GOOD MANUFACTURING PRACTICE

We are knowledgeable, but we do

need our work to be guided by stated
expectations. All aspects of a complex
society require rules.
GOOD MANUFACTURING PRACTICE
-Developed in the 1960s
-Part of the Food, Drug, and Cosmetic act
-Has the force and effect of law

THESE REGULATIONS HAVE THE

FORCE AND EFFECT OF LAW
 OUR EQUIPMENT OUR BUILDING

THE PRODUCTION &

OUR RECORDS
DISTRIBUTION OF OUR
PRODUCTS

LABELLING &
HOW WE PURCHASE AND STORE RAW PACKAGING
MATERIALS
SHARED RESPONSIBILITY OF
ESTABLISHMENT AND EMPLOYEES

Report any injury or illness immediately to

your supervisor.
TO COMPLY WITH GMP
Establishment must provides:
1. Sufficient Space
2. Physical Separation
3. Adequate Lighting
4. Adequate Ventilation
5. Equipment, utensils
6. Adequate facilities for every operations
 WORKERS AND EMPLOYEES

Take necessary steps and follow procedures to

assure sanitary and safe operation of the plant.
 HYGIENE AND SANITATION
WHY IS HYGIENE AND SANITATION IMPORTANT?

Man is a natural carrier of microorganisms. These are

expelled when we

SNEEZE
COUGH

YAWN TALK
 MICROORGANISMS ARE IN MANS HAIR, SKIN,
INTESTINES, URINE, UNDERNEATH FINGERNAILS.

We collect more microorganisms as we travel

from home to our destination due to dust, smoke
generated by vehicles and contact with dirty
items. It is therefore important that we observe
good hygiene and sanitation to avoid
contamination of products we handle.
PLANT UNIFORM

Cover street clothes

that contain
contaminants,
organisms you collect
on your way to the
plant. Cover your
exposed skin which
sheds particles with
germs.
Cover your hair which
have dust & germs.
Prevent hair from falling
into the product.

Cover the nose and mouth

which are natural
reservoir of germs. Trap
particles or droplets from
the nose and mouth.
Street shoes contain
germs from the soil
and dirt we stepped
on, so it must not be
worn inside the plant,
plant shoes must be
used instead.

Cover finger nails and

hands which have
germs.
WHY USE RUBBER
GLOVES???

It prevents microorganism transfer from

our hands to the product we handle.

It prevents transfer of product dust to

our hands.
WHY CANT WE USE COTTON
GLOVES???

It is porous and will not prevent transfer

of microorganisms and perspiration to
the product we handle.

It permits transfer of product dust to

our hands.
1) Place gloves in a clean plastic bag during break time.

2) Wash gloves with soap and water after use. Dry and sanitize.
3) Change gloves for every product
change.

4) Torn gloves or those with holes

should not be used
*Wash hands with soap
and water

After using the toilet

Before starting to work
After blowing your nose
After handling dirty things
After touching body surface
After eating
-Dont touch or scratch your nose, head, body parts while
handling products.

-Cover your nose, mouth when sneezing, coughing, yawning.

-Avoid talking and use mask if necessary.

-Observe good toilet practices by:

-Flushing the toilet after use
-Washing hands with soap and water
1. Remove visible dirt.

2. Rinse with water.

3. Wash with soap and water.

4. Rinse with water

5. Sanitize.
6. Dry hands.
 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.
 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

over and other rubbish 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.
1) Use the product container for the intended product only. Dont
use it for glue, oil, soap, etc.
2) Be in your work assignment all the time. Dont attempt to transfer
to adjacent packing lines to help as you may not be properly
trained to do the job.
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.)
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) Dont touch nose, head or any body parts while handling products.
10) Dont 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 the supervisor. In case of doubt,
seek the help of the supervisor.
15) Dont eat or chew gums while in the work area.
16) Notify supervisor promptly if there is an accidental contamination of
product contact surfaces.
 Cross-
Rushing a Job may cause Contamination

LOOK OUT!!!

