Article          myths of equipment qualification and usage need to          be resolved from the regulatory perspectives ...
Myth-4                                                                  or the spare part used is of different make and di...
Myth -10                                                             operations in SOPs are provided in the proper sequenc...
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Myths of equipment qualification and usage need to be resolved from the regulatory perspectives


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Myths of equipment qualification and usage need to be resolved from the regulatory Perspectives

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Myths of equipment qualification and usage need to be resolved from the regulatory perspectives

  1. 1. Article myths of equipment qualification and usage need to be resolved from the regulatory perspectives J.Ramniwas* Founder & CEO Sai Pharma Solutions Inc. Vadodara Equipment qualification plays key role for the consistent and of equipment. Overlooking User Requirement Specifications(URS)impeccable quality of pharmaceutical products. Right from the is like groping in dark while designing the and construction up to routine usage, care should be takento minimize the risk of contamination so that the patients get Myth -2quality medicines all the times. There are many myths prevailing Vendor has provided equipment qualificationin pharmaceutical industries in view of equipment qualificationeither due to lack of knowledge or misinterpretation of regulatory documents:guidelines which need to be resolved on priority basis. Because When we go for auditing the manufacturing facilities ofsometimes misunderstanding of regulatory aspects can enhance vendors on behalf of drug product manufactures when we insistthe risks of substandard quality of medicinal products and can for the reviewing of qualification status of equipments. The userjeopardise the life of patients. hence, it is never too late when of equipment provides qualification documents and it is observedinitiative is taken immediately without failure. Ultimately human that the qualification documents has been provided by the vendorwelfare is our goal. of equipment manufacturer and he has filled the documents at his end without going for the equipment qualification at the siteNeed of Equipment Qualification: of manufacturer. There is no involvement of engineering, quality Equipment qualification is a necessary and critical step in assurance and user department. Even user does not understandensuring that a product or service is provided accurately and the importance of equipment qualification. As per regulatoryconsistently with requirements. The following are the prerequisites guidelines the design qualification and factory acceptance testingof the equipment qualification: (FAT) are undertaken at the end of equipment vendor by involving the engineering and quality assurance department of user and site• That the equipment is designed meeting the GMP and regulatory acceptance testing (SAT), Installation Qualification (IQ), Operational requirements Qualification (OQ) and Performance Qualification (PQ) is undertaken• That the equipment is installed according to the manufacturer’s at the site of user by involving the quality assurance, engineering instructions. and user department with adequate qualification protocol.• That the equipment is operated properly and consistently. Receiving filled qualification documents from the equipment vendor is not the right practice of equipment qualification at all. This is• That the equipment performs within the requirements determined simply an eye wash by the vendor that he has provided the filled by the facility. qualification documents that serve no purpose because Equipment qualification needs to be executed on user’s shop floor to proveMyths Prevailing For Equipment Qualification and Usage: scientifically that the equipment is suitable for the intended use. InMyth -1 practice, the user needs qualification support from the vendor not the filled qualification documents.From the perspective of Vendors of equipmentmanufacturers: Myth-3 Vendors of equipment manufacturing do not insist for the Calibration for what?User Requirement Specifications (URS) from the customer to My equipment is working properly. Does it still need calibration?understand the design aspects of equipment. Everything happens This is the question frequently asked during inspection when theverbally due to which the user has to face lot of problems when the inspector asks for the calibration status. The answer from the GMPequipment is not delivering as per the GMP requirements. Every and Regulatory aspect is “Calibration is must”. The reason is whentime the service engineer from the vendor’s end keep visiting to we are using the equipment, there are chances of wear and tearresolve the problem but the problems remains unresolved and and only the practice of calibration can state that the equipmentultimately the user reaches on a compromise and every time product and its components are meeting the predetermined specificationsmanufactured either has to be reprocessed or reworked and therewill be no availability of reprocessing or reworking documents and the equipment can be operated for the routine use. As per theand from the GMP perspective neither the equipment can be said regulatory guidelines, all the measuring devices or instrumentsqualified for the intended use and nor the manufacturing process which can affect the quality attributes of product should be calibratedvalidated because equipment is not delivering as per the design and the calibration standards used, should be traceable to the NIST,specifications and product manufactured not meeting the quality NPL and or Pharmacopoeial standards. The calibration should bespecifications. There is great role of user requirement specifications properly documented and calibration status should be displayedso that purchased equipment can meet the GMP and Regulatory on the equipment. The activity of calibration should be mentionedcompliance requirements and there will be no hassle in operation in the equipment sequential logbook.*Email Id: Pharma Times - Vol. 44 - No. 11 - November 2012 27
