Current Good Manufacturing Practice (cGMP)

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Healing minds and Healing Hearts
Please Silence Your Cell Phone

TRAINING
ON
Trainer:
MD. ZAKARIA FARUKI
Manager, Quality Assurance
Silva Pharmaceuticals Limited
Fundamentals of
current Good
Manufacturing
Practice (cGMP)
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Quality Policy
Silva Pharmaceuticals Limited is
committed to deliver Quality, Safe &
Effective Medicines to its valued
customers through continuous
improvement in process, technology
& human resources complying with
the guidelines of current Good
Manufacturing Practices (cGMP) and
the requirements of ISO 9001:2015
Quality Management System (QMS)
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Trainer: Md. Zakaria Faruki, Manager, QA

Company Vision
We continually strive to improve
our core capabilities to address
the unmet medical needs of the
patients and to deliver
outstanding results for our
shareholders.
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Company Mission
We are committed to
enhancing human health and
well-being by providing
contemporary and affordable
medicines, manufactured in
full compliance with global
quality standards.
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Company Values
Quality & Safety
Honesty, Integrity &Transparency
Innovation & Diversification
Commitment to Excellence
Respect for humanity
Think Differently
Never Give up
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Quality & Quality Medicine
• Quality: Quality is the totality feature of the
characteristics of product.
-Fit for use
-Meets the predetermined specification
-Fulfill the customer requirements
• Quality Medicine:
A product that has good therapeutic efficacy and safe
for the patients/consumers
Attributes of quality medicine:
-Efficacy, Safety, Stability, Potency, Purity, Regulatory
compliance
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Attributes of Qualified
Person
• Good knowledge about GMP
• Proper Training
• Have academic qualification
• Good Behavior /Good Conduct
• Time Management
• Fair & Impartial
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What is GMP?
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GMP: (Good Manufacturing Practice)
GMP is the part of Quality Management which ensures
that the products are consistently produced and
controlled to the quality standard appropriate to their
intended use as required by the marketing authorization
and product specification. (Ref: WHO)
―GMP is the bundle of common sense‖
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GxP & ‗c‘of GMP
 The concept of GXP in Pharmaceuticals was
established by the United States Food and Drug
Administration.
 GXP is a general term for Good Practice
Quality guidelines and regulations.
The G stands for "Good" and the P stands for
"Practice". The 'X' in the middle is a variable that can
be substituted with any word that appropriately
completes the acronym. For example, 'X' is replaced by
'M' to make it GMP which represents ‗Good
Manufacturing Practice‘.
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GxP & ‗c‘of GMP
 A ―c‖ is sometimes added to the front of the
acronym,. The preceding ―c‖ stands for
―current‖. For example, cGMP is an acronym
for ―current Good Manufacturing Practice.‖
 The ‗C‘ before the GMP is indicative of the
constantly changing technologies and systems
which are up-to-date in order to comply with the
regulations. These the dynamic changes in Good
Manufacturing Practice to make Pharmaceuticals
manufacture foul proof; assuring a high level of
confidence in the safety and efficacy of the product
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For GxP
 GMP = Good Manufacturing Practice
 GLP = Good Laboratory Practice
 GCP = Good Clinical Practice
 GAP = Good Auditing Practice
 GAMP = Good Automated Manufacturing Practice.
 GRP=Good Regulatory Practice
 GDocP = Good Documentation Practice
 GDP = Good Distribution Practice
 GHP = Good Hygiene Practice
 GEP= Good Engineering Practice
 GSP = Good Safety Practice
 GMiP = Good Microbiological Practice.
Basically the purpose of the GxP QUALITY GUIDELINES is to ensure a
