ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical

Qualification Specification File

In the pharmaceutical industry, quality is not just a priority—it is a regulatory requirement and a critical factor in protecting patient health. As the industry continues to grow and evolve, there is a rising demand for skilled professionals who understand the complexities of pharmaceutical quality systems. The ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical is an advanced qualification designed to develop expert-level knowledge and practical competencies in quality control, regulatory compliance, and pharmaceutical risk management.

This diploma is ideal for experienced professionals seeking to progress into leadership or specialized roles in pharmaceutical quality assurance (QA) and quality control (QC). It builds on foundational knowledge and prepares learners to meet international standards and regulatory expectations in highly controlled environments.

The ICTQual Level 5 Diploma in Quality Control Pharmaceutical delivers an in-depth understanding of advanced quality systems in pharmaceutical manufacturing. The course content is aligned with global Good Manufacturing Practices (GMP), regulatory frameworks, and the latest quality control methodologies.

Learners are introduced to specialized topics such as pharmaceutical microbiology, process validation, equipment qualification, root cause analysis, and internal audit management. The program also focuses on documentation control, supplier assurance, data integrity, and compliance monitoring—all essential areas for maintaining product safety and regulatory readiness.

Through real-world case studies, detailed assignments, and practical tools, this diploma equips learners to lead, improve, and manage pharmaceutical quality systems with confidence and accuracy.

The ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical is a benchmark qualification for those who aspire to lead in the field of pharmaceutical quality. With its advanced content, practical relevance, and international recognition, this diploma ensures you are equipped to drive quality excellence in pharmaceutical manufacturing, testing, and compliance. Whether you’re aiming to enhance your current role or transition into a more senior position, this course provides the expertise and confidence needed to succeed in a highly regulated, high-responsibility industry.


Course overview

Level 5 Diploma in Quality Control Pharmaceutical

To enrol in ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical, applicants must meet the following entry requirements:

  • Age Requirement: Learners must be 18 years of age or older.
  • Educational Background: Learner must hold a relevant Level 3 or Level 4 qualification in pharmaceutical sciences, quality control, laboratory technology, or a closely related field. Qualifications in chemistry, biology, or healthcare disciplines are also acceptable.
  • Work Experience: Learners are expected to have prior work experience in the pharmaceutical, healthcare, laboratory, or life sciences industry. This experience provides essential context for understanding the advanced topics covered in this diploma.
  • English Proficiency: Basic proficiency in English is required to understand course materials and complete assessments.
  • Computer Literacy: Basic digital skills are necessary for accessing online learning platforms, submitting assignments, and participating in virtual workshops or assessments

These entry requirements are designed to ensure that learners are equipped with the foundational knowledge and practical background necessary to excel in this advanced-level diploma and transition confidently into senior roles within the pharmaceutical quality control sector.

This qualification, the ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical, consists of 10 mandatory units.

  1. Advanced Principles of Quality Control in Pharmaceuticals
  2. Pharmaceutical Microbiology and Contamination Control
  3. Process Validation and Equipment Qualification
  4. Good Manufacturing Practices (GMP) and Regulatory Frameworks
  5. Data Integrity and Electronic Documentation Systems
  6. Pharmaceutical Risk Assessment and Management
  7. Quality Management Systems (QMS) in Pharma
  8. Investigations, Root Cause Analysis, and CAPA
  9. Supplier and Raw Material Quality Assurance
  10. Audit Preparation and Regulatory Inspection Readiness

Learning Outcomes for the Study Units:

1. Advanced Principles of Quality Control in Pharmaceuticals – Learning Outcomes

By the end of this unit, learners will be able to:

  • Apply advanced quality control techniques in pharmaceutical manufacturing
  • Interpret complex test results and ensure regulatory compliance
  • Implement strategic quality plans for product development and release
  • Evaluate critical control points to prevent product defects
  • Align quality control activities with organizational and regulatory expectations

2. Pharmaceutical Microbiology and Contamination Control – Learning Outcomes

By the end of this unit, learners will be able to:

  • Understand microbiological hazards in pharmaceutical environments
  • Apply contamination control methods in sterile and non-sterile production
  • Interpret microbiological test data and environmental monitoring results
  • Implement preventive measures to control microbial contamination
  • Comply with microbiological testing standards and GMP requirements

3. Process Validation and Equipment Qualification – Learning Outcomes

By the end of this unit, learners will be able to:

  • Define key stages of process validation in pharmaceutical operations
  • Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Assess process reliability and equipment performance over time
  • Apply validation lifecycle principles according to industry guidelines
  • Ensure equipment meets GMP and safety compliance standards

4. Good Manufacturing Practices (GMP) and Regulatory Frameworks – Learning Outcomes

By the end of this unit, learners will be able to:

