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Develop a detailed FMEA for blister packaging of tablet? ( for each unit steps list 2-3...

Develop a detailed FMEA for blister packaging of tablet? ( for each unit steps list 2-3 potential failure mode)

Expert Solution

FMEA means Failure Modes and Effect Analysis, it promises to become more important risk assessment tool for pharmaceutical manufacturing.

FMEA helps to weed out confusing drug names once a new drug application (NDA) has been submitted. According to iom's latest report failure to use FMEA leads to such problems as

. Clutterd labelling

.small font

.lack of background contrest

.overemphasis on company logos and trade.

Step1:Dosage form (tablet*2 strength) and tablet diamension.

Step2:Dosage regimen,

1) tablet strength in the morning

2)Tablet strength in the evening.

Step3:Projected commercial batch size

Step4:Materila specification for foil and base material.and preferred supplier for temper evident seal to meat falsified medicine direction

Step5:Specific requirement on blister diamension( re stability / shelf life)

Step6:Pack format

Option1-blister-blister print-finished pack in carton

Option2-blister-blister print-wallet card-cartoon

Step7:Lead a time of 3 months

.specific printers requested for sterilisation 12-14 weeks

.Drug categorisation lead to containment requirment for blister line and humidity control in the primary package

.packaging material

.Drug product availability and manufacture of validation batechea delayed

Step 8:packaging Stage:FMEA risk assessment was carried out with input from several key subjects

Handling of drug product :Initial reciept -storage-in and out of product operation -distribution.

.Work place exposure limits

.Containment strategy during packaging.

Step 9: Validation planning

Step 10:Validation execution

Blistering -blister printing -walleting

.Toolset qualifications (blister only)

.Engineering study

.Process qualifications

.process valuation

Nightingale answered 3 years ago

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