FARMASI INDUSTRI - Six Sessions Get You Better at PIC/S GMP · 2016. 7. 14. · 10:00 –10:15...

Six SessionsGet You Better at PIC/S GMP

Session 2 Introduction & Guide Part I (Chapter 3 & 4)

Jun 2016

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8:30 – 10:00 Registration10:00 – 10:15 Opening Session by GP Farmasi10:15 – 11:45 Materials Presentation11:45 – 12:00 Break12:00 – 12:50 Q & A12:50 – 13:05 Quiz13:05 – 13:20 Explanation of Quiz Answer13:20 Closing Session

Todayʼs Schedule


◎Presenter

Dr. Takahashi (Q&A) Mr. Tahara Ms. Lanny

Todayʼs Presenter


Copyright© CM Plus Corporation. All rights reserved®

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

Table of Contents

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Todayʼs Topics

1. A Quick Recap of Our Previous Session

2. PIC/S Part I - Chapter 3 Premises and Equipment

3. PIC/S Part I - Chapter 4 Documentation




Commenced operating on 2 Nov. 1995

History of PIC/S

6

http://www.picscheme.org/

Numbers on PIC/S

48 Members in the world

7 Members in Asia (Singapore, Malaysia, Indonesia, Taiwan, Japan, Korea, Hong Kong)

4 Partner Organizations EDQM EMA UNICEF WHO




EU legal enforcement system

7

• 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 GMPPIC/S GMP




8

Mutual Recognition Arrangement (MRA)

MRA MRA

PIC/S GMP Guide virtually identical to EC GMP guide




9

PIC/S GMP GUIDE PART I:

BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS

Chapters

Part IChapter

１Chapter

2Chapter

3 Chapter

4Chapter

5Chapter

6Chapter

7Chapter

8Chapter

9

1.QMS2. Personnel

3. Premises/equipment4. Documentation

5. Production6. QC

7. CMO8. Complaints/recall

9. Self inspection




Regulatory Compliance

10

To ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products.

PIC/S GMP has been becoming a global standard

The ultimate spirit of GMP:




Quality Management System (QMS)= Quality System

= Quality Assurance

Recap of Chapter 1: Quality Management

11

QMSContinuous improvement throughout the life cycle

GMPQuality assurance in day-to-day production activities

Quality

QC




12

GMP

QC

PQR

Mark

Peter

Thomas Bill

Michael

Richard

QRMPQR

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.

Principle of Quality Management




13

Method

Machine

Man=

Personnel

Material

Personnel

Training

Key personnel

Personnel hygiene

Recap of Chapter 2: Personnel

an adequate numberof personnel

necessary qualifications & practical experience

written job descriptions

Mark

Peter

Thomas Bill

Michael

Richard

organisation chart




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

Principle

14

Personnel

Process

Validation

Sampling

Record

Release

Formula



Todayʼs Topics






2. Chapter 3: Premises and Equipment

16

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

Highly regu

lated Pharmaceutical

industry provides unique challenges N

o correct

answ

er

PIC/S does not specify criteria or numerical for premises and equipment

With

hard &

soft te

chs Your ingenuity

will be everything



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.

3.2


General




18

A typical flowchart in facility project case:

Feasibility

Conceptual development

Project planning

Basic design + DQ

Detailed design +

Specification

Supplier selection

Construction+ installation

IQ/OP/PQ

Production + maintenance

Expertise involved in all phases from design concept to production …



Risk Control*Decreasing Risk *Risk Acceptance(Fish Bone, FMEA etc.)

UR

Ｆｒｏｍ２０１６ＩＳＰＥＩｎｄｏｎｅｓｉａ19

PUR*Product Quality*CQA *CPP,GMP

GUR*Product CapacityEtc.

Conceptual Design

Risk Assessment*Specify Risk*Risk Analysis(SIA)*Risk Assess.

Design ConceptDesign data etc.

URS

PUR*Product Quality*CQA *CPP,GMP

GUR*Product CapacityEtc.

