Project co-financed

by European Union Project co-

financed
by Asean

ASEAN GMP TRAINING MODULE

QUALITY CONTROL
Prepared by :
Stephanie Wong Choong Moy ~ Malaysia
Eusebia Regodon ~ Philippines

Approved by
ASEAN GMP Team

Endorsed by
ASEAN Cosmetic Committee
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CONTENT OF PRESENTATION
by Asean

 Introduction
 Objective
 Scope
 Quality Control Principle
 QC Overview
 QA versus QC
 General Principle
 Basic Requirement of Quality Control
 Quality control unit
 Quality control laboratory
 Responsibility
 Quality Control Documents
 Tasks of Quality Control
 References
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INTRODUCTION

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INTRODUCTION
by Asean

 Good Manufacturing Practice (GMP) is the part of Quality

Assurance that ensures that products are produced and
controlled consistently and reliably. This consistency of
production and control is essential. It can only come
about by having clear descriptions of the way in which
the work will be done.
 GMP specifically addresses risks of cross-contamination
and mix-up that cannot be fully controlled by testing of
the final product.
 These risks can best be controlled by having a properly
managed system of working that takes them into
account. This means that the quality checking system
must be designed with these risks in mind and set out
to find whether any errors
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OBJECTIVES
by Asean

 To understand key elements in

quality control.
 To understand specific
requirements on organization,
procedures, processes and
resources.

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SCOPE
by Asean

 Quality control involved sampling, inspecting

and testing of starting materials, in process,
intermediate, bulk and finished products.

 It also includes where applicable, environment

monitoring program, review of batch
documentation, sample retention programs,
stability studies and maintaining correct
specification of materials and products.

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QUALITY CONTROL PRINCIPLES

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QUALITY CONTROL OVERVIEW

by Asean

Assurance

Objective Product with consistent quality for its intended use

Established Quality System Requirements

How Product contain the correct materials of specified quality & quantity
Manufactured under proper conditions accordingly to SOPs

Sampling
Inspection & testing of: Starting Material, Bulk, Intermediate, Finished product
Key Environment monitoring program Batch record review/documentation
Focus
Area Sample retention program Stability study Calibration Reagent Handling
Release/Reject: Control for materials & product disposition

Reprocessing Specification Control Return

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QA VS QC
by Asean

• The terms quality assurance and quality control are often

used interchangeably to refer to the actions performed for
ensuring the quality of a product, service, or process.
• Both terms, however, have many interpretations because of the
multiple definitions for the words "assurance" and "control."
• The definitions below, for example, point toward a specific
distinction between these two terms:

Assurance
Assurance : = The
The actact of giving
of giving Quality assurance : All the planned and
confidence,
confidence, thethestate
state
of of being
being certain,
certain, systematic activities implemented within
or the
or the act
act of
ofmaking
making certain.
certain. the quality system that can be
demonstrated to provide confidence a
product or service will fulfill
requirements for quality.

Control : An evaluation to indicate needed Quality control :The operational

corrective responses; the act of guiding or techniques and activities used to fulfill
the state of a process in which the requirements for quality.
variability is attributable to a constant
system of chance causes.
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GENERAL PRINCIPLES
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 Each holder of a manufacturing authorization

should have a QC Department
 Independence from production and other
departments is considered to be fundamental
 Under the authority of an appropriately
qualified and experienced person with one or
several control laboratories at his or her
disposal.
 If do not have any facility, it can be managed
by appointed respective external laboratory
institution(s).
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BASIC REQUIREMENTS OF
QUALITY CONTROL

