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Good Manufacturing Practice

(GMP): Principles &
Guideline
Abdallah Abu-Haidar – SABIC,
GPCA’S Product Stewardship
Task Force Chairman
 San Francisco Zoo officials said the
enclosure for a Siberian tiger that killed a
San Jose teenager and injured two friends in
Carlos Sousa Jr., 17,
rampage had a wall lower than they initially of San Jose.
stated and below industry recommendations.

Wall around tiger

enclosure 12.5 feet is
4 feet lower than
recommended by
experts

Responsible Care: The Competitive Advantage

 Driver for Product Qualification - Applications
{ADDED VALUE - $$$}

Objectives: Increase the added value by

meeting the critical applications requirements
and satisfy markets and customers demands.

Process: Define the prerequisites and process for

certifying & qualifying the product to meet Product {Medical}

Stewardship guidelines and legal requirements.

{Electronics}

{Food Contact}

Responsible Care: The Competitive Advantage

2
 GMP Regulatory Agencies

A good manufacturing practice (GMP) is a system that conforms to the guidelines set by the
regulatory agencies that control authorization and licensing for the production and sale of
food, beverages, and pharmaceutical products.

USA:
Food and Drug Administration (FDA), under Title 21 CFR. The
regulations use the phrase "current good manufacturing practices"
(CGMP) to describe these guidelines.

Europe:
COMMISSION REGULATION (EC) No 2023/2006 of 22 December
2006 on good manufacturing practice for materials and articles
intended to come into contact with food

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 Definition
Materials and articles.... shall be
manufactured in compliance with good
manufacturing practice so that, under
normal or foreseeable conditions of use,
they do not………………
 endanger human health (i.e. prevent
harm from occurring to the end user)
 change in the composition of the
food
 allow contaminations in the end
product
 tamper with the organoleptic
characteristics

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 GMP Qualification

1.What do you produce (polymers, chemicals, fertilizers, metals, etc.?

2.What applications (i.e. market segments – Food, Medical)?
3.Odd applications (e.g. UREA for Cattle Feed)
4.Do your customers have specific needs (declarations)?

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Driver for Qualification - Product Application

OTHERS AUTOMOTIVE
• FURNITURE COMPONENTS • INSTRUMENT PANELS
• SHEETS • AUTO TAIL LIGHT
• MEDICAL DEVICES • REFLECTORS

SIGNS LIGHTING
• ADVERTISEMENT PANELS • LENS FOR LED LIGHT
• INTERIOR EMERGENCY SIGN Application • STREETLIGHT COVER
Segments

FABRICATION/ DISPLAYS
HOUSEWARES
• LIGHT GUIDE PLATE • PACKAGING
• LED SCREENS
• KITCHEN-WARE
• TOUCH SCREENS

GLAZING / BUILDING APPLIANCES

• ROOFING ELECTRICAL • SMALL APPLIANCE
• INTERIOR DECORATION COMPONENTS
• HOUSING

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 GMP Scope: Basic Information Required
Finished Safety and Compliance Check
Products
[Grades] Composition (Additive Package) for each grade
Qualify
Finished 118W Irganox 1010 Slip Agent Antiblock Zinc Str.
Products 218W 500 2000 1000 700
for Specific
PP510P
Applications Other Information
PVC 57S
Catalyst Feedstock (purity)
PS100
Processing Conditions Support Chemicals

Product
Qualification

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 GMP Scope: Additives Testing
Composition (Additive Package) for each grade
Irganox 1010 Slip Agent Antiblock Zinc Str.
500 2000 1000 700

Purpose: Ensure that the quantities of all chemical

components are acceptable under certain use
conditions (temperature, pressure, etc.)

Three Levels to Qualify the Chemical Components and their volumes:

1. Based on historical data

2. Computer simulation
3. Conduct migration test under specified testing protocol

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 GMP Scope: Regulatory Check
Purpose: Ensure that all chemical components are not banned neither restricted in the markets
of intended sales

Regulatory Affairs
to check with the
authorities if the
chemicals used
are banned or
restricted

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GMP Scope: Production System Verification
Feed Stock
Process
Additives

Processing Aids
Finished
Catalysts Products

Support Chemicals

Others……..

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FCD (Food Contact Declaration)

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 Corporate Vs. 3rd Party Certification
3rd Party Certification is required for products related
to medical and pharmaceutical applications
INCIPIENTS – Medical Product EXCIPIENTS – Medical Product That do
That go Inside the Body (3rd Party) not go Inside the Body (No 3rd Party)

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Example of 3 rd Party Certification

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 GMP and ISO

ISO is a quality system to ensure that products are

produced according to documented procedures and
specifications

……….. 'good manufacturing

practice' ensures that products are consistently
suitable for the intended use (i.e. Food Contact Legal
Requirements).

{ISO procedures can be an excellent carrier

for GMP}.

