Aspects Of GMP Production

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Aspects Of GMP Production

• Dr. Muslim Suardi, MSi., Apt.
• Faculty of Pharmacy, University of Andalas

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principle

• Production operations must follow clearly
  defined procedures they must comply with the
  principles of GMP in order to provide assurance
  of consistently yielding pharmaceutical product
  which conform to the requisite quality be in
  accordance with the relevant manufacturing
  marketing authorization.

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General

• Production should be performed supervised by
  competent people.
• All handling of materials products, such as
  receipt quarantine, sampling, storage,
  labelling, dispensing, processing, packaging,
  dissrtibution should be done in accordance with
  written procedures/instructions where
  necessary, recorded.

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Starting materials

• Starting materials should only be purchased from
  approved suppliers named in the relevant
  specification.
• The sample should be tested for compliance with
  the starting materials specifications.
• Deliveries of starting materials should be held
  in quarantine until approved and released for use
  on the authority of the head of quality control.

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Validation process

• Validation studies should reinforce GMP be
  conducted in accordance with defined procedures.
  
• Results conclusions should be recorded.
• Significant changes in process, equipment or
  materials should be accompanied by further
  validation steps to ensure that the changes
  continue to yield consistently a product of the
  requirely quality.

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Prevention of contamination

• Segregated areas separate facilities for
• Live vaccines other biological materials
• Penicillin products
• Campaign processing
• Ventilation systems airlocks
• Design of ventilation system
• Incoming air should be filtered
• Pressure differentials air extraction
• Airlocks
• Air flow patterns equipment design
• Recirculation versus 100 fresh air supply

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• Clothing
• Protection of operator product
• Highly potent products or those of particular
  risk - need for special protective clothing
• Personnel should not move between areas producing
  different products
• Garments need to be cleaned
• Closed processing systems
• E.g totally enclosed water purification systems
• Tanks fitted with appropriate filtration -
  without
• removable lids
• Present special cleaning difficulties, sometimes
  use clean-in-place (CIP)

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• Cleaning decontamination
• Procedure for removing soil dirt
• Remove all cleaning chemical residues or
  disinfectant residues
• Must remove or reduce micro-organisms

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• Authorization
• Definition of product quality
• Laboratory operations
• Release decisions
• Investigation reporting