Germany Section 2 1Q/ OQ test plan PHARMATRON 07 HQ Table of contents Approval list of the document Page 2 Change history of the document Page 3 2.1 Brief description of the appliance Page 4 2.2 Abbreviations used Page 5 2.3 Responsibilities 2.4 — Test procedure 2.5 Overview of IQ/ 02 test protocols Page 10 2.6 Qualification report Page 12 2.7 Signature listMESUTRONIC | Master qualification plan vember. roe el Ont mae nema, 1Q/0Q Test plan lee Metal detector PHARMATRON 07 HQ Ser. no.: | 2021-1000-PH Approval list of the document Created by: Date: ‘Signature: 14.12.2012 - > Birbeck Ce BK Engineering GmbH & Co. KG ‘Approved by: Date: ‘Signature: Managing Director: : . Karl-Heinz Diirrmeier MESUTRONIC Geratebau GmbH i M Place of storage of the original documer File name: Remarks: Marketing/Sales ‘TP0107 Created by an external partner company Dated 1072013 Zot {© MESUTRONIC Gmbé 2012Number: | TP0107 MESUTRENIC | Master qualification plan Version: [43 Met Deco modem Geminy 1Q/0Q Test plan Metal detector PHARMATRON 07 HQ Ser. no.: | 2021-1000-PH Change history of the document SMR rT) Name 10 Initial creation 14.12.2012 | C. Bimbeck 14 1Q'5 added and re-sorted, dated July 2013, 08.07.2013 | c. Bimbeck Extension of the 00 test protocols, reports according to 21 CFR 12 ectension of SRO teeteay 21.10.2018 | ¢. Birbeck Dated 102018 Page 3013 {© MESUTRONIC GmoH 2012MESUTRO@NIC Master qualification plan Namoet._TP0107 es Oeecon meWGemany 1Q/0Q Test plan = Metal detector PHARMATRON 07 HQ. Ser. no.: | 2021-1000-PH_ 2.1 _ Brief description of the appliance ‘The MESUTRONIC PHARMATRON 07 HQ metal detector serves to detect metal contamina- tions in product streams and to fully automatically eject the contaminated product. The sen ity of the device for the following types of metal is: Nominal diameter 40 mm: Nominal diameter 50 mi e ball @ 0.3 mm, NFe ball @ 0.25 mm und SS ball @ 0.4 mm. e ball @ 0.3 mm, NFe ball 9 0.4 mm und SS ball @ 0.5 mm. a+ product contaminated by metal b> electromagnetic field ¢* separation flap Functional principle of the metal detection: An electromagnetic field is generated and evaluated in the detector head with the aid of transmission and reception components. 41> Ifa metal object enters the field, the measurement signal is deflected in a certain direc- tion. 2 If the metal particle wes the field, a deflection occurs in the opposite direction. 3+ If both adjustable switching thresholds are exceeded, the separation flap is actuated by the control electronics. The metal-contaminated product is diverted into the bad prod- uct outlet shaft. 4> After the preset separation period has expired, the flap is automatically closed again. Dated 4072013 Page 4 of (© MESUTRONIC GmbH 2012Number: | TPO107 | Master qualification plan = MESUTRENIC | cioa Test plan version: | 4.3 Metal detector PHARMATRON 07 HO Ser. no.: | 2021-1000-PH 2.2 pa Design Qualification 1a Installation Qualification oa Operational Qualification PQ Performance Qualification GMP Good Manufacturing Practice cGMP current Good Manufacturing Practice FDA Food and Drug Administration CFR Code of Federal Regulations amo Quality Management Officer URS User Requirements Specification PIC Pharmaceutical Inspection Convention FMEA Failure Mode and Effects Analysis HW Hardware sw Software vo Input/Output Fe Ferrous (iron) NFe Non-ferrous (e.g. brass) ss Stainless Steel Grade 304/1.4301 ss Stainless Steel Grade 316/1.4401 SOP Standard Operation Procedure PIN Personal Identification Number Dated 1072019 Page Sof 13 {© MESUTRONIC GmbM 2012rae Number: | TP0107 MESUTRENIC Master qualification plan Tacs a ea Oconee memory 1Q/0Q Test plan Metal detector PHARMATRON 07 HQ Ser. no.: | 2021-1000-PH 2.3 Responsibiliti 2.3.1 Creator - Correct and professional creation of plans and documents 2.3.2 Tester Checking the test results Evaluation of errors or deviations Initiation of further measures if necessary Competent and professional execution of the qualification tests 2.3.3. Operating company's production manager or project manager specifications and standards as well as with offic and regulations (before execution of the test) Checking the test results + Checking the 2.3.4 Quality Assurance or QMO Checking the qualification documents for