Certification Links Training & Performance · industrial (C&I) microbiology tests for the...

CE RT I F I C AT I O N O F S C I E N T I S T S in the pharmaceutical industry isprogressively developing into an excellent way to show thatknowledge and skills can be measured by their ability to

enhance job performance. The benefits of certification for profession-al microbiologists have a 25-year proven track record. Certification isadministered by the National Registry of Microbiologists (NRM), aprofessional branch of the American College of Microbiology withinthe American Society for Microbiology (ASM).

A laboratory supervisor and his staff of microbiologists can

become certified through registration of college courses taken, rele-vant work experience and by passing a written exam. This provides apath for continuous learning and skills development.

Initial certification indicates an understanding of basic skills andbackground knowledge required to perform a job with pharmaceuti-cal microbiology responsibilities. Recertification rewards ongoingtechnical training and maintaining up-to-date knowledge of the prac-ticing field. Measuring the competency of educated, skilled scientistsis an important link between their training and success in their jobs.

Certification LinksTraining & Performance

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Pharmaceutical scientists can reap many benefits when they are certified by the American Society for Microbiology.

TI M NI C O L L

Hospira, Inc.DE N N I S RA N S O M

Nelson LaboratoriesDO N SI N G E R

G l a x o S m i t h K l i n e

December 2004 • Pharma & Bio Ingredients 39

What is NRM Certification?The NRM is the only organization in theU.S. that certifies microbiologists in bothclinical and non-clinical specialty areas. Asimilar organization exists in Canada with-in the Canadian College of Microbiologists.

Certification is attained by meetingthree requirements: submitting a transcriptof relevant college coursework, providingadequate job experience and passing aselected written exam.

Eligibility requirements for a registeredm i c r o b i o l o g i s t1 include having a Bachelor’sdegree (BS/BA) with 20 semester hours ofmicrobiology-relevant courses and one yearof full-time work experience or having 12semester hours of relevant courses andseven years full-time work experience. Ifthe work experience is the only require-ment not met, a person can become a con-ditional registrant.

If the educational and work require-ments are met, an exam is then taken. Theexam for registered microbiologist or condi-tional registrant in consumer products andquality assurance microbiology tests forknowledge, concepts and laboratory skillsrequired in a consumer product microbiolo-gy testing laboratory. The exam was createdfor pharmaceutical, medical device and cos-metic microbiologists.

Eligibility requirements for a specialistmicrobiologist include having a Bachelor’sdegree (BS/BA) with 20 semester hours ofmicrobiology-relevant courses and sevenyears of full-time work experience or havinga Master’s or Doctorate degree with 30semester hours of relevant courses and fouryears of work experience. The exam for spe-cialist microbiologist in consumer andindustrial (C&I) microbiology tests for theability to supervise the effective operationof biological procedures in a consumerp r oduct microbiology testing laboratory,specializing in pharmaceutical, medicaldevice or cosmetic microbiology.

Details about registration for NRM cer-tification including a study guide and appli-cation information can be acquired fromASM, based in Washington, D.C., byphone (202) 737-3600 or via e-mail (certi-f i c a t i o n @ a s m u s a . o r g ) .

Drug development and manufacture cancost millions of dollars. Ensuring thatknowledgeable scientists lead the waythrough development and then monitorquality in commercial manufacture is thekey to success in the pharmaceutical indus-t r y.2 Companies seek to hire educated scien-tists to minimize initial on-site training.They also depend on motivated individualsto keep abreast of new scientific develop-ments and achievements, industry compli-ance requirements and management devel-opment education.

Benefits for EmployersHiring an NRM-certified microbiologistreduces lead time to actual on-site work.An understanding of bench-level microbi-ology is necessary for most microbiologylaboratory and quality control employees,since there are many more scientists thanmanagers. A certified microbiologist hassubstantial knowledge that offers a solidfoundation for further career developmentwhere microbiology is useful, e.g. research,regulatory or auditing. A specialist microbi-ologist also has management experience tocomplement his or her basic knowledge andskills background.

Motivation of a certified microbiologistto keep up with the respective field ofknowledge benefits a company in these verycompetitive times. While it costs excessivemoney to get external experts to customizetraining for specialty scientists,2 m i c r o b i o l o-gists bring a breadth of general scientificknowledge and skills to the workplace.Certification substantiates the experience

and understanding of microbiology andoften develops into the ability to train oth-ers internally, at a much lower cost.

