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Module 11 | Slide 1 of 25 January 2006

Basic Principles of GMP

Materials

14

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Module 11 | Slide 2 of 25 January 2006

Materials

Objectives To review specific requirements for each type of material:

Starting materials Packaging materials Intermediate and bulk products Finished products Rejected and recovered materials Recalled products Returned goods Reagents and culture media Reference standardsWaste materials

Miscellaneous materials

To examine (in groups) the problems associated with materials,and how to overcome them

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Module 11 | Slide 3 of 25 January 2006

Materials

PrincipleObjective of the pharmaceutical manufacturer

produce finished products for patient's use from acombination of materials

aterials combinedActive pharmaceutical ingredients and

!cipients "au!iliar# materials$

Packaging materials

aterials include also%ases& solvents& reagents& process aids& etc

Special attention 14.1, 14.2

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Module 11 | Slide 4 of 25 January 2006

14.314.6

Materials

General requirements for materialsaterials for cleaning, lubrication, and pest control(ot in direct contact )ith productSuitable grade& eg food grade if possible

!ll incoming materials and finished products

*uarantined after receipt or processing" until released for use or distribution

stored" under appropriate conditions" orderl# fashion "batch segregation$

" materials management" stock rotation "FF+$

#ater " suitable for use

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Module 11 | Slide 5 of 25 January 2006

14. 14.1!

Materials

"tartin# Materials $$urchasing " important operation

%rom approved suppliers " if possible, direct from themanufacturer

&pecifications for materials

'onsignment checs Integrit# of packageSeal intact,orresponds )ith the purchase order

-eliver# noteSupplier.s labels

'leaned and labelled with information

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Basic Principles of GMP

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Module 11 | Slide 8 of 25 January 2006

Basic Principles of GMP

amage to and problems

with containers

Recorded and reported

to /, Investigated

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Module 11 | Slide 9 of 25 January 2006

Materials

%&amples of 'abellin# of "tartin# Materials

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Module 11 | Slide 10 of 25 January 2006

14.1( 14.1)

Materials

"tartin# Materials $$$se only -' released material if within shelf.life

ispensingdesignated persons)ritten procedure,orrect materials accuratel# )eighedclean& properl# labelled containers

/ndependent checs and record

material and )eight or volume

ispensed materialkept together and labelled

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Module 11 | Slide 11 of 25 January 2006

Basic Principles of GMP

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Module 11 | Slide 12 of 25 January 2006

14.2(14.2!

Materials

Pac*a#in# materials + $$rimary and printed pacaging materials

purchasing& handling and control

" as for starting materials

$rinted pacaging materials: particular attentionStored in secure conditions )ith authori0ed access

Roll labels )here possible in place of cut labels

1oose materials stored and transported in separate& closed

containers 2 to avoid mi!2ups

Issued b# designated personnel

S+P for issue and returns

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Basic Principles of GMP

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14.21 14.23

Materials

Printe an primar- pac*a#in# materials + $$

0ach delivery or batch: specific reference number oridentification mar

elivery to pacaging department

,heck *uantit#& identit# and conformit# to packaging

instructions

Outdated or obsolete material

-estro#ed

-isposal record

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Module 11 | Slide 15 of 25 January 2006

Basic Principles of GMP

$ntermeiate an bul*proucts

1ept under appropriate

conditions

/f purchased as such

3andled on receipt as

though these are

starting materials

14.24 14.2(

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Module 11 | Slide 16 of 25 January 2006

Basic Principles of GMP

inis/e proucts2eld in quarantine until their

final release

Then stored as usable stoc

under suitable storageconditions

0valuation anddocumentation necessaryfor release

Product release procedure 4atch record revie) and

related procedure14.26 14.2

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Module 11 | Slide 17 of 25 January 2006

14.2)

Materials

0ejecte, reor*e an recovere materials

3ejected materials and products

,learl# marked

Stored separatel# in restricted areas

Action 5 returned to supplier6destro#ed& etc in timel# manner

Action approved b# authori0ed personnel 5 records

maintained

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Module 11 | Slide 18 of 25 January 2006

14.2 14.3!

Materials

0ejecte, reor*e an recovere materials

3ewor and recovery

Should be e!ceptional cases

+nl# if7

" Risks involved have been evaluated and the *ualit# offinal product )ill not be affected

" Specifications are met

" -efined procedure

"Records maintained" (e) batch number

additional testing to be considered b# /,

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Module 11 | Slide 19 of 25 January 2006

14.32 14.33

Materials

0ecalle proucts an returne #oos3ecalled products IdentifiedStored separatel#Secure area 2 access controlled-ecision taken on their fate

3eturned goods-estro#ed unless suitable *ualit#S+P7 decision regarding their fate "relabelling& resale& etc$

" ,onsider7 nature of product& special storage conditions&condition& histor#& time elapsed since issue

Action taken to be recorded

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Module 11 | Slide 20 of 25 January 2006

14.34 14.36

Materials

0ea#ents an culture meia3ecords for receipt or preparation3eagents

Preparation in accordance )ith S+P

Appropriatel# labelled7

" concentration& standardi0ation factor& shelf2life& date thatrestandardi0ation is due& storage conditions

" signed and dated'ulture media

positive and negative controls each time prepared and used Inoculum si0e appropriate

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Module 11 | Slide 21 of 25 January 2006

14.3 14.4!, 14.42

Materials

0eference stanars + $

Official reference standards8se preferable )henever these e!ist+nl# for the purpose as per monographStorage conditions

3eference standards prepared by the producer9ested& released and stored in the same )a# as official

standards In a secure areaA responsible person

&econdary or woring standardsAppropriate checks and tests at regular intervalsStandardi0ed against official reference standards 5 initiall# and

at regular intervals

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Module 11 | Slide 22 of 25 January 2006

14.41, 14.43

Materials

0eference stanars + $$

3eference standards labelled with information including

(ame

4atch& lot or control number

-ate of preparation

Shelf2life

Potenc#

Storage conditions

&tored and used in an appropriate manner

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Module 11 | Slide 24 of 25 January 2006

14.4(

Materials

Miscellaneous materials

iscellaneous

Rodenticides& insecticides& fumigating agents

Saniti0ing material(o contamination risk to e*uipment& starting materials&

packaging materials& in2process materials& finished products

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Module 11 | Slide 25 of 25 January 2006

Materials

Group session4ist specific aspects of 5$ requirements, in relation to the

groups of materials listed below, that you would assess wheninspecting a manufacturer

Printed packaging materials

9hermolabile materialsWater

Sterile materials

/dentify three materials that present problems in yourexperience

#hat are some of the problems that you have experiencedbefore and during inspection of materials6