Question

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

Answer 1

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