Documentation and Records:

Harmonized GMP-PIC/S Requirements

PIC/S PE 009-12 (Introduction Part I, II, ANNEX)

Sirivan Pomchaksin
Expert 10

The Government Pharmaceutical Organization (GPO)

TOPICs
Why ?

History

Important

Of PICs
GMP Guide

Document

PE -009
Chapter
4,6

Doc Type

Annex 15

Doc Control
Syst. & Life
cycle

UPDATED ! PIC/S : 2015

CREATION
CONCEPTs

&
Model

GOOD DOCUMENTs

WHY are documents so important?

Communication
Cost
Audit trail

If it was not written it was not done.

9/19/2016

1 January 2013

PE 009-10

Revision of Chapter 4 (Part I)

Revision of Annex 6,7,11 and 13

1 March 2014

PE 009-11

Introduction of QRM principals in

PIC/S GMP Guide - Part II
Revision of Annex 2 and 14

1 Oct 2015

9/19/2016

PE 009-12

Revision of Annex 15

UPDATED PIC/S : 2015

(PE 009-12)

Documentation and Records

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

Introduction
PART I
: CHAPTER 4 DOCUMENTATION
: CHAPTER 6 (6.7-6.10 ) QC DOCUMENTATION

PART II : SECTION 6 DOCUMENTATION AND RECORDS(API Mfg))

Annex11 : Data ,Data Storage ( )

Annex15 : DOCUMENTATION including VMP ( )

What has changed?

.. ( 14 2559)

CHAPTER 4: DOCUMENTATION
-

V.9

Stronger emphasis
on holistic
compliance
Type of Documents
Retention period

V.11

V.10

*Big
Change

V.12

Include all form of document media

Fully defined docs within the QMS
Diff. types of docs & their req.
Retention periods
Line clearance
Real-time testing
Activities of the authorized person
More detailed list of processes req.
SOPs
- Logbooks

Chapter4 DOCUMENTATION

Principle
Required GMP Documentation (by Type)
Generation and Control Documentation
Good Documentation Practices
Retention of Documents

Specifications
Manufacturing Formula and Processing /Packaging Instruction
Batch Processing Record
Packaging Record
Procedures and Records
Receipt
Sampling
Testing
Others

CHAPTER 4 DOCUMENTATION
PRINCIPLE
The main objective of the system of documentation
utilized must be to establish, control, monitor, and record
all activities which directly or indirectly impact on all
aspects of the quality of medicinal products.
To ensure the accuracy, integrity, availability and
legibility of document
There are two types of documents used to manage and
record GMP compliance:
Instructions (direction, req.):free from error, available in writing
Records/Reports : be rendered in a human readable
form.

CHAPTER 4 DOCUMENTATION
REQUIRED GMP DOCUMENT (BY TYPE)
Site Master File
A document describing the GMP related activities of the
manufacturer.

Record/Report type

Instructions type
Specifications

Protocols

Reports

Procedures

Technical
Agreement

Records

Manufacturing Formulae, Processing,

Packaging and Testing Instructions

For electronic records

regulated users should
define which data are to
be used as raw data.

Certificate of
Analysis
Alternatively the
certification may be
based, in-whole or inpart, on the assessment
of the real timed data
from batch related PAT.

CHAPTER 4 DOCUMENTATION
GENERATION AND CONTROL OF DOCUMENTATION
4.1
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.

Controls for electronic documents

To ensure the integrity of the record throughout the retention period

CHAPTER 4 DOCUMENTATION
GENERATION AND CONTROL OF DOCUMENTATION
4.2
Document should be designed, prepared, reviewed, and
distributed with care.
They should comply with the relevant parts of Product specification
files, Manufacturing and marketing authorization dossiers.
The reproduction of working documents from master documents
should not allow any error to be introduced through the
reproduction process.

CHAPTER 4 DOCUMENTATION
GENERATION AND CONTROL OF DOCUMENTATION
4.3
Documents containing instructions should be approved, signed and date by
appropriate and authorized persons.(Qualified :EU )
Documents should have unambiguous contents and be uniquely identifiable. The
effective should be defined.
4.4
Document containing instructions should be laid out in an orderly fashion and be
easy to check
4.5
Documents within the QMS should be regularly review and kept up-to-date.
When a document has been revised, systems should be operated to prevent
inadvertent use of superseded documents.
4.6 Documents should not be hand written, .sufficient space
should be provided for such entries.

