pics seminar series 2 delivery material finaldraft

(1)

Six Sessions

Get You Better at PIC/S GMP

Session 2

(2)

8:30 – 10:00

Registration

10:00 – 10:15

Opening Session by GP Farmasi

10:15 – 11:45

Materials Presentation

11:45 – 12:00

Break

12:00 – 12:50

Q & A

12:50 – 13:05

Quiz

13:05 – 13:20

Explanation of Quiz Answer

13:20

Closing Session

(3)

◎Presenter

Dr.ＧTakahashiＧ(Q&A)Ｇ Mr.ＧTahara Ms.ＧLanny

(4)

Agenda

Session 1. Introduction & GMP Guide Part I (Chapter 1 & 2)

Session 2. PIC/S GMP Guide –Part I (Chapter 3 & 4)

Session 3. PIC/S GMP Guide –Part I (Chapter 5 & 6)

Session 4. PIC/S GMP Guide –Part I (Chapter 7 to 9) and Basic of Site Master File

Session 5. PIC/S GMP Guide –Annex 1 Manufacture of Sterile Medicinal Products

Session 6. PIC/S GMP Guide –Annex 15 Qualification and Validation

(5)

Cop ight© CM Plus Co po atio . All ights ese ed®

Todayʼs Topics

1. A Quick Recap of Our Previous

Session

2. PIC/S Part I - Chapter 3

Premises and Equipment

(6)

1.Ｇ

A Quick Recap of Our Previous Session



Commenced operating on 2 Nov. 1995



History of PIC/S

http:// .pi s he e.o g/



Numbers on PIC/S



48 Members in the world



7 Members in Asia (Singapore, Malaysia, Indonesia,

Taiwan, Japan, Korea, Hong Kong)



4 Partner Organizations

(7)

1. A Quick Recap of Our Previous Session



EU legal enforcement system

• Regulation The most significant

enforcement. Directly applied in preference to national law in EU Member States.

• Directive The applicable enforcement by sector. It must be replaced to national law amended or enacted within 3 years.

• Decision Directly binding while just targeting some specific requirements in a more detail manner.

• Recommendation Not legally binding, but it encourages EU Member States to amend or enact the legislation.

• Opinion To express the current thinking the EU Commission in a particular theme.

PIC/S GMP PIC/S

(8)

1. A Quick Recap of Our Previous Session



Mutual Recognition Arrangement (MRA)

MRA _MRA

(9)

1. A Quick Recap of Our Previous Session

PIC/S GMP GUIDE PART I:

BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS



Chapters

Part I

Chapte Chapte Chapte

Chapte Chapte Chapte Chapte Chapte Chapte

1.QMS

2. Personnel

3. Premises/equipment 4. Documentation

5. Production 6. QC

7. CMO

(10)

1. A Quick Recap of Our Previous Session

Regulatory Compliance

T a a a a a y a a

, a a a a .

PIC/S GMP has been becoming a global standard

(11)

1. A Quick Recap of Our Previous Session

Quality Management System (QMS)

= Quality System = Quality Assurance

Recap of Chapter 1: Quality Management

QMS

Continuous improvement throughout the life cycle

GMP

Quality assurance in

day-to-day production activities

Quality

(12)

1. A Quick Recap of Our Previous Session

GMP QC

PQR

Ma k

Pete

Tho as Bill

Mi hael

Ri ha d

QRM

PQR

To ensure that the medicinal products produced are;

 fit for their intended use,

 comply with the requirements of the market authorization,

 do not place patients at risk

due to inadequate safety, quality or efficacy.

(13)

1. A Quick Recap of Our Previous Session

Method

Recap of Chapter 2: Personnel

a ade uate u e

of pe so el & p a ti al e pe ie ee essa ualifi atio s itte jo des iptio s

Ma k

Pete

Tho as Bill

Mi hael

Ri ha d

(14)

1. A Quick Recap of Our Previous Session

QA relies upon correct manufacture (4Ms), which rely upon

people .



