SOPS
REJECTS
PRODUCT
FORMS
ETC
100

SOP for general visual inspection procedure for commercial product

SOP-0888

100

Critical reject defined by a shadow

CRK

100

Ultra-low 2mL product

BioEQ

100

FRM # for inspection forms of vials

FRM-1209

100

Clinical Part numbers include? (EX: Commerical = X-CO-XXXX)

FF

200

SOP for visual inspection of vials

SOP-0787

200

Major B reject defined as product in center/upper groove of stopper

PRD

200

Product that undergoes incubation

Media

200

FRM # for inspection forms of syringes

FRM-1210

200

T/F: You can wear earrings in offload as long as your bouffant covers your ears

False

300

SOP for visual inspection of syringes

SOP-0788

300
Critical Reject defined as cloudy or discolored solution

DCP

300

Botox cakes

LYO/Revance

300

FRM # for pre-inspection steps

FRM-1768

300

T/F: Partial cross outs are permitted for corrections if only some of the information is incorrect

False

400

SOP for visual inspection of media

SOP-0789

400

Minor reject defined as seal or cap discoloration

DCC
400

Product that contains opaque liquid

Alnylam

400

Sample Breakdown FRM#

FRM-1254

400
What is the minimum LUX requirement for light meter readings?

2000

500

SOP for Good Documentation Practice

SOP-0086

500
Critical reject defined as cake meltback

MLT

500

Product characterized as yellow, only comes in syringes

Glaukos

500

Acceptable Chain of Custody FRM

FRM-0483

500

How many minutes between eye rests PER SOP?

30 minutes

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