Using certification of its microbiologistsas a successful marketing tool has broughtincreased business to some companies. Ac o m p a n y ’s support of the certificationprocess can be a reason for a potentialemployee to join a company, thus attractingcertified or “want-to-be” certified scientists.

Some contract laboratories have gaineda reputation with clients of reliability andtrust, in part, based on a staff that is madeup mostly of certified microbiologists.Within the requirements for an accreditedl a b o r a t o r y, such as accreditation by ISO17025 requirements, is the proof that labo-ratory scientists are trained to perform spe-cific testing. Certification helps build thatproof of competency.

Current Good Manufacturing Practices(cGMPs) compliance requirements haveincreased during the past decade. Tr a i n i n gand increasing documentation of proof thatindividuals can perform skills related tomonitoring product quality can be easilysupported by an NRM certification.

An organization gains a level of assur-ance when it hires an individual that meetsacceptable standards for NRM certification.

Pharmaceutical scientists are constantlyasked to make critical product quality orpatient safety decisions. The importance oftraining scientists in a company in relevantknowledge and skills is crucial to enhancingg o od decision-making and laboratory relia-b i l i t y. Certification offers a specialized, yetstandardized, approach to the evaluation ofscientists. Certification is a recognition ofrelevant education in a specialty area of sci-ence to make practical, science-based deci-sions. It is also a recognition of on-the-jobexperience to enhance work efficiency,effectiveness and reliability. A companyneeds the latter characteristics in its scien-tists to survive in the competitive market-p l a c e .

Benefits for the ScientistGaining certification is a substantiation ofboth college education and job experiencefor a microbiologist. It is satisfying and con-

CERTIFICATION BENEFITS

www.pharmabioingredients.com

“ ”Some companies haveused certification of

their microbiologists asa successful marketing

tool.

fidence-building to know that one can applywhat one has learned in college to the job.

Certification in microbiology maybecome a requirement or condition foremployment in the future. It may providean avenue for career development or finan-cial gain, as well. Many health professionalsare required to take college courses in adegree program and pass a written exam.Licensing of health professionals is certifi-cation.

Clinical nurses, doctors, pharmacistsand pathologists are all certified; so it makessense that professional microbiologists, whoare responsible for the microbiological qual-ity and safety of products used by the healthprofessionals and patients worldwide,should be certified as well. It is a well-known fact that certified professionals aresought more by hiring organizations andpaid more than their non-certified peers.The American Society for Microbiologyhas certified 2,700 professionals in clinical,public health, biosafety and consumer prod-

ucts microbiology.Recognition is given by ASM for certifi-

cation. Organizations in the industry areincreasingly rewarding certificationacquired during employment. CertifiedNRM registrants are found in any numberof prestigious positions throughout thec o u n t r y. They serve as a vital resource to

develop and maintain high levels of techni-cal and administrative competenciesthroughout the profession. “A high level ofprofessionalism is essential to address theneeds of our emerging healthcare system”and industry.3

Peer recognition and networking withother certified microbiologists is a very suc-cessful way to enhance an individual’sknowledge and skills. Networking andongoing education have been inherent ben-efits for more than 75,000 quality practi-tioners certified by the American Societyfor Quality.1 0

Certification in microbiology requiresp e r i odic voluntary recertification.Recertification requires additional hours ofeducation and training over each subse-quent five-year period. So, in addition tonetworking, there is a built-in “motivation”to continue one’s education and participatein training for new skills. If an organizationsupports certification, it also supports con-tinuous education.

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“ ”Certification in microbiology may

become a requirementor condition for

employment in thefuture.

The National Registry of Microbiologists predicts certification will become part of the micro b i o l o g i s t ’s culture .

December 2004 • Pharma & Bio Ingredients 41

Certification is ImportantThe following commentaries are from keyliterature references, which build a solidcase for the necessity of microbiologicaltraining and certification.

Mike Korczynski2 discussed the need forbetter technical training of pharmaceuticalscientists. He suggested the development ofa National Registry to recommend course-work, evaluate training programs of scien-tific organizations, require registrants tocomplete courses and take an exam, andthen keep official records of certified mem-bers.