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BASIC REQUIREMENTS
by Asean

Quality Control department should have :

 resources:
 adequate facilities
 qualified personnel
 approved written procedures
 tasks :
 sampling, inspecting, testing,
 releasing or rejecting
 monitoring
 objects :
 Starting materials, intermediates, bulk, and finished
products
 Returned products
 Environmental conditions
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QC LABORATORY
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• There shall be QC laboratory attached to each

manufacturing unit.
• The laboratory shall be capable of performing all the test
in accordance to approve specification, or to perform part
of test while sub-contracting part of tests to approved
contract laboratory.
• Where appropriate, QC laboratories shall be separated
from production areas especially for microbiology lab.
• The laboratories should be designed to suit the operations
to be carried out in them. Sufficient space should be given
to avoid mix-ups and cross-contamination. There should
be adequate suitable space for sample and records.
• Separate rooms may be necessary to protect sensitive
instruments from vibration, electrical interference,
humidity, etc.
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QUALITY CONTROL UNIT

by Asean

• Large firms : Quality Control Unit(s).

• Small firms :
 specific tasks unit with limited laboratory apparatus,
or
 contract analysis with respective external laboratory
institute(s)
• Responsibilities defined in written procedures
• Independence from production and other
departments is fundamental
• Under the authority of an appropriately
qualified and experienced person
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RESPONSIBILITIES
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• Examines, approves or rejects incoming materials,

intermediates, bulk, the finished products, and returned
products.
• Does the inspection during production (in-process control)
• Establishes, standardizes, and implements all QC procedures,
and also establish the specification of each incoming
materials.
• Establishes specification of intermediates, bulk and finished
goods together with head of Production.
• Approves reprocessing instruction and rework instruction
• Reviews production records to determine errors and ensures
that investigations have been conducted and corrective
action taken
• Involves in all decisions concern with the product quality
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OTHER RESPONSIBILITIES
by Asean

 Establishing, verification, and implementing all QC

procedures
 Evaluating, maintaining, storing, and monitoring all
reference standards and retained samples
 Reviewing batch documentation
 Maintaining correct specification of materials and
finished products
 Stability testing of each finished product
 Participating in :
 complaint investigations
 environmental monitoring
 GMP training

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QC DOCUMENTS

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SPECIFICATION CONTROL
by Asean

 Each specification shall be approved,

signed and dated, and maintained by
QC unit
 The following specification shall be
minimally maintained and controlled:
 Starting materials specification
 Process water specification
 Intermediate or bulk product where
applicable
 Finished product specification
 Master formula
European
 Batch Manufacturing
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STARTING MATERIAL SPECIFICATION

by Asean

 The following details should be included in the

specification:
 designated name, and internal code reference if
applicable
 qualitative and quantitative requirement with acceptance
limits

 Depending on the company practice, other data

may be added to the specification:
 the supplier and the original producer
 direction for sampling and testing, or reference to an
approved procedure
 storage condition or precautions
 the maximum period of storage before re-examination

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PROCESS WATER SPECIFICATION

by Asean

• Drinking water standard is defined as minimum

standard for use in cosmetic processing.
 Appropriate specification for chemical and
microbial quality should be established
based on point of use.
 Periodic testing should be conducted, eg.
weekly
• Further treatment may be necessary based on
the product formula, process and claim
requirements. Specification for water with
further treatment shall be established based on
supplier design specification or pharmacopoeia
standard
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FINISHED PRODUCT SPECIFICATION

by Asean

Finished product specification should include:

 Designated name, and internal code reference if
applicable
 Formula number
 Description of finished product and its package details
 Qualitative and quantitative requirement with
acceptance limits
 Direction for sampling and testing, or reference to an
approved procedure
 Storage condition or precautions, if any
 Shelf life, if any
 Batch numbering requirement (including
manufacturing date or expiry date )

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IN-PROCESS CONTROL
by Asean

• Inspection and testing based on process

monitoring or actual sample testing at defined
sampling interval and location
• Shall be documented in Batch Manufacturing
Record
• The result shall conform to Batch Manufacturing
/ Packaging Record requirements
• Control chart/other statistical tools for process
capability may be used for trend analysis

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OTHER LABORATORY DOCUMENTATION