product is safe and meets its specification for intended use. GxP guidelines
guide quality manufacture in regulated industries including Food. Drugs,
Medical devices and Cosmetics.
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ATTITUDE
 A- 1
 T- 20
 T- 20
 I- 9
 T- 20
 U- 21
 D- 4
 E- 5
= 100
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ATTITUDE
• Every problem has a solution, only if we
perhaps change our ATTITUDE.
• ATTITUDE is everything.
• It is our ATTITUDE towards LIFE and
WORK that makes our life 100%
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Excellent Facilities Negative Attitude Poor Quality
Excellent Facilities Positive Attitude Good Quality
Limited Facilities Positive Attitude Maximizing
Efforts Good Quality
So in conclusion can say, Good quality can‘t be achieved
without positive attitude
ATTITUDE
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20
1. I have a problem
2. I can‘t do it…..
3. I‘m so hungover (―really tired‖ or ―kind of sick‖)
4.Don‘t swear in front of your boss
5.I need a raise
6.I don‘t like working with
7.That‘s not my job
Some Things To Never Say
In Front of Your Supervisor /
Boss
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 Show respect for each others workspace. Knock before
entering
 Don‘t take & see any documents from the desk or room of
any body without seeking prior permission
 Don‘t talk with mobile in front of your superior without
seeking prior permission ‗Mute‘ your cell phone in the office.
No fancy ring tones
 Do not cough or sneeze in anyone's direction. Use a tissue/
handkerchief, if possible, to contain the germs and then say
"Excuse me"
 Wear appropriate office attire, for example correct footwear, not
thongs (flip flops) - they are strictly casual or beachwear.
Office Manners
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Never blame someone else if it is your mistake
Don‘t gossip about any co-worker‘s private life
Make new employees feel welcome and comfortable
around you. Don't be a busy-body
Don‘t hover around while waiting for a co-worker/
superior to get off the phone. Leave a note for them to call
you or return later
Do not dominate the meeting. All communication must take
place through the Chairperson
One Should not be so rigid on his opinion/decision, it
should be remember that over confidence turns into
haughtiness
Office Manners
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Keep your work area tidy. Try not to be messy
Be considerate of others
Be patient with other
Learn, remember and use people‘s names
Be courteous, kind, polite, and fair
Always act with honesty and dignity
We are put off by smelly people. So, be sure to shower
regularly and use a suitable deodorant .
Be helpful and co-operative with each other
Speak clearly without shouting. Loud people are a
vexation
Be discreet and compassionate in your criticism of a co-
worker
Never blame someone else if it is your mistake
Office Manners
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As responses to tragic circumstances and to prevent future
tragedies:
 Use of Diethylene Glycol as solvent in sulfanilamide
(antiinfective) in the 1937s. 107 people died.
 Federal Food, Drug and Cosmetic Act (1938)
 Sulfathiazole tablets contaminated with Phenobarbital
(sedative) in 1941. 300 people were killed.
 Sleeping pill Thalidomide caused serious deformities in
developing fetuses in the 1960s in Europe (about 10,000
estiamted cases)
History of the GMPs
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Thalidomid Tragedy
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 1962: Kefauver-Harris Amendments to the
FD&C Act:
 FDA given authority to establish GMPs
 Failure to follow GMP = Drug Adulteration
 Late 1960‘s through 1970‘s contaminated
IVs produced
 Validation required for sterile products, then all drug products
 1981: Tylenol package tampering – pills were laced
with cyanide, 7 people died
 Tamper-resistant packaging requirements for OTC drugs
History of the GMPs
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 In 1963, FDA in USA prepared the
guide-lines for GMP.
 In 1975, WHO issued the guide-lines
for GMP.
 In 1979, cGMP guidelines were
prevailed.
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History of the GMPs