  2. 2. Myth-4 or the spare part used is of different make and different material of construction (MOC)? As per the regulatory guidelines if theWhat is the need for periodic review of qualification status specifications make and material of construction of the spare partwhen my equipment is performing well? is same as the previously used and it does not affect the quality This is clearly mentioned in GMP guidelines that “systems and attribute of the product, no change control is required but otherprocesses should be periodically evaluated to verify that they are changes should be addressed through change control with impactstill operating in a valid manner. Where no significant changes analysis on product quality. The change control should be properlyhave been made to the system or process, and a quality review documented and details of spare part change should also beconfirms that the system or process is consistently producing provided in the equipment sequential logbook.material meeting its specifications, there is normally no needfor revalidation”. Periodic review is the benchmark to ensure the Myth-8validity of operation and performance of the equipment. hence, it ismandatory to resort to periodic review of the validated equipments. Is preventive maintenance part of equipmentJust simply saying that “my equipment is performing well” is not qualification?adequate until and unless there is scientific justification provided Preventive maintenance is the part of performance qualificationin the documentary form. (PQ) and in some multinational companies it is addressed through maintenance qualification (MQ) which remains equipped with theMyth-5 following documents:What is the need of equipment sequential logbook when • Equipment history cardthe details of equipment are in the Batch Manufacturing • Calibration Scheduleand Control Record (BPCR)? • Preventive Maintenance Schedule and record During GMP inspections when it is asked to show the equipment • Periodic Review of Qualification Statussequential logbook, the answer provided is “What is the need ofequipment sequential logbook when the details of equipment are During inspection it is observed that in many industries,in the Batch Manufacturing and Control Record (BPCR)?” When preventive maintenance is an eye wash. Only checklists are filledasked “Is this equipment dedicated for this particular stage of this without going for preventive maintenance and situation becomesproduct only?” The answer is NO. As per regulatory guidelines if the grave when preventive maintenance is not recorded in theequipment is dedicated for the one stage of the one product only, equipment sequential logbook.the details of equipment use can be provided in the BPCR (BatchManufacturing and Control Records) but if the equipment is not Myth -9dedicated and is used for multiproduct, it should have should haveequipment sequential logbook so that it provide accurate information Re-Qualification is hardly doneabout the usage, cleaning, calibration and preventive maintenance If the equipment is working properly for so many years, whatof the equipment. Sometimes the equipment sequential logbook is the need of requalification? This is the answer provided whenbecomes the tool of investigation when there is any product quality asked during GMP inspection “Is this equipment subjected to re-failure or any complaint from the customer. Therefore, equipment qualification as it is being used for so many years and there has beensequential logbook is GMP requirement and it should be filled online many critical changes?” Further it is narrated that our productionduring operation, cleaning, calibration and preventive maintenance. is going on in full swing. We never felt the need of re-qualificationOffline filling of logbooks is only a history and it can never become and we hardly find time for such activities. They agree only whenthe tool of investigation. they are told that this can lead to break down of equipment due to wear and tear, malfunction due to not matching of changed spareMyth-6 part, product degradation and product quality defects as without re-Is the controlled environment necessary while operating qualification and impact analysis what is will be fate of the product? Nobody knows.the equipment? We keep the rooms clean and sanitized and the personnel It remains clearly mentioned about the revalidation criteriaworking are following the gowning practices. Still is there in the equipment qualification protocol which states that therequirement of controlled environment during the manufacturing? revalidation of the equipment shall be undertaken under theThe answer is “Yes” because Equipment used in the manufacture, following circumstances:processing, packing, or holding which can affect the quality 1. When there is change in location of the equipment.attributes of the product, should be provided controlled environmentbecause controlled environment meets the temperature and 2. Replacement of major component of the equipment with ahumidity