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Other laboratory documentation includes

 Sampling procedures
 Calibration and Maintenance Equipment
 Stability Procedures, where applicable
 Environment Monitoring, where applicable
 Testing procedures and records (including
worksheets and/or laboratory notebooks)
 Analytical reports and/or certificates

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QUALITY RECORD RETENTION

by Asean

• Master Formula and Batch Manufacturing

Record shall be retained for the shelf life + 1
year of the product
• Other laboratory record (e.g. analytical tests
results, environmental controls…) it is
recommended that records be kept in a
manner permitting trend evaluation
• Other raw data such as laboratory notebooks
and/or records should be retained and readily
available

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TASKS OF
QUALITY CONTROL

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QC WORK FLOW
by Asean

Start
Quarantine
Quarantine • Intermediates
• Incoming
• Bulks
materials 2. Receiving • Finished goods
• Water
• Environment
• Returned goods
monitoring
3. Sampling
QC/QA Status
4. Test samples
Quarantine Lab
Quarantine Records
5. Review of batch record
Release
Release
NO 7. Non conformance or
Reject
Reject Meet specification out of specification
YES investigation
6. Goods release
Release
Release
8. Goods Reject Reject
Reject
End
End
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RECEIPT
by Asean

• There should be written procedure on the

receiving, internal labeling, quarantine and storage
of starting materials, packaging materials and
other materials as appropriate
• Upon receiving of the supplied goods, its identity,
legibility of batch number, integrity of its primary
packaging and seal shall be verified prior to
acceptance.
• Certificate of Analysis shall be provided by the
supplier accompanying the receiving of starting
materials
• Quarantine goods shall be segregated from
“Release” goods
• Reject goods shall be stored in a define area with
consideration of control access (eg. Locked area)
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SAMPLING
by Asean

The sample taking shall be done in

accordance with written procedure that
describe:
 The method of sampling
 The sampling tools used
 The amount of samples to be taken
 The type and condition of the sample container
to be used (ie amber glass bottle)
 The identification of the container sampled
 Special precaution for hazardous materials
 The storage condition (if any)
 Instruction for cleaning and storage of
sampling equipment
 Instruction for re-sealing the opened container.
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SAMPLING PROCESS
by Asean

• Sampling tools such as knives, pliers, saws, hammers,

wrenches, implements to remove dust (preferably a vacuum
cleaner)
• Material to re-close the packages (such as sealing tape), as well
as self-adhesive labels to indicate that a part of the contents
has been removed from a package or container.
• Containers due to be sampled should be cleaned prior to
sampling if necessary.
• There should be a written procedure describing the sampling
operation. This should include health and safety aspects of
sampling.
• The container used to store a sample should not interact with
the sampled material nor allow contamination. It should also
protect the sample from light, air, moisture, etc., as required by
the storage directions for the material sampled.
• Microbiology sampling tools shall be sterilised prior to use
• European
Aseptic technique shall be used
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SAMPLING PLAN
by Asean

1. Raw Material
Sampling plan for raw material should be based on defined
sampling standard, for example:
• the “n plan” is based on the formula n = 1+√N, where N
is the number of sampling units in the consignment;
• the “p plan” is based on the formula p = 0.4 √N, where
N is the number of sampling unit; or
• the “r plan” on the formula r = 1.5√N .
• reduce sampling plan such as “p plan” shall be
considered only when there is established confidence
on the material’s uniformity.

2. Packaging materials and Finished Product

Sampling plans for packaging materials should be based on
defined sampling standards, for example British Standard
BS 6001-1, ISO 2859 or ANSI/ASQCZ1.4-1993.