Critical Aspects*Facility/SystemSpecification

Basic Design

Detail Design

DQVMP

ConstructionCommissioning

IQ,OQPQ/PPQ

Risk Review*Monitoring*Self Inspection

CommercialProduction

MaintenanceProgram

*Engineering Flow combined with Risk Management

Tractability Matrix

Qualification

Commissioning




Choose proper clean class for each process！

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

GGrade

ＥGrade

ＦGrade

Min.Intervention

Filling ProcessClean Bench

No Intervention

Critical portion for sterile

Grade C

Ａ

Grade

BGrade

Grade D

Grade Ａ内Critical area

Grade ＡＩＳＯ５

Filling roomGrade ＢＩＳＯ７

SterileGarment

Grade ＣＩＳＯ８

Grade ＤＩＳＯ９

CleanGarment Formulation etc.

Washing Tools etc.

Grade Ｅ＊ CNC

Grade ＦUnclassified

Grade ＧExternal

Uniform+α

Uniform

UniformPrivate

2ry Packaging room

Ordinary AreaOffice ・Warehouse

Canteen・ＱＣMachine room, Out side.

＊Controlled not classified


CleanGarment

OSD







22

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?

Unclear

concep

t

Mountains of books Q

RM

approa

ch Scientific evidencesGood qualification practiceKnowledge 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

Letʼs discuss it in more detail later on the next Chapter: Documentation




23

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

Location

HVAC & M/E

Entry controlAnti‐insects & anti‐squirrel

MaintenanceLab

Utility yard

Production area

Social Interaction

Space

Office

Production area

Ware‐house

Site PlanN



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.

3.3

2. Chapter 3: Premises and Equipment General

3.4



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.

3.5

Clean Corridor

ProcessRoom BProcess

Room A

ProcessRoom C




26

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

Production area (Section 3.6 to 3.17)



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.

3.6





28

Dedicated and self-contained facilities for medical hazard

Highly sensitizing materialse.g. penicillin drugs

Biological preparationse.g. live micro‐organisms

・containment

・isolator・Acceptable Daily Exposure (ADE)

・Occupational Exposure Limits (OEL)

Risk of a serious medical hazard



NonHazard

NonHazard

NonHazard

NonHazard

NonHazard

HazardWith

Containment

NonHazard

SeparateMaterial &PersonnelFlow

Separatewall

Building must be designed andconstructed with containment

Segregation of Hazardous Factory


NonHazard

NonHazard

NonHazard

NonHazard

NonHazard

NonHazard

Hazard

Problem : Hazard may contaminate to non Hazard.



Segregation of Hazardous Factory


Air Lined Suitfor Operator protection

Isolator for Open operation

HazardNON‐Hazard

H13

H13Corridor

H13

H13

H13

H13

Process room

ProcessEquipment

Corridor

SAG4

F8

AHU

RA

0 Pa

DC

Scrubber

EA

FA

EA

H13±０

All FreshHVAC

HEPA onReturn Duct

NegativePressure Control

SegregateOver Ceiling

Process room



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.

3.9

2. Chapter 3: Premises and Equipment Production Area

3.10

Clean room

Machine Room



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.

3.11


PIC/S GMP Annex 150. Sinks and drains should be prohibited in grade A/B areas used for asepticmanufacture. 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 fittedwith traps or water seals to prevent backflow.

PureSteam

Air Brake

Autoclave and/or Process Equipment which has SIP function



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

3.16


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.

3.14

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

3.15

FDA CGMP § 211.44 - Lighting.Adequate lighting shall be provided in all areas.




34

Good M/E work Adequate size of drains Separated weighing room for starting materials

• Avoid creation of recesses• Accessible from outside

Independent unit

Trapped drain/slopeEasy to clean

Static differential（Airflow）

exhaust

MAU

exhaust

Fresh air

Accessible from outside

Weighing room




35

Effectively ventilated with air control facilities

Airflowpattern

DB ℃ RH%

+ pressure

HVAC and

Monitoring

Maintenance

Control facility

Cleanliness

A comprehensive system

• To minimize the introduction, generation and retention of particles inside the room