This is a RUSH job!

Mix-Ups and Errors too!

 Premises/building must be designed and
constructed to facilitate company
productivity, employee safety and product
quality.
Plant site should be carefully selected
considering the physical terrain and the
ground surrounding it.
GMP REQUIREMENTS:
1. Separate area for specific operation.
2. Easy to clean.
3. Easy to maintain.
4. Easy to operate.
5. Adequate space
6. Eliminate unnecessary traffic

Inadequate space and unnecessary traffic cause mix-up and

errors.
 GMP REGULATION:
Defined area for
a. Receiving of materials
b. Storage of materials
c. Quality control laboratory
d. Manufacturing area
e. In-process storage
f. Packaging area
g. Quarantine area
 LIGHTING
-Light all Areas
-Adequate for our needs
-With back-up
 WATER SYSTEM

- STEADY PRESSURE
- FREE OF
PROBLEMS
- NO DRAINAGE
BACK-FLOW
Waste
materials must
be removed and
disposed of in a
safe and
sanitary
manner.
Building must be maintained and kept
in good condition. There must be a
regular housekeeping.
 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.
 People should know how to perform the job
right the first time and every time.
They must have the knowledge to perform
their job and the skills required by the job.
People must have personal responsibility to
develop personal competence.
 Its a CGMP
Regulation

That all of us receive

training in the
procedures relating
to our job and in the
cGMP regulations.
SOLUTIONS
IMPROVE
INSPECTION
METHODS
 Sufficient Training Experience
Education

Adequate number
to perform assigned task or function to give
assurance of product quality, identity, purity.
Sufficient
Education
Training Experience

Adequate number
to perform assigned task or function
TRAINED PERSONNEL=QUALITY PERFORMANCE
=CONTINUAL IMPROVEMENT

LESS PRONE TO ERRORS

LESS DEVIATIONS FROM STANDARDS

REDUCE AMOUNT OF REWORK

REDUCE AMOUNT OF REJECTS

1. EACH INDIVIDUAL SHOULD HAVE A
TRAINING PLAN.

2. COURSES AND TOPICS SHOULD BE LINKED

TO THEIR CURRENT JOBS.

3. CONTENTS OF EACH COURSE SHOULD BE

DOCUMENTED AND APPROVED BY
MANAGEMENT.

4. PLAN FOR RETRAINING.

 What we learn What we Remember

1% by taste 1% of what we read

1,5% by skin senses 20% of what we have

heard
3,5% by smell 30% of what we have
seen
11% by smelling 50% of what we have
heard and seen
83% by vision
 KNOW YOUR COMPANY
- Its products, policies and services.

READ
COMPANY
MANUAL
REGULAR PHYSICAL EXAMINATION OR
HEALTH CHECKS
PRACTICE GOOD SANITATION AND HEALTH
HABITS
WEAR PROTECTIVE CLOTHING AS
NECESSARY

GOWN
GOGGLES
MASK
GLOVES
HEAD CAP
 ADEQUATE PERSONAL RECORDS
Name
Address
Qualification
Signature
 UNDERSTAND THE REQUIREMENTS
And demands of your job. Determine how you
can do your job most efficiently.
 SOPs
RECORDS

.AND SO ARE THE RECORDS WE KEEP!

 AVOID/MINIMIZE MIX-UPS
AND ERRORS

ENSURE CONSISTENT
QUALITY

ENSURE COMPLIANCE WITH

GMP REGULATION
When did I
do. that?

RECORDS MUST BE FILLED OUT AT THE TIME WE

COMPLETE THE JOB!!!
FOLLOW
S.O.P.s

BFAD INSPECTORS ASK TO SEE OUR TRAINING

RECORDS.
FOLLOW
SOPS!!!