Evolution of GMP: At a Glance
1500 Ebers Papyrus, Egyptian manuscript pertaining to pharmacy and therapy.
1546 The Nuremberg Pharmacopoeia (Dispensatory of Valerius Cordus) is perhaps the first to become ―official‖.
1618 First London pharmacopoeia is published.
1736 First law related to pharmacy in America is enacted in Virginia.
1821 Philadelphia College of Pharmacy is founded as the first local association and school of pharmacy in the United States.
1848 First American code of pharmaceutical ethics prepared by Philadelphia College of Pharmacy. First drug import law enacted by congress to
curt adulterations.
1852 American Pharmaceutical Association is founded as the first national organization.
1865 First international pharmaceutical conference is held in Brunswick, Germany.
1888 First National Formulary issued by American Pharmaceutical Association.
1902 First International Pharmacopeial Conference held at Brussels, Belgium.
1906 Federal Food and Drugs Act passed in the US.
1912 First Assembly of International Pharmaceutical Federation (The Hague, Netherlands).
1938 Federal Food, Drug and Cosmetic (FD&C) Act
Tragedy: Sulphanilamide made with poisonous solvent causes 107 deaths. Result: manufactures to prove the safety of products before
marketing.
1941 Two unrelated events
Insulin Amendment requires FDA to test and certify purity and potency of insulin. Tragedy: nearly 300 deaths and injuries from distribution
of sulfathiazole tablets tainted with phenobarbital. Result: FDA revises manufacturing and quality controls drastically, the beginning of what
will later be called GMPs.
1962 Kefauver-Harris Drug Amendments (Important amendments of the US Food, Drug, and Cosmetic Act). Tragedy: Thalidomide causes birth
defects in thousands of European babies. Result: Manufactures must prove efficacy of products before marketing them and ensure stricter
control over drug testing.
1975 Official drug standardization program is unified by Us Pharmacopeia absorbing National Formulary.
1978 CGMPs Final rules for drugs and devices (21 CFR 210-211 and 820)
Establishes minimum current good manufacturing practices for manufacturing, processing, packaging, or holding drug products and
medical devices.
1979 GLPs Final Rule (21 CFR 58)
Establishes good laboratory practices for conducting nonclinical laboratory studies that support application for research or marketing
permits for human and animal drugs, medical devices for human use, and biological products.
1982 Tamper-resistant Packing Regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The
Federal Anti-Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products
2005 Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the
Veterans Administration.
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OBECTIVES OF GMP
To prevent –
 Contamination
 Cross-Contamination
 Mix–up
cGMP

