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WHAT IS GMP ? WHY DO WE NEED GMP?

GOOD
MANUFACTURING

PRACTICE

TYPES OF CONTAMINATION TYPES OF CONTAMINANTS

• PARTICULATES
dust, dirt, paper, metal, fibers, etc.

1. PARTICULATES • MICROORGANISMS
bacteria, yeasts, molds

3. MICROORGANISMS • CROSS-CONTAMINATION
labels, cartons, foil, materials, etc.
5. CROSS-CONTAMINATION

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SOURCES OF CONTAMINATION
PEOPLE CAUSE CONTAMINATION

HEH!
HEH!
HEH!

•IMPURE
•UNCLEAN
•UNFIT FOR USE
AIR , WATER, CONTAMINATION

SURFACES,PEOPLE,PESTS

MICROORGANISMS CAN BE
CGMP REGULATION
DESTROYED OR REDUCED BY:
• Personal Hygiene
• Insect and pest control
• Efficient & effective plumbing
• Clean and potable water
• Correct cleaning & sanitizing of
equipment
• Effective cleaning of processing areas,
Report any injury or illness immediately to storage areas warehouse, etc.
your supervisor.

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CROSS - CONTAMINATION GMP………….…

… a few
ounces? THE
WHOLE BATCH
IS
CONTAMINATE
… BUT IT D
WAS ONLY
A FEW
OUNCES

SHARED RESPONSIBILITY OF
ESTABLISHMENT AND EMPLOYEES

TO COMPLY WITH GMP …

Establishment provides
Sufficient Space WORKERS AND EMPLOYEES
Physical Separation
Adequate Lighting Take necessary steps and follow
Adequate Ventilation procedures to assure sanitary and safe
Equipment, utensils operation of the plant.
Adequate facilities

for every operations

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HYGIENE AND SANITATION MICROORGANISMS ARE IN MAN’S HAIR, SKIN,

INTESTINES, URINE, UNDERNEATH
WHY IS HYGIENE AND SANITATION FINGERNAILS.
IMPORTANT?
Man is a natural carrier of microorganisms.
These are expelled when we We collect more microorganisms as we
travel from home to our destination due
SNEEZE to dust, smoke generated by vehicles and
COUGH
contact with dirty items. It is therefore
important that we observe good hygiene
and sanitation to avoid contamination of
YAWN TALK
products we handle.

PLANT UNIFORM Cover your hair which

have dust & germs.
Cover street Prevent hair from
clothes that falling into the
contain product.
contaminants,
organisms you Cover the nose and
collect on your way mouth which are
to the plant. Cover natural reservoir of
your exposed skin germs. Trap particles
which sheds or droplets from the
particles with nose and mouth.
germs.

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Street shoes
contain germs
from the soil and
dirt we stepped
WHY U SE RU BBER
on, so it must not
be worn inside the GLOVES???
plant, plant shoes
must be used
instead. It prevents microorganism transfer
Cover finger nails from our hands to the product we
and hands which handle.
have germs.
It prevents transfer of product
dust to our hands.

HANDLING OF GLOVES
WHY CAN’T WE USE COTTON
GLOVES??? 1) Place gloves in a clean plastic bag during
break time.

It is porous and will not prevent

transfer of microorganisms and
perspiration to the product we
handle.
2) Wash gloves with soap and water after use.
It permits transfer of product Dry and sanitize.
dust to our hands.

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HYGIENE AND SANITATION

3) Change gloves for every product PRACTICES
change.
*Wash hands with
soap and water

4) Torn gloves or those with holes – After using the toilet

– Before starting to work
should not be used – After blowing your nose
– After handling dirty things
– After touching body surface
– After eating

-Don’t touch or scratch your nose, head, body

parts while handling products.

-Cover your nose, mouth when sneezing, coughing, HOW TO

WASH YOUR
yawning.

-Avoid talking and use mask if necessary.

-Observe good toilet practices by:

-Flushing the toilet after use
HANDS
-Washing hands with soap and water

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3. Wash with soap and

1. Remove visible dirt. water.

2. Rinse with water. 4. Rinse with water

5. Sanitize. 6. Dry hands.

7

GOOD HOUSE KEEPING PRACTICES
-Keep dirt and dust away from work
areas. Pick-up pieces of paper,
foreign and unwanted objects that
may be seen in the work area and
throw them in the trash can.
-Clean up debris as work continuous.
-Do not place tools, materials, objects,
etc. on product contact surfaces.
GMP
IN THE WORK AREA
• Use the product container for the
intended product only. Don’t use it for
glue, oil, soap, etc.
• Be in your work assignment all the time.
Don’t attempt to transfer to adjacent
packing lines to help as you may not be
properly trained to do the job.
7/29/2021
-When job is finished, clean up work area,
surfaces and equipment.
-Keep personal things in the place provided for
them.
-Place lunch wrappers, food left overs and other
rabbish in the containers provided for them.
-Place soft drinks bottles in the container
provided for them.
-Place chairs in orderly position before leaving
the work area.
3. Clean up your debris as work continues.
4. Products falling on the floor or dirty
surfaces must not be put back for
packaging.
5. Cover product container and secure all
materials pertaining to the product like
labels, cartons, etc. before leaving the
work area during break times.
6. Identify all containers used with
product name, batch/lot number, expiry
date. (Containers for rejects, unused
labels, etc.)
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7. Never handle products with bare hands.

Use rubber gloves if you are assigned to
handle products.
8. Clean and sanitize work area surface
following instruction of supervisor when
job is finished.
9. Don’t touch nose, head or any body parts
while handling products.
10.Don’t get items from adjacent lines to
be used in your line.
11)Cover your nose and mouth when
sneezing or coughing.
12)Pay full attention to the assigned task
and refrain from talking to your co-
corkers.
13)Familiarize yourself with assigned
operation taking note of distinct
features to enable detection of mix-up
or mistakes.

