by Mr. Maroa Noa | Nov 24, 2025 | Legal Framework, Operations, Strategy
Alcohol-based hand rubs (ABHRs) remain a key part of infection prevention in Kenya. Pharmacies across the country often produce these products to meet local demand, especially during public health emergencies.
However, the Pharmacy and Poisons Board (PPB) and the World Health Organization (WHO) provide strict guidelines to ensure that hand rubs are effective and safe for community use.
This article explains these requirements in a simple and practical way, giving Kenyan pharmacy operators a clear path toward compliant production.
Understanding Alcohol-Based Hand Rubs
Alcohol-based hand rubs are disinfectant formulations used to inactivate harmful microorganisms. They provide fast action and require no water, making them ideal for both community and clinical settings. WHO recommends ABHRs containing ethanol or isopropyl alcohol at specific concentrations to maintain antimicrobial activity.
Why Kenyan Pharmacies Must Follow Approved Guidelines
Regulatory compliance protects consumers and protects your pharmacy from penalties. PPB enforces production standards to ensure safety, prevent contamination, and reduce the circulation of substandard products.
Adhering to guidelines also builds trust. Customers are more likely to rely on pharmacies that follow scientific and regulatory instructions. Furthermore, compliant production promotes public health during outbreaks such as COVID-19, cholera, and flu waves.
Essential Ingredients for Hand Rub Production
A compliant alcohol-based hand rub must use high-quality pharmaceutical-grade ingredients. WHO recommends only four main ingredients:
1. Alcohol (Ethanol 80% v/v or Isopropyl Alcohol 75% v/v)
This is the active ingredient that kills germs. Concentrations lower than recommended weaken the product’s effectiveness.
2. Hydrogen Peroxide 3%
Hydrogen peroxide inactivates bacterial spores in the solution. It protects the formulation during storage but does not act on the skin.
3. Glycerol (Glycerine) 98%
Glycerol acts as a humectant, preventing skin dryness. Only small amounts are needed to maintain skin comfort.
4. Sterile Distilled or Boiled Water
Water is used to dilute the alcohol to the required concentration. Ordinary tap water is not allowed.
These ingredients must remain pure and uncontaminated. Kenyan pharmacies should source them from PPB-approved suppliers.
Required Equipment for Production
Safe production requires clean, well-organised pharmacy space and proper equipment. Common tools include:
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Measuring cylinders and beakers
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Stainless steel mixing containers
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Funnel and spouted bottles
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Alcoholometers for concentration verification
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PPE: gloves, masks, goggles
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Clean, dust-free working benches
Using food containers or unverified plastic bottles may lead to contamination or chemical reactions. Pharmacies should use chemical-resistant materials that comply with PPB and WHO guidelines.
Step-by-Step Production Process (WHO Standard Method)
Step 1: Prepare the Working Space
Begin by cleaning and disinfecting surfaces. Ensure good ventilation because alcohol vapors accumulate easily.
Step 2: Measure Ingredients Accurately
Use calibrated tools to avoid errors. Even small inaccuracies may alter the alcohol concentration, rendering the product ineffective.
Step 3: Mix Ingredients in the Correct Order
Add alcohol first, then hydrogen peroxide, followed by glycerol. Mix using sterile conditions. Finally, add water to achieve the exact volume.
Step 4: Transfer Solution to Storage Containers
Seal containers tightly to prevent evaporation. Alcohol evaporates quickly and any exposure reduces the final concentration.
Step 5: Label the Final Product Clearly
Labels should include:
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Product name
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Composition
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Production date
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Batch number
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Expiry date
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Storage instructions
Clear labelling helps pharmacies track quality and respond to customer queries.
Step 6: Store in a Cool, Controlled Environment
Keep the product away from heat and sunlight. High temperatures degrade alcohol concentration and compromise efficacy.
Regulatory Requirements in Kenya
1. PPB Approval
PPB regulates pharmaceutical manufacturing and compounding. Pharmacies producing hand rubs must comply with PPB compounding and good manufacturing practice (GMP) guidelines.
2. Quality Assurance
Pharmacies must verify alcohol concentration through alcoholometers or laboratory tests. Substandard products violate the Public Health Act and may attract penalties.
3. Documentation and Batch Records
Every batch must have clear records for traceability. These include quantities used, dates, staff involved, and final yields.