Principle

Pe so el

P o ess

Validatio

Sa pli g

Re o d Release

(15)

Todayʼs Topics

1. A Quick Recap of Our Previous

Session

2. PIC/S Part I - Chapter 3

Premises and Equipment

(16)

2. Chapter 3: Premises and Equipment

 Premises and equipment must be located, designed,

constructed, adapted and maintained to suit the operations to be carried out.

 The layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust/dirt and any adverse effect on the quality of products.

Itʼs about design + engineering

Hi

d _{Pharmaceutical} industry

provides unique

challenges No

o specify criteria or numerical for premises and

equipment W

hs Your ingenuity _{will be}

(17)

 PRINCIPLE

Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products.

Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written

procedures.

.

2. Chapter 3: Premises and Equipment

(18)

2. Chapter 3: Premises and Equipment

A typical flowchart in facility project case:

Feasi ilit

Co eptual de elop e t

P oje t

pla i g Basi desig + DQ

Detailed desig + Spe ifi atio

Supplie

sele tio Co st u tio_{+ i stallatio}

IQ/OP/PQ

P odu tio + ai te a e

(19)

Risk Co t ol

*De easi g Risk *Risk A epta e

Fish Bo e, FMEA et . UR

６ ＩＳＰ

Ｉ

ｉａ

PUR

*P odu t Qualit *CQA *CPP,GMP GUR

*P odu t Capa it Et .

Co eptual Desig

Risk Assess e t

*Spe if Risk *Risk A al sis

SIA

*Risk Assess. Desig Co ept Desig data et .

URS PUR

*P odu t Qualit *CQA *CPP,GMP

GUR

*P odu t Capa it Et .

C iti al Aspe ts *Fa ilit /S ste Spe ifi atio

Basi

Desig Detail Desig DQ *Self I spe tio

Co e ial

Qualifi atio

Co issio i g

(20)

Choose proper clean class for each process！

Example of Aseptic process ISPE Baseline Guide Vol.3, Jan 1999

G Grade Grade

Grade

Min.

Intervention FillingＧProcessCleanＧBench

NoＧ

Intervention Critical portionＧfor sterile

Grade C

Garment FormulationＧ etc.

WashingＧToolsＧetc.

Machine room,ＧOut side.

Co t olled ot lassified

2. Chapter 3: Premises and Equipment

Clean Garment

(21)

(22)

2. Chapter 3: Premises and Equipment

 Whether a new or existing facility, clarify the concept first.

 Be certain it can be explained by you.

 What do you want the premises to do?

U

Mountains of

books QRM _app

oa

h _{Scientific evidences}

Good qualification practice Knowledge management  Use of quality risk management (QRM) approach

 Implementation of DQ/IQ/OQ/PQ

 Make all records comprehensible to any personnel.

 Turn your mountains of books into the best practice

(23)

2. Chapter 3: Premises and Equipment

 Situated in a suitable environment

 Carefully maintained ensuring the cleanliness

 Appropriate lighting, temperature, humidity and ventilation

 Designed as to afford protection against the entry of insects

 Steps taken to prevent the entry of unauthorized people

 General requirements for premises

(24)

Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal

products during their manufacture and storage, or the accurate functioning of equipment.

Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals.

.

2. Chapter 3: Premises and Equipment

 General

(25)

2. Chapter 3: Premises and Equipment

 General

Steps should be taken in order to prevent the entry of unauthorized people,

Production, storage and quality control areas should not be used as a right of way be personnel who do not work in them.

.

CleanＧ Corridor

Process RoomＧB Process

RoomＧA Process

(26)

2. Chapter 3: Premises and Equipment

 Dedicated and self-contained facilities for medical hazard

 Zoning and layout

 Flow of material and product to prevent mix-ups

 Interior surfaces (walls, floors and ceilings) consideration

 Good M/E work

 Adequate size of drains

 Effectively ventilated with air control facilities

 Separated weighing room for starting materials

 Specific provisions taken for where dust is generated

 Packaging rooms to avoid mix-ups or cross-contamination

 Adequate room brightness

 In-process controls may be conditionally carried out within the production area

(27)

 Production Area

In order to minimize the risk of a serious medical hazard due to

cross-contamination, dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly sensitizing materials (e.g. penicillins) or biological preparations(e.g. from live micro-organisms).