10 Golden rules of GMP (PICS)
1.Get the facility design right from the starting
2.Validate Process
3.Write good procedures and follow them
4.Keep good records
5.Identify who does what
6.Train and develop staff
7.Practice good hygiene
8. Maintain facilities and equipment
9.Build quality into the whole product lifecycle
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GMP
General
Provision
Organization &
Personnel
Building &
Facilities
Equipment
Control of Components,
Containers & Closures
Returned & Salvaged
Drug
Products
Records & Reports
Laboratory Controls
Holding & Distribution
Production &
Process Control
Packaging & Leveling
Control
Sub-Parts of the cGMP
21 CFR-Part-211
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Subpart A-General Provisions
 Definitions
 Scope
Subpart B-Organization and Personnel
 Responsibilities of quality control unit
 Personnel qualifications
 Personnel responsibilities
 Consultants
Subpart C-Buildings and Facilities
 Design and construction features
 Lighting
 Ventilation, air filtration, air heating and cooling
 Plumbing
 Washing and toilet facilities
 Sanitation
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• Subpart- D - Equipment
 Equipment design, size and location
 Equipment construction
 Equipment cleaning and maintenance
 Automatic, mechanical and electronic equipment
 Filters
• Sub part E- Control, Components and Drug
product containers and closers
 General requirements
 Receipt and storage of untested components, drug product
containers and closures
 Testing and approval or rejection of components, drug
product containers and closures
 Use of approved components, drug product containers and
closures
 Retesting of approved components, drug product containers
and closures
 Rejected components, drug product containers and closures
 Drug product containers and closures
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• Subpart F- Production and Process Controls
 Written procedures; deviations
 Charge-in of components
 Equipment identification
 Sampling and testing of in-process materials and drug
products
 Time limitations on production
 Control of microbiological contamination
 Reprocessing
Subpart G-Packaging Labeling Control
 Materials examination and usage criteria
 Labeling issuance
 Packaging and labeling operations
 Tamper- evident packaging requirements for over the
counter (OTC) human drug products
 Drug product inspection
 Expiration dating
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Subpart H- Holding and Distribution
 Warehousing procedures
 Distribution procedures
Subpart I - Laboratory Controls
 Testing and release for distribution
 Stability testing
 Special testing requirements
 Reserve samples
 Laboratory animals
 Penicillin contamination
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Subpart J-Records and Reports
 Equipment cleaning and use log
 Component, drug product container, closure and labeling
records
 Master production and control records
 Batch production and control records
 Production record review
 Laboratory records
 Distribution records
 Complaint files
Subpart K- Returned and Salvaged Drug Products
 Returned drug products
 Drug product salvaging
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Why GMP ?
GMP is for
Quality product
Productivity
Higher quality attainment
Uniformity & consistency of the quality
Reduce Batch failure
Reduce rejection cost
Safety & Security
Good traceability
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Quality Products
Market Acceptability Regulatory Compliance
Quality
Products
P
O
T
E
N
C
Y
S
T
A
B
I
L
I
T
Y
E
F
F
I
C
A
C
Y
S
A
F
E
T
Y
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CFRs – Code of Federal
Regulations (USA)
• There are basically 5 Standards in the Food, Drug
and Cosmetic Act and the CFR
Safety
Quality
Identity
Purity
Potency
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Basic Requirements of GMP
► Suitable Premises & Equipment
► Adequate Cleaning procedures.
► Correct Materials, Labels & Containers
► Clearly Documented & Approved procedures
► Consistent Manufacturing procedures
► Practices regularly monitoring by Auditing
► Good Traceability.
► Accurate Testing methods
► Ability to Investigate & solve problems
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– Clearly defined and systematically
reviewed processes
– Validation of processes
– Appropriate resources
– Clearly written procedures
– Trained operators/personnel
Basic Requirements for GMP
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– Good documentation, complete
records
– Failure investigations
– Proper storage and Distribution
– Recall system
– Complaint handling
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Basic Requirements for GMP

