44 | Advertising Feature Wednesday, April 17, 2019 | DAILY NATION

As we celebrate this milestone, I wish to

congratulate the Board’s management and staff for their individual and corporate contribution. This achievement would not have been possible without the support of Board’s esteemed clients, stakeholders and development partners.

Entrenching quality management in healthcare delivery

The attainment of ISO 9001:2015 certification by the Pharmacy and Poisons Board marks a very

important milestone in Kenya’s Health Sector. The right to the highest standards of health can only be achieved when all health system blocks are efficient and optimal.

The role of medical products and health technologies of good quality, safety and efficacy in healthcare cannot be over-emphasised. Therefore, the attainment of the ISO 9001:2015 certification is proof that the Board has a Quality Management System that assures better service delivery and quality products for Kenyans.

As we celebrate this milestone, I wish to congratulate the Board’s management and staff for their individual and corporate contribution. This achievement would not have been possible without the support of Board’s esteemed clients, stakeholders and development partners.

IS0 9001:2015 CERTIFICATION

MINISTRY OF HEALTH

Sicily Kariuki (Mrs), EGH, MBS, CBS, Cabinet Secretary, Ministry of Health

Dr. F.M. Siyoi, Chief Executive Officer, Pharmacy and Poisons Board Dr. Ronald Inyangala, Head of QMS

Susan Mochache, (Mrs), CBS, Principal Secretary

The implementation of ISO 9001: 2015 Quality Management Standards has earned the Pharmacy and Poisons Board global recognition as an institution committed to excellence in service delivery. This includes ensuring enhanced operational efficiency, improved customer satisfaction, and effective communication, both internally and externally with customers.

We thank PPB staff and collaborating partners who have worked tirelessly as a team and succeeded in achieving the coveted ISO certification.

ISO certification to improve health services

Dr Rashid Aman, Chief Administrative Secretary

Quality management for superior delivery

This is a great day for the Government, its citizens and health workers across the nation. By achieving the ISO Certification, the Pharmacy and Poisons Board has gained a label of recognition: that of operating according to international ISO quality management standards, which progressively contribute towards the attainment of the Sustainable Development Goals and Universal Health Coverage.

Big milestone in Kenya’s Health Sector

Today, the Pharmacy and Poisons Board has evolved into a globally recognised regulatory agency for control of the profession of pharmacy and the manufacture and trade in drugs and poisons. This attainment of the ISO 9001:2015 certification is a commitment to ensuring Kenyans enjoy the progressive realisation of the right to highest standards of health care as prescribed by the constitution.

We shall continue to apply modern technology and international best practices to develop and strengthen the regulatory systems in order to meet the needs of the population and to contribute to the sustainable development of the nation and attainment of Universal Health Coverage.

Today, we are celebrating the achievement of ISO 9001:2015 standard, one of the objectives in the Pharmacy and Poisons Strategic Plan 2014-2019. This achievement will propel us towards achieving our Vision of being “A Centre of Regulatory Excellency”.

The Board is extremely proud of its workforce for this accomplishment. I take this opportunity to thank the process owners, team leader, ISO Champions and staff for their commitment to this process.

An innovative QMS integration Moving towards excellence

Advertising Feature | 45DAILY NATION | Wednesday, April 17, 2019

Achieving the ISO 9001:2015 certification

and risk-based thinking in developing, implementing and improving the effectiveness of its Quality Management System (QMS). This approach underscores the importance of understanding and meeting customer and applicable statutory and regulatory requirements; the need

The Journey to ISO certification for Pharmacy and Poisons Board (PPB) started in 2014, when the Board identified weak

internal operations as one of the organisation’s weaknesses. Relevant documents were developed between 2014 and 2016. The staff were trained and a certifying body identified.

To enhance effectiveness, the PPB pursued ISO 9001:2015 certification in 2016. ISO 9001:2015 sets out the criteria for a quality management system, and is the only standard in the family that can be certified to. This standard is based on a number of quality management principles, including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.

Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

The attainment of ISO 9001:2015 certification demonstrates our ability to meet our customers’ requirements and applicable statutory and regulatory requirements aimed at enhancing customer satisfaction.

The Board has adopted the process approach

IS0 9001:2015 CERTIFICATION

MINISTRY OF HEALTH

to consider processes in terms of added value; the importance of obtaining results of process performance and effectiveness; and the improvement of processes based on objective measurement.

The risk-based thinking ensures risk is considered throughout the process. This

The attainment of ISO 9001:2015 certification demonstrates our

ability to meet our customers’ requirements and applicable statutory and regulatory requirements aimed at enhancing customer satisfaction.

PPB lab analysts with spectrophotometers used in the identification and quantification of active pharmaceutical ingredients. The machine is used in the disintegration of pharmaceutical products.

makes prevention of error integral to the management system, and can help identify opportunities.

The alternate goal is to achieve our strategic objectives: To establish good governance and management of the Pharmacy and Poisons Board (PPB); strengthen internal operations and improve efficiency in service delivery to ensure that regulatory and customer requirements and expectations are met and exceeded.

Pharmacy & Poisons Board on attaining ISO 9001:2015 Certification.

We are proud to be associated with you!

Our Vision:To empower our members and promote professionalism and ethics

Our Objectives:• To advance the practice of Pharmacy

• To create and maintain a standard for professional conduct and code ethics

• To foster a high standard of control over the quality and distribution of medicines and other pharmaceutical products.

• To promote the role of Pharmacists as integral members of the healthcare team to ensure rational drug use

PHARMACEUTICAL SOCIETY OF KENYAPCEA Foundation, Block C, Jabavu Road.

P.O Box 44290-00100 Nairobi- Kenya Tel: 0722 817 264 I Email: info@psk.or.ke I Website: www.psk.or.ke

46 | Advertising Feature Wednesday, April 17, 2019 | DAILY NATION

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Pharmacy & Poisons Boardon attaining ISO 9001:2015 Certification

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RANGECHEM PHARMACEUTICALS

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As you celebrate your ISO Certification

We are proud to be associated with you

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The Pharmacy and Poisons Board milestones indexing of students, administration of professional examinations, internships, practice, inspection of premises, issuance of certificates, disciplinary and attrition of professionals.

To date, the Board has registered 3576 pharmacists and enrolled 9972 pharmaceutical technologists. Out of this number, 970 pharmacists and 5099 pharmaceutical technologists have applied for and have been issued with their practice licenses for the year 2019.

The directorate, in conjunction with other providers, has developed a continuing professional development (CPD) programme that is now being automated and linked to licensure system. CPD has been made mandatory to ensure all the pharmacy professionals are updated and fit to practice at all times. This is now the standard practice worldwide.

3. Quality Control • Established Quality Control LaboratoryPPB has established a laboratory to support in authenticating quality, safety and efficacy of medical products and health technologies. The laboratory tests locally manufactured and imported drugs or medicinal substances to determine if they comply with the set standards.

The laboratory also tests medical devices, and herbal medicines, cosmetics, food supplements and radiation emitting substances.

It is furnished with state-of-the-art equipment’s designed in full compliance with the specifications defined in the

1. Drug Product Evaluation & Registration• Introduction of regulatory tools and

processes for regulation of Blood and Blood Products; Guidelines and Committee of Experts

• Introduction of regulatory tools and processes for Regulation of Medical Devices and IVDs; Guidelines, Committee of Experts, Registration assessments for Class C and Class D devices

• Full automation of all systems at the DPER, including online applications (new and variations), re-submissions (additional data and appeals), evaluation and final outcome to the Clients. Online portal development for registration of blood and blood products is ongoing.

• Initiated full screening of medical products applications in line with EAC screening guideline thus eliminating chances of a poor application going through to assessment; this will further enhance DPER’s efficiency.

• Initiated weekly training on the assessment of Quality part of the Dossier and Efficacy (Bioequivalence) impacting positively on dossier assessment reports.

