good manufacturing practice by Anna Lundén AB ... - Textalk · 3. Annexes - Content. A...

THE GMP HANDBOOKgood manufacturing practice

quality systems for the pharmaceutical industry

by Anna Lundén

ANNEXES Key2Compliance AB

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3

Annexes - Content

A Requirements for procedures and records in 4 each respective GMP The symbols at the margins in the chapters of the handbook refer to the specific minimum requirement from the three differentGMP texts. These requirements are shown here with referrals to their respective paragraph in the separate GMPs.

B Referral to the requirements for verification of a 17 second individual (or equivalent systems) In the different GMP texts there are specific referrals to different forms of verifications or double checks of a second individual that is presented in this annex.

C Reference matrix ISO 9001 and GMP-texts 18In this matrix, the starting point is ISO 9001 and for each section there are references to corresponding requirements in the different GMPs. This matrix can be used as a supporting tool when a comprehensive quality system shall be designed with the ISO principles as a basis.

Annexes - Content

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The GMP Handbook – quality systems for the pharmaceutical industry – Annexes

Req

uire

men

tsP

roce

dure

sR

ecor

dsD

escr

ipti

onId

enti

ficat

ion

Man

ager

ial/i

ndiv

idua

l res

pons

ibili

ties

1.04

, 1.0

5, 1

.07

Cha

p 2

Prin

cipl

e2.

03

Proc

essi

ng/p

acka

ging

pro

cedu

res

1.04

, 4.1

7, 4

.18

Rel

ease

pro

cedu

re a

nd Q

P ce

rtifi

catio

n1.

04, 4

.27

1.04

, 1.0

9, 2

.06

Self

-Ins

pect

ion

1.01

, 4.2

9, 9

.01

4.29

, 9.0

3

Qua

lity

Man

ual

1.07

Sam

plin

g, in

spec

tion

and

test

ing

of s

tart

ing

mat

eria

ls, i

nter

med

iate

, bul

k, a

nd fi

nish

ed p

rodu

ct1.

09, 4

.22,

4.2

5,

4.26

, 6.

07, 6

.11,

6.

12, 6

.15,

6.1

8

1.09

, 4.2

2, 4

.26,

5.

38, 6

.07,

6.1

1,

6.16

, 6.1

7, 6

.18

6.13

Env

iron

men

tal/m

edia

mon

itori

ng1.

9, 4

.29

3.19

, 4.2

9, 5

.43,

6.

07

Prod

uct Q

ualit

y R

evie

w1.

10 (

acco

rdin

g to

4.

29)

1.10

, 4.2

9

Ong

oing

rev

iew

of

corr

ectiv

e an

d pr

even

tive

actio

ns1.

04, 1

.11

1.04

, 1.1

1

Ris

k m

anag

emen

t (pr

oced

ure

not m

entio

ned

but m

ay b

e re

ques

ted)

1.12

1.12

Org

anis

atio

n ch

art

2.02

Eva

luat

ion

of p

rodu

ctio

n re

cord

s of

Pro

duct

ion

depa

rtm

ent

2.07

Tra

inin

g2.

11, 4

.29

2.11

, 4.2

9

An

nex

A.

Req

uir

emen

ts fo

r p

roce

du

res

and

rec

ord

s in

eac

h r

esp

ecti

ve G

MP

The

sym

bols

at t

he m

argi

ns in

the

chap

ters

ref

er to

the

spec

ific

min

imum

req

uire

men

t fro

m th

e th

ree

diff

eren

t GM

P te

xts.

The

se r

equi

rem

ents

are

sho

wn

here

with

ref

erra

ls to

thei

r re

spec

tive

para

grap

h in

the

sepa

rate

GM

Ps.

EU

GM

P G

uid

e P

art

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Annex A© 2016 Key2Compliance AB

Req

uire

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dure

sR

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dsD

escr

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onId

enti

ficat

ion

Pers

onne

l hyg

iene

, hea

lth, a

nd c

loth

ing

2.15

, 2.1

6, 4

.29

4.29

Info

rmat

ion

abou

t con

sulta

nts

2.23

Prem

ises

- c

lean

ing,

dis

infe

ctio

n an

d id

entifi

catio

n3.

02, 4

.29,

5.2

14.

29, 5

.21

3.21

, 5.1

2, 5

.13

Equ

ipm

ent -

use

, cle

anin

g an

d id

entifi

catio

n3.