Different GMP Guidelines
GMP guidelines are named in different ways in different countries based on
WHO-GMP and US FDA guideline.
 USFDA = United States Food & Drug Administration
 MHRA = Medicine and Healthcare Products Regulatory Agency- UK
 PMDA = Pharmaceuticals and Medical Devices Agency
 TGA = Therapeutic Good Administration- Australia
 KFDA = Korea Food and Drug Administration-Korea.
 MCC = Medicine Control Council -South Africa
 ANVISA = Agencia Nacional de Vigilancia Sanitaria-Brazil.
 EMEA = European Medicines Agency.
 TPD = Therapeutic Product Directorate—Canada.
 ICH = International Conference on Harmonization.
 PIC/S = Pharmaceutical Inspection Convention &
Pharmaceutical Inspection Co-operation Scheme
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ICH-Guidelines
 Q1A--Stability testing of new drug substances and products.
 Q1B—Stability testing: Photo stability testing of new drug
substances and products.
 Q2---Validation of Analytical Procedures: Text and Methodology.
 Q3A—Impurities in new drug substances.
 Q3B---Impurities in New Drug Products
 Q4B---Evaluation and Recommendation of Pharmaceutical Texts for
use in the ICH region on Residue on Ignition/Sulphated Ash
 Q5A---Viral Safety Evaluation of Biotechnology Products
 Q6A---Specifications : Test procedures and acceptance criteria for
new drug substances and new drug products.
 Q6B—Specifications: Test procedures and acceptance criteria for
Biotechnological / Biological products.
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ICH-Guidelines: Contd..
 Q7 ---- GMP Guide for API.
 Q8 ---- Pharmaceutical development.
 Q9 --- Quality Risk Management.
 Q10 --- Pharmaceutical Quality System‘
 Q11 --- Development and Manufacture of Drug Substances
 Q12 --- Lifecycle Management
 Q13 --- Continuous Manufacturing of Drug Substances and Drug
Products
 Q14 --- Analytical Procedure Development
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Quality Risk Management
ICH-Q9
Basic Risk Management Facilitation Methods
• FMEA = Failure Mode Effects Analysis
• FMECA=Failure Mode Effects Criticality Analysis
• FTA = Fault Tree Analysis.
• HACCP= Hazard Analysis on Critical Control
Points.
• HAZOP=Hazard Operability Analysis
• PHA =Preliminary Hazard Analysis
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Medicines and Healthcare Products
Regulatory Agency (MHRA)
• MHRA: MHRA is a UK government agency which
is responsible for ensuring that medicines and
medical devices work and are acceptably safe.
• MHRA was formed in 2003 with the merger of the
Medicines Control Agency (MCA) and the Medical
Devices Agency (MDA). In April 2013, it merged
with the National Institute for Biological Standards
and Control (NIBSC) and was rebranded, with the
MHRA identity being used for the parent
organization and one of the centres within the
group. It is an executive agency of the department
of health.
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MHRA: 9
Chapter/Appendixes
1.Q- Quality Management
2.P-Personnel
3.P-Premises & Equipment
4.D-Documentation
5.P-Production
6.Q-Quality Control
7.C-Contract Manufacture & Analysis
8.C-Complaint & Product Recall
9.S-Self Inspection
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United States Food and Drug
Administration (US-FDA)
FDA: The Food and Drug Administration (FDA or
USFDA) is a regulatory agency of the United States
Department of Health and Human Services, one of the
United States federal executive departments. The FDA
is responsible for protecting and promoting public
health through the regulation and supervision of food
safety, tobacco products, dietary supplements,
prescription and over-the-counter pharmaceutical
drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic
radiation emitting devices (ERED), cosmetics and
veterinary products.
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US FDA: SUB Part 11
1.G- General Structure
2.O-Organization Structure
3.B-Building & Facility
4.E-Equipment & Machineries
5.C-Control of Compliant
6.P-Production & Process Control
7.P-Packaging & Labeling
8.H-Holding & Distribution
9.L-Laboratory Control
10.R-Record & Report
11.R-Return & Service
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ISO
International Organization for Standardization
ISO has come from Greek word ISOS. The
meaning of ISOS is unique. Later the word
ISOS has changed into English word ISO.
It is an international body involved in
developing standards in various
industries, including the Pharmaceuticals.
ISO is an independent contractors who
inspect organizations for compliance with ISO
standards.
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ISO
International Organization for Standardization
• In 1946, 65 delegates from 25 countries gathered in London
for the future of world standardization.
• In 1947, Feb 23 ISO Head office was established in Geneva
Switzerland. Now the total member countries are 162.
• Till now it has published 19,500 standards. First ISO Standard
is ISO 1:1951. This standard is for Geometrical Product
Specification.
• The current standard for Quality Management System
(QMS) is ISO 9001:2015, and previously it was ISO
9001:2005.
• The ISO 9000 family of quality management systems (QMS)
is a set of standards that helps organizations to ensure they
meet customer and other stakeholder needs within
statutory and regulatory requirements related to a product
or service.