2. Pharmacy Practice The Pharmacy Practice Directorate ensures that Pharmacy professionals are competent and fit to practice and contribute to human resource for health.

To make service delivery more transparent and efficient, the directorate has automated all the processes from

IS0 9001:2015 CERTIFICATION

MINISTRY OF HEALTH

United States Pharmacopeia (USP) and other Pharmacopeia. • Screening of medical productso Installed Minilab kits in regional

offices, namely Nairobi, Kisumu, Kisii, Sirare, Mombasa, Kericho, Nakuru, Busia and Eldoret.

o Libraries have been created on the handheld Raman spectrometers to include several classes of medical products, including anti-malarials, anti-TB’s, ARV’s, antibiotics, sex enhancers, anti-diuretics, antidiabetics, antihypertensives, reproductive health products

4. Medicine Information Pharmcovigilance • Systems Strengthening/Systemic Capacity building o To promote innovation, cost-

effectiveness and sustainability, PPB, with support from HCSM Programme, developed and implemented a Pharmacovigilance Electronic Reporting System, the 1st Vigiflow compatible e-reporting system in Africa (www.pv.pharmacyboardkenya.org) in the year 2013.

The system allows for reporting of suspected ADRs and poor quality medicines, and has seen the increase in reporting of adverse drug reactions (ADRs) from 1459 in September 2011 to over 12,000, and from 3 in 2008 to over 1,000 of suspected poor quality medicinal products in 2018. Safety updates based on these reports are available at www.pharmacyboardkenya.org/e-shots,

undergraduate students have been sensitised and trained in PV and PMS since 2010.

PPB also collaborated with University of Nairobi, HCSM, University of Washington and SIAPS programme to implement a Masters course in Pharmacoepidemiology and Pharmacovigilance (EPIVIGIL). Almost 60 graduates of EPIVIL are currently implementing PV activities in public health programmes, PPB, at national and county levels. PPB has 5 EPIVIL specialists.

o To build capacity in assessment of clinical trials regulations, there is a functional experts committee on clinical trials that reviews the clinical trial applications.

• Success storieso Kenya was designated a Regional

Centre for Regulatory Excellence (RCORE) in Pharmacovigilance in 2014 by the New Partnership for Africa’s Development (NEPAD), under the African Medicines Harmonisation Project. This was primarily due to the regional centre’s ideal location and the quality of services it provides.

The Kenya PV-RCORE continues to strive for excellence to serve as a hub for good Pharmacovigilance practices in the continent and as the technical lead country for Pharmacovigilance and Postmarketing Surveillance in the East African Community under the Medicine Regulation Harmonisation Project.

o The multi-pronged approach to PV system strengthening in Kenya has led to increased reporting of adverse drug reactions (ADRs) up from 1459 in September 2011 to over 12,000 reports in 2018. These reports have informed several decisions, including

o In the same year (2013), through the EDCTP grant, the Clinical Trials Registry was launched (http://www.ctr.pharmacyboardkenya.org) and submission and evaluation of clinical trials applications. So far 205 Clinical Trials Application have been reviewed and processed from 2013 to date.

o The development of guidelines for advertisement and promotion of medicines and medical devices in Kenya has led to the review 968 applications on advertisement and promotion of medicines from 2011 to July 2018.

o With the development of the post marketing surveillance strategy, there has been surveys carried out to continuously monitor the quality of anti-malarials, anti-TB, antiretroviral and reproductive health medicine, anti-hypertensive and diabetics medicines, among others. The routine surveys have shown improved quality of medicines following post-market activities, leading to improved compliance to regulatory requirements. Reports of these surveys are available in the website. www.pharmacyboardkenya.or/Postmarket-Surveillance.