4. Packaging Requirements
PPB requires safe packaging, child-proof caps, and tamper-evident seals where possible.
5. Retail and Distribution Standards
Pharmacies must separate production from service areas to maintain hygiene and customer safety.
Common Mistakes to Avoid
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Using non-pharmaceutical-grade ingredients
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Inaccurate measurements that weaken alcohol concentration
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Storing hand rubs in hot environments
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Poor labelling
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Using unsterile bottles
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Ignoring PPE and hygiene protocols
Avoiding these mistakes protects consumers and improves product quality.
Safety Precautions for Pharmacy Staff
Alcohol-based products are highly flammable. Pharmacies must:
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Keep fire extinguishers nearby
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Avoid open flames and sparks
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Train staff on safe handling
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Ensure proper ventilation
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Store alcohol securely away from heat
These precautions reduce risks during production.
Why Quality Matters for Kenyan Pharmacies
High-quality hand rubs reduce infections within communities and healthcare environments. Kenya’s busy public spaces, transport systems, and hospitals rely heavily on effective sanitizers. Pharmacies that produce quality ABHRs fulfil a public health duty while building stronger customer trust.
Professional Support for Compliant Production
Pharmacies that want to improve their production processes can benefit from expert guidance. Clarity Pharma Consultancy offers support on regulatory compliance, WHO production protocols, PPB requirements, and quality assurance systems.
Their team helps pharmacies set up safe procedures and avoid common compliance errors in ABHR production.
FAQs
by Mr. Maroa Noa | Nov 24, 2025 | Legal, Operations, Strategy
Managing controlled substances in Kenya demands attention to detail, strong systems and full regulatory compliance. This article walks you through the key steps—from licences to safe-storage to record-keeping—so you can operate confidently and legally.
Understanding Controlled Substances in Kenya
In Kenya, the regulation of drugs and poisons falls under the Pharmacy and Poisons Board (PPB) established via the Pharmacy and Poisons Act (Cap 244).
The Act gives the Board powers to make rules relating to “safe custody and storage of poisons” and to require registers and books to be kept.
Controlled substances typically include Part I poisons and other regulated medicines. You must treat them with stricter control.
Licensing: Getting Authorised to Handle Controlled Substances
Before you handle controlled substances, you must ensure proper licensing:
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Apply for the correct licence via the PPB’s Online Licensing portal.
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Ensure your business registration and professional staff (e.g., a registered pharmacist) are in place.
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Submit documentation for premises, storage, and security arrangements.
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Await inspection and approval before stocking or dispensing controlled substances.
By securing the correct licence, you mitigate risks of non-compliance and enforcement action.
Storage & Safe Custody: Protecting Controlled Substances
Once licensed, proper storage becomes crucial.
Key Storage Practices
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Store controlled substances in a separate room or compartment locked and clearly labelled “Poisons Only”.
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Restrict access so that only authorised personnel can reach the controlled substance area.
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Keep storage physically apart from food or drink, and maintain environmental conditions (temperature, light, humidity) appropriate for the medicines.
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Ensure containers are appropriate, secure, and clearly labelled. The law demands poisons be placed in impervious containers and sealed properly.
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Periodic inspections—within your own facility—help monitor storage integrity and prevent diversion or theft.
By applying these measures you maintain integrity of your stock and protect public health.
Record-Keeping: Tracking, Auditing & Compliance
Accurate records form the backbone of your system for controlled substances.
What to Document
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Maintain a Poison Book or equivalent register for Part I poisons as required under the Act and Rules.
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Log incoming quantities (batch numbers, expiry dates), outgoing supplies, prescriptions filled, returns and destructions.
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Ensure records are retained for the time period specified by law and are readily available for inspection.
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Conduct internal audits regularly to reconcile stock, compare with records and identify discrepancies early.
Records help you trace each unit of controlled substance from receipt to dispensing or disposal.
Inspection & Audit: What Regulators Expect
The PPB and authorised officers hold statutory powers to inspect your premises, paperwork and storage.
During an inspection they will check:
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Licence validity and display
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Storage conditions (locked, labelled, separated)
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Record-books and registers
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Proof of authorised personnel handling the substances
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Compliance with rules on supply and possession
Preparing in advance reduces risk of penalties and operational disruptions.
