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

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 equipment.
design and construction up to routine usage, care should be taken
to minimize the risk of contamination so that the patients get Myth -2
quality medicines all the times. There are many myths prevailing
Vendor has provided equipment qualification
in pharmaceutical industries in view of equipment qualification
either 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 of
sometimes misunderstanding of regulatory aspects can enhance vendors on behalf of drug product manufactures when we insist
the risks of substandard quality of medicinal products and can for the reviewing of qualification status of equipments. The user
jeopardise the life of patients. hence, it is never too late when of equipment provides qualification documents and it is observed
initiative is taken immediately without failure. Ultimately human that the qualification documents has been provided by the vendor
welfare is our goal. of equipment manufacturer and he has filled the documents at
his end without going for the equipment qualification at the site
Need 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 understand
ensuring that a product or service is provided accurately and the importance of equipment qualification. As per regulatory
consistently with requirements. The following are the prerequisites guidelines the design qualification and factory acceptance testing
of 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 prove
Myths Prevailing For Equipment Qualification and Usage: scientifically that the equipment is suitable for the intended use. In
Myth -1 practice, the user needs qualification support from the vendor not
the filled qualification documents.
From the perspective of Vendors of equipment
manufacturers: 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 the
verbally due to which the user has to face lot of problems when the inspector asks for the calibration status. The answer from the GMP
equipment is not delivering as per the GMP requirements. Every and Regulatory aspect is “Calibration is must”. The reason is when
time the service engineer from the vendor’s end keep visiting to
we are using the equipment, there are chances of wear and tear
resolve the problem but the problems remains unresolved and
and only the practice of calibration can state that the equipment
ultimately the user reaches on a compromise and every time product
and its components are meeting the predetermined specifications
manufactured either has to be reprocessed or reworked and there
will be no availability of reprocessing or reworking documents and the equipment can be operated for the routine use. As per the
and from the GMP perspective neither the equipment can be said regulatory guidelines, all the measuring devices or instruments
qualified for the intended use and nor the manufacturing process which can affect the quality attributes of product should be calibrated
validated 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 be
specifications. There is great role of user requirement specifications properly documented and calibration status should be displayed
so that purchased equipment can meet the GMP and Regulatory on the equipment. The activity of calibration should be mentioned
compliance requirements and there will be no hassle in operation in the equipment sequential logbook.
*Email Id: jramniwas@saipharmasolutions.com
Pharma Times - Vol. 44 - No. 11 - November 2012 27

2. Myth-4 or the spare part used is of different make and different material
of construction (MOC)? As per the regulatory guidelines if the
What is the need for periodic review of qualification status
specifications make and material of construction of the spare part
when 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 other
processes should be periodically evaluated to verify that they are changes should be addressed through change control with impact
still operating in a valid manner. Where no significant changes analysis on product quality. The change control should be properly
have been made to the system or process, and a quality review documented and details of spare part change should also be
confirms that the system or process is consistently producing provided in the equipment sequential logbook.
material meeting its specifications, there is normally no need
for revalidation”. Periodic review is the benchmark to ensure the Myth-8
validity of operation and performance of the equipment. hence, it is
mandatory to resort to periodic review of the validated equipments. Is preventive maintenance part of equipment
Just 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 qualification
in the documentary form. (PQ) and in some multinational companies it is addressed through
maintenance qualification (MQ) which remains equipped with the
Myth-5 following documents:
What is the need of equipment sequential logbook when • Equipment history card
the details of equipment are in the Batch Manufacturing • Calibration Schedule
and Control Record (BPCR)? • Preventive Maintenance Schedule and record
During GMP inspections when it is asked to show the equipment • Periodic Review of Qualification Status
sequential logbook, the answer provided is “What is the need of
equipment 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 filled
asked “Is this equipment dedicated for this particular stage of this without going for preventive maintenance and situation becomes
product only?” The answer is NO. As per regulatory guidelines if the grave when preventive maintenance is not recorded in the
equipment 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 (Batch
Manufacturing and Control Records) but if the equipment is not Myth -9
dedicated and is used for multiproduct, it should have should have
equipment sequential logbook so that it provide accurate information Re-Qualification is hardly done
about the usage, cleaning, calibration and preventive maintenance If the equipment is working properly for so many years, what
of the equipment. Sometimes the equipment sequential logbook is the need of requalification? This is the answer provided when
becomes 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 been
sequential logbook is GMP requirement and it should be filled online many critical changes?” Further it is narrated that our production
during operation, cleaning, calibration and preventive maintenance. is going on in full swing. We never felt the need of re-qualification
Offline filling of logbooks is only a history and it can never become and we hardly find time for such activities. They agree only when
the 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 spare
Myth-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 criteria
working are following the gowning practices. Still is there in the equipment qualification protocol which states that the
requirement of controlled environment during the manufacturing? revalidation of the equipment shall be undertaken under the
The 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 environment
because controlled environment meets the temperature and 2. Replacement of major component of the equipment with a
humidity conditions required for the product simultaneously protects new component.
the product from contamination and degradation. The personnel 3. Any major critical change, modification, breakdown in
working 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 of
quality. The controlled environments also take care of dust, dirt,
QA dept through change control procedure.
grime and microbial growth which are detrimental to the product
quality, 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 many
Myth-7 critical changes have occurred but the equipment is not subjected
to re-qualification. This practice is against the risk management
Changing 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 been
the GMP requirements and change the spare parts of equipments devised by the experts with scientific rationale taking practical and
as 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. Myth -10 operations in SOPs are provided in the proper sequence which is
Why mention equipment identification code in BPCR not possible to remember point to point. The need of displaying
because 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 that
of the equipment to be used but the equipment identification
operations can be carried out in logical sequence by reading them
code 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 your
equipments are not dedicated the how can you claim that your There are many myths prevailing in industries regarding the
process is validated? Have you validated your process by using usage, cleaning, calibration and maintenance of equipments due
all these equipments which are being used in the manufacturing? to lack of understanding. There is need of awakening in this age
On review of process validation protocol it is found that the of science and risk based GMP environment. All manufacturers
equipments used during the process validation were different and will have to understand the insights of regulatory requirements
the equipments being used for the current manufacturing practices because pharmaceutical business ensures the safety of
are different. In these circumstances, the exercise of process patients. Regulatory bodies approve our products and facilities
validation and cleaning validation is meaningless and futile. This based on the assurance provided by us to maintain the GMP
is age of science based GMPs involving risk management in every standards even after post approval. The purpose of statement of
aspect of manufacturing. When we are not meeting the regulatory commitment by us to the regulatory bodies will be fulfilled only
requirements, it can be a serious issue and even lead to business when all the myths are resolved and we become practical in our
closure. approach and there is no difference in our saying and doing.
We can resolve any myths if we inculcate healthy philosophy
Myth -11
of life and sense of belongingness to the humanity. We have to
Why SOPs are required to be displayed in the vicinity of forget the bygone era and have to learn to live in the modern
equipments when our operators are operating them on and contemporary era. As such pharmaceutical sector has no
routine 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 approach
maintained by following the procedure mentioned in SOPs. All the for the implementation of regulatory systems.
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Pharma Times - Vol. 44 - No. 11 - November 2012 29