Cleaning Validation

About this course

Control of cross-contamination is a major compliance issue in our industry today.

Central to any effective strategy for control is the demonstration that our cleaning procedures are robust and capable of consistently removing residual products down to levels which do not pose a risk to patient safety.

Validation of cleaning procedures is thus critical to any Quality Assurance programme and is currently a topic of great concern to regulators worldwide.

This course has been designed to provide practical advice on how to design and execute cleaning validation studies to meet current regulatory expectations in a cost-effective way.

General principles of cleaning validation will be supplemented by specific case studies from industry specialists from…

• Dosage form manufacture and packing
• Active pharmaceutical ingredient manufacture
• Biopharmaceuticals manufacture

The special challenges of clinical trials manufacture and packing will also be covered in detail.

What you will learn

• Current international regulatory expectations for cleaning validation studies
• How to use risk assessment to…
  • set validation priorities
  • devise a scientifically sound cleaning matrix
• How to devise cleaning validation protocols which meet regulatory expectations and help you to gain the maximum amount of information from the minimum amount of work
• What to do when things go wrong!

Course outline

Current Regulatory Expectations

• EU
• FDA
• ICH

Using Risk Assessment to set Priorities and Acceptance Criteria Cleaning Procedures

• Manual procedures
• Automated systems
• Clean In Place (CIP)
• Clean Out of Place (COP)

Study Design

• Holding times
• Selection of sampling sites
• Sampling methods
  • swabs vs. rinse samples etc
• Creating a defendable cleaning matrix

Analytical Methods

• Specific vs. non-specific methods
• Method selection
• Method validation requirements

Setting Acceptance Limits

• Current industry norms
• Different approaches
  • dosage form manufacture
  • API manufacture
  • biotech applications

Change Control and Ongoing Monitoring

• Ensuring continuing effectiveness
• What to do when things go wrong!

Industry Case Studies

• Biotechnology
• Active pharmaceutical ingredients
• Dosage form manufacture

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work,where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

Glen Hove Conferencing, Johannesburg, South Africa

Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.

For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]

The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]

Catering

During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.

After each day’s activities a closed bar service will be available, chargeable to your account where relevant.

Special Dietary Requirements

If you have any special dietary requirements, please contact the conference management.

Venue Address and Contact Details

Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196

PO Box 2467, Houghton, 2041

Tel: 011 442-3601
Fax: 011 442-3678

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• Dr Allan Thomas
  Partner
  Dip.Pharm, MPharm, DPharm, MPS(SA), MPD(IMD), CHE(NWU)

  • [email protected]
  • +27 (0) 21 558 4515
• Ms Anna Naidoo
  Consultant
  Chemist

  • [email protected]
  • +27 (0) 21 558 4515

What you've said

“It’s a great course, it aims at the correct people, it helps you understand that cleaning is not as a consequence of manufacturing the drugs but it’s where the manufacturing process starts and ends. It’s important for your drug’s efficacy. It also helps one realise that the only way to fight against these bad bugs is proper cleaning”

Mthokozisi Nyawose, National Bioproducts Institute, SA

“Valuable insight into industry guideline. Loved the overview and in depth product material”

Heinrich Behr, The Biovac Institute, SA

“Course has put cleaning validation into perspective with the practical exercise being of great value”

Joanne Hiep, Adcock Ingram Ltd, SA