  • Interpret international GMP regulations and standards (e.g., WHO, FDA, EMA)
  • Implement GMP policies in routine pharmaceutical operations
  • Evaluate regulatory updates and integrate them into compliance systems
  • Train staff on GMP procedures and documentation practices
  • Support inspections and regulatory submissions with appropriate evidence

5. Data Integrity and Electronic Documentation Systems – Learning Outcomes

By the end of this unit, learners will be able to:

  • Define principles of data integrity in pharmaceutical environments
  • Use ALCOA+ standards to ensure reliable and traceable records
  • Manage electronic systems for batch records and QC data
  • Identify and mitigate risks related to data manipulation or loss
  • Comply with international data integrity guidelines and audit trails

6. Pharmaceutical Risk Assessment and Management – Learning Outcomes

By the end of this unit, learners will be able to:

  • Conduct comprehensive risk assessments in pharmaceutical processes
  • Apply tools like FMEA, HACCP, and risk matrices in quality planning
  • Identify, assess, and prioritize operational and compliance risks
  • Develop risk mitigation and control strategies
  • Integrate risk-based approaches into quality system design

7. Quality Management Systems (QMS) in Pharma – Learning Outcomes

By the end of this unit, learners will be able to:

  • Understand the structure and function of a pharmaceutical QMS
  • Design and implement QMS elements aligned with ICH Q10 and ISO standards
  • Monitor QMS performance using key quality indicators (KPIs)
  • Facilitate continuous improvement through change control and CAPA
  • Ensure compliance and effectiveness of QMS processes across departments

8. Investigations, Root Cause Analysis, and CAPA – Learning Outcomes

By the end of this unit, learners will be able to:

  • Lead investigations into deviations, out-of-specification (OOS) results, and non-conformances
  • Apply root cause analysis tools such as the 5 Whys and Fishbone Diagram
  • Develop effective Corrective and Preventive Action (CAPA) plans
  • Monitor CAPA implementation and effectiveness over time
  • Document findings in alignment with regulatory and internal requirements

9. Supplier and Raw Material Quality Assurance – Learning Outcomes

By the end of this unit, learners will be able to:

  • Evaluate supplier qualifications and conduct audits
  • Assess raw material specifications and quality standards
  • Develop and manage supplier approval programs
  • Collaborate with procurement and QA teams for consistent material quality
  • Address supply chain risks related to material quality and traceability

10. Audit Preparation and Regulatory Inspection Readiness – Learning Outcomes

By the end of this unit, learners will be able to:

  • Prepare for internal, external, and regulatory audits effectively
  • Identify gaps in documentation and compliance before inspections
  • Support audit teams with evidence and responses during inspections
  • Develop audit readiness checklists and protocols
  • Foster a quality culture that promotes continuous audit readiness

Completing the ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical opens doors to advanced professional opportunities in the global pharmaceutical and healthcare industries. Learners gain a competitive edge and are well-positioned to progress into specialized, supervisory, or managerial roles within quality and compliance domains.

Future progression opportunities include:

  • Senior Quality Control Officer
  • Quality Assurance Supervisor
  • Pharmaceutical Compliance Specialist
  • GMP Compliance Auditor
  • Regulatory Affairs Associate
  • Documentation and Validation Lead
  • Pharmaceutical Manufacturing Supervisor
  • Risk and CAPA Coordinator
  • Internal Audit Manager (GMP & QMS)
  • Supplier Quality Assurance Executive

Additionally, learners may choose to pursue specialized certifications in pharmaceutical validation, regulatory compliance, GMP auditing, or quality risk management, enhancing their expertise even further.

FAQs

This diploma is ideal for quality professionals, laboratory supervisors, production managers, regulatory officers, or individuals with prior experience or qualifications in pharmaceutical sciences. It is suited for those aiming to advance into leadership or compliance-focused roles in the pharmaceutical industry.

Applicants should have a relevant Level 3 or Level 4 qualification in pharmaceutical sciences, quality assurance, or a related field. Industry experience in pharmaceutical manufacturing or laboratory operations is highly recommended. Proficiency in English and basic computer skills are also required.

ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical is 50 Credits training program. As this Training program have mandatory assessment which will be conducted through Approved Training Centers.

ICTQual AB allows to offer Level 5 Diploma in Quality Control Pharmaceutical in various formats, including online, in-person, or a combination of both. Participants can choose the format that best fits their schedule and learning preferences. But final decision is made by ATC.

Yes, ICTQual AB Level 5 Diploma in Quality Control Pharmaceutical consist of 10 mandatory assessments . These assessments are designed to evaluate participants’ comprehension of course material and their capacity to apply concepts in practical situations. It is mandatory to pass assessments with a minimum score of 75%