36, 4

.29,

4.3

0,

5.21

4.29

, 4.3

1, 5

.21

3.42

, 3.4

4, 5

.12,

5.

13

Cal

ibra

tion,

mai

nten

ance

, and

che

ckin

g 3.

41, 4

.29,

6.0

73.

41, 4

.29,

4.3

1,

6.07

Sani

tisin

g of

wat

er s

yste

ms

3.43

”Site

Mas

ter

file”

C

hap

4 Pr

inci

ple

Com

pute

rize

d sy

stem

s4.

01

Alte

ratio

ns in

doc

umen

ts4.

09

Just

ifica

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for

retir

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reco

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4.12

Spec

ifica

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for

sta

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d pa

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mat

eria

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4.13

, 4.1

4, 6

.07

Spec

ifica

tions

for

fini

shed

pro

duct

s4.

13, 4

.16,

6.0

7

Spec

ifica

tions

for

inte

rmed

iate

and

bul

k pr

oduc

ts

4.15

, 6.0

7

Pack

agin

g in

stru

ctio

ns4.

19

Bat

ch p

roce

ssin

g re

cord

s4.

201.

08, 4

.20

Bat

ch p

acka

ging

rec

ords

4.21

4.21

Inte

rnal

labe

ling

4.24

Dis

trib

utio

n re

cord

s1.

08, 4

.28,

8.2

3

EU

GM

P G

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)

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Req

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men

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roce

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sR

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escr

ipti

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enti

ficat

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Rat

iona

l for

poi

nt o

f be

ginn

ing

1.2

Syst

em f

or q

ualit

y m

anag

emen

t2.

11

Pers

ons

auth

oris

ed to

rel

ease

2.14

Not

ifica

tion

to m

anag

emen

t2.

18

Ris

k m

anag

emen

t (pr

oced

ure

not m

entio

ned

but m

ay b

e re

ques

ted)

2.21

2.21

Res

pons

ibili

ties

of q

ualit

y un

it2.

32

Res

pons

ibili

ty f

or p

rodu

ctio

n2.

40

Inte

rnal

aud

its/s

elf

insp

ectio

n2.

502.

51

Prod

uct q

ualit

y re

view

2.60

, 2.6

1

Pers

onne

l res

pons

ibili

ties

3.11

Tra

inin

g3.

12

Rec

ords

on

cons

ulta

nts

3.31

Util

ity s

yste

ms

4.20

Wat

er q

ualit

y sp

ecifi

catio

ns4.

32

Val

idat

ion

and

qual

ifica

tion

4.33

, 4.4

1, 5

.40,

5.

41, 8

.45,

12.

10,

12.2

0, 1

2.30

, 12

.80,

18.

51

4.33

, 4.4

1, 5

.40,

5.

41, 5

.42,

8.4

5,

12.2

2, 1

2.23

, 12

.30,

12.

80,

12.8

3, 1

8.51

Inac

tivat

ion

and

clea

ning

4.41

Prev

entio

n of

cro

ss-c

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min

atio

n4.

42

EU

GM

P G

uid

e P

art

II

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EU

GM

P G

uid

e P

art

II (c

on

t.)

Req

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tsP

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Sew

age

and

refu

se4.

60

Sani

tatio

n an

d cl

eani

ng o

f bu

ildin

gs a

nd f

acili

ties

4.71

Use

of

rode

ntic

ides

etc

.4.

72

Dra

win

gs f

or e

quip

men

t and

inst

alla

tions

5.16

4.23

, 7.2

3

Equ

ipm

ent m

aint

enan

ce5.

206.

20, 6

.21

Cle

anin

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d re

leas

e of

equ

ipm

ent

5.21

, 5.2

5, 1

9.30

6.20

, 6.2

15.

26, 8

.16

Cal

ibra

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of e

quip

men

t5.

30, 1

9.30

5.32

, 6.6

15.

33

Cha

nges

to d

ata

5.43

Ope

ratio

n an

d m

aint

enan

ce o

f co

mpu

teri

zed

syst

ems

5.44

5.46

, 5.4

8

Cha

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to c

ompu

teri

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syst

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5.47

5.47

Doc

umen

t con

trol

6.10

2.15

Ret

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doc

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12

Spec

ifica

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and

acc

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ria

6.17

, 7.1

2, 9

.11,

11

.13

6.30

, 7.1

3

Equ

ipm

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and

use

reco

rd6.

20

Mas

ter

prod

uctio

n re

cord

s6.