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SAMPLING TOOLS
by Asean

Scoop for solid

Dip tube Spears for bag

for liquid

Weighted container for large tank

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TESTING & ANALYSIS

by Asean

• All tests shall be performed in accordance with

the test methods as stated in the specification
• Reduce testing rational shall be documented
• Test can be performed by in-house laboratory
or external laboratory
• Where test is performed in-house, laboratory
shall be available

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LABORATORY DATA (1)

by Asean

 QC should maintain adequate analytical

records concerning the examination of
materials and products.
 Such records should include among others:
 The result of every test performed, including
observations and calculations, relating to compliance
with the established specifications (calculations done
on scratch paper shall be included in the record).
 The source of the specification used.
 Signature(s) of the person(s) who performed the
quality control procedure.
 A final review (eg. laboratory management), the
decision taken, and a dated endorsement by a duly
authorized expert (eg. supervisor/manager).
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LABORATORY DATA (2)

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• Laboratory data must be recorded in a manner

that assures its accuracy, authenticity and
completeness, preserves its integrity and assures
its retrievability
• Data recording should be clear, permanent (not
pencil) and traceable to the item tested.
• Records, either handwritten or equipment/
computer generated, shall be reviewed, signed off
and dated.
• There should be a written policy about averaging
of numbers, cross-outs of mistakes, significant
figures, leaving notebook pages or fill-in-the-blank
entries empty, etc.
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RETAIN SAMPLE (1)

by Asean

• Retain sample should be representative of the

batch of materials or products from which they
are taken.
• Retain sample shall be of a size sufficient to
permit at least 2 full re-examinations
• Retain samples for each batch of finished
products shall be retained at a defined period
• Finished product should be kept in their final
packaging and stored under the recommended
condition (eg. Consumer use condition at room
temperature)
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RETAIN SAMPLE (2)

by Asean

• A retain sample log shall be maintained

with the sample identification, batch
number and its storage location for ease
of retrieval
• Prior to disposal of retain sample, visual
inspection should be carried out

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STARTING MATERIAL ACCEPTANCE

1. All starting materials shall be verified prior to
use.
2. Verification should include the following:
 Review of Certificate of Analysis from the manufacturer
versus approved specification
 Other tests may be conducted as appropriate:-
 Identification test / package identification and other
characteristic of the material shall be examined.
 Primary packaging: No leakage, sharp dents, tear ,
exposed parts and seal integrity
 Legible label and identification and batch number
 Frequency: Every batch of manufacturer’s batch

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PROCESS WATER ACCEPTANCE

• Minimally meet National or WHO Drinking

Water standard.
• Treated water specification shall be based on
supplier’s design specification or
pharmacopoeia standard

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IN-PROCESS BULK/PRODUCT ACCEPTANCE

• In-process inspection and testing should be

performed by monitoring the process or by
actual sample analysis at defined locations and
time.
• The results should conform to established
process parameters or acceptable tolerances.
• Line clearance shall be practiced on all
packaging lines
• Where necessary, standard reference for
labeling and coding format/ requirement should
be available.
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FINISHED PRODUCT ACCEPTANCE

• Review of Batch Manufacturing Record

• Review all non-conformance or deviation
documented on the BMR and its reprocessing
or rework instruction
• Review of physical, chemical and
microbiological results
• Review of sample from the batch for
verification on its conformance to BMR
requirement.
• Approve Certificate of Analysis with clear
summary statement on the product status, ie
“Release” or “Reject”
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OUT OF SPECIFICATION INVESTIGATION

 Written procedure should be made available.
 Typically, an investigation includes:
• A review of the calculation to ensure they are correct.
• A review of test procedures utilized.
• A review of equipment, columns, charts and previous
analyses of samples of the same product/material
• A review of reagent/ standardization carried out for the test
(e.g., pipettes).
• A complete investigation and evaluation of initial results
prior to a retest.
• A review of product/material history
• Assigned person responsible for investigation
• Documented rational for retest and re-sampling
 Proper documentation of investigations,
recommendation and disposition must be in place.