conformity with company-internal and legal requirements Evaluating and eliminating existing errors and deviations reports after completion of the test = Checking the qualification documents for conformity with company-internal specifications and standards as well as with official and legal requirements and regulations (before execution of the test) - Approval of the qualification documents before and after execution - Evaluation of errors or deviations - Approval of the final report after compl ion of the quali ion tests Dated 1072013 Page 6 of 13 {© MESUTRONIC GmbM 20127 Number: | TP0107, MESUTRGNIC [Master qualification plan Version: [1.3 tea ection made nemay 1Q/0Q Test plan Metal detector PHARMATRON 07 HQ Ser. no.: | 2021-1000-PH 2.4 Test procedure 2.41 General Qualification plans (IQ and OQ) are made available for the qualification of the PHARMATRON 07 HQ metal detector in order to ensure the correct installa- tion and functionality of the appliance according to the specified design. This section describes the system according to which the following are car- ried out: - The execution of the test protocols = Recordings, handling of errors and reporting. ©& The 0a may not be started until the IQ has been successfully completed 2.4.2 Preparation of the test Before commencing with the tests, the tester must study the technical docu- mentation (operating manual) for the system in order to understand the test protocols and their acceptance criteria, which are associated with the system and the checked process. Each test protocol has several steps. Each step describes the activity to be carried out and the expected result in order to determine whether the step was successful or not. Each test protocol refers to functional specifications in the operating manual or to other reference documents. If additional test equipment is used for the qualification tests, the type and serial number must be recorded. Test equipment for calibration must be traceable to international standards (copy of calibration certificate). Before executing the test, this IQ / OQ test plan and the test protocols associ- ated with it must be checked and approved by the persons responsible. Dated 102013 Page of {© MESUTRONIC GmbN 2012Number: | TPO107 Master qualification plan — ESE TEENIE: | cica testinian Nersion: | 4.3 Metal detector PHARMATRON 07 HQ. ‘Ser. no.: | 2021-1000-PH 2.4.3 Execution of the test After approval, the execution of the test may commence. For each test, the tester must ensure that the necessary materials and pre-requirements, as ‘specified in the test protocol, are availat All test steps in the test protocol should be carried out by one tester. It makes ‘sense to carry out each test without interruption, since some tests are based on the preceding test. The steps described in each test protocol must be executed in the speci order. The actual result must be compared to the expected result and evaluated for each step. Sections of the test protocol which are not filled in must be struck through. id ae Sara DO Cea | a) Pe CUR Caucus items must be provided with initials and date. 2.4.4 Acceptance criteria If the results conform to the acceptance criteria, the tester must enter “Yes” in the “Successful?” column. If the results do not conform to the acceptance criteria, the tester must enter “No” in this column and enter an error number in the “Error No.” column (e.g. the first case is numbered F1, all others consecutively). When all steps have been carried out, the tester must fill in the conclusion and add the date. If all steps were successful, the conclusion must be marked “Yes” (Test fulfilled?) If at least one step was not fulfilled, the conclusion must be marked “No” (Test fulfilled?) The tester must list all documents which have been attached as proof of test- ing. This is done in the section “Proof of testing” with reference to the docu- ment. The tester must reference each attached document with an unique number to the associated test, including page number, signature and date (e.g. Appendix IQ 1, Page 1 of 2). If no documentation can be attached as proof, the test protocol must be signed by a witness to confirm its correct- ness. The test protocols and their appendices are approved by the