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Equipment compliance requirement from the regulatory perspective
 

Equipment compliance requirement from the regulatory perspective

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Equipment Compliance Requirement from the Regulatory Perspective

Equipment Compliance Requirement from the Regulatory Perspective

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    Equipment compliance requirement from the regulatory perspective Equipment compliance requirement from the regulatory perspective Document Transcript

    • ARTICLE Equipment Compliance Requirement from the Regulatory Perspective J.Ramniwas* CEO, Sai Pharma Solutions Inc., Vadodara. Equipment used in the manufacture, 1. That the equipment is installed according 3. Equipment Descriptionprocessing, packing, or holding of a drug to the manufacturer’s instructions. 4. Responsibilitiesproduct should be of appropriate design, 2. That the equipment is operated properly 5. Identification and Verification of theadequate size, and suitably located to and consistently. equipment systemfacilitate operations for its intended use andfor its cleaning and maintenance. Process 3. That the equipment performs within 6. Identification and verification of majorequipments play a very important role for the requirements determined by the componentsdelivering drug products of impeccable and facility. 7. Identification of process controlconsistent quality. Right from the design The journey of equipment qualification instrumentsand construction to routine usage, care starts from the User Requirementshould be taken to minimize the risk of 8. Verification of correct installation and Specifications which are discussed with the calibrationcontamination so that the patients get quality vendor and based on the agreement signed.medicines all the times. The user requirement specifications cover 9. Identification and Verification of direct the following details about the equipment: contact surfacesDesign 10. Identification and verification of required 1. Process/ Product Requirements utilities The design of process equipment used 2. Operational Requirements 11. Identification and verification of requiredin the manufacture of drug substances anddrug products should be of appropriate 3. GMP/GLP Requirements documentationdesign and adequate size, and suitably 4. Safety Requirements 12. Deviation and Corrective Actionslocated for its intended use and there should 5. Documentation Requirements 13. Summary Reportbe an ease in cleaning, sanitization andmaintenance. 6. Discussion/Review/Comments After installation qualification, the equipment is subjected to operational Based on URS, the equipment designConstruction is discussed and equipment design qualification where each and every component and control panel is tested for The construction of the equipment qualification is undertaken. The protocol its functional and operational requirementsshould be undertaken in such a way that of design qualification covers the following to ensure the suitability of the operationthe surfaces in contact with the components, parameters: of components and control panels forin-process materials, or drug products are 1. Preapproval their intended use. During operationalnot reactive, additive, or absorptive so as to qualification, the training needs are identified 2. Overviewalter the safety, identity, strength, quality or and all procedures for the routine usepurity of the drug product beyond the official 3. Acceptance Criteria of the equipment become effective. Theor other established requirements. 4. Description of Equipment operational qualification protocol contains 5. Statement of Qualification the following informations: Any substance which is required foroperation of the equipments such as 6. Design Qualification Final Report 1. Objectivelubricants or coolants should not come into 7. Post Approval 2. Scopecontact with components, drug product 3. Equipment Descriptioncontainers, closures, in-process materials, After the design Qualification, the factory acceptance testing (FAT) is 4. Responsibilitiesor drug products so as to not alter the safety,identity, strength, quality, or purity of the undertaken jointly by the customer and 5. Identification of OQ tests and conductingdrug product beyond the official or other vendor engineering team. Once FAT is the functional testsestablished requirements. The lubricants approved, the equipment is dispatched to 6. Verification of calibration of critical the customer’s end and over there SAT (Site process instrumentsused should be of food grade. Acceptance Testing) is undertaken by the engineering team of the customer. Once the 7. Identification and verification of functionalEquipment Qualification equipment meets the SAT requirements, it is tests for interlocks and alarms Equipment qualification is a necessary subjected to installation. The IQ (Installation 8. Identification and verification of functionaland critical step in ensuring that a product or Qualification) Protocol contains the following tests for safety and securityservice is provided accurately and is consist- information: 9. Identification and verification of SOPsent with the requirements. Following are the 1. Objectiveprerequisites of equipment qualification: 10. Identification and verification of training 2. Scope needs*Email id: info@saipharmasolutions.com Pharma Times - Vol. 43 - No. 10 - November 2011 29
    • 11. Deviation and Corrective Actions 5. Instructions for the removal or obliteration Incidents related to computerized systems12. Summary Report of previous batch identification. that could affect the quality of products or The consistent performance of the 6. Instructions for the protection of clean the reliability of records or test results shouldequipment to manufacture products of equipment from contamination prior to be recorded and investigated. Changes toimpeccable quality is determined by the use. the computerized system should be madeperformance qualification. The preventive 7. Inspection of equipment for cleanliness according to a change control procedure andmaintenance of equipments is also a part immediately before use. should be formally authorized, documentedof the performance qualification. Some and tested and records thereof should be 8. Establishing the maximum time thatregulatory guidelines address preventive maintained. The computerized data should may elapse between the completion ofmaintenance separately under maintenance be protected and should be secured in the processing and equipment cleaning.qualification (MQ). Preventive maintenance incremental order.is