AND WHERE REQUIRED, SUPPLEMENTED BY A REVIEW

TRAINING COURSE.
1. EDUCATION AND
TRAINING

2. ON-THE-JOB
EXPERIENCE
 COMPETENCE
IS DEMONSTRATED BY
SUCCESSFUL

JOB PERFORMANCE
WEBSTER
1. Having ability or qualities
2. Legally qualified or able

DR. LAWRENCE J. PETER

(PETER PRINCIPLE)
COMPETENCE like truth, beauty and contact lenses,
is in the eye of the beholder.
 NUMBER OF SUCCESSES?

NUMBER OF FAILURES?

PROMPTNESS OF ACTION?

LEADTIME?

QUALITY OF ACTION?
 Proof of Successful Performance

1. DOCUMENTATION AFTER COMPLETION OF EACH STEP

2. VALIDATION OF SYSTEMS, EQUIPMENT AND PROCESSES

ON THE JOB EXPERIENCE
MUST
DO

MUST
KNOW
PERFORMANCE
PRIDE
PROOF
PART 2
Equipment design must be carefully examined.
Dedicated equipment should be used for
products which are difficult to remove, difficult
to clean and for products with a high safety
risk.
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.
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.
 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 dont belong to

them.
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.
MUST NOT REACT WITH OR ABSORB ANY OF THE
COMPONENTS THEY CONTACT.
EQUIPMENT MUST BE LOCATED FOR
EASY MAINTENANCE!
 This is an
important
CGMP
Regulation!

Equipment should be designed for the particular

purpose for which it is intended.
 WHEN ?

WHAT ?

WHO ?

EQUIPMENT LOG BOOK

WE DONT DO THINGS THIS WAY!
DONT DO THINGS THIS WAY!
 MAINTENANCE

- RETAIN EQUIPMENT IN ACCEPTABLE

OPERATING CONDITION

- RESTORE EQUIPMENT TO AN ACCEPTABLE

OPERATING CONDITION
 IMPORTANCE OF MAINTENANCE

1. REDUCE DOWNTIME

2. INCREASE PLANT AVAILABILITY

3. INCREASE EFFICIENCY

4. REDUCTION OF MANPOWER
LEVEL

5. REDUCTION OF PRODUCTION
COST
1. RUN TIME IN OPERATING HOURS BEFORE
MAINTENANCE.

2. SEVERITY OF USE

3. VIBRATION DATA

4. EXPECTED LIFE OF COMPONENTS.

IT IS NOT ACCEPTABLE TO WAIT FOR A MACHINE TO

BREAKDOWN BEFORE SERVICING IT. A CLEANED AND WELL
MAINTAINED EQUIPMENT IS MORE RELIABLE AND
PRODUCES LESS NON-CONFORMING PRODUCTS.
 MECHANICAL AND
PRECISION
EQUIPMENT MUST
BE CHECKED
REGULARLY.

ALL AUTOMATIC AND

ELECTRONIC EQUIPMENT
LIKE COMPUTERS MUST
ALSO BE TESTED
AND INSPECTED.
 SEQUENTIAL LOG
NAME OF MACHINE: TAG NO:
CAPACITY:
DATE ACTIVITY DATE STARTED DATE FINISHED SIGNATURE

1-16-09 MFG. RHEA ALC. 1-16-09 1-17-09

BATCH 1234

1-18-09 CLEANING 1-18-09 1-18-09

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

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

1-25-09 VALIDATION OF 1-25-09 1-26-09

NEW MIXTURE

1-26-09 MFG. 1-26-09 1-27-09

ALCOMFORADO
B#1
PREVENTIVE - ROUTINE

- PLANNED

CORRECTIVE - EMERGENCY

- PLANNED

MODIFICATION - PLANNED
 1. PROCEDURES AND SCHEDULES

2. CALIBRATION LOGS

3. EQUIPMENT LOGS

4. DOCUMENTATION OF MAINTENANCE

CLEAN ENVIRONMENT + MAINTAINED EQUIPMENT =

QUALITY PRODUCT
 MAINTENANCE RECORD
NAME OF EQUIPMENT: TAG NO.
DATE INSTALLED:
SUPPLIER:

A. MONTHLY MAINTENANCE
SERVICE JAN. FEB. MAR. APR.

DONE

NOT DONE

REASON

B. QUARTERLY MAINTENANCE

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

DONE

NOT DONE

REASON
 YEARLY MAINTENANCE RECORD

NAME OF EQUIPMENT: TAG NO.