• Capacity Building o Through technical assistance from

Health Commodities and Services Management (HCSM), World Health Organisation and other stakeholders, the Kenya PV system has borne fruits, including implementation of national PV guidelines and training package. Over 15,000 healthcare providers and

Advertising Feature | 47DAILY NATION | Wednesday, April 17, 2019

SCHOOL OF PHARMACYMount•Kenya•University•(MKU)•is•a•chartered•premier•institution•committed•to a•broad-based,•holistic•and• inclusive•system•of•education• to•promote•human resource• development.• MKU• is• a• member• of Association•of•Commonwealth Universities, Inter-•University•Council•of•East•Africa•and•Kenya•Association•of Private•Universities

in•East•Africa•and•a•global•footprint•through•Open,•Distance•and•electronic•learning supported•by•SAKAI•web-based•platform.•The•university•admits•both•Government-sponsored and self-sponsored students.

Accreditation

The•School•of•Pharmacy•at•Mount•Kenya•University•(MKU)•is•accredited•by•the Pharmacy•and•Poisons•Board•(PPB),•the•Pharmacy•regulatory•authority•in•Kenya•in accordance•with•the•Pharmacy•and•Poisons•Act•(CAP•244).•The•Bachelor•of•Pharmacy programme is also approved by the Commission for University Education (CUE). The MKU•School•of•Pharmacy•is•the•oldest•private•Pharmacy•training•institution•in•Kenya,•having been an accredited trainer of Pharmaceutical personnel for the last 16 years.

Program objective

The•prime•objective•of•the•Bachelor•of•Pharmacy (BPharm)•program•is•to•delivergraduates•endowed•with knowledge•and•skills•requisite•for•the•provision•of•patient-centered•Pharmaceutical Care. We believe that the patient is the center of all ourefforts in provision of pharmaceutical•care,•and•also•in•the•need•to•collaboratewith•other•healthcare professionals in providing care to our patients.

Graduates

The•pioneer•BPharm•students•were•admitted•in•January•2009•and•graduated•in December•2013;•since•then•the•University•has•graduated•over•300•pharmacists.•The•BPharm•graduates•have•found•employment•in•public•and•private•hospitals,•disciplined Forces,•community pharmacy, industrial pharmacy and academia.

Cultural diversity

MKU•Bachelor•of•Pharmacy•program•attracts•students•from•all•over•the•continent and•currently•more•than•20%•of•the•School•of•Pharmacy•student•population•is composed•of• international•students,•from•Rwanda,•Uganda,•Tanzania,•Burundi,•Sierra•Leone,•South•Sudan•and•Nigeria.•The•international•outlook•in•the•MKU•School of Pharmacy extends to the faculty. The highly experienced Kenyan faculty has been enriched•by•academicians•from•Belgium,•India,•and•Rwanda,•who•constitute•more

Incorporating the needs of stakeholders in curriculum review

Based•on•experience•gained• in•Pharmacy•training•and•a•needs•assessment•of the••Pharmaceutical•Industry,•the•School•has•reviewed•the•BPharm•curriculum to•incorporate•emphasis•in•Industrial•Pharmacy•by•incorporating•areas•such•as Cosmetology and Pharmaceutical Engineering.

It•is•our•endeavor•to work•with•all•stakeholders•in•the•pharmaceutical•sector•such•as the Pharmaceutical•Society•of•Kenya,•the Pharmacy•and•Poisons•Board,•and the pharmaceutical industry in providing the required personnel in the sector.

P. O Box 342-01000, Thika•| Cell: 0709153000, WhatsApp: 0722 999 399 | Email: info@mku.ac.ke |••Website: www.mku.ac.ke

MAY 2019 INTAKEBACHELOR OF PHARMACY (B.Pharm)

MINIMUM ENTRY REQUIREMENTS PROGRAMME DURATION TUITION FEESa) KCSE (Direct) Entry:

• Mean Grade: B- With C+ in Mathematics/Physics, Chemistry/Physical Science, Biology/Biological Science, and English/Kiswahili.

10 Semesters(5 Academic Years)

Ksh 165,300 per semester

b) A-Level Entry:• Minimum of two principal passes in Biology and Chemistry, and a

Subsidiary Pass in Mathematics or Physics.