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GMP Qualification Guideline
 GMP Guidelines
1 Quality Assurance System and Quality Policy
2 Management Leadership and Personnel
3 Hygiene Policy and Pest Control
4 Documentation, Labelling, Document Retention and Traceability
5 Starting and/or Raw Material Specifications and Acceptance
6 Contamination Prevention
7 Management of Change
8 Storage, Packaging, Warehousing, and Transportation
9 Work Contracted Out
10 Finished Products Quality Control and Specifications
11 Complaint handling, Product Recall and Incident Management
12 Regular Internal and Suppliers Audits

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GMP Product Stewardship Movie

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1. Quality Assurance System and Quality Policy
Support Documents, Evidences, and
Aspects
Practices

a. Quality Policy;  Comprehensive GMP

consistently produce Procedure
materials for food contact in
compliance with the  Plant certifications (ex.
applicable regulations ISO9001:2008)

b. Active participation of  Well defined structure [lead

management and personnel & attend meetings]

c. QC Department to  Product quality check

independently  QC is independent from the
approve/reject all materials Production and the Business
in the process. Departments
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 2. Management Leadership and Personnel

Aspects Support Documents, Evidences, and Practices

a. Management responsibilities  Designate site GMP coordinator with support
are assigned, defined, and personnel from different functions [Organization
documented Chart]

b. The concerned personnel  Support evidence of training for operators AND

should have the education, Contractors (training material, attendance list,
training and proper experience frequency)

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3. Hygiene Policy and Pest Control
Aspects Support Documents, Evidences, and Practices
a. Maintain adequate hygiene  Maintain good indoor and outdoor housekeeping, with
measures for personnel, adequate washing facilities for personnel
factories, warehouses, and
transportation  Frequency of inspection supported by documents

 Identify the responsible department for Pest Control

b. A pest control program
 The Process is governed by a written procedure
should be available
 Observations (rats, mice, snakes, cats, dogs, etc.)

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4. Documentation, Labelling, Document Retention and Traceability

Support Documents, Evidences, and

Aspects
Practices
a. Records of Product formulation,
specifications, operating parameters,  Easy access to concerned personnel only
and other critical information
b. Procedures for tracing incoming  Provide traceability procedure to trace
starting material to outgoing food one step up and one step down by
contact material using batch record procedure

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5. Starting and/or Raw Material Specifications and Acceptance – Cont’d

Aspects
d. Carefully store and
handle material to
prevents their mix-up
and/or adulteration
Support Documents,
Evidences, and Practices
 Storage locations and
conditions
 Bags, drums, & boxes are
clearly labeled
 Eliminate potentials of
picking the wrong
material from the WH

e. Identify out of spec  Procedure to remove

material and dispose and isolate rejected
properly material

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6. Contamination Prevention
Support Documents, Evidences,
Aspects
and Practices
a. Contamination
 Risk Assessment and Risk
prevention system based
Mitigation Procedure
on risk assessment.

b. Water that comes into  Use of DM water with no

contact with the food minerals and relinquish the
contact materials should system with the same quality
be of suitable quality. water

c. The equipment  Separate production lines or

designed to mitigate apply stringent measures
contaminations (water wash, purge, etc.)
Centrifugal Dryer

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7. Management of Change (MOC)
Aspects Support Documents, Evidences, and Practices
a. MOC to track all relevant changes;
• Processing conditions
• Formulations  MOC contains thorough process for
• RM spec changes changes stipulated
• Suppliers changes  Auditors might review the MOC
• Operating outside the processing document
windows
• Etc.

 Identify the party responsible for

b. Process identifying the impact of
technically assessing the changes before
changes on finished products
changes are accepted

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8. Storage, Packaging, Warehousing, and Transportation
Aspects Support Documents, Evidences, and Practices
 Physically separate different types of chemicals
a. There is sufficient and (catalysts, additives, etc.) in the same warehouse
well managed storage for  Use closed loop system in transferring chemicals to
raw materials. the processing area
 Apply FIFO to better manage inventory rotation
b. Good storage
conditions to avoid  Use air conditioned or well ventilated warehouse
adulteration of materials
c. Clean Silo's and bulk  Use dedicated equipment or apply water wash
trucks  Inspect containers before loading
d. Ensure printing and  Use automated labeling system connected to your
labels are correct IT Tool (e.g. SAP)

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9. Work Contracted Out (Contractors Management)
Support Documents, Evidences, and
Aspects
Practices
a. Any contracted out manufacturing operation
(e.g., warehousing, toll manufacturing, sanitation  Check if contracts are
services, transportation services, on-site available and whether the
contractors) shall be subject to a written contract contracted companies
and should be performed according to 'good apply GMP or follow
manufacturing practice' comparable to the one similar standards.
assured by the own operation.

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11. Complaint Handling, Product Recall, and Incident Management

Aspects Support Documents, Evidences, and Practices

 Complaints Handling Procedure with specific
a. Record and investigate ownership and responsibilities
complaints, including product
 Risk Assessment process
recall.
 Corrective actions followed and implemented
b. Non-conforming or recalled
 A system to immediately detect and isolate the
products are not released
off-spec material, label properly, and block in
without extensive investigation
the IT System
and proper authorization.

c. Keep a sample of every lot

 Retained samples (quantity, storage period, usage
for future investigations (if
in complaints investigations, etc.)
needed)

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12. Regular Internal and Supplier Audits

Support Documents, Evidences, and

Aspects
Practices
a. Conduct regular internal  Plant to provide evidence for
audits or self-assessments conducting yearly internal audits to
in order to monitor the ensure proper follow-ups and systems
implementation of 'Good checks are in place to maintain GMP
Manufacturing Practice'. compliance.

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 Thank You

gpca.org.ae info@gpca.org.ae GulfPetChem @GulfPetChem GPCA GPCAOrg