Mix Up and Cross Contamination in Pharmaceutical Manuacturing : Pharmaceutical Guidelines

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.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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2 comments: Post Yours! Read Comment Policy ▼

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

    ReplyDelete


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