Common Compliance Mistakes & How to Avoid Them
Here are typical pitfalls—and how you can avoid them:
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Mistake: Storing controlled substances alongside general stock or food.
Solution: Create a dedicated locked compartment and train staff accordingly.
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Mistake: Failing to maintain up-to-date registers.
Solution: Use daily logs and reconcile monthly.
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Mistake: Operating without the correct licence or registration.
Solution: Verify licencing status before handling any controlled substance.
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Mistake: Delayed inspection preparation.
Solution: Implement regular mock audits and keep documentation ready.
Avoiding these helps you stay compliant and safeguard your business.
Best Practices: Building a Robust Compliance System
To operate at a high standard, follow these practices:
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Develop standard operating procedures (SOPs) for receipt, storage, dispensing and destruction of controlled substances.
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Train all staff in the rules: Part I poisons, lock-and-key storage, record-keeping.
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Schedule regular internal audits (weekly/monthly) to check logs and stock.
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Review licences and registrations annually and renew on time.
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Display your licence and relevant signage prominently in your facility.
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Use technology where possible: digital registers, barcode systems, alerts for expiry and stock discrepancies.
By embedding compliance into your daily operations you stay ahead of regulation and reassure stakeholders.
How Clarity Pharma Consultancy Can Support You
If navigating licences, storage rules and record-keeping for controlled substances seems complex, you’re not alone. At Clarity Pharma Consultancy we support Kenyan health-sector businesses with:
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Regulatory gap analyses and readiness checks
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Licence application assistance with the PPB
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Designing secure storage facilities and SOP documentation
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Staff training on controlled substance handling and record systems
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Internal audit frameworks and mock inspections
Partner with us to ensure you stay compliant, minimise risk and maintain smooth operations.
Handling controlled substances in Kenya requires more than just compliance—it demands a system. Licensing under the PPB, secure storage, meticulous record-keeping and proactive auditing form the core of a strong compliance programme.
When you build solid practices and partner with knowledgeable consultants, you safeguard your business, patients and reputation.
FAQs
by Mr. Maroa Noa | Nov 24, 2025 | Operations, Strategy
n Kenya, regulatory efficiency matters. The Pharmacy and Poisons Board (PPB) has introduced a set of reliance mechanisms. These mechanisms allow the agency to leverage decisions from trusted regulators. In doing so, they speed up medicine approvals without compromising safety, efficacy or quality.
This article explains what reliance mechanisms are, how they work in Kenya, and what companies need to do to take advantage of them.
What Are Reliance Mechanisms?
A reliance mechanism is a regulatory tool where one national regulatory authority gives significant weight to the work performed by another trusted regulator when approving a medicine.
The World Health Organization defines this approach as beneficial in optimising resources and improving timelines.
In Kenya’s context, the PPB issued the “Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies in Kenya”. These guidelines create pathways for faster approvals by recognising work done by reference authorities, reducing duplication.
Why Kenya Needs Faster Medicine Approvals
Kenya faces increasing pressure to deliver essential medicines timely. Demand for new treatments, emerging diseases and technology‐driven innovations have grown. By adopting reliance pathways, the PPB aims to reduce regulatory bottlenecks and improve access.
Also, global regulatory convergence encourages Kenya to align with international best practice. A recent workshop in Nairobi highlighted the low adoption but significant potential of reliance approaches in Kenya.
The Legal and Regulatory Framework
The PPB derives its mandate from the Pharmacy and Poisons Act and supportive regulations such as the Medicines and Allied Substances Act (as amended).
Under these laws, the PPB may approve, suspend or revoke marketing authorisations. With the new reliance guideline, the PPB formalises the use of trusted regulators’ assessments to inform its decisions.
Key Reliance Pathways Introduced by PPB
1. Reference Regulator Pathway
This pathway accepts a marketing authorisation granted by a recognised stringent or well-established regulatory authority. The PPB then uses that approval as a basis to expedite review.
2. Work-sharing or Collaborative Review Pathway
Applicants submit data simultaneously to multiple jurisdictions. The PPB may coordinate with other regulators and leverage their findings to shorten timelines.
3. Verification or Abridged Review Pathway
For products already approved elsewhere, the PPB conducts a targeted review of specific modules (such as manufacturing or clinical summary) instead of full standard review.
