Learning from GMP Inspections.

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Learning from GMP Inspections.

• Richard Bateman
• QA Specialist Pharmacist
• East and South East England Specialist Pharmacy
  Services

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Overview
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Common Deficiencies

• What do you think the most common deficiencies
  are?
• Are there new / emerging topics at inspections?
• Can / should we share information to increase
  learning?
• What are the barriers to addressing deficiencies
  effectively and in a timely manner?

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MHRA Inspection Data

• No specific category for repacking /
  overlabelling
• Need to focus on specific areas and some not so
  relevant included to give big picture

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Quality Management

• CAPA we may have systems but do we really do
  both parts?
• Can we show this?
• RM should be proactive not reactive
• Statements on exception reports?
• Recalls MHRA, Regional System, Company Alerts
  and communications.

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Personnel

• Training Records do we really show competency?
• Checking evidence, logs and statistics?
• It is a simple process until it goes wrong!

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Premises and Equipment

• NHS Problem
• We know this so do MHRA!

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Production

• Completion and accuracy of batch documentation
  signatures, timeliness of completion, accuracy re
  suppliers
• Segregation and line clearances records,
  checking?, how thorough?
• Products and leaflets packing line,
  photocopier, storage areas
• Dont forget storage areas as well

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Quality Control

• Starting Materials approval, specification,
  contract changes, out of stocks and substitutions
• Release procedures sampling, testing

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Materials Management

• Starting materials see QC
• Technical Agreements customers, contracting for
  services
• Contingency Arrangements
• Warehousing and distribution GDP issues

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Validation

• Labelling systems access, validation, checking
  systems
• Barcoding?
• VMP
• Cleaning
• Equipment?

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Regulatory Compliance
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Related GDP Deficiencies

• General Storage temperature control and
  monitoring
• Mapping, records, deviation handling, SOPs,
  returns
• Cold storage and transport temperature control
  and monitoring
• As above, in transit if applicable receipt and
  dispatch. NB returns?
• Systems for returns and recalls
• In house and MHRA / company led. Communication
  within host organisation? Testing of SOP?

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Related GDP Deficiencies

• Counterfeiting Issues and controls
• NHS contracting process gives good protection
• Supplier bona fides
• Destruction of packaging
• SOP
• Would staff receiving know what to look out for
  training and records

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Questions revisited

• What do you think the most common deficiencies
  are?
• Are there new / emerging topics at inspections?
• How can we improve the way we share information
  to increase learning?
• How can we overcome the barriers to addressing
  deficiencies effectively and in a timely manner?