DATE INSTALLED:
SUPPLIER:

SERVICES 2006 2007 2008 2009

DONE

NOT DONE

REASON
 Automatic
&
Electronic
Equipment &
Computers

..RECORDED ON PROPER FORMS!!

 A. PRESENCE OF COMPONENTS
PRESUMED TO BE THERE

B. CONTAMINANTS PRESUMED
MIGHT BE THERE
1.INADEQUATE MANUFACTURING CONTROLS

2. INADEQUATE ENVIRONMENTAL CONTROLS

3. IMPROPER HANDLING
 Maintenance
&
Cleaning
Record

RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE

THE JOB!
 Building quality into the product starts
with components control.
Source, origin and suitability of
components should be clearly defined.
Components should come from qualified
or approved manufacturers.
 Any material
intended for use in
the manufacturing
of our product

Includes packaging
materials as well
as raw materials
 Must come
from approved
suppliers.

We must
control upon
receipt and in
use.

CORRECT SPECIFICATION + CORRECT MATERIALS = CORRECT

PRODUCT
IN GOOD CONDITION

CLEAN AND IDENTIFIED

RAW
RAW
MATLS
MATLS

Intact, no damage
 to ensure that they
conform to
standards.

All containers must be carefully resealed after each

sample has been taken!!!
All new materials must be quarantined until approved for use.

All newly received

materials must be:

Properly identified
and recorded

Examined to make sure

that each container is
still tightly sealed

Examined to make sure

that each container
is not damaged

Examined to make sure

there is no visible sign of
contamination
or impurity
GMP REQUIRES THAT COMPLETE RECORDS ARE KEPT ON ALL NEWLY
RECEIVED COMPONENTS.

Proper identification

When received and inspected?

Who did the inspection?

Who took samples ?

When were they tested?

Who did the test?

?????
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.
After testing and examination by quality control .

It may then be approved and released for manufacturing use!

 Reserve samples for
every approved
component..

Clearly identified
Kept for at least

one year after the

expiration of the
Product

A rejected component must be

properly identified and kept
separate until it is disposed
of.
 Good!!! Makes
Sense!

.an exception may be made if it is temporary and

appropriate.
are the ingredients
that go into our
products

include both
active and
inactive
Has no effect
on the user
Protects the product

Covers up unpleasant odor

Makes product look good

 Makes the
product
effective

With direct effect on the user

 Maybe accepted if analytical
competence has been established

Typical analysis not accepted

Full analysis is a must

Equivalency of testing must be established for new supplier. Supplier

must use same testing methods as the user.
 BULK MATERIALS

IT IS PERMISSIBLE TO MIX DELIVERIES OF A MATERIAL IN A SINGLE TANK

PROVIDED:

- THE TANK IS EMPTY AND CLEAN BEFORE THE FIRST DELIVERIES

- ALL DELIVERIES ARE WITHIN SPECIFICATION BEFORE UNLOADING.

- NONE OF THE MATERIAL IS USED UNTIL ALL OF THE DELIVERIES ARE

ANALYZED

- A SINGLE CONTROL NUMBER IS ASSIGNED TO THE ENTIRE TANK

PACKAGING MATERIALS
Includes such
Items as:
All the materials
used in the Caps
packaging of a Bottles
product Labels
Inserts
Boxes
Bags
Wrappers
Droppers
Shippers
Seal
Plugs
 STORAGE
SIMILAR PRINTED MATERIALS SPATIALLY SEGREGATED IN
ORDER TO PREVENT MIX-UP

