REGULATION IN THE PHARMACEUTICAL INDUSTRY: MANUFACTURING AND DISTRIBUTION Level 5 Certificate

Level 5
Higher Education
eCampus

Overview

This qualification is targeted at learners who are currently working in or who wish to work in laboratory-based occupations.

The Regulation in the Pharmaceutical Industry: Manufacturing and Distribution Level 5 Certificate is an specialised programme designed to provide students with a comprehensive understanding of the regulatory frameworks and requirements related to manufacturing and distribution processes within the pharmaceutical industry. This certificate focuses on equipping students with the specialised knowledge and skills necessary to ensure compliance with regulatory standards and promote product quality, safety, and efficacy.

The programme covers a broad range of topics related to regulation in pharmaceutical manufacturing and distribution. Students will study the principles of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). They will gain insights into the requirements for facility design, equipment qualification, process validation, and quality control in pharmaceutical manufacturing.

Pharmaceutical manufacturing and distribution processes are highly regulated and require strict adherence to quality standards. Students will learn about risk management, change control, deviation management, and CAPA (Corrective and Preventive Actions) processes to maintain compliance and ensure continuous improvement. They will also examine the documentation, record-keeping, and data integrity requirements necessary for regulatory audits and inspections.

Throughout the course, students will be supported by experienced faculty staff who are experts in the field and will benefit from a supportive learning environment that encourages critical thinking, problem-solving, and the application of regulatory principles and best practices.

Applicants should have achieved:

At least 5 GCSEs (or equivalent) including English and Mathematics at Grade C or above AND
A level 4 qualification in a science related area.

On completion of this qualification learners will be able to:

understand the procedures required to ensure Good Laboratory Practice (GLP) in the pharmaceutical industry.
understand the procedures required to ensure Good Manufacturing Practice (GMP) in the pharmaceutical industry.
develop a systematic approach for in-process control (IPC) tests in the pharmaceutical industry.
understand the procedures and systems required to ensure GMP in a distribution setting in the pharmaceutical industry.

Grading for this qualification is pass/fail.

The following assessment method/s may be used to ensure all learning outcomes and assessment criteria are fully covered:

Portfolio of evidence
Practical demonstration/assignment
Coursework
E-assessment

Graduates may choose to pursue additional higher education qualifications to enhance their career prospects within the field of pharmaceutical regulation and operations.

Upon successful completion of the Regulation in the Pharmaceutical Industry: Manufacturing and Distribution Level 5 Certificate, students will be well-prepared for positions in pharmaceutical manufacturing companies, distribution centres, or regulatory affairs departments. They may find employment as manufacturing supervisors, quality assurance managers, supply chain coordinators, or regulatory compliance specialists.