RFQ/OBP370/2025/26
See details below or the tender documentation
Tender Closed on: 2026-02-18 15:00
Onderstepoort Biological Products Limited
Consulting Services, Education, Training, Mentorship and Coaching, Professional Services
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Tender Description: Training contents requirements: Key Learning Objectives On completion of this course, trainees must be able to: Explain the origin and reasons for GMP Apply the practical interpretation of GMP expectations and best practices Identify EudraLex and PIC/S expectations To perform better audits Become a Certified GMP Pharmaceutical Quality Systems Lead Auditor. Understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control. Course Outline Overview of EU law and requirements relating to medicines EudraLex Volume 4 Quality Risk Management - ICH Q9 Pharmaceutical quality systems and ICH Q10 Management responsibilities Documentation and records Validation - the basics Supplier assurance Facility design and GMP requirements for different dose forms/routes of administration Good Control Laboratory Practice Self-inspections Change management Investigations - deviations and CAPA Complaints, quality defects and recalls Training Principles and Audit Planning -Planning and preparation -Audit types and techniques -Establishing an audit program for suppliers, contractors and company sites -Internal vs. external audits -The audit process Auditor Skills and Competencies -what makes a good auditor -Communication skills, questioning and listening -Body language and non-verbal communication -Overcoming apathy, resistance and aggression -Effective note taking -Auditor continuing professional development -Assessing the auditor -Managing auditors Initiating, Preparing and Conducting the Audit -Materials management -Documentation systems -Pharmaceutical quality systems -Sterile products -Oral solid dose -Packaging and many more Concluding the Audit -Wrap-up -Follow-up The course must also be designed for auditors assessing: Manufacturing operations Contract manufacturing organizations API suppliers Excipient suppliers Packing component suppliers Service providers Training method: Face to face/In class Assessment: Required Training Material: Include study material /copy of presentation Competency certificate: Required Facilitator Requirement: background in 5 years' experience in training GMP implementation and auditing. SETA certified as a facilitator, Training provider: Services SETA registered/accredited
Information:
Contact:Quotations should be submitted online
For futher enquiries please contact: 012 522 1500
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Tender URL: https://eprocurement.obpvaccines.co.za/Opportunities/Details?Id=81f6e5c1-46b2-4ad9-8081-375a24638e96
Application URL: https://eprocurement.obpvaccines.co.za/Suppliers/Bids/Add?id=81f6e5c1-46b2-4ad9-8081-375a24638e96
The primary objective of this tender is to procure GMP (Good Manufacturing Practice) Implementation and Auditing Training. The training aims to equip delegates with the knowledge and skills necessary to understand pharmaceutical quality systems, GMP practices, and auditing procedures. Upon completion, trainees should be able to assess pharmaceutical manufacturing processes, ensure compliance with GMP standards, and conduct GMP audits effectively.
The scope of the tender includes:
The technical requirements for the tender are as follows:
The skills and qualifications required from the training provider include:
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