ISO VERSIONS
• First version: ISO 9001:1987
• Second version: ISO 9001:1994
• Third version: ISO 9001:2000
• Fourth version: ISO 9001:2008
• Fifth version: ISO 9001:2015
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ISO 9001:2015 is an international standard dedicated to Quality
Management Systems (QMS).
It outlines a framework for improving quality and a vocabulary of
understanding for any organization looking to provide products and
services that consistently meet the requirements and expectations of
customers and other relevant interested parties in the most efficient
manner possible.

ISO 9001:2015
A new version of ISO 9001 appears about every seven years. ISO
9001:2015 was published on 23 September 2015.
ISO 9001:2015 has ten (10) clauses instead of eight.
1.Scope
2.Normative references
3.Terms and definitions
4.Context of the organization
5.Leadership
6.Planning
7.Support
8.Operation
9.Performance operation
10.Improvement
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How can we implement the GMP in the
Manufacturing Plant?
Ø To appoint Trained personnel
Ø To appoint Qualified personnel
Ø To clean Premises and equipment
Ø To implement the Change-over activities properly
Ø To use correct Materials, Containers, and Labels
Ø To follow approved SOP
Ø To control Contamination & Cross-contamination
Ø To monitor the practices regularly by Auditing
Ø To follow accurate testing Methods
Ø To Investigate and identify the problems and positive actions for error
cause removal
Ø To eliminate the risk of Mix up‘s
Ø To establish proper batch Documentation
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Safety: First,
Last & Always
Read the material safety data sheets for all
materials that everyone works with.
Always wear safety glasses, safety shoes,
respirators, and personal protective
equipment.
Avoid situation that look potentially
dangerous and inform supervisors.
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Contamination & Cross-contamination
Contamination
Contamination is presence of any external substances
in a product that was not intended to be part of it. A
contaminant could harm the process, the product and
YOU! also.
Cross-
Contamination
The term cross-contamination refers to product-to-
product contamination. It can be through careless
sharing of the manufacturing equipment & utensils,
sharing of space without proper cleaning, poor
production planning and particularly inadequate dust
control.
Types of
contamination
► Particulate Contamination
► Chemical Contamination
► Microbial Contamination
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Source of Contamination
Main Source
► Personnel
► Premises
► Raw material and Packaging material
► Equipment
► Air, Water and Gas
► Garments
► Operational Systems
► Cleaning agents
► Control System
*Of above mention sources,
people are the single largest
source of contaminant
► Skin cells
► Dandruff, scalp flakes, hair
► Respiratory bacterial aerosols
► Coughs, colds, sneezes and Boils and wounds
► Splashes of saline droplets released while blinking
Other contaminants are Extrinsic
and which humans help carry.
Lint and fluff from clothing
Dirt under finger nails
►Street dust and Cross contamination through contact
-- Cosmetics
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Cleaning & House-keeping
5S
Seiri Clearing up Sort out
Seiton Organizing Systematize
Seisu Cleaning Sweep
Seiketsu Standardizing SOP
Shitsuke Training & Discipline Self discipline
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Cleaning
 One of the first things that investigators or
visitors notice when they visit plant is the
facility’s general cleanliness.
 Keep surfaces and equipment clean.
 Follow approved cleaning
procedures, and use approved
cleaning solutions.
 If possible, open the equipment and look
inside to make sure that no rinse water was
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Read
&
observe
 Caution and warning
signs which are located in
plant should be printed in
all languages spoken in the
manufacturing area.
 All labels and signs.
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GMP
During
Break time
GMP and safety violations occur most often
right before break times, before lunch, during
shift change, when it’s time to go home.
Be especially careful around breaks.
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lifting
Products
 Because most common injuries in
pharmaceutical manufacturing area seem to
be hand and back injuries.
 Use proper lifting techniques, and think
about what you are about to do before
putting your hands or back at risk.
Lifting Products
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Clothing
 Some types of jewelry are not allowed
in certain areas.
 Wear only appropriate clothing (such
as sterile gowning).
 One common GMP error is not
wearing your lab coat while you are in
the laboratory.
 Another common error is wearing lab
coat or plant uniform outside the
building.
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Clothing
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Clothing
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Personal Hygiene
 Wash your hands Properly.
 Most pharmaceutical plants have signs in the
Bathrooms reminding employee to wash their
hands before returning to the plant.
 Disinfect hands by pressing the dispenser
containing disinfectant solution.
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Illness
Your illness may contaminate product as well
as other colleagues of you. So, it is a matter of
concern.
Report an illness.
It is a GMP requirement that employees and
temporary employee do this.
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About released
materials
 A common error is to store expired materials
with current materials. So, be aware of it.
 Use only released raw materials, packaging
materials and labels.
 Use no expired materials.
 Under GMP only released materials can be used
in all clinical and commercial lots of product.
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Slow & Steady
 Every time anyone allowed himself/
herself to be rushed, he/she made a critical
mistake.
 The pace in our industry is fast and
everyone has more to do than they can
possible get done; everyone deserves the
time to think through.
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Complete
the
Paperwork
•If pages or sections of forms are not
applicable, line through them, write N/A, your
initials and the date.
•Always fill in the blanks.
• Record all requested information.
• If it’s truly not applicable, write
N/A; your initials and the date.
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Proper Record
 One common GMP error is to speed through
documents at the end of the day or at the end
of your shift, filling in all the blanks at one
time. But we all know that it is impossible to
remember what we did five minutes ago.
 Record results as you get them.
Never backdate or falsify records. Always use
today’s date when documenting your work.
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cGMP

Proper record
(Contd.)
 Do not write original data on a scrap
paper, napkins or paper towels and transfer
the information to the appropriate form or
notebook.
 Record data directly on the
appropriate form or notebook.
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cGMP