10 Semesters Ksh 165,300 per semester

c) Diploma in Pharmacy/Pharmaceutical Technology Entry:• The Diploma should have been obtained from a PPB accredited

Institution;• KCSE Mean Grade C with C in Mathematics/Physics, Chemistry/

Physical Science, Biology/Biological Science, and English/Kiswahili. • Enrolled as a Pharmaceutical Technologist by the PPB.

(Subject to the PPB Credit Waiver Policy Guidelines)

Ksh 165,300 per semester

d) Higher National Diploma in Pharmacy Entry:• The Diploma and Higher National Diploma should have been obtained

from a PPB Accredited Institution;• KCSE Mean Grade C with C in Mathematics/Physics, Chemistry/

Physical Science, Biology/Biological Science, and English/Kiswahili. • Enrolled as a Pharmaceutical Technologist by the PPB.

(Subject to the PPB Credit Waiver Policy Guidelines)

Ksh 165,300 per semester

e) Holders of a diploma or degree in Biological or Health Sciences. 10 Semesters Ksh 165,300 per semester

Diploma in Pharmaceutical Technology (DPT)KCSE Mean Grade C with C in Mathematics/Physics, Chemistry/Physical Science, Biology/Biological Science, and English/Kiswahili.

9 Trimesters (3 Academic Years)

Ksh 34,550 per trimester

Applications;Apply to the Registrar, Academic Administration enclosing copies of relevant academic/ professional certificates. Application fee of Ksh.1, 000 to be deposited at either;

Equity Bank - 0090292435067 Standard Chartered Bank - 0102049817400GT Bank - 2014200002 Kenya Commercial Bank - 1121032222Family Bank - 005000019336 Co-operative Bank - 01129279981300NIC Bank - 21200008796Dollar account (KCB) - 1173740309 (swift No. KCBLKENX)

Applications can be done online or application forms can be downloaded from University website www.mku.ac.ke or visit any of our campuses/centers.

For more information visit www.mku.ac.ke; Email: pharmacy@mku.ac.ke 

Thika (Main) CampusGeneral Kago Rd, P.O.BOX 342-01000, ThikaTel +254 67 2820 000 / 0709 153 000Cell: +254 720 790796WhatsApp: +254 722 999 399Email: info @mku.ac.kewww.mku.ac.ke

Mount Kenya University Kigali Kagarama, Kicukiro District, Near Africa New Life MinistriesP.O Box 5826 Kigali.Tel: +250785709824 / +250728551199/ +250782081885Email: rwanda@mku.ac.ke;Website : www.mku.ac.ke

SCHOOL OF PHARMACYThe School of Pharmacy at Mount Kenya University congratulates the Pharmacy and Poisons Board for award of ISO 9001:2015 Certification. As the oldest private pharmacy training institution in Kenya, our relationship with the Pharmacy and Poisons Board stretches back close to two decades.

In 2003, after a rigorous inspection of the Pharmacy training infrastructure, the Pharmacy and Poisons Board accredited Thika Institute of Technology (the Precursor of Mount Kenya University) as the first private institution in Kenya approved to offer the Diploma in Pharmaceutical Technology programme. Five years later, in 2008, the Pharmacy and Poisons Board conducted an inspection of the training infrastructure for the then newly established Mount Kenya University (MKU) and another milestone was attained when MKU became the first private university accredited to offer the Bachelor of Pharmacy programme in Kenya in accordance with the Pharmacy and Poisons Act (CAP 244). The Bachelor of Pharmacy programme had also just been approved and accredited by the Commission for University Education (CUE).

Graduates of both the Bachelor of Pharmacy programme and the Diploma in Pharmaceutical Technology are subjected to pre-registration (for Pharmacists) and pre-enrollment (for Pharmaceutical Technologists) examinations which are administered by the Pharmacy and Poisons Board. The performance of our graduates in these examinations has always provided a good feedback and is treasured as an external quality assurance tool by the School of Pharmacy. The harmonious working relationship between MKU and PPB has enabled the University graduate over 350 Pharmacists and over 700 Pharmaceutical Technologists. The graduates of the MKU Pharmacy programmes have always been granted internship opportunities under the supervision of the Pharmacy and Poisons Board.