LABELS MUST BE STORED IN SEPARATE AREA TO PREVENT LABELS OF

DIFFERENT PRODUCT, STRENGTH OR QUANTITIES BEING MIXED
AND CAUSE ERROR IN PRODUCTION

RETURNS FROM PACKAGING MUST BE CHECKED AND IDENTIFIED

BEFORE RETURNING TO STOCK

DAMAGED AND REJECTED MUST BE DESTROYED IN WAY THAT WILL

MAKE THE MATERIAL UNUSABLE
 LABELS AND PRINTED MATERIALS

SHOULD HAVE IDENTIFYING CODE NUMBER OR MARKS

MUST BE CHECKED AGAINST A STANDARD OR ARTWORK UPON RECEIPT

OBSOLETE MATERIALS MUST BE REMOVED FROM THE CONTROL SYSTEM

AND INVENTORY

SPECIMEN MUST BE SIGNED OFF BY QA TO INDICATE APPROVAL

LIMITED ACCESS TO LABEL STORAGE

LABELS AND PRINTED MATERIALS ISSUED ONLY WHEN AUTHORIZED

KNOW NUMBER OF LABELS USED AND RECONCILE USAGE

 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
 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
 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
 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.
 MASTER FORMULA

TO ASSURE UNIFORMITY FROM BATCH TO

BATCH IT SHALL BE PREPARED BY ONE
PERSON, DATED AND SIGNED(FULL
SIGNATURE, HANDWRITTEN) AND
INDEPENDENTLY CHECKED, DATED AND
SIGNED BY A SECOND PERSON.
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
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
4. INSTRUCTION FOR IN-PROCESS CONTROLS
5. STATE STORAGE CONDITION, INCLUDING THE
CONTAINER TO BE USED, LABELLING, ETC.
6. PROVISION FOR SIGNATURES AND CHECKS FOR
EACH STEP OF PROCESSING
7. SPECIAL PRECAUTIONS
8. STATE MINIMUM AND MAXIMUM PRECENTAGES
OF THEORETICAL YIELD, BEYOND WHICH
INVESTIGATION IS CARRIED OUT.
9. IDENTIFICATION OF THE PERSONS PERFORMING
DIRECTLY, SUPERVISING OR CHECKING EACH
SIGNIFICANT STEP.
PACKAGING INSTRUCTIONS

MUST BE PREPARED FOR EACH PRODUCT, PACK SIZE AND

TYPE.
SHALL INCLUDE:
1.NAME OF PRODUCT
2.STRENGTH AND DESCRIPTION OF THE PRODUCT
3.PACK SIZE EXPRESSED IN TERMS OF NUMBER OR
WEIGHT OR VOLUME OF THE FINAL PRODUCT IN THE
CONTAINER
4.COMPLETE LIST OF ALL PACKAGING MATERIALS
REQUIRED FOR A STANDARD BATCH SIZE, INCLUDING
QUANTITIES, SIZES, TYPES, WITH CODES OR
REFERENCE NUMBER RELATING TO THE
SPECIFICATION OF THE MATERIAL
5 .A STATEMENT WHERE TO INDICATE LOT
NUMBER AND EXPIRY DATE
6. SPECIAL PRECAUTIONS
7. DESCRIPTION OF THE PACKAGING OPERATION AND
EQUIPMENT TO BE USED
8. DETAILS OF IN-PROCESS CONTROLS AND SAMPLING AND
ACCEPTANCE LIMITS
9. DESCRIPTION OF THE PRODUCT CONTAINER AND
CLOSURE
10. YIELD AND PERCENTAGE OF THEORETICAL YIELD
REQUIREMENTS:
A. RAW MATERIALS
MUST BE APPROVED BY Q.C.
MUST BE THE LOT NUMBER SPECIFIED IN MO.
MUST NOT SHOW EVIDENCE OF TAMPERING OR
DETERIORATION.