conditions required for the product simultaneously protects new component.the product from contamination and degradation. The personnel 3. Any major critical change, modification, breakdown inworking in the room can work comfortably and without sweating equipment.profusely which mix with the product and can alter the product 4. Re-qualification shall be done by the recommendation ofquality. The controlled environments also take care of dust, dirt, QA dept through change control procedure.grime and microbial growth which are detrimental to the productquality, safety and efficacy. But during review of documents it is found that the equipment is being used for many years, its location is changed and manyMyth-7 critical changes have occurred but the equipment is not subjected to re-qualification. This practice is against the risk managementChanging spare parts without change control and a challenge to the regulatory compliance requirements. We We have the qualified engineering department and they know should not violate the regulatory guidelines because they have beenthe GMP requirements and change the spare parts of equipments devised by the experts with scientific rationale taking practical andas and when required. When asked “Was it like to like change risk management approach in to consideration.Pharma Times - Vol. 44 - No. 11 - November 2012 28
  3. 3. Myth -10 operations in SOPs are provided in the proper sequence which isWhy mention equipment identification code in BPCR not possible to remember point to point. The need of displayingbecause we can use any equipment? SOPs is because of consistency of operations in the same logical sequence which vary person to person if SOPs are not followed. During GMP inspections, it is observed that there is mention This is why regulatory bodies insist on displaying the SOPs so thatof the equipment to be used but the equipment identification operations can be carried out in logical sequence by reading themcode is left blank in the batch manufacturing and control records without affecting the quality of products and simultaneously SOPs(BPCRs). When asked “why the equipment identification code is boost the confidence of doers.not preprinted? Why is it written in Ink?” The answer provided is“we can use any equipment when there is production load so that Conclusion:we need not wait for the particular equipment”, this means yourequipments are not dedicated the how can you claim that your There are many myths prevailing in industries regarding theprocess is validated? Have you validated your process by using usage, cleaning, calibration and maintenance of equipments dueall these equipments which are being used in the manufacturing? to lack of understanding. There is need of awakening in this ageOn review of process validation protocol it is found that the of science and risk based GMP environment. All manufacturersequipments used during the process validation were different and will have to understand the insights of regulatory requirementsthe equipments being used for the current manufacturing practices because pharmaceutical business ensures the safety ofare different. In these circumstances, the exercise of process patients. Regulatory bodies approve our products and facilitiesvalidation and cleaning validation is meaningless and futile. This based on the assurance provided by us to maintain the GMPis age of science based GMPs involving risk management in every standards even after post approval. The purpose of statement ofaspect of manufacturing. When we are not meeting the regulatory commitment by us to the regulatory bodies will be fulfilled onlyrequirements, it can be a serious issue and even lead to business when all the myths are resolved and we become practical in ourclosure. approach and there is no difference in our saying and doing. We can resolve any myths if we inculcate healthy philosophyMyth -11 of life and sense of belongingness to the humanity. We have toWhy SOPs are required to be displayed in the vicinity of forget the bygone era and have to learn to live in the modernequipments when our operators are operating them on and contemporary era. As such pharmaceutical sector has noroutine basis? dearth of wisdom, genius, knowledge, brilliance and intellectual All equipments are operated, cleaned, calibrated and potential. Only thing is to adopt interactive and practical approachmaintained by following the procedure mentioned in SOPs. All the for the implementation of regulatory systems. Logo Designing Contest for IPA Platinum Jubilee Celebrations In order to commemorate its Platinum Jubilee, Indian Pharmaceutical Association (IPA) proposes to conduct year-long celebrations from December 23, 2013 to December 23, 2014. In this context, IPA has pleasure in announcing IPA Platinum Jubilee Logo Designing Contest We invite readers to send in their versions of IPA Platinum Jubilee logo. This logo should basically reflect the ethos of the Association and be symbolic of the professional journey that IPA has covered in these 75 years. The IPA Platinum Jubilee logo would be featured on all Platinum Jubilee program announcements and promotional material as well as on IPA publications round the year. A team of distinguished jury members would select the best out of the shortlisted logos. The final selected logo would be given a cash prize and the winner’s name would be announced prominently in Pharma Times and other IPA publications. Last date for sending in entries: January 31st, 2013 You can send your entries to Participate in this contest and leave your imprint on this momentous occasion!! Pharma Times - Vol. 44 - No. 11 - November 2012 29