The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal

products should not be conducted in the same facilities. For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.

.

(28)

2. Chapter 3: Premises and Equipment

 Dedicated and self-contained facilities for medical hazard

Highl se sitizi g ate ials

e.g. pe i illi d ugs

Biologi al p epa atio s

e.g. li e i o‐o ga is s

o tai e t

isolato

A epta le Dail E posu e ADE O upatio al E posu e Li its OEL

(29)

2. Chapter 3: Premises and Equipment

(30)

SegregationＧofＧHazardousＧFactory

2. Chapter 3: Premises and Equipment

Air Lined Suit

(31)

Where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth, free from cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and, if necessary, disinfection.

Pipe work, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.

.

2. Chapter 3: Premises and Equipment

.

Clean room

(32)

Drains should be of adequate size, and have trapped gullies. Open channels should be avoided where possible, but if necessary, they should be shallow to facilitate cleaning and disinfection.

.

2. Chapter 3: Premises and Equipment

PIC/S GMP Annex 1

50. Sinks and drains should be prohibited in grade A/B areas used for aseptic

manufacture. In other areas air breaks should be fitted between the machine or sink and the drains. Floor drains in lower grade clean rooms should be fitted

with traps or water seals to prevent backflow.

Pure Steam

Air Brake

(33)

Productions areas should be well lit, particularly where visual on-line controls

are carried out.

.

2. Chapter 3: Premises and Equipment

In cases where dust is generated (e.g. during sampling, weighing, mixing and processing operations, packaging of dry products), specific provisions should be taken to avoid cross-contamination and facilitate cleaning.

.

Premises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination.

.

FDA CGMP § 211.44 - Lighting.

(34)

2. Chapter 3: Premises and Equipment

 Good M/E work

 Adequate size of drains

 Separated weighing room for starting materials

• Avoid creation of recesses • Accessible from outside

I depe de t u it

T apped d ai /slope Eas to lea

Stati diffe e tial Ai flo

e haust

MAU

e haust

F esh ai

A essi le f o outside

(35)

2. Chapter 3: Premises and Equipment

 Effectively ventilated with air control facilities

Ai flo patte

DB ℃ RH%

+ p essu e

HVAC a d

Mo ito i g

Mai te a e

Co t ol fa ilit

Clea li ess

A comprehensive system

(36)

2. Chapter 3: Premises and Equipment

 Interior surface (wall, floor and ceiling) consideration

• Smooth surfaces

• Free from cracks/open joints

• Permit easy and effective cleaning

Mate ials

Co st u tio

Co figu atio

• Co osio

• Peeli g • Diffi ult to lea• Residual dete ge t

E

uip

e

t

(37)

2. Chapter 3: Premises and Equipment

 Specific provisions taken for where dust is generated

i di atio

Level 1

Spa e + i di atio

Level 2

Light pa titio

Level 3

Lo ked

Full isolatio Sepa ate HVAC

Level 5

Lo ked

Pa titio all

Level 4 With eili g _{Haza d t pe}

(38)

2. Chapter 3: Premises and Equipment

 Packaging rooms to avoid mix-ups or cross-contamination

P odu t B

Ca to o es fo B P i a pa kage

P odu t A Ca to o es fo A

Se o da pa kage

Sepa ated pa titio s Sepa ated

(39)

2. Chapter 3: Premises and Equipment

 In-process controls may be conditionally carried out within the production area

 Adequate room brightness

 Productions areas should be well lit, particularly where visual on-line controls are carried out.

Slightly different between cGMP and EU-GMP

e.g. on particle sizes:

5μm is not applicable.

both 0.5 & 5μm are applicable.

on continuing monitoring requirement

remote monitoring is not a mandate.

remote monitoring is not a mandate for Grade B area, but a mandate for Grade A.