B. CONTAINERS
NEW PLASTIC OR PE BAG.
FOR LIQUIDS, STAINLESS STEEL CONTAINER WITH COVER.
MUST BE CLEANED, SANITIZED AND DRIED.
C. BALANCE
MUST BE CALIBRATED
MUST BE CLEANED
MUST BE SENSITIVE ENOUGH FOR THE AMOUNT BEING
WEIGHED.
D. WEIGHING TOOLS
SCOOPS MUST BE STAINLESS STEEL.
MUST BE CLEANED, SANITIZED AND DRIED BEFORE USE.
ONE MATERIAL PER SCOOP; TO BE CLEANED BEFORE USE
FOR OTHER MATERIAL.
E. WEIGHING
BRING IN ONE MATERIAL AT A TIME (CLEAN THE CONTAINER
OUTSIDE )
ZERO THE BALANCE
TARE THE CONTAINER AND RECORD THE WEIGHT.
 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.
F. 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
D. DISPENSING ATTIRE
LONG GOWN
MASK
CAP
GLOVES
E. 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.
 ?

POWDER LEFT ON THE SCOOP WHEN WEIGHING DIFFERENT

COMPONENTS CAN CONTAMINATE THE PRODUCT AND CAUSE A
VERY SERIOUS DRUG INTERACTION
 QUALITY MATERIALS
+
QUALITY PROCESSING
=
QUALITY PRODUCTS

Processing system ..we produce

well designed and quality
correctly operated.. products
every time
1. MANUFACTURING 3. CONTROL
2. BATCH RECORD
MONOGRAPH MONOGRAPH

RECIPE WHAT TESTS

4. SOPs
QUALITY CONTROL MANUFACTURING

..THROUGHOUT THE PRODUCTION PROCESS

 They tell us what
and how to Manufacturing
produce our Monograph
products

SOPs
 No one changes the SOPs
Manufacturing and Control
Monographs

...until it has been approved by

the heads of Manufacturing and
Quality Control
 Each step is spelled out in detail

Person
STEP RESPONSIBLE DATE
FOR STEP
Responsible for
step

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

Sample Batch Record

 FUNCTIONS OF WRITTEN PROCEDURE

1. Instruction 2. Training guideline 3. Reference / checklist

4. Control 5. Reviewer 6. Record

 MANUFACTURING AND PACKAGING OPERATION IS
THE FINAL STEP OF BUILDING QUALITY INTO THE
PRODUCT.

IN THESE OPERATION WE MUST PRECLUDE POTENTIAL

MIX-UPS AND ERRORS AND CONTAMINATION.

PROCEDURES MUST BE STRICTLY FOLLOWED AND

EFFECTIVE CONTROLS SHOULD BE IN PLACE.

IN-PROCESS CHECKS MUST BE CARRIED OUT AT

SPECIFIC TIME INTERVALS TO MONITOR GMP
COMPLIANCE
 TWO STEPS MUST BE DONE BEFORE ANY
MANUFACTURING BEGINS.

STEP 1. ASSIGNMENT OF THE LOT NUMBER TO THE PRODUCT TO

BE MANUFACTURED.

This number will

identify that
particular product
throughout
manufacturing
 THIS LOT NUMBER
IS THE KEY TO THE
RECORDED HISTORY OF
THE:

MANUFACTURING

PROCESSING

PACKAGING

HOLDING AND

DISTRIBUTION OF THE
PRODUCT
 LOT NUMBER is the specific
identification assigned to each
individual lot .. We call it the
control number
We call it
We call it the
batch number
We call it the lot
number
Can mean It can be a
an entire part of a
batch batch

some companies split their batches into

several lots!!
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

of manufacture
From start to
finish
The lot number remains
with the batch from start
to finish

Must appear on the ..

label
shelf carton
shipping carton
 To minimize
Wear possibility of
protective bringing in
clothing such
gloves, gown,
cap, mask

For our foreign

safety materials in the
health. production area.
 This cannot
change
from batch to
batch!

STRENGTH OF
A PRODUCT

It is important to carefully measure correct

portions when you are dispensing
ingredients.
STEP 2. PREPARATION OF EQUIPMENT BEFORE ANY
MANUFACTURING BEGINS

All equipment and utensils

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

All manufacturing equipment, storage

containers and processing lines must
be be marked with the product name and
lot number.