The Pharmacy and Poisons Board’s policy guidelines on Pharmacy training have greatly assisted in streamlining and standardizing the operations of the Pharmacy training sector in Kenya. These guidelines have been developed with a lot of stakeholder involvement and employing a participatory approach. The PPB guidelines that have proved pivotal to the MKU School of Pharmacy operations include:• Guidelines on the National Minimum Standards for Bachelor of Pharmacy Programmes• Credit Waiver Policy Guidelines for progression from Diploma in Pharmacy/Pharmaceutical Technology to the Bachelor of Pharmacy

Degree Level• Pharmacy and Poisons Board Core Curriculum for Bachelor of Pharmacy Degree Programme• Pharmacy and Poisons Board Harmonized National Curriculum for Diploma in Pharmaceutical Technology

Due to continuous improvement, a close working relationship with key stakeholders and a great deal of investment by the University Management into the MKU School of Pharmacy, the MKU Pharmacy programmes has continued to attract students from all over Africa. Currently, more than 20% of the Pharmacy student population is composed of international students from Rwanda, Uganda, Tanzania, Burundi, Sierra Leone, South Sudan and Nigeria. The international outlook in the MKU School of Pharmacy extends to the faculty. The highly experienced Kenyan faculty has been enriched with academicians from Belgium, India, and Rwanda who constitute one-third of the School of Pharmacy faculty.

We therefore look forward to unlocking infinite possibilities as we continue to strengthen our great working relationship with a now ISO Certified Pharmacy and Poisons Board.

PPB Milestones processing from manual to online. This has lessened client interactions, reduced permit approval time and minimised paper-work load with phenomenal increase of revenue.

o Drug registration/good manufacturing practice, online system-availability of product database in drug registration.

o Pharmacy Practice system: This includes online premise registration, dashboard. system, online indexing system and health safety code.

o Quality Management System (QMS): The Alfresco system that enables integrations with other systems within the organisation.

o Establishment of a data centre at the PPB to host all activities of the Board.

• Inspectorate achievementso The Board has established 10 regional offices

across the country, with inspectors deployed in the regions.

o The Inspectorate, Surveillance and Enforcement Directorate has developed guidelines to ensure smooth running of operations from distribution, transport and storage, to waste disposal.

o The directorate has increased surveillance, leading to apprehension of illegal practices. This has seen closure of 1258 illegal outlets, with 1138 cases having been arraigned from 2016-2019, and their products confiscated.

o Stakeholder engagements at county level with the county officials has seen a synergetic improvement in countering the emergence of illegal outlets.

o The Good Manufacturing Roadmap has improved the standards of manufacturing, thus attracting investors who are interested in setting up pharma industries in the country.

review of Kenya ART guidelines in 2011 and improved monitoring of patients on Isoniazid Preventive Therapy.

• National and Regional Collaborations o Enhanced collaboration with Public Health

Programmes: Currently the PV department in collaboration with the HIV Programme are carrying out Cohort Event Monitoring of antiretroviral medicines with support from the Global Fund. With financial support from MSH and technical support from Uppsala Monitoring Centre, PPB is finalising the development of an active surveillance data management tool for collecting and analysing all active surveillance studies in Kenya.

o The strong PPB-led Pharmacovigilance system have attracted a number of countries to visit and learn from Kenya. They include Afghanistan, Angola, Tanzania, Zimbabwe and Somalia.

o Kenya spearheaded the development of the East Africa Community Pharmacovigilance Strategic Business Plan 2018-2023 that will oversee the strengthening of PV in the region.

• ICT Achievementso Business Processes re-engineeringo Automation: Ensured and enabled online

Pharmacovigilance electronic reporting system (PVeRs) and electronic clinical trials registry (CTR).

o National window system: Implementation of KenTrade, which has enabled ease of permit

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