CHAPTER 4 DOCUMENTATION
GOOD DOCUMENTATION PRACTICE
4.7 Handwritten : clear, legible, indelible way
4.8 Records : at the time each action, traceable
4.9 Alteration : signed and dated
permit the reading of the original information
the reason for the alteration should be recorded

CHAPTER 4 DOCUMENTATION
RETENTION OF DOCUMENT
4.10
Records is located, ensure the integrity, validated
4.11
Specific requirements apply to batch documentation which must be kept for one
year after expiry of the batch to which it relates or at least five years after
certification of the batch by the Authorized Person, whichever is longer.
4.12
For other types of documentation, the retention period will depend on the
business activity which the documentation supports. Critical documentation,
including raw data (for example relating to validation or stability), which support
information in the Market Authorization should be retained whilst the
authorization remains in force. It may be considered acceptable to retire certain
documentation where the data has been superseded by a full set of new data.

CHAPTER 4 DOCUMENTATION
SPECIFICATIONS 4.13-16
Starting and
Packaging Materials

Intermediate and
Bulk Products

Finished Products

Starting and packaging material:

a)Name and internal code reference
Reference
approved suppliers ; original producer
specimen of printed material
b) Direction for sampling and testing
c) Requirement and acceptance limits
d) Storage conditions and precautions
e) The maximum period of storage before re examination

CHAPTER 4 DOCUMENTATION
SPECIFICATIONS
Intermediate and Bulk Products:
Should be available for critical steps or if these are purchased or
dispatched. The specifications should be similar to specifications for
starting materials or for finished products, as appropriate.
Finished Products:
as starting
+ The Formula
+ Storage conditions and special handling precautions, where
application
+ The shelf life

CHAPTER 4 DOCUMENTATION
MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 4.17-4.21
Approved, written Manufacturing Formula and Processing Instructions should exist
for each product and batch size to be manufactured.

Manufacturing Formula
Should include :
a)

The name of the product, with a product reference code relating to its specification

b)

A description of the pharmaceutical form, strength of the product and batch size

c)

A list of all starting materials to be used, with the amount of each, described; mention

should be made of any substance that may disappear in the course of processing;
d)

A statement of the expected final yield with the acceptable limits, and of relevant

intermediate yields, where applicable

CHAPTER 4 DOCUMENTATION
Processing
Instructions

Packaging
Instructions

Batch Processing
Record

Batch Packaging
Record

work station are clear of previous products

equipment is clean and suitable for use.
Line Clearance
Reconciliation (Batch Packaging Record):
The quantities and reference number or identification of all printed
packaging materials and bulk products issued, used, destroyed or
returned to stock and the quantities of obtained product, in order
to provide for an adequate reconciliation.

CHAPTER 4 DOCUMENTATION
Batch Processing
Record

Name batch no. /dates /times

Significant step, who check ,sign/date
Actually weighed including batch no,
IPC /Environment
Major equipment
Product yield /Reconciliation
Deviation from Formula, processing operation
Approval for processing operation (validated)

++ Formula + Instruction

Chapter 4 : Procedure and Records

Receipt

(4.22-4.24)
each delivery of starting material, Intermediate, primary, secondary
and printed PM
Record + COA , supplier, manufacturer

Sampling

(4.25) + Chapter 6 QC documentation (6.11)

+ Annex 8 sampling of starting and packaging material

SOP : Methods, equipment, quantity

Precaution avoid contamination, any deterioration

Testing (4.26)

+ Chapter 6 QC testing
SOP at different stage ;approved method, equipment
Record (6.17)

Procedure and Records

SAMPLING chapter6
6.11. The sample taking should be done in accordance with approved
written procedures that describe:
the method of sampling;
the equipment to be used;
the amount of the sample to be taken;
instructions for any required sub-division of the sample;
the type and condition of the sample container to be used;
the identification of containers sampled;
any special precautions to be observed, especially with regard to the
sampling of sterile or noxious materials;
the storage conditions;
instructions for the cleaning and storage of sampling equipment

Procedure and Records

TESTING chapte6
6.17. The tests performed should be recorded and the records should include
at least the following data:
a) name of the material or product and, where applicable, dosage form;
b) batch number and, where appropriate, the manufacturer and/or supplier;
c) references to the relevant specifications and testing procedures;
d) test results, including observations and calculations, and reference to any
certificates of analysis;
e) dates of testing;
f) initials of the persons who performed the testing;
g) initials of the persons who verified the testing and the calculations, where
appropriate;
h) a clear statement of release or rejection (or other status decision) and the
dated signature of the designated responsible person.