Use of ink
 Pencil is unacceptable because it
smears easily and can be erased.
 Use indelible ink.
 The industry standard is
blue/black indelible ink
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cGMP

Responsibility
 Be the responsible employee who picks the
piece of paper from the floor rather than
steps over it.
 Take actions to make things
better.
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cGMP

Calibration
 Check to make sure that your equipment is
within calibration before you use it. Otherwise
your results or measurements could be
inaccurate.
 Ensure that equipment
is calibrated before using
it.
 Equipment that must be calibrated in a
manufacturing or laboratory environment
typically has an equipment calibration tag.
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cGMP

Bring
No Food
 Smoking, eating, and drinking are
prohibited in a GMP area.
 Do not bring food, gum, and tobacco into
production and laboratory areas.
 A common GMP error is bringing drinks
into a laboratory.
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cGMP

Check !!!!!
 In industry, a signature is a
legal and ethical responsibility.
While sign-
1. Check for accuracy.
2. Review it thoroughly and completely.
3. Make sure that all calculations are correct.
 Never sign something that you know to be
wrong. Get it correct and then sign it. 83 of 95
cGMP

Double check !!
GMPs require that you have sufficient staff
to do this.
Double check is required in
every critical step.
A double check means that
one person performs the work
while another person observes
and makes any suggestions or
corrections. (4 eyes principle)
Individuals then sign or initial the batch
record where indicated.
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cGMP

Reporting
• The truth is that we are all human
and human being make mistakes
as a Supervisor encourage your
people to tell the actual things.
• Report mistakes or suspected
mistakes as soon as possible to
your Supervisor.
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cGMP

SOPs & STPs
?????
 You must know your SOPs. If an
SOP needs to be revised, tell your
supervisor and offer to help revise it
and get it approved.
 Read and become familiar with all
SOPs, STPs and other documents that
relate to your work.
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MP
cGMP
No analytical to be performed with
approved STP (Standard Operation
Procedure)

Record keeping
 So when filling out a batch record or recording
your results, record equipment status, document
and revision numbers.
 Record ID, lot, document,
revision, and other control
numbers.
 The GMP require that-
 you assign and use unique numbers on each
lot of your raw materials, reagents, documents,
and all lots of produced product to permit
traceability.
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cGMP

Printing
 Fill out all logs and other documents
completely. Handwriting must be clear and
legible.
 Print clearly in logs, and
fill them out completely.
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cGMP

Change control
 Out of specification (OOS)
Deviation management
Market complaints handling
Product recall handling
 Corrective & Preventive action (CAPA)
QMS
 Risk Management
 Quality Audit
Quality Management
System (QMS)
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cGMP

90
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cGMP
Good Documentation
Practices (GDocP)

C.L.I.D.E Method:
a) Correct
b) Line through the complete erroneous
entry (single line)
c) Initial
d) Date
e) Explain
853.786
853.768
Remarks: Recording error
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cGMP
Good Documentation
Practices (GDocP)

Good Documentation Practices
(for Test scripts)
• Do‘s
Do cross out any mistakes with a single
line
Do explain, initial and date where an
entry was crossed out (must be one
person who is making the change)
Do provide references to test procedures
if a long procedure is applied
Do sign and date on testing documents.
Do report numbers exactly (no ranges)
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cGMP

• Don'ts
– Do Not type in results (write in ink)
– Do Not obliterate underlying results when
making changes
– Do Not leave any empty result boxes
– Do Not forget to initial and date results when
you write them down (for each line)
– Do Not report results as ―as expected‖ or
―conforms‖
– Do Not use ditto marks
– Do Not record entries on scraps of paper or
other non-permanent media
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cGMP
Good Documentation Practices
(for Test scripts)

Documents & Record-keeping
• Two fundamental rules for recordkeeping in GxPs:
Rule #1
“ If it’s not documented, it wasn’t
done. ”
Rule #2
“ If it’s not signed and dated, it’s not
documented. ”
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cGMP

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Current Good Manufacturing Practice (cGMP)

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