Quality Assur- ance Department or by the QMO. Dated 1072013 Page 8 of 13 ‘© MESUTRONIC GmbH 20122.4.6 24.7 , 2 TPO107 MESUTRENIC Master qualification plan aa pblesatrey ty 1Q/0Q Test plan Metal detector PHARMATRON 07 HQ Ser. no.: | 2021-1000-PH 2.4.5 Errors and deviations If the test is not successful, the cause of the problem must be examined and a solution found. The cause of the problem and the solution should be docu- mented together with an approach towards a solution in an error / deviation report. Test repetition After elimination of an error or another solution to the problem (e.g. change of plan in the case of deviation), the test must be repeated. The number of test repetitions must be clearly marked in the header of the repeat test document. In the case of repetitions, all previous test protocols must be attached. The tests are repeated until the test plan is successful. The qualification can only be concluded if all tests were successful or if only GMP-uncritical and passable errors exist. All test protocols and proofs of testing must be attached to the qualification documentation. Final report After execution of all tests, the qualification report is drawn up (paragraph 2.6 in this section). All errors/deviations that occurred during the execution are listed. Solved or unsolved problems are hereby named. An evaluation of the error and the reaction to it should be recorded. Subse- quently, an evaluation of the system is carried out. The purpose of this is to judge whether the system can be used for the planned purpose, possibly with restrictions. Dated 102019 Page 90f13 ‘© MESUTRONIC GmbH 2012Number: | TP0107 Master qualification plan . MESUTREINIC | icioa Test plan Version: (13 Metal detector PHARMATRON 07 HQ. Se 2021-1000-PH 2.5 rview of IQ / OQ test protocols Important note! The customer issues a customer-specific document number for the IQ test protocol and the 0Q test protocol in order to be able to make a reference to the superordi- nated IQ / 0Q test plan. A customer-specific document number can also be issued for the IQ / OQ test plan in order to fit the document into the customer's documentation structure. 2.5.1 1Q test protocols IQ test protocol reference: | (Number/Version) bss Pei ried Pee (yes / no) 1Q1 | Test of the correct condition of the delivery unit 1Q2 | Check of the test documents 13 _| Test of the system components 1Q4 | Test of the electrical components & connections 1Q5 | Test of the hardware components rer euy EU Percy Srey ates 1072019 Page 10013, “@ MESUTRONIC GmbH 2012MESUTRONIC Master qualification plan Naver qeoner ed Dect ate nema, 1Q/0Q Test plan 4 Metal detector PHARMATRON 07 HQ. Ser. no.: | 2021-1000-PH_ 2.5.2 OQ test protocols 0Q test protocol reference: I (Number/Version) Poet dale aes mer aio 01 | Product learning test 0Q2 | Detection threshold test 0Q3 | Separation test 004 | Separation and monitoring test 005 | Parameter limits test 006 | Test of the recording of alarms/messages 007 | Test of reports according to 21 CFR Part 11 008 | Access protection test 009 | Authorisations test 0@ 10 | Test of the saving/loading of appliance settings 0011 | Test of power supply failure and restart oer mC Deed eur Created ‘© MESUTRONIC GmbH 2012 Dated 102019 Page 14 0F13,Master qualification plan Number: | TRO1OT. Dee ee | Gioa Tastiplan Version: | 13 Metal detector PHARMATRON 07 HQ Ser. no.: | 2021-1000-PH 2.6 Qualification report __(use an extra sheet if necessary) The appliance is: Status of the qualification: 0 qualified without errors O preliminary report © qualified with uncritical errors final report not qualified open errors / deviations iletneley ocak Created by: Checked | by: ‘Approved by: ry pr Sorc? Dated 1072073 Page 1201 13 ‘© MESUTRONIC GmbM 2012Number: | TPO107 Master qualification plan . MESUTRENIC | aioa Test plan Version: | 13 Metal detector PHARMATRON 07 HQ ‘Ser. no.: | 2021-1000-PH 2.7 __ Signature All persons involved in the qualification are listed here for identification. Ensure that the documentation is comple DOO rey Perenrcn Ts fo eke EC Dated #072013 Page 13 0f 13 (© MESUTRONIC Gmbé 20%neste welts’ Pilsup 1etesM fe sm 5 : alg ‘87 DOAD! sided vieaie aa igoftitsnp oitt ni bevicvnl anoxia tt 6ielg tyo0 zi coltalnomuoob ptt