14)Follow strictly the instruction given by

BACTERIA
the supervisor. In case of doubt, seek
the help of the supervisor.

15)Don’t eat or chew gums while in the Pneumococci Bacilli Bacterial Spores
work area.

16)Notify supervisor promptly if there is

an accidental contamination of product
contact surfaces. Yeast Molds

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GOOD MANUFACTURING PRACTICE

Rushing a Cross- -Developed in the 1960’s
may cause
Job Contamination -Part of the Food, Drug, and Cosmetic
act
-Has the force an d effect of law

LOOK OUT!!!

This is a RUSH
job!
THESE REGULATIONS
HAVE THE FORCE AND
EFFECT OF LAW
Mix-Ups and Errors too!

BFAD HAS THE

AUTHORITY TO
RECOMMEND
RECALL

BFAD IS RESPONSIBLE FOR SEEING

THAT OUR COMPANY COMPLIES WITH
CGMP REGULATIONS.

IF WE HAVE NOT FOLLOWED

CGMP REGULATIONS

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PREMISES
• Premises/building must be designed and
OUR EQUIPMENT OUR BUILDING
constructed to facilitate company
productivity, employee safety and product
quality.
THE PRODUCTION &
• Plant site should be carefully selected
OUR RECORDS
DISTRIBUTION OF OUR
PRODUCTS
considering the physical terrain and the
ground surrounding it.

LABELLING &
HOW WE PURCHASE AND STORE PACKAGING
RAW MATERIALS

BUILDING PREMISES
GMP REGULATION:
GMP REQUIREMENTS:
Defined area for
1. Separate area for specific operation.
2. Easy to clean.
a. Receiving of materials
3. Easy to maintain. b. Storage of materials
4. Easy to operate. c. Quality control laboratory
5. Adequate space d. Manufacturing area
6. Eliminate unnecessary traffic e. In-process storage
f. Packaging area
Inadequate space and unnecessary traffic cause mix-up
and errors. g. Quarantine area

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GMP REGULATION GMP REGULATION

WATER SYSTEM

- STEADY PRESSURE
LIGHTING - FREE OF PROBLEMS
-Light all Areas - NO DRAINAGE
-Adequate for our needs
BACK-FLOW

-With back-up

GMP REGULATION GMP REGULATION

Waste
materials must
be removed and
disposed of in a
safe and
sanitary
Building must be maintained and
manner. kept in good condition. There
must be a regular housekeeping.

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• Building must be protected from infiltration
of contaminants and from outside
elements like dust, odors, filth, pests.
• Adequate space is necessary in designing
a plant.
• Adequate space is critical to the plant
productivity, personnel safety and the
quality of the product.
• Lack of space can cause confusion in the
workflow and this can adversely affect
productivity.
• Lack of space can also cause
unnecessary traffic in the work area which
can endanger employee safety.
• Lack of space can result in contamination,
mix-ups and errors.

PERSONNEL It’s a
CGMP
Regulation
• People should know how to perform the
job right the first time and every time.
That all of us
• They must have the knowledge to perform
their job and the skills required by the job.
receive training in
the procedures
• People must have personal responsibility
to develop personal competence. relating to our
job and in the
cGMP regulations.

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Proper Training in relation to Engaged in supervision of manufacture

their assigned task or function processing, packing and holding of product
Sufficient Training Experienc
Education
•SOLUTIONS e

•IMPROVE
INSPECTION
METHODS

Adequate number
……to perform assigned task or function to give
assurance of product quality, identity, purity.

Engaged in manufacture, processing,

packing and holding of product TRAINED PERSONNEL=QUALITY PERFORMANCE
=CONTINUAL IMPROVEMENT
Sufficient
Education
Training Experienc LESS PRONE TO ERRORS
e
LESS DEVIATIONS FROM STANDARDS

REDUCE AMOUNT OF REWORK

REDUCE AMOUNT OF REJECTS

Adequate number
……to perform assigned task or function

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TRAINING PROGRAM
1. EACH INDIVIDUAL SHOULD HAVE A Confucius…
TRAINING PLAN.

2. COURSES AND TOPICS SHOULD BE LINKED TO

THEIR CURRENT JOBS.
I hear and I forget
3. CONTENTS OF EACH COURSE SHOULD BE
DOCUMENTED AND APPROVED BY I see and I remember
MANAGEMENT.
I do and I understand
4. PLAN FOR RETRAINING.

PATTERN OF LEARNING AND REMEMBERING

KNOW YOUR COMPANY
What we learn What we Remember

1% by taste 1% of what we read - Its products, policies and services.

1,5% by skin senses 20% of what we have READ
heard COMPANY
3,5% by smell 30% of what we have MANUAL
seen
11% by smelling 50% of what we have
heard and seen
83% by vision

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REGULAR PHYSICAL EXAMINATION OR PRACTICE GOOD SANITATION AND

HEALTH CHECKS HEALTH HABITS

WEAR PROTECTIVE CLOTHING AS

NECESSARY ADEQUATE PERSONAL RECORDS
•GOWN • Name
•GOGGLES • Address
•MASK
• Qualification
•GLOVES
• Signature
•HEAD CAP

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FOLLOWING SOP’S IS VITAL

•SOP’s
•RECORDS
UNDERSTAND THE REQUIREMENTS
And demands of your job. Determine how you
can do your job most efficiently. …….AND SO ARE THE RECORDS WE KEEP!

REASONS FOR WRITING PROCEDURES ACCURATE RECORD KEEPING IS VITAL …….

