When pharmaceutical products reach the Kenyan market, stakeholders must guarantee they meet rigorous quality standards. The Pharmacy and Poisons Board (PPB) has long mandated these standards and published guidance that laboratories must follow.
This article unpacks PPB’s quality manual (and analogous standards) to help you understand what pharmaceutical testing labs must do.
Understanding PPB’s Role in Laboratory Standards
The PPB exists under the Pharmacy and Poisons Act (Cap 244) in Kenya. It regulates manufacture, trade, import/export, registration, and quality of medicines. As part of this mandate, the PPB influences the standardisation of pharmaceutical testing laboratories.
Laboratories that test medicines must operate under recognised quality management systems to produce valid and reliable results.
Why a Quality Manual for Pharmaceutical Testing Matters
A quality manual sets the blueprint for how labs should operate and ensures consistent, high-quality outcomes. Without it, results may vary, risking public health, regulatory non-compliance, and loss of credibility. Globally, standards like ISO/IEC 17025 define the competence of testing labs.
When the PPB requires such frameworks, laboratories align with them to gain regulatory approval and maintain trust. In short, a strong quality manual = reliable test results + regulatory confidence + public safety.
Core Elements of a Laboratory Quality Manual for PPB Compliance
Here are the key topics your quality manual should cover:
Policies and Organisational Structure
Define the lab’s mission, scope of activities, and authority structure. Make clear who’s responsible for quality, competence, and compliance.
Describe how the facility meets PPB norms, including oversight, internal audits, and training programmes.
Document Control and Records Management
Establish procedures for version control of documents, secure storage of test records, and retention timelines.
Ensure records include calibration logs, reagent lot numbers, equipment maintenance, and test results.
Equipment, Calibration and Maintenance
State how equipment is selected, calibrated, qualified, and maintained.
Include schedules for preventive maintenance, calibration certificates, and logbooks.
Calibration traceability ensures test accuracy and aligns with external regulatory bodies.
Test Methods and Validation
Clearly document test methods (e.g., pharmacopoeial methods). Declare how methods are validated, verified, and reviewed.
Define acceptance criteria and how to handle deviations or out-of-specification results.
Ensure all standard operating procedures (SOPs) link to the manual.
Quality Control and Assurance
Include internal QC (e.g., control samples) and external QA (e.g., proficiency testing) programmes.
Cover how non-conforming work is managed, corrective actions implemented, and trends analysed.
Show how continuous improvement is embedded in lab culture.
Personnel and Training
Detail staff qualifications, roles, responsibilities, and training programmes.
Keep training records, supervise juniors, and update competency assessments regularly.
Safety, Environmental Conditions and Facilities
Define safe practices for handling hazardous materials, waste disposal, and chemical storage.
Ensure facility conditions (temperature, humidity) meet required tolerances for tests.
Show how the lab meets infrastructure requirements and environmental safety standards.
Monitoring, Audits and Review
Describe how internal audits occur, how management reviews take place, and how the quality manual is updated.
Continuous review ensures alignment with PPB updates and best-practice standards.
Practical Steps to Develop or Update Your Quality Manual
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Perform a Gap Analysis – Compare existing lab practices against PPB guidance and ISO/IEC 17025 fundamentals.
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Define Scope and Document Structure – Use clear headings, version controls, and table of contents.
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Draft Policies for Each Element – Write concise statements for each section above.
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Link SOPs and Records – Ensure each policy refers to relevant SOPs and forms.
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Train Staff on New Manual – Conduct workshops and obtain staff acknowledgement.
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Implement and Monitor – Execute the manual, run internal audits, capture non-conformances.
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Review Annually or On Regulatory Change – Adjust manual content when PPB or industry standards change.
How Clarity Pharma Consultancy Can Help
If you need expert guidance to develop, review or implement a laboratory quality manual aligned with PPB standards, Clarity Pharma Consultancy stands ready. We offer tailored support in documentation, staff training, audit preparation and regulatory readiness. Contact us for consulting services that ensure your laboratory meets the highest standards.
FAQs
What happens if a laboratory fails to comply with the PPB quality manual requirements?
Non-compliance can lead to invalid test results, regulatory rejection of product dossiers, reputational damage, and potentially legal or licensing penalties under the Pharmacy and Poisons Act.
How often should a quality manual be reviewed?
Review at least annually or any time regulatory frameworks (such as PPB rules) or internal processes change.
Review at least annually or any time regulatory frameworks (such as PPB rules) or internal processes change.
Start with a gap analysis: assess the lab’s current status, compare against PPB expectations and international standards, then draft a structure and implementation plan.