Procedure and Records (cont.)

4.27
Batch release ; authorized person(s) ,COA
4.28
Records; to facilitate recall
4.29
There should be written policies, procedures, protocols, reports, and the
associated records of actions taken or conclusions reached, where appropriate,
for the following examples;

Validation and Qualification of

processes, equipment and systems
Equipment assembly and calibration
Technology Transfer
Maintenance, cleaning and sanitation
Personnel matter including signature
lists, training in GMP and technical
matters, clothing and hygiene and
verification of the effectiveness training
Environment monitoring
Pest control

Complaints
Returns
Recalls
Change Control
Investigation into deviations and nonconformances
Internal quality / GMP compliance
audits
Summaries of records where
appropriate (e.g. product quality
review)
Supplier audit

Procedure and Records (cont.)

Others SOP (4.27-4.32)
4.30
4.31
4.32

Major/critical manufacturing and testing equipment

Log books; chronological order , dates, identity of people who carried
An inventory of documents within the QMS should be maintained

Part I CHAPTER 6 : QUALITY CONTROL

6.7 LABORATORY DOCUMENTATION;
Should be readily available to the Quality Control
Department

Specifications
Sampling procedures +Annex8
Testing Procedures and Records
Analytical Reports and/or certificates
Data from environmental monitoring, where required
Validation records of test methods, where applicable
Procedures for and records of the calibration of
instruments and maintenance of equipment.

Part I CHAPTER 6 : QUALITY CONTROL (cont.)

6.8
Any Quality Control documentation relating to a batch record
should be retained for one year after the expiry date of the batch.
6.9
For some kinds of data (e.g. analytical test results, yields,
environmental controls,) it is recommended that records in a
manner permitting trend evaluation be kept.

6.10
In addition to the information which is part of the batch record, other
original data such as laboratory notebooks and/or records should
be retained and readily available.

Part II Chapter 6

DOCUMENTATION AND RECORDS (API)

6.1
6.2
6.3
6.4
6.5
6.6
6.7

Documentation and Specification

Equipment Cleaning and Use Record
Records of RM, Intermediate, API Labelling and PM
Master Production Instructions and Control Records
BPR
Laboratory Control Records
BPR Review

LIFE CYCLE OF DOCUMENT

Revision

TRAINING
(plan, OJT)

Internal document:
Numbering System

Each document is to be given a unique number

consisting of 3 sections

Type of document

Sequential number

Department code / Owner

Each Form is to be given a unique number consisting of 2 sections

Document Number

Sequential number
of the form

sign & symbol

The DCC personnel issues hard copies of approved documents
on an as-requested basis.

will be stamped a unique,

controlled copy number with blue ink on
every page.
COPY No.
Controlled copy

will be stamped a unique,

controlled copy number with red ink
on every page.
UNCONTROLLED
Uncontrolled copy

sign & symbol

The Obsolete or Superseded copies will be shredded to ensure they
are not used to perform work. Only the master document will be kept
as reference in Document Control Center after each of the pages has
been stamped in red with
SUPERSEDED
The cancellation of controlled copies and documents will be
shredded to ensure they are not used to perform work. Only the
master document will be kept as reference in Document Control
Center after each of the pages has been stamped in red with
CANCELLED

DOCUMENT
CREATION/REVISION
All new or revised documents must pass
through the document approval process by
using the Document Action Request

Document Preparer or Designee requests a

controlled number from Document Control
Center (DCC) for a new document.
The DCC Personnel notify the Document
Preparer at least 30-day before the periodic
review date is due by using the Periodic Review
Notice form

DOCUMENT
REQUEST & DISTRIBUTION
The hard copies both Controlled and Uncontrolled can be requested by using
Document Request Form.