The a i u allo a le pa ti les u e /

At rest In operation Grade 0.5μm 5.0μm 0.5μm 5.0μm A (ISO 5) 3,520 20 3,520 20

B (ISO 7) 3,520 29 352,000 2,900

C (ISO 8) 352,000 2,900 3,520,000 29,000

D 3,520,000 29,000 －－

Reference: EU-GMP Glasses of air cleanliness (2008）

cGMP

EU GMP

cGMP

(40)

2. Chapter 3: Premises and Equipment

 Sufficient capacity to meet various storage needs

 Storage condition considerations (temperature, humidity)

 Receiving/dispatch bays and receptions areas

 Quarantine status considerations

 A separate sampling area for starting materials

 ・・・・・・・

 Storage area (Section 3.18 to 3.25)

QC

La Ma ufa tu i g a ea

Wa ehouse

Re ei i g a Dispat h a

Qua a ti e Sa pli g

(41)

Storage areas should be designed or adapted to ensure good storage

conditions. In particular, they should be clean and dry and maintained within

acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.

2. Chapter 3: Premises and Equipment

.

There should normally be a separate sampling area for starting materials. If

sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination.

.

 Storage Area

Printed packaging materials are considered critical to the conformity of the

medicinal products and special attention should be paid to the safe and secure storage of these materials.

(42)

2. Chapter 3: Premises and Equipment

 Normally, QC lab should be separated from production area.

 QC lab should have Sufficient space to avoid mix-ups and cross-contamination

 Sensitive instruments need to be protected in separate

rooms from vibration, electrical interference, humidity, etc.

 ・・・・・・

 Quality control area (Section 3.26 to 3.29)

QC

La Ma ufa tu i g a ea Wa ehouse

Re ei i g a Dispat h a

Qua a ti e Sa pli g

(43)

Normally, Quality Control laboratories should be separated from production

areas. This is particularly important for laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be separated from each other.

2. Chapter 3: Premises and Equipment

 Quality Control Area

(44)

2. Chapter 3: Premises and Equipment

 Rest and refreshment rooms should be separate from other areas.

 Facilities for gowning, washing purposes to be easily accessible and appropriate for the number of users.

 Maintenance workshops to be as far as possible separated from production areas.

 Whenever parts/tools are stored in production area, to be kept in rooms or lockers reserved for that use.

 ・・・・・・・

(45)

2. Chapter 3: Premises and Equipment

Facilities for changing clothes, and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not directly communicate with production or storage areas..

.

 Ancillary Area

Example of Aseptic process ISPE Baseline Guide Vol.3, Jan 1999

G

Machine room,ＧOut side.

Co t olled ot lassified

Clean Garment No

(46)

2. Chapter 3: Premises and Equipment

 Designed/located/maintained to suit its intended purpose.

 Maintenance should not present hazard to product quality.

 Equipment should be easily/thoroughly cleaned.

 ………

 Measuring/control equipment should be calibrated and checked at defined intervals. Records of such tests should be maintained.

 ………

 Requirements for equipment (Section 3.34 to 3.42)

P

Ope ati g I st u tio

Re o d Data ase

P og a

T

Co puti g Computerized system validation

(47)

Manufacturing equipment should be designed so that it can be easily and thoroughly cleaned. It should be cleaned according to detailed and written procedures and stored only in a clean and dry condition.

Washing and cleaning equipment should be chosen and used in order not to be a source of contamination.

.

2. Chapter 3: Premises and Equipment

.

 Equipment

Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.

.

Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.

(48)

2. Chapter 3: Premises and Equipment

PIC/S does not specify criteria or

numerical for premises and equipment, Your ingenuity will be everything.

