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Principle

Aspects o f GMP P remises Dr. Muslim Suardi , MSi ., Apt. Faculty of Pharmacy, University of Andalas. Principle. Premises must be located, designed, constructed, adapted & maintained for the operations: Minimize risks of errors & cross-contamination Permit effective cleaning

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Principle

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  1. Aspects of GMPPremisesDr. Muslim Suardi, MSi., Apt. Faculty of Pharmacy, University of Andalas

  2. Principle Premises must be located, designed, constructed, adapted & maintained for the operations: • Minimize risks of errors & cross-contamination • Permit effective cleaning • Permit effective maintenance • Minimize build-up of dirt & dust • Eliminate any adverse effects on quality

  3. Location • Geography, climate, noise & economic factors • Neighbours • What do they do? • What impact can they have on the business? • Pollution/effluent control

  4. Premises should be built to: • Facilitate sanitation. • Be maintained & cleaned easily • Services availability • Protection against entry of insects or other animals

  5. Ancillary Areas • Rest & refreshment rooms • Changing, washing & toilet areas • Maintenance workshops • Animal houses

  6. Storage areas Storage areas of sufficient capacity for: • Clean, dry & maintained within acceptable temperature limits • Area under cover, protection from heat, dirt, & rain • Areas clearly marked & access limited for quarantine status good. • QC sampling area with GMP standards • Segregated areas for rejected, recalled & returned materials • Separate areas for highly active, hazardous, narcotic materials • Printed materials storage

  7. Weighing areas • Control systems • Environmental controls, dust control • Segregation • Smooth, impervious, durable, easy to clean finishes • Cleaning • Documentation

  8. Manufacturing & Packaging Dedicated & self-contained facilities for: • Logical flows of materials & people • Adequacy of working space & orderly & logical positioning of equipment • Interior surfaces smooth, crack-free, easy to clean

  9. In-Process & QC Laboratories • Located separate from but near manufacturing • prevention of cross-contamination • separate biological , microbiological, radioisotopic areas • Designed for the operations being carried out • suitable storage space

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