The DCC personnel will generate and send a Controlled

Document Receipt Acknowledgement Form, included with
the controlled hard copies to all users in the distribution
list or the requestors while the users shall acknowledge
the receipt of the document and must be returned the
superseded version to the DCC personnel.

THE USE OF ANNEX/FORM

The use of annex (form for recording), the
DCC personnel shall distribute the
controlled copy to each unit operation as
defined in distribution list.
The form can be copied without the cover
page for routine operation and each
operation shall control them to stay in the
current status.

DOCUMENT CANCELLATION
The Document Preparer or Designee must be completed a
DAR Form when he/she wants to cancel a controlled
document. Approval signatures must include the following at
minimum:
Document Preparer
Responsible Manager

The DCC Personnel shall dispose of cancellation of controlled copies

and documents by shredding to ensure they are not used to perform

work.

Only the master document will be kept as reference in Document

Control Center after each of the pages has been stamped in red with
CANCELLED.

DOCUMENT RETENTION

PINK DOCUMENT
In training and trial period, the DCC will generate the
documents for training purposes ::: Signed & Copied on
Pink paper.
Purposes of pink paper are also warning the operator who
read them, these instructions have some changes. They
will stay in pink paper for a month.

When the Pink document is ready for removal from the

training /warning status, the DCC should generate the
master of White document with original approval same
revision but set the new effective date .
DCC distribute the white hard copy version to each
operation units and get the pink document return to
DCC.

DOCUMENT FORMAT : Header

TITLE

DOCUMENT CONTROL SYSTEM

Document No.
SOP-QA-001
Rev. 02
Eff. Date:
4 Jul 2014

DEPARTMENT

QUALITY ASSURANCE

PAGE 12 of 24

THE GOVERNMENT PHARMACEUTICAL ORGANIZATION

RANGSIT PHARMACEUTICAL PRODUCTION PLANT

THE GOVERNMENT PHARMACEUTICAL ORGANIZATION

RANGSIT PHARMACEUTICAL PRODUCTION PLANT
TITLE

PREVENTIVE MAINTENANCE PLAN

Document No.
SOP-EN-001
Rev.01
Eff. Date :
20 Oct 2013

DEPARTMENT

ENGINEERING DIVISION

PAGE 1 of 10

TITLE

DOCUMENT ACTION REQUEST (DAR) FORM

Document No.
SOP-QA-001_Annex01
Rev.02
Eff. Date :
4 Jul 2014

DEPARTMENT

QUALITY ASSURANCE

PAGE 4 of 5

THE GOVERNMENT PHARMACEUTICAL ORGANIZATION

RANGSIT PHARMACEUTICAL PRODUCTION PLANT

DOCUMENT FORMAT :
Distribution List

Copy No.
Master

Area / Position
Document Control Center - QA

QA Manager

Manager of Rangsit Pharmaceutical Production Plant 1

Director of Validation Division

Director of Compliance and Quality System Division

Director of Quality Control Division

Director of Administration Division

Director of Production Division

Director of Warehouse Division

Director of Engineering Division

DOCUMENT FORMAT : REVISION HISTORY

Rev.
No.

Change & Reason For changes

01

Initial Release

02

Revised:
Header: Change the plant name from
Rangsit Manufacturing Plant to Rangsit
Pharmaceutical Production Plant.
Rearrange the sequence of topics.
Distribution List: Rename and add the newly
divisions and sections as per the approved
organization chart. (p. 2/23)
Internal Document Control System: remove
the section of Numbering System. (p. 10/23)
Internal Document Control System: change
the process and lifecycle of pink document.
(p. 10/23)
Attachment: remove template of VMP, QM,
BPR, SOP
Release in white paper
Revised:
- Updated the format of document header for
using in eQMS.
- Add definition of term that used in eQMS.
- Add detail for document control procedure in
eQMS
- Cancel the use of pink document
- Cancel the use of SOP-QA-001_Annex04

02
03

Effective
Date
19 Sep 2011
4 Jul 2014

4 Aug 2014
As per an
effective
date in
electronic
system

DOCUMENT FORMAT : Table of Contents

IMPLEMENTATION:DOCUMENT MODEL
Level 1

Policy, Quality Manual

Define what will be done.
Policy

Level 2

Procedures (SOPs)

Procedures
Level 3

Operation Instructions
Level 4

Records and Reports

Who, What, When

Work Instructions
How

Evidences, Tag, Labels , Logbook

Level 1 for Whole GPO

(GMP Cert., Quality Policy, Product Licence,
Quality Manual, Site Master Files)

Level 2 for Cross Functional Managing

Procedure
Plant layout, QP, Qplan, Specification [BDR, BMR,
BPR, (Master)], SP, WQM, GMP Activity Plan
(Validation Master Plan, PM Plan, Review
Documentation Plan, etc.)