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LABORATORY REAGENT
by Asean

• Reagent should be prepared in accordance with written

procedures.
• Volumetric solution, the last date of standardization and
the last current factor should be indicated.
• Where necessary, the date of receipt of any reagents
should be indicated on the container. Instruction for
use and storage should be followed.
• Where necessary, the identification test and/or other
testing of reagent materials is required upon receipt or
before use.
• Reagent to be certified by the original producer to the
quality of reagent grade purchased, typically a CoA shall
be available for review and verification on acceptance.
• Laboratory safety manual shall be available for safe
operation of the reagent and chemicals.
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LABORATORY REAGENTS
by Asean

All reagents should bear a label

containing the following information :
The name of the reagent
Its strength or concentration
Its expiration date
Date of preparation
Name of the individual who prepared
it
Material Safety Data Sheet (MSDS)

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ENVIRONMENT MONITORING (1)

by Asean

• Environment Monitoring to be implemented

where appropriate.
• The objective is to demonstrate the
manufacturing environment is functioning at
an adequate level of microbial control for the
specific product/product group.
• Sample site selection based on:
Room design/ size
Manufacturing process
Product susceptibility
• Potential sampling site shall include
Starting material sampling room/area
Dispensing area
Manufacturing area
Microbiological lab
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ENVIRONMENT MONITORING (2)

by Asean

• Alert and Action limits should be

established based on statistical methods.
• Sampling frequency shall be established,
eg weekly.
• The media selection for use of detection
and growth of viable airborne particulate
shall be established.
• Direct and in-direct methods available,
most commonly used are STA air sampler,
SAS air sampler and settling plate.

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STABILITY STUDY (1)

by Asean

 Stability test shall be carried out where applicable

 Real time stability shall extend to the end of shelf

life period for any new products and should
include the following parameters:-
 Number of batch(es) for different batch size
 Relevant physical, chemical, microbiological test methods
 Acceptance criteria
 Description of the container closure system(s)
 Testing intervals (time points)
 Description of the condition of storage

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STABILITY STUDY (2)

by Asean

• The number of batches and frequency of testing

shall provide a sufficient amount of data to
allow for trend analysis.
• Bracketing and matrixing design may be applied
where applicable.
• Worst case situation shall be covered within the
real time stability program after any significant
change or deviation to the process or package,
ie. After rework or reprocessing.
• A summary of data should be generated, with
interim conclusion on the trend analysis.
• Result of stability studies should be reviewed by
authorized person(s).
European
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CALIBRATION
by Asean

• To maintain the accuracy and precision of test

equipment at all times.
• To ensure highest level of confidence in all
measurement that affect materials disposition
decision, with unbroken chain of traceability to
national standard.
• To determine whether the equipment is still fit for
its intended purpose.
• It is based on the comparison of a primary
standard or instrument of known accuracy with
another equipment (to be calibrated)
• It is used to detect, correlate, report or eliminate
by adjustment of any variation in the accuracy of
the equipment being calibrated.
European
Committee for
Module 7
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EQUIPMENT CLASSIFICATION
by Asean

 Critical equipment:
 Direct measurement that affect the final
product quality
 Measurement on critical process
parameters in the process specification

 Non critical equipment:

 Indirect measurement that will not directly
affect the final product quality
 Shall be maintained based on company
maintenance schedule

European
Committee for
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Implementing
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CALIBRATION INTERVAL
by Asean

Depending on:
 Classification of Critical or non-critical
 Usage (light or heavy usage)
 Handling (light or heavy handling)
 Manufacturer’s recommendation
 Reference to NIST or accreditation
body guideline for a specific
measurement system
European
Committee for
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PRIMARY STANDARD
by Asean

• Highest accuracy order in the

measurement system
• Traceable to National or
International standard

European
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REFERENCE STANDARD*/MATERIAL
by Asean