Summary of this Chapter:

Premises

 design + engineering

 Expertise in all stages from design concept to production

Production area

 Classified area & zoning

 Flow & anti-cross-contamination

QC laboratory

Storage area

(49)

Todayʼs Topics

1. A Quick Recap of Our Previous

Session

2. PIC/S Part I - Chapter 3 Premises

and Equipment

(50)

Good documentation constitutes an essential part of the quality assurance system and is

key to operating in compliance with GMP requirements. The various types of documents

and media used should be fully defined in the manufacturer's Quality Management

System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. The main objective of the system of documentation utilised must

be to establish, control, monitor and record all activities which directly or indirectly impact

on all aspects of the quality of medicinal products. The Quality Management System

should include sufficient instructional detail to facilitate a common understanding of the requirements, in addition to providing for sufficient recording of the various processes and evaluation of any observations, so that ongoing application of the requirements may be demonstrated.There are two primary types of documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports. Appropriate good documentation practice should be applied with respect to the type of

document.Suitable controls should be implemented to ensure the accuracy, integrity,

availability and legibility of documents. Instruction documents should be free from errors

and available in writing. The term ‘written’ means recorded, or documented on media from which data may be rendered in a human readable form.

.

3. Chapter 4: Documentation

(51)

3. Chapter 4: Documentation

 Documentation is the material that provides official information or evidence or that serves as a record.

 Documentation is the process of classifying and annotating texts, photographs, etc.

 What is documentation?

Mate ial

P o ess

Do u e tatio

Offi ial i fo atio

•App o ed & dated

•Regula l e ie ed

•Re isio o t ol

(52)

3. Chapter 4: Documentation

 Unlike other industrial products, you cannot test each finished drug on your production line end.

 All concepts of GMP, SOP and Validation have been

introduced to address the issues on drug manufacturing.

 Notably, all these concepts are based on documentation and by documentation.

 Why documentation is essential?

GMP

≠

G

et

M

ore

P

aper

But, pape eall does atte

The truth about GMP

(53)

3. Chapter 4: Documentation

For example: FDA Inspection Observation Summaries by frequency

Cited ef. # Sho t des iptio Lo g des iptio FY FY FY

CFR . d P o edu es ot i _{iti g, full follo ed} The espo si ilities a d p o edu es appli a le to the ualit o t ol u it a e ot [i iti g] [full follo ed]. Spe ifi all , ***

CFR . I estigatio s of _{dis epa ies, failu es}

The e is a failu e to tho oughl e ie [a

u e plai ed dis epa ] [the failu e of a at h o a of its o po e ts to eet a of its a d p o ess o t ols desig ed to assu e that the d ug p odu ts ha e the ide tit , st e gth, ualit , a d pu it the pu po t o a e ep ese ted to possess. Spe ifi all , ***

CFR

. S ie tifi all sou d la o ato o t ols

La o ato o t ols do ot i lude the esta lish e t of s ie tifi all sou d a d

app op iate [spe ifi atio s] [sta da ds] [sa pli g pla s] [test p o edu es] desig ed to assu e that [ o po e ts] [d ug p odu t o tai e s] [ losu es] [i ‐p o ess ate ials] [la eli g] [d ug p odu ts]

o fo to app op iate sta da ds of ide tit , st e gth, ualit a d pu it . Spe ifi all , ***

Procedures not in writing, fully followed

(54)

3. Chapter 4: Documentation

 Good documentation constitutes an essential part QAS.

 It is key to operating in compliance with GMP

requirements.

 Types of documents should be fully defined in QMS.

 To establish, control, monitor and record all activities which directly or indirectly impact on the quality of products.

 There are two types of documentation used to manage and record GMP compliance: instructions and

records/reports.

 Suitable controls should be implemented to ensure the accuracy, integrity, availability

and legibility of documents.

 Six key points for documentation

Ele t o i ase data ase dataPape

(55)

3. Chapter 4: Documentation

 Required GMP documentation (two primary types)

Site Master File

Specifications Manufacturing _Formulae

Processing

Instructions Procedures Packaging/

Testing Instructions

Protocols

Records

Certificates of Analysis Reports

 Instruction type

 Record/Report type

(56)

3. Chapter 4: Documentation

 Definitions of each material:

 Instructions type:

Specifications: Describe in detail the requirements with which the products or materials have to conform as a basis for quality evaluation.