• AVOID/MINIMIZE When did

MIX-UPS AND ERRORS I do….
that?
• ENSURE CONSISTENT
QUALITY

• ENSURE COMPLIANCE
WITH GMP
REGULATION

RECORDS MUST BE FILLED OUT AT THE TIME

WE COMPLETE THE JOB!!!

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TRAINING MUST BE REINFORCED BY cGMP TRAINING MUST BE REINFORCED BY

THE SUPERVISOR….. ON THE JOB SUPERVISION
FOLLOW
S.O.P.‘s FOLLOW
SOP’S!!!

BFAD INSPECTORS ASK TO SEE OUR AND WHERE REQUIRED, SUPPLEMENTED BY A

TRAINING RECORDS…. REVIEW TRAINING COURSE.

DEVELOPING COMPETENCE
COMPETENCE
2. EDUCATION
AND
TRAINING IS DEMONSTRATED BY
SUCCESSFUL
4. ON-THE-JOB
EXPERIENCE JOB
PERFORMANCE

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DEFINITION OF COMPETENCE MEASURE OF COMPETENCE

WEBSTER • NUMBER OF SUCCESSES?
1. Having ability or qualities
2. Legally qualified or able • NUMBER OF FAILURES?

DR. LAWRENCE J. PETER • PROMPTNESS OF ACTION?

(PETER PRINCIPLE)
“COMPETENCE like truth, beauty and • LEADTIME?
contact lenses, is in the eye of the
beholder.” • QUALITY OF ACTION?

Proof of Successful Performance

DEMONSTRATE COMPETENCE

2. DOCUMENTATION AFTER COMPLETION

OF EACH STEP

2. VALIDATION OF SYSTEMS, EQUIPMENT ON THE JOB EXPERIENCE

AND PROCESSES

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Y O U R J O B
MUST
DO

MUST
KNOW

THREE P’s OF GMP EQUIPMENT

PERFORMANCE Equipment design must be carefully

examined.

PRIDE
Dedicated equipment should be used for
products which are difficult to remove,
difficult to clean and for products with a

PROOF high safety risk.

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EQUIPMENT
REQUIREMENTS:
MUST BE MADE OF MATERIALS THAT WILL
NOT REACT WITH OR ABSORB ANY
COMPONENTS THEY CONTACT.
MUST BE DESIGNED FOR THE PARTICULAR
PURPOSE FOR WHICH IT IS INTENDED.
MUST BE LOCATED FOR EASY MAINTENANCE.
SUBSTANCES USED FOR OPERATION LIKE
LUBRICANTS, COOLANTS SHOULD NOT COME
IN CONTACT WITH THE PRODUCT.
EQUIPMENT USED EXCLUSIVELY BY A PRODUCT,
INDIVIDUAL LOG IS NOT REQUIRED.
ALL EQUIPMENT MUST BE SANITIZED AFTER
CLEANING.
ALL EQUIPMENT MUST BE VALIDATED.
EQUIPMENT MUST NOT BE USED AS STORAGE
OF THINGS THAT DON’T BELONG TO THEM.
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ALL MANUFACTURING EQUIPMENT NOT IN USE
MUST BE STORED IN A MANNER TO KEEP IT
CLEAN AND IN GOOD WORKING CONDITION.
ALL EQUIPMENT MUST HAVE AN ACCURATE WELL
DOCUMENTED LOG SHOWING WHAT WAS
PRODUCED IN IT.
ALL EQUIPMENT MUST HAVE A CLEANING LOG
SHOWING WHEN, HOW AND BY WHOM EACH
PIECE OF EQUIPMENT WAS CLEANED.
ALL EQUIPMENT MUST HAVE AN
IDENTIFICATION NUMBER WHICH SHOULD
APPEAR ON THE BATCH RECORDS.
DETERGENTS USED FOR CLEANING MUST NOT BE
SOURCE OF CONTAMINATION.
MEASURING, WEIGHING, RECORDING AND
CONTROL EQUIPMENT SHOULD BE CALIBRATED
AND CHECKED AT DEFINED INTERVALS.
MIXERS, PUMPS MUST HAVE CLEANABLE
BEARINGS AND NON-LEAKING OIL SEALS.
TANKS SHOULD HAVE COVED EDGES AND SLOPED
BOTTOMS WITH THE OUTLET AT THE LOWEST
POINT.
21

TANKS MUST HAVE DOMED TOP TO ALLOW
CONDENSATION TO DRAIN BACK TO THE
TANK.
TANK VENTS AND OVERFLOW LINES SHOULD
HAVE SCREEN TO PREVENT ENTRY OF PESTS.
HOPPERS OF FILLING EQUIPMENT,
RESERVOIRS MUST HAVE COVERS THAT ARE
FIT AND EASY TO CLEAN.
FIXED PIPEWORK MUST BE CLEARLY LABELED
TO INDICATE CONTENTS AND DIRECTION
OF FLOW.
MUST NOT REACT WITH OR ABSORB ANY OF THE
COMPONENTS THEY CONTACT.
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ALL PIPE WORK MUST BE SLOPED SO THAT THEY
WILL DRAIN AND TO AVOID LOW SPOT AND DEAD
LEGS.
INTERNAL WELDS MUST BE SMOOTH, NOT PITTED
TO AVOID FLUX-CONTAMINATION.
DUST EXTRACTORS MUST NOT LODGE POWDER IN
THE DUCTING WHICH MAY FALL BACK INTO THE
PRODUCT.
DEFECTIVE EQUIPMENT SHOULD BE REMOVED IN
THE PRODUCTION AREA, QC, ETC. AND CLEARLY
LABELED AS DEFECTIVE.
EQUIPMENT MUST BE LOCATED FOR
EASY MAINTENANCE!
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This is an
important WHEN ?
CGMP
Regulation!
WHAT ?