The PDA technical report No. 35, “AProposed Training Model for theMicrobiological Function in thePharmaceutical Industry, ”5 detailed anapproach to the development of appropri-ate education and training for a practicingmicrobiologist. One of the key points statedwas “a crucial ingredient in a company’straining program is the requirement oftrained individuals to demonstrate compe-tency (proficiency) in their appointedtasks.” Three of the critical ways to meetthis requirement are:

• proficiency certification;• written examination, and • maintenance of current technical and

regulatory knowledge through continuinge d u c a t i o n .

The USP chapter, “Sterilization andSterility Assurance,”4 offers guidance aboutquality control testing and assurance ofsterilized articles. In the text, it is stated“The overall responsibility for the opera-tion of the (quality control) test unit andinterpretation of results…should be in thehands of those who have appropriate formaltraining in microbiology and have knowl-edge of industrial sterilization, aseptic pro-cessing, and the statistical conceptsinvolved in sampling.”

While there is no question that a personengaged in pharmaceutical quality testingshould have appropriate education to per-form that testing, “the demands of microbi-ological testing require that the core educa-tional background of the microbiologicalstaff and supervision be in microbiology or aclosely related biological science,” as simply

stated in the draft USP chapter7 a b o u tmicrobiology laboratory practices.

The new global standard for accredita-tion of a quality control laboratory, ISO17025:1999, requires laboratory manage-ment to ensure “the compliance of all whooperate specific equipment, perform testsand/or calibrations, evaluate results, andsign test reports…”.8 Competence can beproven by “qualification on the basis ofappropriate education, training, experi-ence, and/or demonstrated skills.”

Regulations Require ItFederal GMP regulations, 21 CFR 211,state that “each person engaged in ...(or)responsible for supervising the manufac-ture, processing, packing or holding of adrug product shall have the education,training and experience…to performassigned functions…to provide assur-ance…(of) quality and purity…(of thep r od u c t ) . ”6 The FDA draft guidance for“Sterile Drug Products Produced by AsepticP r o c e s s i n g , ”9 recommends that laboratorypersonnel have knowledge of basic princi-ples of aseptic technique and aseptic manu-f a c t u r i n g .

The NRM certification fits all of these“job” description requirements for measur-ing competency and offering a professionalregistry for professional microbiologists inGMP-regulated industries.

Professional certification has a proventrack record for individual performance andproviding company benefits. Certificationof a pharmaceutical microbiologist offers awin-win result for both industry and indi-viduals. ■

R e f e re n c e s1. Board Certification by the National

Registry of Microbiologists, study guide. 2000.American College of Microbiology, Wa s h i n g t o n ,D . C .

2. Korczynski, M. 2001. "A New ParadigmFor Pharmaceutical Technical Training", inMicrobiology in Pharmaceutical Manufacturing(ed. R. Prince), pp. 831-846, PDA, Baltimore,M D .

3. D’Amato, J. 1999. The Loop. Fall 1999issue. The National Registry of Microbiologists.Washington, D.C.

4. USP-NF 2004, (1211) Sterilization andSterility Assurance. 27:2616-2621. Rockville,M D .

5. A Proposed Training Model for theMicrobiological Function in the PharmaceuticalI n d u s t r y, Technical Report No. 35. 2001. PDA J.Pharm. Sci. Technol. 55:6, pp. 1-20. PDA.Baltimore, MD.

6. 21 CFR Part 211, Current GoodManufacturing Practices for FinishedPharmaceuticals. Food and Drug Administration,Washington, D.C.

7. Microbiological Laboratory Practices,Draft chapter (1117). 2003. Pharm. Forum, USP,29:3, pp. 842-850.

8. Accreditation Criteria for LaboratoriesPerforming Food Microbiological and ChemicalAnalyses in Foods, Feeds, and PharmaceuticalTesting. 2001. AOAC Int'l., Gaithersburg, MD.

9. Guidance for Industry, Sterile DrugP r oducts Produced by Aseptic Processing -Current Good Manufacturing Practice. (2003).F o od and Drug Administration, Wa s h i n g t o n ,D . C .

10. American Society for Quality. 2004.Discussion with ASQ Certification. AmericanSociety for Quality, Milwaukee, WI.

CERTIFICATION BENEFITS

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“ ”Professional certificationhas a proven track

record for individual performance and

providing company benefits.

Note:Each of the authors is certified and reg-istered as a specialist microbiologist bythe American Academy of Microbio-logy, Washington, D.C.