4. Emergency/Expedited Reliance Pathway
In public health emergencies, the PPB may use reliance mechanisms to fast-track approvals of vital medicines or vaccines.
Benefits of Using Reliance Mechanisms
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Shorter approval timelines – Applicants spend less time waiting for decisions.
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Reduced duplication of effort – The PPB uses existing assessments from trusted regulators, reducing the burden on applicants.
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Resource optimisation – The regulator can focus its resources on high-risk products and post-market surveillance.
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Improved access – Patients gain faster access to new, safe, effective medicines.
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Global alignment – Kenya signals commitment to regulatory convergence and international standards.
Practical Steps for Applicants: Navigating the Reliance Pathways
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Check eligibility – Verify whether the product is approved by a recognised reference regulator and meets the criteria in the guideline.
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Prepare a robust dossier – Include a summary of the reference agency’s approval, quality/manufacturing data, clinical evidence and safety profile.
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Engage with PPB early – Consider pre-submission meetings to clarify which reliance pathway applies and what supporting documents are needed.
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Submit through the designated online portal – Use PPB’s submission channel and tag the application as “Reliance Pathway”.
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Respond promptly to queries – Once submitted, engage quickly with regulators to avoid delays.
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Plan for post-market obligations – Even with reliance pathways, maintain pharmacovigilance, manufacturing oversight and local registration obligations.
Challenges and Considerations
The reliance model brings advantages but also challenges:
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Data transparency – Companies must supply unredacted reports from reference regulators.
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Local relevance – The regulator still assesses local context, disease profile and manufacturing site suitability.
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Infrastructure/Capacity – PPB and applicants need strong systems to handle reliance workflows. As one workshop found, industry awareness and regulatory capacity remain gaps in Kenya.
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Legal clarity – The guideline is relatively recent and stakeholders must monitor updates as practice evolves.
How Clarity Pharma Consultancy Can Help
If you are an innovator, manufacturer or distributor looking to leverage Kenya’s reliance pathways, Clarity Pharma Consultancy offers expert support.
We guide clients through the eligibility assessment, dossier preparation, submission planning, regulator engagement and post-market compliance.
Contact us for a tailored consultation and ensure your products are fast-tracked under Kenya’s reliance framework.
Kenya’s adoption of reliance mechanisms marks an important step toward faster, efficient, and safe access to medicines. The PPB’s guideline sets out clear pathways that reduce duplication and speed review without lowering standards. If you plan to register your product in Kenya, understanding and leveraging these mechanisms becomes vital. Early engagement, precise documentation and strategic planning position you for success.
FAQs
by Mr. Maroa Noa | Nov 20, 2025 | Marketing, Operations, Strategy
Trust is the foundation of every successful healthcare interaction, especially in pharmacy practice. In Kenya, patients rely on pharmacists not only for medications but also for guidance, assurance, and accurate health information.
As healthcare continues to evolve, Good Pharmacy Practice (GPP) has become an essential framework for enhancing professionalism, accountability, and quality service delivery.
GPP provides clearly defined standards that help pharmacists offer safe, ethical, and patient-centered care. When these standards are consistently applied, patients feel valued, informed, and protected—leading to better health outcomes and stronger relationships between pharmacists and the community.
Understanding Good Pharmacy Practice (GPP) in Kenya
Good Pharmacy Practice refers to the standards set to ensure that pharmacists deliver quality pharmaceutical care responsibly and safely. In Kenya, GPP is guided by the Pharmacy and Poisons Board (PPB), which outlines the minimum requirements for ethical practice, patient safety, and professional conduct.
GPP also aligns with international recommendations issued by the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP). These guidelines emphasize the need for competent, patient-focused services across all pharmaceutical settings.
Why Trust Matters in Pharmacy Practice
Trust influences how patients follow treatment plans, share accurate health information, and return for continued care. When patients trust their pharmacists, they feel confident about medication use and are more likely to avoid harmful self-medication.
Moreover, trusted pharmacists play a key role in public health by providing reliable advice on immunization, chronic disease management, and rational drug use.
In environments where misinformation is common, trust becomes a critical protective factor for community well-being.