WHO ?

Equipment should be designed for the particular

purpose for which it is intended. EQUIPMENT LOG BOOK

WE DON’T DO THINGS THIS WAY! DON’T DO THINGS THIS WAY!

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• IMPORTANCE OF MAINTENANCE
MAINTENANCE
1. REDUCE DOWNTIME

2. INCREASE PLANT AVAILABILITY

- RETAIN EQUIPMENT IN ACCEPTABLE
OPERATING CONDITION 3. INCREASE EFFICIENCY

4. REDUCTION OF MANPOWER
LEVEL
- RESTORE EQUIPMENT TO AN
ACCEPTABLE OPERATING CONDITION
5. REDUCTION OF PRODUCTION
COST

FOLLOW SOP’s ………………… BFAD CAN

THANK
GOOD YOU! HOLD US
JOB!

RESPONSIBLE

FOR ANY

CGMP

VIOLATION.
……. WHEN CLEANING EQUIPMENT

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FACTORS TO CONSIDER IN DEVELOPING EQUIPMENT MAINTENANCE

MAINTENANCE PROCEDURES

1.RUN TIME IN OPERATING HOURS BEFORE MECHANICAL AND

MAINTENANCE. PRECISION
EQUIPMENT MUST
2. SEVERITY OF USE BE CHECKED
REGULARLY.
3. VIBRATION DATA

4. EXPECTED LIFE OF COMPONENTS. ALL AUTOMATIC AND

ELECTRONIC EQUIPMENT
IT IS NOT ACCEPTABLE TO WAIT FOR A
MACHINE TO BREAKDOWN BEFORE SERVICING LIKE COMPUTERS MUST
IT. A CLEANED AND WELL MAINTAINED ALSO BE TESTED
EQUIPMENT IS MORE RELIABLE AND PRODUCES
LESS NON-CONFORMING PRODUCTS. AND INSPECTED.

SEQUENTIAL LOG
NAME OF MACHINE:
CAPACITY:
TAG NO:
TYPES OF MAINTENANCE
DATE ACTIVITY DATE DATE SIGNATURE
STARTED FINISHED
1-16-09 MFG. RHEA 1-16-09 1-17-09
ALC. BATCH
1234
PREVENTIVE - ROUTINE
1-18-09 CLEANING 1-18-09 1-18-09
- PLANNED
1-19-09 MFG. RHEA 1-19-09 1-19-09
ALCOLOGNE
B#5
1-20-09 MIXER REPAIR 1-20-09 1-23-09
CORRECTIVE - EMERGENCY

1-24-09 CLEANING 1-24-09 1-24-09 - PLANNED

1-25-09 VALIDATION 1-25-09 1-26-09
OF NEW
MIXTURE MODIFICATION - PLANNED
1-26-09 MFG. 1-26-09 1-27-09
ALCOMFORADO
B#1

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MAINTENANCE RECORD
MAINTENANCE RECORD NAME OF EQUIPMENT: TAG
NO.
DATE INSTALLED:
SUPPLIER:
1. PROCEDURES AND SCHEDULES A. MONTHLY MAINTENANCE
SERVICE JAN. FEB. MAR. APR.
2. CALIBRATION LOGS DONE

NOT DONE
3. EQUIPMENT LOGS
REASON

4. DOCUMENTATION OF MAINTENANCE B. QUARTERLY MAINTENANCE

SERVICE FIRST Q. SECOND Q. THIRD Q. FOURTH Q.

DONE

NOT DONE
CLEAN ENVIRONMENT + MAINTAINED
EQUIPMENT = QUALITY PRODUCT REASON

YEARLY MAINTENANCE RECORD

REGULAR MAINTENANCE CHECKS…..
NAME OF EQUIPMENT:
TAG NO.
DATE INSTALLED:
SUPPLIER:
SERVICES 2006 2007 2008 2009

Automatic
DONE &
Electronic
Equipment &
Computers
NOT DONE

REASON
………..RECORDED ON PROPER FORMS!!

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WE DO NOT LOOK FOR

WE TEST OUR PRODUCTS FOR: CONTAMINANTS INTRODUCED BY:

A. PRESENCE OF COMPONENTS 2. INADEQUATE MANUFACTURING

PRESUMED TO BE THERE
CONTROLS
B. CONTAMINANTS PRESUMED
MIGHT BE THERE
2. INADEQUATE ENVIRONMENTAL
CONTROLS

3. IMPROPER HANDLING

DON’T TRUST YOUR MEMORY!! COMPONENTS CONTROL

• Building quality into the product starts with
components control.
Maintenance • Source, origin and suitability of
& components should be clearly defined.
Cleaning
Record • Components should come from qualified or
approved manufacturers.

RECORDS MUST BE FILLED OUT AT THE TIME

WE COMPLETE THE JOB!

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COMPONENTS
COMPONENT
Any material
intended for use
Must come
in the
manufacturing from
of our product approved
suppliers.
We must
control upon
receipt and in
use.
Includes packaging
materials as well
CORRECT SPECIFICATION + CORRECT MATERIALS
as raw materials
= CORRECT PRODUCT

All components must be sampled and tested

ALL MATERIAL RECEIPT MUST BE by quality control……….

IN GOOD CONDITION

……to ensure that they

CLEAN AND IDENTIFIED conform to
RAW
RAW standards.
MATL’
MATL’
S
S

Intact, no damage

All containers must be carefully resealed

after each sample has been taken!!!

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All new materials must be quarantined until approved for use…….