40, 6

.41

Han

dlin

g, s

tora

ge, t

est a

nd u

se o

f m

ater

ial

6.41

, 7.1

06.

307.

23, 7

.24

Bat

ch p

rodu

ctio

n re

cord

6.50

6.50

, 6.5

26.

51

Doc

umen

tatio

n an

d in

vest

igat

ion

arou

nd d

evia

tions

an

d fa

ilure

s6.

53, 1

1.15

2.16

, 5.4

6, 8

.15,

8.

20

Bat

ch a

nd c

ontr

ol r

ecor

d re

view

6.70

6.30

, 6.6

0

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Req

uire

men

tsPr

oced

ures

Rec

ords

Identifi

cation

Res

pons

ibili

ties

of Q

CU

211.

22(d

)

Con

sulta

nts

211.

34

Cle

anin

g an

d sa

nita

tion

of b

uild

ings

and

fac

ilitie

s21

1.56

(b)

Use

of

rede

ntic

ides

etc

211.

56(c

)

Cle

anin

g, s

anita

tion,

mai

nten

ance

and

insp

ectio

n of

eq

uipm

ent

211.

67(b

)21

1.67

(c )

, 211

.182

Cal

ibra

tion

of e

quip

men

t21

1.68

(a),

211

.160

(b)

(4)

211.

68(a

), 2

11.1

82,

211.

194(

d)

Dat

a ba

ck-u

p21

1.68

(b)

Com

pute

r pr

ogra

m v

alid

atio

n21

1.68

(b)

211.

68(b

)

Rec

eipt

, ide

ntifi

catio

n, s

ampl

ing

etc

of c

ompo

nent

s,

cont

aine

rs a

nd c

losu

res

211.

80(a

), 2

11.8

4(c)

, 21

1.16

0(a)

211.

184(

a)&

(b)

211.

80(d

), 2

11.8

4(c

),

211.

89

Com

pone

nt s

peci

ficat

ions

211.

84(d

)(2)

211.

184(

b)

Con

tain

ers

and

clos

ures

spe

cific

atio

ns21

1.84

(d)(

3) &

(5)

, 21

1.94

(d)

Val

idat

ion

of s

uppl

iers

’ te

st r

esul

ts21

1.84

(d)

211.

84(d

)

Val

idat

ion

of d

epyr

ogen

atio

n pr

oces

ses

211.

9421

1.94

Prod

uctio

n an

d pr

oces

s pr

oced

ures

211.

100(

a)21

1.10

0(b)

Dev

iatio

n fr

om w

ritte

n pr

oced

ures

211.

100(

b)

Cha

rge-

in o

f co

mpo

nent

s21

1.10

121

1.10

1(b)

The

oret

ical

and

act

ual y

ield

211.

103

211.

103

US

21

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US

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con

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Req

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Rec

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Identifi

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Equ

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ifica

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211.

105

In-p

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and

valid

atio

n21

1.11

0(a)

211.

110(

a)

In-p

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211

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(b)

Spec

ifica

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, sta

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oced

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211.

110(

c ),

21

1.16

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&(b

),

211.

165,

211

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(b)

211.

160(

a), 2

11.1

94(a

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1.16

0(b)

Rej

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l21

1.11

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Tim

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1.11

121

1.11

1

Con

tam

inat

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cont

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211.

113(

a)

Con

tam

inat

ion

cont

rol,

ster

ile p

rodu

cts

211.

113(

b)

Val

idat

ion

of a

sept

ic a

nd s

teri

lizat

ion

proc

esse

s21

1.11

3(b)

211.

113(

b)

Rep

roce

ssin

g21

1.11

5(a)

Exa

min

atio

n of

pac

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nd la

belin

g m

ater

ials

211.

122(

a)21

1.12

2(c

), 2

11.1

84

(b),

211

.184

(d)

211.

122(

d)

Rec

onci

liatio

n of

labe

ling

211.

125(

c)12

2.12

5(e

)

Issu

ance

of

labe

ling

211.

125(

f)

Pack

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d la

belin

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1.13

021

1.13

0(d)

&(e

),

211.

184(

d)21

1.13

0(b)

&(c

)

Dru

g pr

oduc

t ins

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211.

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datin

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1.13

7(c

)&(d

)

War

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sing

211.

142

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Annex B© 2016 Key2Compliance AB

Annex B. Referral to the requirements for verification of a second individual (or equivalent systems)

In the different GMP texts there are specific referrals to different forms of verifications or double checks of a second individual that is presented in this annex.