Core Principles of Good Pharmacy Practice (GPP)
1. Patient-Centered Care
GPP emphasizes that every pharmacy interaction should prioritize patient needs. Pharmacists must offer individualized counseling, listen actively, and ensure each patient understands their treatment.
Through patient-centered care, pharmacists strengthen relationships built on empathy, respect, and clear communication. This approach improves adherence and empowers patients to take control of their health.
2. Professional Competence and Continuous Learning
Pharmacists must remain competent by updating their knowledge and staying informed about new therapies, safety alerts, and emerging diseases. In Kenya, PPB requires pharmacists to participate in Continuing Professional Development (CPD) programs.
Continuous learning ensures pharmacies maintain high professional standards and provide patients with safe, evidence-based recommendations.
3. Ethical and Responsible Service Delivery
Ethical practice is central to GPP implementation. Pharmacists must protect patient confidentiality, avoid conflicts of interest, and make decisions that put patient safety first.
Responsible service delivery also means refusing to dispense medications without valid prescriptions and reporting suspected misuse. These measures protect patients and promote responsible pharmaceutical use.
4. Quality Assurance and Safety Standards
GPP requires pharmacies to maintain strict quality control measures from medication procurement to dispensing. These measures include proper storage conditions, batch tracking, and adherence to expiry-date protocols.
With strong quality assurance systems in place, patients receive genuine, safe, and effective medications. This transparency strengthens their confidence in the pharmacy’s services.
5. Effective Communication and Counseling
Clear, friendly, and professional communication helps patients understand their medications and avoid dangerous errors. Pharmacists should use simple language, check for understanding, and encourage patients to ask questions.
Good counseling supports better health outcomes and prevents confusion, especially among patients managing chronic illnesses.
Implementing GPP in Kenyan Pharmacies
1. Strengthening Standard Operating Procedures (SOPs)
Pharmacies must establish SOPs that outline daily workflows for dispensing, record-keeping, counseling, and handling controlled substances. SOPs ensure consistency and reduce risks related to human error.
Additionally, SOPs help new staff integrate smoothly while maintaining the organization’s expected service standards.
2. Enhancing Pharmacy Infrastructure
A well-organized pharmacy signals professionalism and competence. Clean counters, well-labeled shelves, and secure storage areas demonstrate the pharmacist’s commitment to safety.
Modern infrastructure—such as computerized stock systems—also reduces errors and enhances service efficiency.
3. Training and Empowering Pharmacy Staff
Support staff such as technicians and assistants must receive proper training to maintain the integrity of GPP standards. Skilled staff create a seamless patient experience and reduce unnecessary delays.
Furthermore, empowered staff contribute to a culture of accountability and teamwork.
4. Promoting Digital Health Tools
Digital tools improve efficiency, accuracy, and patient engagement. Electronic dispensing systems, telepharmacy, and digital recordkeeping support faster decision-making and reduce medication errors.
In Kenya, digital platforms also help pharmacies collaborate with insurers, clinicians, and supply chains to improve service quality.
5. Ensuring Transparency in Pricing and Medication Availability
Patients value honesty and clarity. Transparent pricing builds trust and prevents misunderstandings. Pharmacies should clearly display service charges and inform patients about affordable generic options when appropriate.
Additionally, keeping essential medicines in stock reduces frustrations and enhances trust.
How GPP Builds Trust with Patients
Implementing GPP creates a safe environment where patients feel respected and protected. When pharmacies operate ethically and professionally, patients develop long-term loyalty.
Moreover, GPP reduces medication errors, improves patient understanding, and ensures ethical responsibility. These efforts build credibility, strengthen community confidence, and enhance public health outcomes.
The Role of Technology in Advancing GPP in Kenya
Technology is reshaping pharmacy practice in Kenya. Digital prescription systems, automated stock management, and online patient education improve accuracy and efficiency.
Furthermore, technology helps pharmacists track patient history, identify interactions, and provide personalized care. These capabilities enhance safety and foster deeper patient trust.
Regulatory Bodies Supporting GPP in Kenya
Kenya’s regulatory ecosystem supports GPP through strict licensing, inspection, and compliance protocols. Key bodies include:
These institutions ensure pharmacies uphold standards that promote patient safety and trust.
How Pharmacies Can Strengthen Patient Engagement
Pharmacies can adopt simple but effective strategies to engage patients:
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Provide friendly consultations.
