Mix Up and Cross Contamination in Pharmaceutical Manuacturing

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