Level 3 for Operational ways of working

at the functional level
Validation Protocol & Report (VP), Stability Study Protocol,

Work Instruction (WI), [BDR, BMR, BPR, (Original copy)]

Level 4 for Quality Record & Report

, Form (FM), Worksheet, Calibration Record, Tag, Logbook,
Water System Operation Record,

 6
Quality
System

Personnel

Facilities,
Utilities &
Equipment,
IT/Comp.

Documentation

Laboratory

System

Production

Materials

Packaging&
Labeling

Document Control Instruction

Document Numbering System
Operation for Procedure and Instruction
Specification and
Operation of Record
Document Distribution
Generation of Validation Documents
Generation of BDR/BMR/BPR

The first documents auditor asks ??

SMF PE 008
QM
VMP Annex 15
SOP list
SOP PLANT GOWNING

SMF and Quality Manual

Site Master Files
What does the document contain?
A SMF contains information about the GMP activities
occurring specifically at a site quality management,
production and/or QC operations, or any closely
integrated operations at nearby buildings. It doesnt
contain information about GMP operations completed
elsewhere.

SMF PE008-4
EXPLANATORY NOTES FOR PHARMACEUTICAL MANYFACTURERS
ON THE PREPARATION OF A SITE MASTERFILE
1.

GENERAL INFORMATION ON THE MANUFACTURER

2.

QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER

3.

PERSONNEL

4.

PREMISES AND EQUIPMENT

5.

DOCUMENTATION

6.

PRODUCTION

7.

QUALITY CONTROL (QC)

8.

DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS

9.

SELF INSPECTIONS

SMF PE008-4
EXPLANATORY NOTES FOR PHARMACEUTICAL MANYFACTURERS ON
THE PREPARATION OF A SITE MASTERFILE

Contents 5. Documentation
Description of documentation system (i.e. electronic ,manual)
When documents and records are stored or archived off-site
(including pharmacovigilance data when applicable)
List of types of documents/records
Name and address of storage site and estimate of time required
retrieving documents from the off-site archive

SMF PE008
Appendix 1 Copy of valid manufacturing authorisation
Appendix 2 List of dosage forms manufactured including the INN-names or
common name (as available) of active pharmaceutical ingredients (API) used
Appendix 3 Copy of valid GMP Certificate
Appendix 4 List of contract manufacturers and laboratories including the
addresses and contact information, and flow-charts of the supplychains for
these outsourced activities
Appendix 5 Organisation charts
Appendix 6 Lay outs of production areas including material and personnel
flows, general flow charts of manufacturing processes of each product type
(dosage form)
Appendix 7 Schematic drawings of water systems

Appendix 8 List of major production and laboratory equipment

QM
Quality Manuals
What does the document contain?
The Quality Manual is the overarching document of the QMS used
to describe:
the quality policy of the business entity
the boundaries, operations and process improvement of the QMS
throughout the product lifecycle
management responsibilities
the road map of the key processes of the QMS and their relationship to
each other.
The Quality Manual may encompass multiple sites or a business entity
operating within a larger site. Larger companies may not have a single
document, or even call it a Quality Manual, but implement the quality policy
using a series of individual documents this is perfectly acceptable. Smaller
companies may use the Quality Manual alone to describe their QMS
(particularly in ISO 9001, though not so much in pharmaceutical companies).

What do the different regulations require?ollowinable compares

The following table compares different regulations that have
criteria for the SMF and/or a Quality Manual within the QMS
egulations that have criteria for the SMF and/or a Quality
Manual within
the QMS.
Regulation
or Standard
Site Master File
Quality Manual
PIC/S GMP version 8 (in
use in Australia)
PIC/S GMP version 9

No (but preferred)

No specific requirement

EU GMP
PIC/S GMP version 10

Yes (mandated in Ch 4.)