• Reference Standard
It shall be calibrated by a body that can provide
traceability. Such reference standard of
measurement held by the laboratory shall be
used for calibration only. It shall be calibrated
before and after any adjustment
• Reference Materials
Where possible, it shall be traceable to SI units
of measurement, or to Certified Reference
Materials. Internal Reference Material shall be
checked as far as is technically and
economically practical Note: * Working Standards
European
Committee for
Module 7
Standardization GMP Workshop Kuala Lumpur 14-16 Nov 2005 52
Implementing
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CALIBRATION RESULT
by Asean

• Traceable to National or
International standard
• Measurement standard to be
specified with validity period
• Conclusion made on the validity of
calibration
• Certificate to be reviewed by
authorize personnel
European
Committee for
Module 7
Standardization GMP Workshop Kuala Lumpur 14-16 Nov 2005 53
Implementing
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VERIFICATION
by Asean

• Applicable to equipment that cannot be

calibrated (adjustment, correlation, etc)
• Verification against measurement
standard with correction factor
documented
• Actual reporting of result shall include
the correction factor
• Temperature correction factor “- 2 0C”.
 Measured value: 240 C
 Reported value = 24 0 C –2 0 C= 22 0 C

European
Committee for
Module 7
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Implementing
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OUT OF CALIBRATION
by Asean

• Remove equipment from use

• Out of Calibration Investigation to be
carried out to determine the source of
inaccuracy
• Evaluate the impact of OOC result on
the final product quality and other
previously measured data
• All investigation findings should be
documented
European
Committee for
Module 7
Standardization GMP Workshop Kuala Lumpur 14-16 Nov 2005 55
Implementing
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CALIBRATION RECORDS
by Asean

• Calibration Master Plan

Include the control of all critical measurement
equipment that contain the following details
 Name
 Identification by model # and serial #
 Location
 Owner/Responsible
 Calibration Frequency
 Calibration due date
• Calibration Certificate
• Calibration Procedure

European
Committee for
Module 7
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Implementing
Project co-financed
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CALIBRATION CERTIFICATE
by Asean

• Name and address of contracted

calibration laboratory
• Name and address of client
• Description and identification of item
calibrated
• Environment conditions when calibration
was made
• Date of receipt of instrument, date of
calibration and date of next calibration
• Calibration method
• Result of calibration
• Signature and title of person responsible
for the calibration
• External calibration contract shall be
awarded to Accredited by the nation
institution
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CALIBRATION IDENTIFICATION
by Asean

• Status of equipment calibration shall be

available and affixed to the equipment
where applicable.
• Equipment identification shall bear the
following information:
 name of equipment
 serial no.
 date calibrated
 status
 schedule of next calibration and
 initial/signature of the person who
performed the calibration
European
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Module 7
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REPROCESSING (1)
by Asean

• Reprocessing includes both definitions of

Reprocessing and Rework
• Definitions
 Reprocessing: Subjecting all or part of the
batch/lot of an in-process bulk, intermediate
or product of a single batch or lot to the
previous step of the approved
manufacturing/packaging process due to
failure to meet pre-determined specification.
 Rework: Subjecting all or part of the batch /lot
of an in-process bulk, intermediate or product
of a single batch or lot to an alternate
manufacturing/ packaging process due to
European
Committee forfailure toGMP
Standardization
meet pre-determined
Module 7 specification. 59
Workshop Kuala Lumpur 14-16 Nov 2005
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REPROCESSING (2)
by Asean

• Complete OOS/Non-conformance investigation

with risk assessment on recovery decision,
based on approved procedure
• Reprocessing Instruction includes the following
details:
Additional Ingredient where necessary
Reprocessing instruction
Responsibility
Sampling Plan
Acceptance Criteria
• Approval of Reprocessing Instruction by QC
• Where batch adjustment which is part of the In-
Process Quality Control, this should not be
considered where there
European
Committee for
is7 reprocessing.
Module
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Project co-financed
Project co-
by European Union
CONTROL OF financed
by Asean

REPROCESSING PRODUCT

• Meeting the Reprocessing Instruction

acceptance criteria
• Where the stability of the product is in
doubt, additional testing of any finished
product which has been reprocessed
should be performed, stability study to
be included as appropriate.