GMP REQUIRES THAT COMPLETE RECORDS ARE KEPT ON
All newly received ALL NEWLY RECEIVED COMPONENTS.
materials must be:
• Proper identification
• Properly identified
and recorded • When received and inspected?

• Examined to make sure • Who did the inspection?

that each container is
still tightly sealed • Who took samples ?
• Examined to make sure
• When were they tested?
that each container
is not damaged
• Who did the test?
•Examined to make sure
there is no visible sign of • ?????
contamination
or impurity

After testing and examination by quality control

All components
must be stored in
…….
a safe and orderly
way . . . It helps prevent
mix-ups and
errors!!

And must be protected from damage by outside

elements such as wind, rain and insects. It may then be approved and released for manufacturing
use!

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COMPONENTS MUST BE
PROTECTED FROM HARMFUL BACTERIA
Important: report all accidents, cuts, sores, or illness!!

Bacteria =
Contamination

Reserve samples for COMPONENTS MUST BE USED IN

every approved PRODUCTION ON THE BASIS OF
component…..
“FIRST IN – FIRST OUT”
• Clearly identified Good!!! Makes
• Kept for at least
Sense!
one year after the
expiration of the
Product

A rejected component must be …….an exception may be made if it is

properly identified and kept
separate until it is disposed
temporary and appropriate.
of.

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EXCIPIENTS OR INACTIVE
RAW MATERIALS INGREDIENTS
are the
ingredients Has no
that go into effect on
our products the user • Protects the product

include both • Covers up unpleasant odor

active and
• Makes product look good
inactive

ACTIVE INGREDIENT CERTIFICATE OF ANALYSIS

•Maybe accepted if
analytical competence has
Makes the been established
product
effective •Typical analysis
not accepted

•Full analysis is
a must

With direct effect on the user Equivalency of testing must be established for new
supplier. Supplier must use same testing methods as the
user.

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BULK MATERIALS PACKAGING MATERIALS

IT IS PERMISSIBLE TO MIX DELIVERIES OF A MATERIAL Includes such
IN A SINGLE TANK PROVIDED: All the Items as:
materials used
in the Caps
- THE TANK IS EMPTY AND CLEAN BEFORE Bottles
packaging of a
THE FIRST DELIVERIES Labels
product
Inserts
Boxes
- ALL DELIVERIES ARE WITHIN Bags
SPECIFICATION BEFORE UNLOADING. Wrappers
Droppers
- NONE OF THE MATERIAL IS USED UNTIL ALL Shippers
Seal
OF THE DELIVERIES ARE ANALYZED
Plugs

- A SINGLE CONTROL NUMBER IS ASSIGNED

TO THE ENTIRE TANK

STORAGE LABELS AND PRINTED MATERIALS

SIMILAR PRINTED MATERIALS SPATIALLY SEGREGATED
IN ORDER TO PREVENT MIX-UP SHOULD HAVE IDENTIFYING CODE NUMBER OR MARKS

MUST BE CHECKED AGAINST A STANDARD OR ARTWORK UPON

• LABELS MUST BE STORED IN SEPARATE AREA TO RECEIPT
PREVENT LABELS OF DIFFERENT PRODUCT,
STRENGTH OR QUANTITIES BEING MIXED AND OBSOLETE MATERIALS MUST BE REMOVED FROM THE CONTROL
CAUSE ERROR IN PRODUCTION SYSTEM AND INVENTORY

SPECIMEN MUST BE SIGNED OFF BY QA TO INDICATE APPROVAL

• RETURNS FROM PACKAGING MUST BE CHECKED
AND IDENTIFIED BEFORE RETURNING TO STOCK LIMITED ACCESS TO LABEL STORAGE

LABELS AND PRINTED MATERIALS ISSUED ONLY WHEN

• DAMAGED AND REJECTED MUST BE DESTROYED IN AUTHORIZED
WAY THAT WILL MAKE THE MATERIAL UNUSABLE
KNOW NUMBER OF LABELS USED AND RECONCILE USAGE

32

COMPONENTS
• IN GOOD CONDITION, CLEAN AND IDENTIFIED
INTACT, NO DAMAGE
•
• SAMPLED AND TESTED BY QC
• STORED IN A SAFE MANNER
• PROTECTED FROM WIND, RAIN, INSECTS
• WITH COMPLETE RECORDS
• COME FROM APPROVED SUPPLIERS
• FIRST IN-FIRST OUT OR FIRST EXPIRE-FIRST OUT
• RECONCILE USAGE
PROCESSED WATER
• CONSIDERED AS STARTING MATERIAL
• MUST BE SAMPLED, TESTED AND RESULTS DOCUMENTED
• SHOULD NOT BE STORED FOR MORE THAN 4 HOURS
BECAUSE IT ALLOWS BACTERIA TO PROLIFERATE
UV LAMPS
• MUST BE REPLACED ANNUALLY OR IF RADIATION DROPS
BELOW 90% OF THE OPTIMUM
• MUST BE CLEANED DAILY TO REMOVE BIOFILM
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ANTI-MICROBIAL FILTERS
• REPLACE WHEN PRESSURE DIFFERENTIAL ACROSS THE
FILTER REACH THE LEVEL SET BY THE SUPPLIER
• SUDDEN DROP INDICATES FAILURE OF THE FILTER AND MUST
BE REPLACED
• NEW FILTER SHOULD BE INTEGRITY TESTED
WATER SYSTEM MUST BE SANITIZED AT
LEAST TWICE A YEAR
APPROPRIATE TESTING OF WATER
• CHEMICALLY-DAILY
• MICRO TESTING
• CONDUCTIVITY MEASUREMENTS
PRODUCTION DOCUMENTS
PRODUCTION DOCUMENTS ARE THE BLUEPRINTS WE
FOLLOW WHEN WE PRODUCE A PRODUCT.
PRODUCTION DOCUMENTS SHOULD BE WRITTEN
WITH DETAILED STEPS IN A CLEAR AND LOGICAL
MANNER TO ACHIEVE SAFE AND EFFECTIVE
PRODUCT.
ASSURES PERFORMANCE OF THE SAME JOB THE
SAME WAY EACH TIME.
33

