Procurement for GMP Manufacturing – Regulatory Requirements and Expectations
- Which regulations are applicable?
- Marketing authorisation
- Manufacturing and import licensing
- Supplier qualification: equipment, starting materials, disposables and consumables
- Risk-based qualification and validation
Consumables for GMP Areas – “C-items” and their Impact
- What impact do consumables have in terms of cost and quality?
- Specifications of the user and effective action of the purchasing Department
- Risk assessment and evaluation in the event of a possible product change (change control)
- Possible internal cots, depending on the respective consumable, in the case of a product change
GMP Requirements for Raw Materials
- What are raw materials?
- What is “pharmaceutical grade” for excipients?
- GMP for raw materials – risk assessment
- GMP requirements for final intermediate & APIs
- Supplier qualification & traceability
Requirements of Packaging Materials
- The challenge for packaging purchasing
- Regulations and their requirements for packaging materials
- New products and their applicators
- Extended challenges for packaging purchasing
Supplier Contract Management
- Quality and risk Management
- Technical Agreements
- cGMP requirements
- Control of content
Change Control – Part I
- Impact and consequences
- Submissions – Friend or enemy?
- Why ignorance is dangerous
Change Control – Part II
- Lectures from supply chain disruptions
- Why packaging can be a major headache
Documentation for GMP Materials – What is necessary? Retention Periods
- Regulatory requirements
- Defense against legal Claims
Qualification of Technical Suppliers - a Risk-based Approach
- Technical equipment and utilities
- Analytical equipment & reagents
- Supplies, disposables and consumables - What regulations apply?
- Risk-based qualification and procurement
GDP Effects on Procurement and Purchase
- GDP requirements to manufacturer
- Ideas to handle the requirements
- Discussions between the involved departments
Supply Chain Improvement or Continuous (Process) Improvement - What is it? How can it be Implemented at 100% Capacity with Potential Regulatory Hurdles?
- What is Lean, Six Sigma, Scrum, Agile... and why the system doesn’t matter in the end
- Ideo, the design champions and what we can learn from them
- Why all this can actually be very simple. Improvements in purchasing and supply chain at 100% capacitiy and a completely regulated environment
Case Study: Time is Money – Reconstruction & Building of a Pharmaceutical Production
- Why this topic? - The special situation?
- Good start of the project! - a long time ago
- The arising budget issue!?
- The result of the different budget issue solutions!
- My key learnings - or perhaps “take home messages” for some participants.