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Offer follow-up support for chronic conditions.
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Educate patients on proper medication use.
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Guide patients on preventive care services.
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Use digital reminders for refills and monitoring.
Such strategies demonstrate commitment, deepen patient relationships, and enhance community trust.
Challenges Affecting GPP Implementation in Kenya
Pharmacies often face challenges such as limited staffing, high patient volumes, and supply chain inconsistencies. Additionally, counterfeit medications and rapid changes in treatment guidelines create operational pressure.
However, through professional collaboration, government support, and continuous training, pharmacies can overcome these challenges and improve service quality.
Good Pharmacy Practice forms the backbone of trustworthy, reliable, and patient-centered pharmacy services in Kenya. By applying GPP principles, pharmacies strengthen patient relationships, reduce errors, and deliver safe, ethical, and high-quality healthcare.
As the sector continues to evolve, embracing GPP remains essential for building strong, lasting trust between pharmacists and the communities they serve.
FAQs
by Mr. Maroa Noa | Nov 19, 2025 | Marketing, Operations, Strategy
Ensuring quality education in pharmacy is vital for Kenya’s health sector. The Pharmacy and Poisons Board (PPB) regulates not only practicing pharmacists but also the institutions that train them.
In this article, we explain how the PPB approves and monitors pharmacy training institutions, what you need to know, and why it matters.
Understanding the Regulatory Framework
The PPB exists under the Pharmacy and Poisons Act, Cap 244, which empowers it to regulate pharmacy practice and training.
The Board publishes a list of approved institutions offering pharmacy or pharmaceutical-technologist training.
Institutions must seek PPB approval before operating programs that train pharmacists or pharmaceutical technologists. The process ensures that students graduate from recognised schools and meet professional entry standards.
Why Approval and Monitoring Matter
When training institutions meet standards, quality graduates enter the workforce. Good regulation protects public health, raises professional standards and promotes the credibility of training institutions.
Without proper approval, students risk attending unrecognised courses and employers may decline graduates. The PPB emphasises that it only accepts qualifications from recognised institutions.
Monitoring, meanwhile, ensures ongoing compliance. Institutions may change curriculum, facilities, or staff, and oversight ensures standards remain high.
Key Steps to Institutional Approval
1. Submit Application to PPB
An institution wishing to train must apply to PPB’s Training & Assessment division. The application typically includes infrastructure plans, staffing, curriculum and resources. While a detailed PPB guideline may exist, institutions must adhere to listed requirements.
2. Demonstrate Facilities & Staffing
PPB inspects whether the institution has appropriate labs, teaching material, qualified staff and student support. Accreditation often includes visits and facility audits.
3. Curriculum Approval & Program Recognition
The institution must align its curriculum with PPB’s standards for pharmacy or pharmaceutical-technologist training. Graduates must fulfil PPB recognition criteria for registration or enrolment.
4. Indexing of Students
Once approved, the institution should ensure students are indexed with PPB. This step is essential for those students to sit PPB exams, register/enrol and practise.
5. Final Accreditation & Listing
On approval, PPB lists the institution among approved training institutions. The public list confirms which schools meet the regulatory requirements.
Monitoring and Quality Assurance by PPB
Regular Inspections
The PPB conducts routine inspections of approved institutions. The inspections may cover teaching quality, facilities, student outcomes and compliance with the original approval.
Continued Professional Development (CPD) Oversight
PPB also regulates CPD for practitioners and works with institutions to ensure training providers meet CPD accreditation standards.
Sanctions and Deregistration
If an institution fails to maintain standards, PPB has authority to suspend its approval, remove it from the approved list, or impose corrective measures. Training in non-approved institutions may lead to non-recognition of qualifications.
Standards and Criteria Institutions Must Meet
Here are key criteria institutions should fulfill:
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Adequate teaching facilities (laboratories, library, teaching aids)
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Qualified faculty and staff with relevant credentials
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Clear curriculum aligned with PPB/commission guidelines
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Student registration and indexing with PPB
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Transparent assessment and internship attachment arrangements
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Continuous evaluation, student feedback and training improvement systems
Practical Tips for Institutions and Students
For Training Institutions:
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Ensure your institution appears on the PPB approved list before enrolling students.