MASTER PRODUCTION
RECORDS
• MASTER FORMULA
TO ASSURE UNIFORMITY FROM BATCH
TO BATCH SHALL BE PREPARED BY
ONE PERSON, DATED AND
SIGNED(FULL SIGNATURE,
HANDWRITTEN) AND INDEPENDENTLY
CHECKED, DATED AND SIGNED BY A
SECOND PERSON.
MASTER MANUFACTURING
PROCEDURE
1. STATE THE PROCESSING LOCATION AND THE
PRINCIPAL EQUIPMENT TO BE USED.
2. STATE THE METHODS OR REFERENCE TO THE
METHODS TO BE USED FOR PREPARING THE
EQUIPMENT
3. DETAILED STEPWISE PROCESSING
INSTRUCTIONS:
CHECKS ON MATERIALS,
PRE-TREATMENT ,ASSEMBLING,
SEQUENCE OF ADDING MATERIALS,
MIXING TIME, SPEED, TEMPERATURE
7/29/2021
SHALL INCLUDE:
1. NAME AND STRENGTH OF THE PRODUCT
2. NAME AND WEIGHT OR MEASURE OF EACH ACTIVE
INGREDIENT PER DOSAGE UNIT AND A STATEMENT
OF THE TOTAL WEIGHT OR MEASURE OF ANY
DOSAGE FORM.
3. COMPLETE LIST OF COMPONENTS WITH CODES
4. AN ACCURATE STATEMENT OF WEIGHT OR
MEASURE OF EACH COMPONENT USING THE SAME
WEIGHT SYSTEM
5. STATEMENT ON CALCULATED EXCESS OF
COMPONENT
6. STATEMENT OF THEORETICAL WEIGHT OR MEASURE
AT ANY STAGE OF PROCESING
2. INSTRUCTION FOR IN-PROCESS CONTROLS
3. STATE STORAGE CONDITION, INCLUDING THE
CONTAINER TO BE USED, LABELLING, ETC.
4. PROVISION FOR SIGNATURES AND CHECKS
FOR EACH STEP OF PROCESSING
5. SPECIAL PRECAUTIONS
6. STATE MINIMUM AND MAXIMUM PRECENTAGES
OF THEORETICAL YIELD, BEYOND WHICH
INVESTIGATION IS CARRIED OUT.
7. IDENTIFICATION OF THE PERSONS
PERFORMING DIRECTLY, SUPERVISING OR
CHECKING EACH SIGNIFICANT STEP.
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PACKAGING INSTRUCTIONS
5 .A STATEMENT WHERE TO INDICATE LOT
MUST BE PREPARED FOR EACH PRODUCT, PACK SIZE AND NUMBER AND EXPIRY DATE
TYPE. 6. SPECIAL PRECAUTIONS
SHALL INCLUDE:
1. NAME OF PRODUCT 7. DESCRIPTION OF THE PACKAGING
2. STRENGTH AND DESCRIPTION OF THE PRODUCT OPERATION AND EQUIPMENT TO BE USED
3. PACK SIZE EXPRESSED IN TERMS OF NUMBER OR 8. DETAILS OF IN-PROCESS CONTROLS AND
WEIGHT OR VOLUME OF THE FINAL PRODUCT
IN THE CONTAINER
SAMPLING AND ACCEPTANCE LIMITS
4. COMPLETE LIST OF ALL PACKAGING MATERIALS 9. DESCRIPTION OF THE PRODUCT CONTAINER
REQUIRED FOR A STANDARD BATCH SIZE, AND CLOSURE
INCLUDING QUANTITIES, SIZES, TYPES, WITH CODES
OR REFERENCE NUMBER RELATING TO THE
10. YIELD AND PERCENTAGE OF THEORETICAL
SPECIFICATION OF THE MATERIAL YIELD

DISPENSING C. BALANCE
• MUST BE CALIBRATED
REQUIREMENTS: • MUST BE CLEANED
B. RAW MATERIALS • MUST BE SENSITIVE ENOUGH FOR THE AMOUNT
BEING WEIGHED.
• MUST BE APPROVED BY Q.C.
• MUST BE THE LOT NUMBER SPECIFIED IN MO. D. WEIGHING TOOLS
• MUST NOT SHOW EVIDENCE OF TAMPERING OR • SCOOPS MUST BE STAINLESS STEEL.
DETERIORATION. • MUST BE CLEANED, SANITIZED AND DRIED BEFORE
USE.
• ONE MATERIAL PER SCOOP; TO BE CLEANED
C. CONTAINERS BEFORE USE FOR OTHER MATERIAL.
• NEW PLASTIC OR PE BAG.
• FOR LIQUIDS, STAINLESS STEEL CONTAINER WITH E. WEIGHING
COVER. • BRING IN ONE MATERIAL AT A TIME (CLEAN THE
• MUST BE CLEANED, SANITIZED AND DRIED. CONTAINER OUTSIDE )
• ZERO THE BALANCE
• TARE THE CONTAINER AND RECORD THE WEIGHT.