No specific requirement

EU and PIC/S SMF

guidance document
(essentially identical)

Yes (PIC/S used by TGA)

No specific requirement

WHO SMF guidance

Yes

Yes

SMF Checklist

ANNEX15 VALIDATION

The key elements of the site qualification and validation

program should be clearly defined and documented in a
validation master plan (VMP) or equivalent document.

ANNEX15 VALIDATION
The VMP or equivalent document should define the
qualification/validation system and include or reference
information on at least the following:
I.

Qualification and Validation policy;

IV.

II.

The organizational structure including

roles and responsibilities for
qualification and validation activities

Change control and deviation

management for qualification and
validation

V.

Guidance on developing
acceptance criteria

VI.

References to existing documents

VII.

The qualification and validation

strategy, including requalification,
where applicable

III.

Summary of the facilities, equipment,

systems, processes on site and the
qualification and validation status

ANNEX15 VALIDATION
DOCUMENTATION, INCLUDING VMP (2.1-2.10)
2.1 To support Km throughout the product lifecycle

2.2 All documents ;approved and authorized by appropriate

personnel as defined in the pharmaceutical quality system.
2.3 Inter-relationship between document ; clearly defined

2.4Validation protocols should be prepared which defines the

critical systems, attributes and parameters and the associated
acceptance criteria.
2.5 Qualification documents may be combined

ANNEX15 VALIDATION
2.6
Where validation protocols and other documentation are
supplied by a third party providing validation services,
appropriate personnel at the manufacturing site should
confirm suitability and compliance with internal procedures
before approval.

Vendor protocols may be supplemented by additional

documentation/test protocols before use.

ANNEX15 VALIDATION
2.7
Any significant changes to the approved protocol during
execution, e.g. acceptance criteria, operating parameters
etc., should be documented as a deviation and be
scientifically justified.
2.8
Results which fail to meet the pre-defined acceptance criteria
should be recorded as a deviation, and be fully investigated
according to local procedures. Any implications for the
validation should be discussed in the report.
2.9
The review and conclusions ; against criteria/justification
change/recommendation

ANNEX15 VALIDATION
2.10
A formal release for the next stage in the qualification and
validation process should be authorized by the relevant
responsible personnel either as part of the validation
report approval or as a separate summary document.
Conditional approval to proceed to the next qualification
stage can be given where certain acceptance criteria or
deviations have not been fully addressed and there is a
documented assessment that there is no significant
impact on the next activity

LIST OF PROCEDURES
Laboratory

QMS

Document Control System

Quality Risk Management

PERMIT TO OPERATE
/ (CAPA SYSTEM)

(Change Control System)

Product Quality Review
(GMP Self-Inspection/Internal audit)

(Failure Investigation)

(Batch Release)
Incident Report
Investigating Out of Specification /Out of Trend Test
Results and control of Non-Conformance
Supplier Approval and Evaluation System
(Returned and Salvaged Drug Products)
(Recall Procedure)

Customer Complaint
Record (CCR)
(Item Number)

Packaging and Printing Material Supplier
Approval and Evaluation

(Product Specification)

Analytical Results and Trends

Microbiological Laboratory Management and Safety

Procedure
Storage and Handling of Reference Working Standards
Microbiological Laboratory Instrument Management
Microorganism and Media Management
Microbiological Testing Procedure
(Backup of Electronic Data)

LIST OF PROCEDURES
Production

Penicillin

Lot No.

Material

VMI


/

LIST OF PROCEDURES
Personnel

Facility Utility and Equipment

Shut Down

(Purified Water)

Process Validation Procedure

Method Validation Procedure
Cleaning Validation Procedure
Validation and Monitoring of Microbiological
Laboratory Cleanroom and Aseptic Process
Excel Spreadsheet Validation

Computer System

GMP

CREATION CONCEPTs
REGULATION

REGULATION
RECORDS
&
REPORTS

5R

Product Dossier (REG.)

Legislation
GMP PIC/S

RESOURCE
RESPONSI
BILITY

Personnel (Role & Responsibility)

Premise
Equipment

RESPONSIBILITY

Clear authorization
RESOURCE

RISK

RISK

Validation/Deviation /CAPA/change

RECORDS & REPORTS

Traceability

GOOD DOCUMENTS

siri_van@gpo.or.th