QAS-006 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 237

abc Pharmaceutical comPany

LEVEL 3

SOP No.:

Issued on:

Revision No.:

Initiator name:

OINTMENT & CREAM

Pack Size (g) Adjustment Limits (Preset) (g) In-process Limits (g)

10 10-10.5 9.5-10.5

15 15-15.5 14.4-15.6

20 20-20.5 19.2-20.8

25 25-25.5 24.2-26.0

30 30-31.0 29.2-31.0

50 50-52.0 48.5-52.0

75 73.5-76.5 72.8-77.3

500 500-525 500-525

(No single jar should contain less than 475 g)

Minimum fill

• The average net content of the 10 containers is not less than the labeled amount, and the net
content of any single container is NLT 90% of the labeled amount where the labeled
amount is 60 g or 60 mL or less, or NLT 95% of the labeled amount where the labeled
amount is more than 60 g or 60 mL but not more than 150 g or 150 mL.