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• SCOOP THE REQUIRED AMOUNT OF THE MATERIAL

TO THE TARED CONTAINER SLOWLY AND RECORD
THE GROSS WEIGHT.
• CLOSE THE MATERIAL, INNER BAG AND DRUM.
• RETURN MATERIAL TO STORAGE.
B. DISPENSED MATERIAL
• REMOVE ENTRAPPED AIR, TWIST THE OPEN END,
FOLD AND TIE WITH TWISTER WIRE OR RUBBER
BAND
• ATTACH WEIGHING LABEL.
• PLACE IN A CONTAINER LINED WITH CLEAN PE BAG
TOGETHER WITH THE OTHER MATERIALS FOR ONE
BATCH
B. DISPENSING ATTIRE
• LONG GOWN
• MASK
• CAP
• GLOVES
C. OTHERS
1. WEIGHING LABELS MUST BE IN DUPLICATE; THE
ORIGINAL ATTACHED TO THE IMMEDIATE
CONTAINER OF THE MATERIAL DISPENSED AND THE
DUPLICATE ATTACHED TO THE JOB ORDER FOR
POSTING OF MATERIAL USAGE.
2. QUANTITY OF MATERIALS WITH ASSAY MUST BE
ADJUSTED TO 100%; CHECKED BY QC OR A
RESPONSIBLE PERSON. NO DOWNWARD
ADJUSTMENT IS ALLOWED.
3. DISPENSED MATERIALS MUST BE USED
IMMEDIATELY.

QUALITY MATERIALS

?
+
QUALITY PROCESSING
=
QUALITY PRODUCTS

Processing system …..we produce

well designed and quality
correctly operated….. products
every time

POWDER LEFT ON THE SCOOP WHEN WEIGHING

DIFFERENT COMPONENTS CAN CONTAMINATE THE
PRODUCT AND CAUSE A VERY SERIOUS DRUG
INTERACTION.

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BATCH PRODUCTION RECORDS MUST BE

DOCUMENTS REQUIRED FOR PRODUCTION CAREFULLY FOLLOWED AND
MONITORED…..
1. MANUFACTURING 3. CONTROL
2. BATCH RECORD
MONOGRAPH MONOGRAPH

“RECIPE” “WHAT” “TESTS”

QUALITY CONTROL MANUFACTURING

4. “SOP’s”
……..THROUGHOUT THE PRODUCTION PROCESS

… They tell us
what and how to Manufacturing
produce our Monograph No one changes the SOP’s…
products
Manufacturing and Control
Monographs

SOP’s ...until it has been approved by

the heads of Manufacturing and
Quality Control

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Each step is spelled out in detail FUNCTIONS OF WRITTEN PROCEDURE

Person
STEP RESPONSIBLE DATE
FOR STEP
Responsible for
step

---------------
--------------- Mary Jones Sept. 15, 2008
----------------

1. Instruction 2. Training guideline 3. Reference /

Sample Batch Record checklist

4. Control 5. Reviewer 6. Record

MANUFACTURING AND TWO STEPS MUST BE DONE BEFORE ANY

MANUFACTURING BEGINS.
PACKAGING
STEP 1. ASSIGNMENT OF THE LOT NUMBER TO THE PRODUCT TO
MANUFACTURING AND PACKAGING OPERATION IS BE MANUFACTURED.
THE FINAL STEP OF BUILDING QUALITY INTO THE
PRODUCT. IN THESE OPERATION WE MUST
PRECLUDE POTENTIAL MIX-UPS AND ERRORS AND This number
will identify
CONTAMINATION. PROCEDURES MUST BE that particular
STRICTLY FOLLOWED AND EFFECTIVE CONTROLS product
SHOULD BE IN PLACE. IN-PROCESS CHECKS MUST throughout
BE CARRIED OUT AT SPECIFIC TIME INTERVALS TO manufacturing

MONITOR GMP COMPLIANCE

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LOT NUMBER is the specific identification

THIS LOT NUMBER assigned to each individual lot ……..
IS THE KEY TO THE
We call it the
RECORDED HISTORY OF
THE: “control
number” We call it…
We call it the
“batch number”
We call it the
“lot number”

MANUFACTURING

PROCESSING

PACKAGING

HOLDING AND

DISTRIBUTION OF THE
PRODUCT

LOT BATCH
Can mean It can be a
an entire part of a
batch batch Specific quantity of a drug or other
material, intended to have

-Uniform character and

quality within specific
limits

-Produced according to a
Single manufacturing order

-During the same cycle

some companies split their batches into of manufacture
several lots!!

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From start to
To minimize
finish Wear possibility of
protective bringing in
The lot number remains clothing such
with the batch from start gloves, gown,
cap, mask…
to finish

Must appear on the ..

label
shelf carton
shipping carton For our … foreign
safety materials in
health. the production
area.

This cannot STEP 2. PREPARATION OF EQUIPMENT BEFORE ANY

change
from batch to
MANUFACTURING BEGINS
batch!

All equipment and utensils

must be properly maintained,
cleaned, and records must
be kept.

STRENGTH
OF A All manufacturing equipment, storage
PRODUCT containers and processing lines must be
marked with the product name and lot
number.

BATCH
It is important to carefully measure correct PRODUCTION All major equipment must have ID number
portions when you are dispensing RECORD
recorded in the Batch Record.

ingredients.

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TWO SIGNATURES ARE REQUIRED FOR SIGNIFICANT

STEPS… During manufacturing,
in-process testing is done
by Quality Control to make
sure that the product meets
RESPONSIBLE FOR the specifications in the
PERFORMING THE WORK batch Production Records.
BATCH PRODUCTION
RECORD RESPONSIBLE FOR ….and SOP’s
Quality
CHECKING THE WORK have been
Control
followed and
recorded
where required.

BATCH RECORDS MUST BE FILLED IN AND SIGNED IMMEDIATELY AFTER A

STEP IS DONE.

