Transcript Refresh your GMP Training

Refresh your GMP Training
Maintaining GMP and GMP Training in a
high product turnaround facility.
Suzanne Dunne
STADA Production Ireland
Intro to Stada Production Ireland
History…
1970’s
1970:
•
Founded by a local interest group to manufacture over the counter
(OTC) medicines for Irish and export markets.
•
Company Name – Clonmel Chemicals.
1977:
•
Acquired by the Cross Chemical Group, which had a successful
record in the manufacture and marketing of veterinary and animal
health products.
18-Jul-15
3
History…
1980’s
1986:
Re-located to it’s current site – one plant (Unit 1).
1987:
A new solid dose Antibiotic Plant (Unit 2) was built to
manufacture Beta-Lactam products
(i.e. capsules, tablets, powders).
1988:
FDA approval received for the Beta-Lactam range.
18-Jul-15
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History…
1990’s
18-Jul-15
1993:
Renamed Clonmel Healthcare.
1995:
Extension to Antibiotic Plant.
1997:
Acquired by Fuisz Technologies International (USA).
1999:
Fuisz International merged with Biovail Corporation (Canada).
5
History…
2000’s
2000:
STADA Germany purchased Clonmel Healthcare.
2006:
Clonmel Healthcare split into two legal entities
• Clonmel Healthcare – sales, marketing and distribution division.
• STADA Production Ireland – contract manufacturer and packager.
18-Jul-15
6
Intro to Stada Production Ireland
• Generic Pharmaceutical Products
– Antibiotic
– Analgesic
– Tranquilliser
– Antihypertensive
– Corticosteroid
– Antidepressant
– Etc...
• Rx and OTC
Multi-Product Site
• Multiple Product forms
– Tablets [film and sugar coated]
– Capsules
– Powder for suspension
• Multiple APIs
– Currently in the region of 80.
GMP Approvals
• Regulator - IMB
• Approved by FDA
– [Unit 2: β-lactam antibiotics]
GMP TRAINING IN SPI
Overview of this Presentation
• How SPI manages and structures GMP training
and,
• GMP refresher training in a site where there is
such a high number of products.
GMP Training
Induction
Refresher
Job specific
New
personnel
All
personnel
Specific
personnel
GMP Training in SPI
• GMP Training
– Content and documentation described in the site
Training SOP.
• Including assessment
– Induction: from a “no previous knowledge” point
of view
– Vary media
• Presentation, discussion, video, exercises, workshops...
Refresher GMP Training:
Structure and Management
• Do large numbers of APIs make a difference?
• Processes don’t change much from product to
product.
• Focus on
– Line Clearance
– Cleaning
– Prevention of Cross Contamination
– Following batch record/SOP requirements
Structure of GMP Refresher Training
• Changed from 2007 to 2008
– Made less “powerpoint-y”
• Designed to include
– Group Discussion points
– Participative exercises/problem solving games
– Company specific case studies/workshops
– Variety of media
– More fun!
Feedback [2008]
• Over 90% of participants “strongly agreed”
that the new GMP training was more
informative, more effective and more relevant
to them in their jobs.
GMP Refresher Training in SPI
• How to keep it fresh and relevant
– Use company specific examples to create case studies
– Present the company’s own data to show how
processes are performing
– Get interesting stories on GMP issues in the industry
and relate to the “hot topics” seen by regulatory
authorities
– Be inventive and resourceful in presenting information
and getting people to think for themselves.
Remember...
• Appeal to the different Learning Styles
– Activist
– Pragmatist
– Theorist
– Reflector
Add some FUN!
• The more memorable a training intervention
is, the more likely adult learners are to retain
the information they were exposed to.