21CFR210/211 211.67(b)(6) Inspection of equipment211.101(c) Weighing of drug components211.101(d) Adding of drug components211.103 Calculation of yield211.122(g)(3) Use of cut labeling211.182 Equipment cleaning and maintenance211.188(b)(11) Significant steps

EU Guide to GMP Part I4.18(c) Manufacturing equipment checks4.19(f) Packing equipment checks4.20(c)&4.21(c) Significant steps, e.g. weighing5.38 Dispensed material 6.16 Test result calculations6.17(g) Laboratory test result verification

EU Guide to GMP Part II 5.21 Inspection of equipment5.45 Entering critical data manually in computerized systems6.52 Critical steps in production6.60 Laboratory records8.12 Critical weighing, measuring, or subdividing operations8.13 Critical activities9.44 Inspection of packaging and labelling facilities

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Annex C. Reference matrix ISO 9001 and GMP texts

In this annex we have used the structure from ISO 9001:2015 as the base and correlated it to the corresponding requirements in the GMP’s. Note that the requirements of the ISO- standard does not have the same degree of detail and not specifically require procedures and

ISO 9001 Requirement description EU GMP PART I 21CFR210/211 EU GMP PART II

4.4.1;7.5.1

Quality management system established Ch. 1, Principle;1.1;1.7

na 2.11;2.19;17.30

4.4.1 a, b Determining processes, sequence and their interaction 1.8(i) na 2.12

4.4.1 c,d,e,f Criteria, methods and resources for control of processes 1.4(i)&(iv) na 2.124.4.1 f;6.1

Risk management Ch. 1, Principle;1.3;1.12-135.20-21;Ch. 8, Principle;

na 2.20-21

4.4.1 g Monitor, measure and analyze processes and act on the results. Ch. 1, Principle;1.4(vi);1.4(viii)&(ix);1.10;2.8-9;Ch. 4, Principle;6.2;6.9;6.26-36;7.7

211.100;211.180(e);211.192

2.60;6.71;11.15;15.12

na Quality manual 1.7;4.32

na na

4.4.2 Documented procedures and specifications Ch. 4, Principle 211.22(c)&(d);211.100(a);211.160(a)

2.12

4.4.2 Records Ch. 4, Principle;4.8

211.180 2.15;6.14

5.1.1 f Top management shall communicate the importance of quality 1.5 na 2.115.2.1 ;5.1.1 b;6.2.1

Quality policy and quality objectives established by management Ch. 1, Principle; 2.4

na 2.19

5.2.2 Quality policy communicated and understood within the organization Ch. 1, Principle; 1.5

na 2.10-11

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Annex C© 2016 Key2Compliance AB

records the same way as in the GMP’s, but contains general principles for a complete quality management system. Requirements in the ISO standard where there is no equiva-lent in the GMP’s have been omitted (eg requirements related to design and development).

ISO 9001 Requirement description EU GMP PART I 21CFR210/211 EU GMP PART II

4.4.1;7.5.1

Quality management system established Ch. 1, Principle; 1.1; 1.7

na 2.11;2.19;17.30

4.4.1 a, b Determining processes, sequence and their interaction 1.8(i) na 2.12

4.4.1 c,d,e,f Criteria, methods and resources for control of processes 1.4(i)&(iv) na 2.124.4.1 f;6.1

Risk management Ch. 1, Principle; 1.3; 1.12-135.20-21;Ch. 8, Principle;

na 2.20-21

4.4.1 g Monitor, measure and analyze processes and act on the results. Ch. 1, Principle; 1.4(vi); 1.4(viii)&(ix); 1.10; 2.8-9; Ch. 4, Principle; 6.2; 6.9; 6.26-36; 7.7

211.100; 211.180(e); 211.192

2.60;6.71;11.15;15.12

na Quality manual 1.7; 4.32

na na

4.4.2 Documented procedures and specifications Ch. 4, Principle 211.22(c)&(d); 211.100(a); 211.160(a)

2.12

4.4.2 Records Ch. 4, Principle; 4.8

211.180 2.15;6.14

5.1.1 f Top management shall communicate the importance of quality 1.5 na 2.115.2.1 ;5.1.1 b;6.2.1

Quality policy and quality objectives established by management Ch. 1, Principle; 2.4

na 2.19

5.2.2 Quality policy communicated and understood within the organization Ch. 1, Principle; 1.5

na 2.10-11

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