Q
U

…And we have to A
I’M NOT
approve it. L
MEAN…
I
At any point, adjustments to IM JUST
TOUGH! T
bring the batch up to
specifications may be made Y
according to the SOP’s.
C
O
N
T
R
O
L

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PREPARATION FOR PACKAGING & LABELLING

Ok
LINE CLEARANCE
Ok
GO!! GO!!

Packing lines and Packaging lines must

machines must be be identified with
cleaned and inspected GO!! GO!! proper identifying
Lot Number.

ENSURES THAT THE WORK AREA AND EQUIPMENT ARE

Every thing is ready to roll when Quality Control and Production give the CLEAN AND FREE FROM MATERIALS, RESIDUES OR
approval DOCUMENTS OF THE PREVIOUS PRODUCT

COMPONENTS TO BE USED MUST BE CHECKED AND VERIFIED

It’s All AGAINST THE PACKAGING ORDER.

here!! -IDENTITY

The packaging - QUALITY

department
follows the -QUALITY
packaging directions CONTROL
for each RELEASE
individual lot.

This includes
affixing the lot
number and Packaging
expiration date. Order

The packaging directions are very important part of the PACKAGING DEPT.
Batch Production Record.

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PRODUCT CONTAINERS MUST BE MADE OF

WHAT’S SUBSTANCES……………………..
THIS!!!
ERRRrrrr…

Empty containers must not be used to store things that

don’t belong in them…these must be cleaned immediately ………….THAT WILL NOT REACT WITH OR ABSORB ANY
and covered during storage! COMPONENTS THEY CONTACT.

CONTAINERS ARE CONTAMINATED BY IMPROPER

It’s no Everything is CLEANING
use!!! tightly sealed!!
CONTAMINATE!
!

ALL CONTAINERS MUST PROVIDE

WE MUST HAVE SOP ON CLEANING CONTAINERS
PROTECTION FROM EXTERNAL
CONTAMINATION

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IF CONTAINERS ARE NOT STURDY, AND IF THE

ALL CONTAINERS MUST BE STORED SAFELY ………………. COVERS OR LIDS DO NOT CLOSE TIGHTLY….

WHICH COULD
REDUCE THE
IT COULD CAUSE STRENGTH
DETERIORATION
… OF THE
PRODUCT!!!

…………….TO PREVENT DAMAGE AND CONTAMINATION

Account for all materials used in production….

 Name of Product
 Control Number CARTONS ARE
 Quantity TIGHTLY
SEALED
All materials must reconcile…

* usage in each batch

After * returned to inventory

packaging * scrap
and labeling
are * samples

completed…

Hold for
Release
Reconciliation to within +/- % is acceptable.

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We must make sure…packages in batch are correctly DESTROYED LABELS MUST BE ACCOUNTED FOR AND SIGNED FOR
labeled and packaged IN THE APPROPRIATE FORM.
It’s gotta’ Be
Correct!

WHY….WHEN….BY WHOM….AND NOTATION OF THE PRODUCT AND

LOT NUMBER.

• PRODUCTS PRIOR TO RELEASE
SHOULD MEET THE PHYSICAL AND
CHEMICAL STANDARDS.
• SELF- INSPECTION AND SPOT
CHECKS INCLUDING REVIEW OF
BATCH RECORDS SHOULD
DEMONSTRATE THAT PRODUUCTION
AND TESTING HAVE COMPLIED WITH
RELEVANT REQUIREMENTS.
COMPLAINTS
• ALL COMPLAINTS AND OTHER
INFORMATION CONCERNING
POTENTIALLY DEFECTIVE PRODUCT
MUST BE CAREFULLY REVIEWED AND
INVESTIGATED ACCORDING TO
WRITTEN PROCEDURES.

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Records of complaints and results of investigation must be Any complaints of a product is automatically Investigated.
kept…

The entire Batch Production Record and Batch Control

……for at least one year after the expiry date or Record must be reviewed.
according to policy

Nature of Complaint

Name and Address Product

• THE SOURCE AND CONTENT OF DEFICIENCIES, of person complaining Name
REMEDIAL MEASURES TAKEN AND TESTS
PERFORMED SHOULD BE DOCUMENTED IN WRITING
AND ADDED TO THE BATCH RECORDS. Result of
• CONSIDERATION SHOULD BE GIVEN TO CHECK IF investigation
and follow-up its strength
OTHER BATCHES COULD BE AFFECTED AND TO
CEASE SUPPLY UNTIL THE PROBLEM IS FULLY Record of complaint
INVESTIGATED. Lot Number
If no investigation…
• PRODUCT RECALL SHOULD BE INITIATED IF reason why and the name
of the person making the
DEFICIENCY IS POTENTIALLY HARMFUL TO HEALTH.
decision Reply

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• THE PROGRESS OF RECALL SHOULD
BE RECORDED.
• A FINAL REPORT SHOULD BE ISSUED,
INCLUDING RECONCILIATION
BETWEEN THE DELIVERED AND
RECOVERED QUANTITIES OF THE
QUESTIONABLE PRODUCT.
STABILITY PROGRAM
• THE STABILITY OF PRODUCTS
SHOULD BE MONITORED ACCORDING
TO A CONTINUOUS APPROPRIATE
PROGRAM THAT WILL PERMIT
DETECTION OF ANY INSTABILITY
ASSOCIATED WITH THE
FORMULATION IN THE MARKETED
PACKAGE.

• THE ON GOING OR REAL TIME

STABILITY PROGRAM AIMS TO
MONITOR THE PRODUCT OVER ITS
SHELF LIFE AND TO DETERMINE IF
THE PRODUCT REMAINS OR CAN BE
EXPECTED TO REMAIN WITHIN
SPECIFICATION UNDER THE
LABELLED STORAGE CONDITIONS.

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