the key for the consistence performance Periodic Review of Validation/ Documentationof the equipment. The performance Qualification Status Documentation is the evidence ofqualification protocol contains the following All the qualified equipments should be execution of any activity. From the regulatorydetails: periodically evaluated to verify that they perspective, following documents for1. Purpose are still operating in a valid manner. There the equipment should be prepared and2. Description should be an annual review and conclusion maintained:3. References should be drawn whether equipment stands 1. Equipment qualification protocols and4. Responsibilities in validated state or not. If the equipment reports (URS, DQ, FAT, SAT, IQ, OQ5. Performance Qualification (Test Plan) or the system is consistently producing and PQ).6. PQ Acceptance Criteria material meeting its specifications, there is 2. Standard Operating Procedure for7. Modification/ Change Control and normally no need for revalidation. Operation, Calibration, Cleaning and Revalidation Change Control maintenance.8. Comments/ Action Items 3. Sequential log books.9. PQ Attachments Any changes in the equipment which 4. Calibration, Cleaning and Preventive • Test Data Sheet can have impact on the product quality maintenance records. • Test Instrument Calibration and should be addressed through the change 5. Change control and deviation records. Analytical Instrument Validation control system depending upon the nature of 6. History cards etc.Calibration impact of the change on the product quality. The regulatory requirements for the The test equipments which are equipped They may cause major and minor impacts on product quality. All changes related to the equipments are becoming stringent day bywith test instruments and are used for the day as there has been a paradigm shift incontrol, weighing, measuring, monitoring equipments should be evaluated based on the criticality of the operation and impact on the focus of regulatory auditors. The keyand are critical for assuring the quality criterion has been risk management andof drug substances and drug products the product quality. product safety. All manufacturers will haveshould be calibrated according to written Computerized Systems to comply with all the forthcoming challengesprocedures and the established schedule. to stay in pharmaceutical business. GMP related computerized systemsCalibrations should be performed using should be validatedstandards traceable to certified national depending upon the Advertisers’ Indexand international standards like NPL or diversity, complexityNIST. The calibration records should be Sr. No. Company Name Page No. Sr. No. Company Name Page No. and the critical naturemaintained and calibration status label 1. A H Industries .................................78 23. Integrated Cleanroom of the computerizedshould be displayed. The Instruments that 2. Accin Packaging Pvt. Ltd. ...............98 Technologies Ltd. ............................49 application. Thedo not meet calibration criteria should not 3. Accupack Engineering Pvt. Ltd. ......99 24. IMA-PG India Private Ltd. .................4 installation qualificationbe used. 4. Accura Pharmaquip Pvt. Ltd. ..........91 25. Krishtech Solutions .........................88 and operationalMaintenance and Cleaning qualification should 5. Adam Febriwerk Pvt. Ltd. ................98 26. Kesari Tours & Travels ....................97 27. Kevin Process demonstrate the 6. Agam & Gem Engineers .................88 There should be standard operating Technologies Pvt. Ltd. .....................85procedures in place for the preventive suitability of computer 7. Ambica Pharma .............................101 28. Labtop Instruments Pvt. Ltd. ...........84maintenance and cleaning of all equipments. hardware and software 8. Ami Polymer Pvt. Ltd. ......................92 29. Labsystems & Biotech (I) Pvt. Ltd. ..55There should be a preventive maintenance to perform assigned 9. API & bFormulation Unit for Sale ....50 30. N. K. P. Pharma Pvt. Ltd. ................87program for all equipments and it should tasks. There should 10. Bectochem Consultants & 31. National Pharma Machinery ............77 be controls to prevent Engineers Pvt. Ltd. ........................ 94,95 32. Newtronic Equipmentbe followed as per the check list provided. 11. Brothers Pharmamach (India)Similarly, cleaning of equipments is of omissions in data (e.g. Company Pvt. Ltd. ...........................14 Pvt. Ltd. ...........................................90 33. Nimach Engineering Co. .................88utmost importance in the prevention of system turned off and 12. Cadmach .........................................79 34. Parle ................................................82batch to batch and product to product data not captured). 13. Captech Engineers ..........................92 35. Precitech Industries .........................89contamination. There should be a 14. Cealsons Industries .........................88 36. Promas Engineers Pvt. Ltd. ..............8 record of any data The cleaning procedure should contain 15. Centre for Clinical Research & 37. Sannira Associates .........................89 change made, the Training ...........................................36 38. Shreeji PharmaTech .......................93the following: previous entry, who 16. Chamunda .....................................100 39. Tapasya Engineering Works Pvt. Ltd. . 831. Assignment of responsibility for cleaning made the change, 17. Cronimach .......................................56 40. Target Innovations ..........................93 of equipment. and when the change 18. Dhara Engineers .............................80 41. Technofour Electronic Pvt. Ltd ........862. Cleaning and sanitizing schedules. was made. There 19. Dipesh Engineering Works ..............05 42. Thermo Scientific ..............................63. A complete description of the methods should be written 43. Thermolab Scientific Equipment .....12 20. Elmach Packages (India) and materials. standard procedures Pvt. Ltd. ...............................52,53,102 44. TSA Process Equipments Pvt. Ltd. .81 for the operation 45. UBM India Pvt. Ltd ..........................514. Instructions for disassembling and 21. Fabtech Technologies and maintenance of International Ltd. ..................2,3,13,15 46. Universal Madicap Ltd. ....................54 reassembling each article of equipment computerized systems. 22. Galaxy Shivtek ................................36 47. West Pharma ..................................10 to ensure proper cleaning.Pharma Times - Vol. 43 - No. 10 - November 2011 30