36

Interior surface (wall, floor and ceiling) consideration

• Smooth surfaces• Free from cracks/open joints• Permit easy and effective cleaning

1) Materials 2) Construction 3) Configuration

• Corrosion• Peeling

• Difficult to clean• Residual detergent

Equipment

Impossibleto clean




37

Specific provisions taken for where dust is generated

indication

Level 1

Space + indication

Level 2

Light partition

Level 3

Locked

Full isolationSeparate HVAC

Level 5

Locked

Partition wall

Level 4 With ceiling Hazard type

Separated/classified level




38

Packaging rooms to avoid mix-ups or cross-contamination

Product B

Carton boxes for B

Primary package

Product A

Carton boxes for ASecondary package

Separated by partitions

Separated by Wall




39

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 forGrade B area, but a mandate for Grade A.

The maximum allowable particles (number/m3)

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

EU GMP




40

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 Lab

Manufacturing area Warehouse

Receiving bay

Dispatch bay

QuarantineSampling

Cold storage



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.


3.19

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.

3.22

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.

3.25




42

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 Lab

Manufacturing area Warehouse

Receiving bay

Dispatch bay

QuarantineSampling

Cold storage



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.


Quality Control Area3.26




44

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.

・・・・・・・

Ancillary area (Section 3.30 to 3.33)




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..

3.31

Ancillary Area

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

GGrade

ＥGrade

ＦGrade

Grade D

Grade ＤＩＳＯ９

Washing Tools etc.

Grade Ｅ＊ CNC

Grade ＦUnclassified

Grade ＧExternal

Uniform+α

Uniform

UniformPrivate

2ry Packaging room

Ordinary AreaOffice ・Warehouse

Canteen・ＱＣMachine room, Out side.

＊Controlled not classified

CleanGarment

NoToilet




46

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

Operating Instruction

Record

Database ProgramT

Computing

Calibration & traceability

Computerized system validation

IQ/OQ/PQ

Cleanliness



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.

3.36


3.37

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.

3.41

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

3.42




PIC/S does not specify criteria or numerical for premises and equipment, Your ingenuity will be everything.

Summary of this Chapter:

48

Premises design + engineering Expertise in all stages from design

concept to productionProduction area Classified area & zoning Flow & anti-cross-contamination

QC laboratory

Storagearea

Equipment



Todayʼs Topics






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.

3.43

3. Chapter 4: Documentation PRINCIPLE



3. Chapter 4: Documentation

51

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?

Material

Process

Documentation

Official information

•Approved & dated•Regularly reviewed•Revision control

Evidence•Accountability•Traceability




52

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 ≠ Get More Paper

But, paper really does matter

The truth about GMP

ye, of course,




53

For example: FDA Inspection Observation Summaries by frequencyCited ref. # Short description Long description FY2013 FY2014 FY2015

21 CFR 211.22(d) Procedures not in writing, fully followed

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***

155 145 160

21 CFR 211.192 Investigations of discrepancies, failures

There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, ***

131 94 124

21 CFR 211.100(a)

Absence of Written Procedures

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, ***

106 87 95

21 CFR 211.160(b)

Scientifically sound laboratory controls

Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in‐process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, ***

99 109 130

“Procedures not in writing, fully followed” that has ranked the top for three consecutive years




54

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 toensure the accuracy, integrity, availabilityand legibility of documents.

Six key points for documentation

Electronic base data

Paper base data


Paper base data


Paper base data




Required GMP documentation (two primary types)

55

Site Master File

SpecificationsManufacturing

Formulae

Processing Instructions

Procedures

Packaging/

Testing Instructions

Protocols

Records

Certificates of Analysis Reports

Instruction type

Record/Report type

We will specify it in Session 4




Definitions of each material:

56

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.

Reports: Document the conduct of exercises, projects or investigations, together with results, conclusions and recommendations.



Kind of Document in PIC/S GMP Section 4PIC/S GMP Part I

1. QMS

2. Personnel

3. Premises/equipment

4. Documentation

5. Production

6. QC

7. CMO

8. Complaints/recall

9. Self inspection

Site Master File

Instruction type

Record/Report type

Specifications

Processing, PackagingTesting Instructions

Procedures（SOP）

Format

ProtocolsTechnical Agreements

Records

Certificatesof Analysis

Reports




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.

