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Mix Up and Cross Contamination in Pharmaceutical Manuacturing


What is mix-up and what are basic causes & risks of mix-ups and cross contamination.

Mix up

  • A blend of diverse elements.
  • A mistake that results from taking one thing to be another.
  • A wrong action attributable to bad judgment or ignorance or inattention.

Likely Causes

  • Close proximity of the two products i.e Size, shape, colour etc.
  • Pack i.e Same colour combination, size and type
  • Multiple products/ packs handled in the same area
  • Same apparatus/ Instrument (for IPC checks) is used for multiple products.
  • No proper storage/ segregation of products i.e during manufacture, sterile and non sterile product
  • During packaging and repackaging
  • During dispensing
  • No proper line clearance procedure followed
  • Left out labels/cartons/ leaflets from previous product/ batch overprinting materials e.g. stereos etc. of earlier batch not removed.
  • Improper labeling/ documentation
  • No identification code
  • No training/inappropriate training
  • Failure of processing equipment
  • Manual labelling/ packaging/repackaging
  • Improper controls
  • Rejection handling
  • Improper labelling
  • Reprocessing
  • At vendor’s site;
          -Same vendor used for printing of [packaging material at vendor’s site
          -No adequate control at printer’s end.
  • Lack of understanding/ communication
  • Same operator handling two or more machines/ products at the same time.
  • Lack of proper validation procedures

Contamination

      The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.

Cross Contamination

      Contamination of a starting material, intermediate product or finished product with another starting material or a product during production
      Typical sources of Contamination
·         Premises
·         Equipment
·         People
·         HVAC System
·         Processing Operations
·         Clothing
·         Utilities and Services

Risk of cross contamination

The significant of risk varies with the type of contaminant and product being contaminated.
The most hazardous contaminant are ;
·         Highly sensitizing materials
·         Biological preparations containing living organisms
·         Hormones
·         Cytotoxics etc.
Products where contaminant is more significant are;
·         Injections
·         given in large doses
·         Over a long period of time
·         Applied to open wounds

Consequences

Company

·         Show cause notice
·         Warning letter
·         Closure of premises
·         Suspension of manufacturing licence
·         Withdrawal of product licence
·         Monetary losses
·         Frequent audits by regulatory authorities
·         Market reputation / Adverse Publicity

Employee

·         Suspension order
·         Termination of services
·         Show cause notice
·         Jail / Penalty
·         Monetary losses
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


2 Comments so far : Add yours...

SHIVA KUMAR Reddy said...

sir, ur articles are very useful. please try to concentrate on API production seperately. it will be so kind of u.

bala subramaniam said...

It is very useful.

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