European
Committee for
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RETURN (1)
by Asean

• Definition- Finished product that has been

distributed and is being returned for reasons other
than a product complaint reason.

• Returned products shall be identified as such and

put on hold. If the conditions under which returned
products have been held, stored, or shipped before
or during their return, or if the condition of the
product, its container, carton, or labeling, as a
result of storage or shipping, casts doubt on the
safety, identity or quality of the product, the
returned product shall be destroyed unless
examination, testing, or other investigations prove
the product meets appropriate standards of safety,
identity or quality.
European
Committee for
Module 7
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Implementing
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RETURN (2)
by Asean

• A product may be reworked/reprocessed

provided the subsequent product meets
appropriate standards, specifications,
and characteristics.

• Records of returned products shall be

maintained and shall include the name,
lot number (or control number or batch
number), reason for the return, quantity
returned, date of disposition, and
ultimate disposition of the returned
product.

European
Committee for
Module 7
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Implementing
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RETURN (3)
by Asean

• If the reason for a product being returned

implicates associated batches, an appropriate
investigation shall be conducted.
• Procedures for the holding, testing, and
reprocessing of returned products shall be in
writing and shall be followed.
• The recovery rational shall be documented with
approval from the QC unit.
• Disposal of return goods shall be based on
approved procedure.
European
Committee for
Module 7
Standardization GMP Workshop Kuala Lumpur 14-16 Nov 2005 64
Implementing
Project co-financed
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CONTROL OF RETURN PRODUCTS

by Asean

 Products that have been subjected to improper storage

conditions including extremes in temperature, humidity,
smoke, fumes, pressure, age, or radiation due to natural
disasters, fires, accidents, or equipment failures shall not
be salvaged and returned to the marketplace.

 Whenever there is a question whether products have

been subjected to such conditions, salvaging operations
may be conducted only if the following acceptance
criteria were fulfilled:
 Product labeling meeting current regulatory
requirements
 Laboratory tests that the product meet the product
specification
 Visual inspection on the product and their associated
packaging were intact and comparable to standard
European
Committee for
Module 7
Standardization GMP Workshop Kuala Lumpur 14-16 Nov 2005 65
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RELATED HYPERLINK DOCUMENTS

by Asean

 Trainer Manual of GMP ASEAN Quality Control

 ASEAN GMP Supplementary Module : Water
 ASEAN GMP Supplementary Module : Calibration
 WI of QC Working Procedure
 WI of Sampling of Incoming Raw Materials
 WI of Sampling of Incoming Packaging Materials
 WI of Handling Incoming Materials
 WI of Handling Finished Goods
 WI of Handling and Testing of Raw Materials
 WI of Stability Study
 WI of Environment Monitoring
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Project co-financed
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REFERENCES
by Asean

1. Guideline on ASEAN Cosmetic GMP (2003)

2. U.S. Food Drug Administration, Center for Food Safety
Applied Nutrition, Cosmetic Compliance program
3. NIST
4. WHO Guideline for Drinking Water Quality
5. EUDRALEX, Medicinal Products for Human and
Veterinary Use : Good Manufacturing Practice, ,Volume
4.
6. WHO, Good Manufacturing Practices: Starting Materials.
7. Ariffin F., Consultation to Discuss : Stability Studies in a
Global Environment.
8. International Pharmacopoeia
9. WHO Guideline For Sampling OF Pharmaceuticals and
related materials.
10. PDA Technical Report No. 13 revised, Fundamentals of
an Environmental Monitoring
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Project co-financed
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financed
by Asean

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Committee for
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Standardization GMP Workshop Kuala Lumpur 14-16 Nov 2005 68
Implementing