4.1

3. Chapter 4: Documentation GENERATION AND CONTROL OF DOCUMENTATION

You have to understand “Electric Data”, define what is your electric data in your plant.

You have to learn “ER/ES” knowledge.



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.

4.3

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.

4.6

4.4



Handwritten entries should be made in clear, legible, indelible way.4.7

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.

4.9




Generation and control of documentation

61

Define the document type and adhere to it.Electronic base vs. Paper baseMaster documents vs. Official copies

Comply with the relevant parts of; Product Specification Files Manufacturing and Pre-Market Authorization

PSF

MA

PMA


Paper base data

Master file

Official copy

Instructions Records

Be approved and regularly reviewed Lay out in an orderly fashion In an imperative mandatory style



3. Chapter 4: Documentation Good documentation practice

62

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.

RecordVol. I

RecordVol. IIIQ Protocol

Record 2016.08.17 ST correction of erroneous

IQ ProtocolRecord Cannot read

originalBach recordInstructionsa) ・・・・・・・・・・・XXb) ・・・・・・・・・・・YYc) ・・・・・・・・・・・11d) ・・・・・・・・・・・99e) ・・・・・・・・・・・ ‐

Sign ; S.Tahara

Easy to Check!



3. Chapter 4: Documentation Retention of documents

63

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:

retention period for its batch documentation

retention period for the PV raw data



3. Chapter 4: Documentation Example of instruction type document

64

Specifications for starting/packaging materials

a) • Description of the materials

b) • Directions for sampling and testing

c) • Qualitative and quantitative requirements with acceptance limits

d) • Storage conditions and precautions

e) • The maximum period of storage before re‐examination



3. Chapter 4: Documentation Example of record type document

65

Receipt for starting/packaging materials

a) • The name of the material on the delivery note;

b) • The "in‐house" name and/or code of material;

c) • Date of receipt;

d) • Supplier’s name and manufacturer’s name;

e) • Manufacturer’s batch or reference number;

f) • Total quantity and number of containers received;

g)• The batch number assigned after receipt and any relevant comment.



3. Chapter 4: DocumentationSummary of this Chapter:

66

Site Master File

SpecificationsMFG

Formulae

Processing Instruction

ProceduresPackage&Testing

InstructionsProtocols

Records

Certificates of Analysis Reports

Instructions

Records

Material

Process

Documentation

Official info

•Approve/date•Regularly reviewed

•Revision control

Evidence•Accountability•Traceability

Turn your mountains of books into the best documentation practice


Thanks and see you ...

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

＠Aug 25 2016

67



製造標準書（製品毎）

標準書

報告書

生データ

指図

記録、ログ

指図・記録（バッチ毎）

1. マネジメントレビュー規程2. 文書管理規程3. 教育訓練規程4. CAPA規程5. 変更管理規程6. バリデーション規程7. 外部委託規程8. 内部監査規程9. 品質レビュー規程

生データ

品質マネジメントシステム

規則類

1. 出荷承認規程2. 製造管理規程（基準書）3. 試験室管理規程（基準書）4. 衛生管理規程（基準書）

製造システム

規程

報告書・記録

品質システムの概要と GMP省令の文書体系


PIC/S GMP第4章の文書

GMP省令

第7条

製品標準書

第8条第1～3項三基準書第8条第4項

品質システム手順書衛生管理製造管理品質管理

サイトマスターファイル ○ ○ ○ ○ ○

指

図

規格書 ○ ○

製造等指図書 ○

手順書 ○ ○ ○ ○

（様式・フロー図）

○

要領書 ○ ○ ○ ○

技術契約書 ○ ○ ○ ○

記録報告

記録書 ○ ○ ○ ○ ○

試験成績書 ○ ○

報告書 ○ ○ ○ ○

GMP省令の文書体系と PIC/S GMP

製品毎に固有製造所に固有の事項が多い本質は世界共通


Date post:	18-Jan-2021
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