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Maintain rigorous internal audits to ensure standards do not slip between PPB inspections.
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Keep records of facilities upgrades, staff changes and curriculum reviews.
For Students:
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Check the PPB list of approved institutions prior to admission.
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Ensure you get your student index number as required by PPB.
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Confirm that the qualification you seek is recognised by PPB for registration/enrolment.
How Clarity Pharma Consultancy Can Help
If you operate or plan to establish a pharmacy training institution—or you are a student seeking clarity—Clarity Pharma Consultancy offers targeted advisory services.
We can guide you through PPB accreditation, institutional compliance reviews, student indexing processes and monitoring readiness. Contact us to strengthen your institution’s regulatory alignment and ensure recognition of your program.
FAQs
by Mr. Maroa Noa | Nov 19, 2025 | Marketing, Operations, Strategy
Kenya’s pharmaceutical sector relies on competent personnel to protect public health and ensure safe dispensing of medicines. The Pharmacy and Poisons Board (PPB) mandates that all registered pharmacists and enrolled pharmaceutical technologists hold valid licences to practise.
In this article, we map out a clear path to licensing pharmaceutical personnel in Kenya — from registration to renewal to compliance. We write in a simple, educative way suited for a broad audience.
Understanding the Regulatory Framework
The Licensing of pharmaceutical personnel in Kenya is based on the Pharmacy and Poisons Act (Cap 244). This act requires pharmacists and pharmaceutical technologists to meet qualification standards and to obtain licences before they practise.
The PPB handles registration of practitioners, enrolment of technologists, issuing of practice licences and enforcement of compliance.
Why Licensing Matters
Licencing safeguards the public by ensuring that only qualified personnel handle medicines and poisons.
It also enhances trust in the pharmaceutical sector, supports good pharmacy practice and ensures legal accountability.
Practicing without a valid licence amounts to professional misconduct and may trigger sanctions.
Key Requirements for Licence Eligibility
Educational Qualifications
To be registered as a pharmacist, one must hold a recognized Bachelor of Pharmacy (or equivalent) and meet the PPB’s internship and examination requirements.
For pharmaceutical technologists, the person must hold an approved diploma and satisfy the enrolment requirements set by PPB.
Practice Licence Application
Once registered or enrolled, the practitioner must apply for a practice licence through the PPB’s online portal. This applies whether practising in a retail pharmacy, hospital, wholesaler or other pharmaceutical establishment.
Step-by-Step: Obtaining a Practice Licence
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Register or enrol with the PPB – Submit the necessary academic certificates and internship results.
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Choose your practise location or facility – Identify whether you will work in a pharmacy, hospital, wholesale, etc.
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Apply online for the practice licence – Use the PPB’s online services portal.
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Submit documentation and pay fees – Ensure all required documents are attached early to avoid delays.
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Await approval – Once processed, you receive the licence signifying lawful practice.
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Start practising in compliance – Display your licence, adhere to professional standards, and always keep the license current.
Renewal and Continuing Professional Development (CPD)
Licence renewal is mandatory annually. The PPB demands ongoing CPD activities for all licensed practitioners.
Failure to renew or engage in CPD may lead to suspension or sanctions. The system flags practising without a license as misconduct.
Common Mistakes to Avoid
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Uploading incomplete documentation or missing attachments in the online application.
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Practising in more than one facility as the superintendent pharmacist – the law restricts a license to one premise at a time.
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Delaying renewal and overlooking CPD obligations.
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Operating without a valid licence or practising under an expired licence – penalty risk is real.
How Clarity Pharma Consultancy Can Support You
At Clarity Pharma Consultancy, we provide tailored consultation services for pharmaceutical personnel and establishments.
We help you:
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Navigate the PPB licensing portal.
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Gather and prepare required documentation efficiently.
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Understand CPD requirements and maintain compliance.
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Avoid licensing delays and regulatory setbacks.
Reach out to us and let us streamline your licensing journey.
Securing and maintaining a valid practice licence in Kenya is indispensable for pharmaceutical personnel. By following the steps above and engaging with regulatory requirements proactively, you protect your profession, serve the public and safeguard your career.
With the right guidance and compliance mindset, you are well-positioned to thrive in Kenya’s dynamic pharmaceutical sector.
FAQs