BATCH
All major equipment must have ID
PRODUCTION number
RECORD recorded in the Batch Record.
TWO SIGNATURES ARE REQUIRED FOR SIGNIFICANT STEPS

RESPONSIBLE FOR
PERFORMING THE WORK

BATCH PRODUCTION RECORD RESPONSIBLE FOR

CHECKING THE WORK

BATCH RECORDS MUST BE FILLED IN AND SIGNED IMMEDIATELY AFTER A

STEP IS DONE.
During manufacturing,
in-process testing is done
by Quality Control to make
sure that the product meets
the specifications in the
batch Production Records.

.and SOPs have

Quality
been
Control
followed and
recorded
where required.
 And we have to
approve it.
At any point, adjustments
to bring the batch up to
specifications may be made
according to the SOPs.
 Q
U
A
IM NOT
L
MEAN
IM JUST I

TOUGH! T
Y

C
O
N
T
R
O
L
LINE CLEARANCE

ENSURES THAT THE WORK AREA AND EQUIPMENT ARE CLEAN AND
FREE FROM MATERIALS, RESIDUES OR DOCUMENTS OF THE PREVIOUS
PRODUCT
 Its All here!!

The packaging
department
follows the
packaging directions
for each
individual lot.

This includes
affixing the lot
number and
expiration date.

The packaging directions are very important part of the

Batch Production Record.
COMPONENTS TO BE USED MUST BE CHECKED AND VERIFIED
AGAINST THE PACKAGING ORDER.

- IDENTITY

- QUALITY

- QUALITY
CONTROL
RELEASE

Packaging
Order

PACKAGING DEPT.
 WHATS THIS!!!
ERRRrrrr

Empty containers must not be used to store things that

dont belong in themthese must be cleaned
immediately and covered during storage!
PRODUCT CONTAINERS MUST BE MADE OF
SUBSTANCES..

.THAT WILL NOT REACT WITH OR ABSORB ANY

COMPONENTS THEY CONTACT.
Its no Everything is
use!!! tightly sealed!!

ALL CONTAINERS MUST PROVIDE

PROTECTION FROM EXTERNAL
CONTAMINATION
 CONTAINERS ARE CONTAMINATED BY IMPROPER
CLEANING

CONTAMINATE!!

WE MUST HAVE SOP ON CLEANING CONTAINERS

 ALL CONTAINERS MUST BE STORED SAFELY .

.TO PREVENT DAMAGE AND CONTAMINATION

 WHICH COULD
REDUCE THE
IT COULD CAUSE STRENGTH
DETERIORATION
OF THE
PRODUCT!!!
 Name of Product
Control Number CARTONS ARE
Quantity TIGHTLY
SEALED

After packaging
and labeling are
completed

Hold for
Release
Account for all materials used in production.

All materials must reconcile

* usage in each batch

* returned to inventory

* scrap

* samples

Reconciliation to within +/- % is acceptable.

We must make surepackages in batch are correctly labeled and packaged

Its gotta Be
Correct!
DESTROYED LABELS MUST BE ACCOUNTED FOR AND SIGNED FOR IN
THE APPROPRIATE FORM.

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 production and testing have complied
with relevant requirements.
 All complaints and other information
concerning potentially defective product must
be carefully reviewed and investigated
according to written procedures.
Records of complaints and results of investigation must
be kept

for at least one year after the expiry date or according to policy
Any complaints of a product is automatically Investigated.

The entire Batch Production Record and Batch Control

Record must be reviewed.
 The source and content of deficiencies, remedial
measures taken and tests performed should be
documented in writing and added to the batch
records.

Consideration should be given to check if other

batches could be affected and to cease supply until
the problem is fully investigated.

Product recall should be initiated if deficiency is

potentially harmful to health.
 Nature of Complaint

Name and Address Product

of person complaining Name

Result of
investigation
and follow-up its strength

Record of complaint
Lot Number
If no investigation
reason why and the name
of the person making the
decision Reply
 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.
 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.
THE END