Module 9 2024

03/09/2024

Examples of Manufacturing Process CPPs and IPCs

DP Flow Manufacturing Flow Chart

Step Number

Operation

Purpose

CPP

IPC

Thaw of DS ahead of mixing

Thaw temperature and duration

DP-1

Drug substance thawing

-

Appearance, pH, density Endotoxin, pH

DP-2

Mixing

Homogenization of solution

Stir speed and duration

Product flush volume, static hold time on filter

DP-3

Sterile Filtration

Bioburden reduction

Filter integrity

DP-4

Filling and half-stopper

Filling into vials

Filling time

Fill weight, fill volume

Temperature, vacuum pressure

Appearance, bioburden, endotoxin

DP-5

Freeze-drying

Improve DP stability

DP-6

Capping

Container Closure

Total filling time

Container closure integrity

Appearance, particulate matter

DP-7

Visual inspection

Quality control

-

DP-8

Labelling

-

-

Visual inspection

DP-9

Storage

-

Storage temperature

Release testing

The Organisation for Professionals in Regulatory Affairs

15

Examples of CQA Assignments - Obligatory

Category

Obligatory CQA

DS IPC

DS

DP IPC

DP

HCP HCD

X X X X X X X X X

X X X X X X X X X

X X X X X X X X

Ptn A

Viruses

Bioburden Endotoxin

pH

Osmolality

Protein Content

Appearance

X X

X X

Excipient content

Sub vis particles

X

X

Visible particles

X

X

Extractable vol Sterility/CCIT

X X X X X

X X X X X

Leachables

X

Heavy Metals

Glass delamination

Raw materials (safety relevant)

X

X

X

Amino acid sequence

X

X

Higher order stucture

X

X

The Organisation for Professionals in Regulatory Affairs

16

8