Manufacturing Formulae, Processing, Packaging and Testing Instructions:

In detail all the starting materials, equipment and all processing, packaging, sampling and testing instructions.

Procedures: Also known as SOPs, give directions for performing certain operations.

Protocols: Give instructions for performing and recording certain discreet operations.

 Record/Report type:

Records: Provide evidence of various actions taken to demonstrate compliance with instructions .

Certificates of Analysis:

Provide a summary of testing results together with the evaluation of compliance to a stated specification.

(57)

KindＧofＧDocumentＧinＧPIC/SＧGMP SectionＧ4 PIC/S GMP Part I

1. QMS

Instruction type

(58)

All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and

control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems.

Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.

.

3. Chapter 4: Documentation

 GENERATION AND CONTROL OF DOCUMENTATION

Y

a

,

a

y

a

y

a

(59)

Documents containing instructions should be approved, signed and dated by

appropriate and authorised persons. Documents should have unambiguous

contents and be uniquely identifiable. The effective date should be defined.

.

3. Chapter 4: Documentation

 GENERATION AND CONTROL OF DOCUMENTATION

Documents containing instructions should be laid out in an orderly fashion and be easy to check. The style and language of documents should fit with their intended use. Standard Operating Procedures, Work Instructions and Methods should be written in an imperative mandatory style.

Documents should not be hand-written; although, where documents require the

entry of data, sufficient space should be provided for such entries.

(60)

Handwritten entries should be made in clear, legible, indelible way.

.

3. Chapter 4: Documentation

 GOOD DOCUMENTATION PRACTICES

Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

(61)

3. Chapter 4: Documentation

 Generation and control of documentation

Define the document type and adhere to it. Electronic base vs. Paper base

Master documents vs. Official copies Comply with the relevant parts of;

 Product Specification Files

 Manufacturing and Pre-Market Authorization

PSF

MA

PMA

Ele t o i

ase data ase dataPape

Maste

file Offi ial op

I st u tio s Re o ds

Be approved and regularly reviewed  Lay out in an orderly fashion

(62)

3. Chapter 4: Documentation

 Good documentation practice

 Be clear, legible, indelible for hand-writing

 Records to made completed at the time each action is taken and in such a way that all significant activities are traceable. Alteration made to the entry on a document to be signed and

dated; and to permit the reading of the original information.

Re o d

Sig ; S.Taha a

(63)

3. Chapter 4: Documentation

 Retention of documents

Retention period

 Batch documentation must be kept for 1 year after expiry of the batch, or at least 5 years after the batch release, whichever is the longer.

 For investigational drugs, the batch documentation must be kept for at least 5 years after the last clinical trial.

 Critical documentation, relating to validation or stability, etc. which supports information in the MA should be retained whilst the MA remains in force.

 It is acceptable to retire certain documentation if the data has been superseded by a full set of new data, after doing the followings;

• document the justification,

• consider the requirements for retention of batch documentation.

For example, in the case of Process Validation:

(64)

3. Chapter 4: Documentation

 Example of instruction type document

Specifications for starting/packaging materials

a

• Des iptio of the ate ials

• Di e tio s fo sa pli g a d testi g

• Qualitati e a d ua titati e e ui e e ts ith a epta e li its

d

• Sto age o ditio s a d p e autio s

(65)

3. Chapter 4: Documentation

 Example of record type document

Receipt for starting/packaging materials

a

• The a e of the ate ial o the deli e ote; • The "i ‐house" a e a d/o ode of ate ial;

• Date of e eipt;

d

• Supplie ’s a e a d a ufa tu e ’s a e;

e

• Ma ufa tu e ’s at h o efe e e u e ;

f

• Total ua tit a d u e of o tai e s e ei ed;

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3. Chapter 4: Documentation

Summary of this Chapter:

Specifications MFG Formulae

Certificates of Analysis Reports

 Instructions

Turn your mountains of books into the best

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Thanks

and see you ...

Session 3.

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