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Martyn Becker training management and
operators of an aseptic plant in Turkey in 2007 (courtesy Esra Aytac) |
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In
addition to any specific GMP (Good Manufacturing Practice) issues that you may require assistance
with, specialist services offered by Martyn Becker Associates
include: |
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Aseptic manufacture/sterile medicinal
products
- all aspects of guidance, audit and advice - from the regulatory
perspective of an ex-Inspector who is routinely involved with the
update of regulatory guidance
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Biological operations
- specialist regulatory knowledge and experience in bulk
biologicals, vaccines and other biological operations from an ex-biologicals/blood
service inspector
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In
addition to these regulatory high-risk areas, the services offered
include:
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Quality By Design and Operational Support
- building strong systems for the future
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Compliance assessment/recommendations
- for all dosage forms and API facilities, and for suppliers to the
pharmaceutical industry
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Regulatory guidance
- detailed EU and FDA expertise from an ex-Inspector’s viewpoint
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Inspection readiness process
- detailed and formalised structure to get your operation ready
for EU, US and other inspections
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Facility design/re-design expertise
- proven experience in design/re-design of aseptic, biological and
non-sterile operations
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Pre-approval assessment and recommendation,
both US FDA and EU
- mock-regulatory-inspection from an ex-regulator experienced in
global GMP requirements
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Internal/supplier audit
- 18 years' experience of all types of audit, self-inspection and
regulatory inspection
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GMP training/education
- proven excellence in motivation and communication
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Specific troubleshooting
- 33 years' experience to cover all types of pharmaceutical
situation
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Martyn
Becker Associates Global GMP consultants aseptics and steriles specialist
GMP consultancy. Good Manufacturing Practice standards for the
pharmaceutical industry systems.