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WHAT IS GMP ? GOOD MANUFACTURING PRACTICE

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Page 2: Back To Basic Gmp

WHY DO WE NEED GMP?

BAKIT KAILANGAN ANG GMP?

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TYPES OF CONTAMINATION

1. PARTICULATES

2. MICROORGANISMS

3. CROSS-CONTAMINATION

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TYPES OF CONTAMINANTS• PARTICULATES

(Pira-pirasong bagay)dust, dirt, paper, metal, fibers, etc.

• MICROORGANISMS (Mikrobyo)

bacteria, yeasts, molds

• CROSS-CONTAMINATION (Pag halo sa iba’t-ibang produkto)

labels, cartons, foil, materials, etc.

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SOURCES OF CONTAMINATION

AIR , WATER, SURFACES,PEOPLE,PESTS

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•IMPURE•UNCLEAN•UNFIT FOR USE

CONTAMINATION

PEOPLE CONTAMINATIONCAUSE

HEH! HEH!

HEH!

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CGMP REGULATION

Report any injury or illness immediately to your supervisor.

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MICROORGANISMS CAN BE 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, storage areas warehouse, etc.

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CROSS - CONTAMINATION

… BUT IT WAS ONLY

A FEW OUNCES

… a few ounces? THE

WHOLE BATCH IS

CONTAMINATED

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GMP………….…

SHARED RESPONSIBILITY OF ESTABLISHMENT AND EMPLOYEES

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TO COMPLY WITH GMP …Establishment provides

Sufficient SpacePhysical SeparationAdequate LightingAdequate VentilationEquipment, utensilsAdequate facilities

for every operations

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WORKERS AND EMPLOYEES

Take necessary steps and follow procedures to assure sanitary and safe operation of the plant.

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MICROORGANISMS ARE IN MAN’S 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.

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Cover street clothes that contain contaminants, organisms you collect on your way to the plant. Cover your exposed skin which sheds particles with germs.

PLANT UNIFORM

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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.

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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.

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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.

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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.

WHY CAN’T WE USE COTTON GLOVES???

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HANDLING OF GLOVES

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

2) Wash gloves with soap and water after use. Dry and sanitize.

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3) Change gloves for every product change.

4) Torn gloves or those with holes should not be used

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HYGIENE AND SANITATION PRACTICES

*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

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-Don’t 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

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HOW TO WASH YOUR

HANDS

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1. Remove visible dirt.

2. Rinse with water.

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3. Wash with soap and water.

4. Rinse with water

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5. Sanitize.

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6. Dry hands.

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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.

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-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.

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GMPIN THE WORK AREA

1) Use the product container for the intended product only. Don’t use it for glue, oil, soap, etc.

2) 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.

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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.

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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.

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14) Follow strictly the instruction given by the supervisor. In case of doubt, seek the help of the supervisor.

15) Don’t eat or chew gums while in the work area.

16) Notify supervisor promptly if there is an accidental contamination of product contact surfaces.

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BACTERIA

Bacilli Bacterial Spores

Molds

Pneumococci

Yeast

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Mix-Ups and Errors too!

Rushing a Job

Cross-Contamination

LOOK OUT!!!

This is a RUSH job!

may cause

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GOOD MANUFACTURING PRACTICE-Developed in the 1960’s-Part of the Food, Drug, and

Cosmetic act-Has the force and effect of law

THESE REGULATIONS HAVE THE FORCE AND EFFECT OF LAW

CGMP Regulations

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BFAD IS RESPONSIBLE FOR SEEING THAT OUR COMPANY COMPLIES WITH CGMP REGULATIONS.

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IF WE HAVE NOT FOLLOWED

CGMP REGULATIONS

BFAD HAS THE AUTHORITY TO RECOMMEND

RECALL

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HOW WE PURCHASE AND STORE RAW MATERIALS

CG

MP

OUR BUILDING

LABELLING & PACKAGING

THE PRODUCTION & DISTRIBUTION OF OUR PRODUCTS

OUR RECORDS

OUR EQUIPMENT

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PREMISES• 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.

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BUILDING PREMISESGMP REQUIREMENTS:

1. Separate area for specific operation.2. Easy to clean.3. Easy to maintain.4. Easy to operate.5. Adequate space6. Eliminate unnecessary traffic

Inadequate space and unnecessary traffic cause mix-up and errors.

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GMP REGULATION: Defined area fora. Receiving of materialsb. Storage of materialsc. Quality control laboratoryd. Manufacturing areae. In-process storagef. Packaging areag. Quarantine area

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GMP REGULATION

-Light all Areas-Adequate for our needs-With back-up

LIGHTING

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GMP REGULATION

WATER SYSTEM

- STEADY PRESSURE- FREE OF PROBLEMS

- NO DRAINAGE BACK-FLOW

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GMP REGULATION

Waste materials must be removed and disposed of in a safe and sanitary manner.

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GMP REGULATION

Building must be maintained and 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.

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• 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.

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PERSONNEL

• 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.

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That all of us receive training in the procedures relating to our job and in the cGMP regulations.

It’s a CGMP

Regulation

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Proper Training in relation to their assigned task or function

•SOLUTIONS•IMPROVE INSPECTION METHODS

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Engaged in supervision of manufacture processing, packing and holding of

product

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

Sufficient Education Training Experienc

e

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Engaged in manufacture, processing, packing and holding of product

Adequate number……to perform assigned task or function

Sufficient Education Training Experienc

e

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TRAINED PERSONNEL=QUALITY PERFORMANCE =CONTINUAL IMPROVEMENT

LESS PRONE TO ERRORS

LESS DEVIATIONS FROM STANDARDS

REDUCE AMOUNT OF REWORK

REDUCE AMOUNT OF REJECTS

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TRAINING PROGRAM1. 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.

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Confucius…

I hear and I forgetI see and I rememberI do and I understand

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PATTERN OF LEARNING AND REMEMBERINGWhat we learn What we

Remember1% by taste 1% of what we read1,5% by skin senses 20% of what we have

heard3,5% by smell 30% of what we have

seen11% by smelling 50% of what we have

heard and seen83% by vision

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KNOW YOUR COMPANY- Its products, policies and

services.READ

COMPANY MANUAL

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REGULAR PHYSICAL EXAMINATION OR HEALTH CHECKS

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PRACTICE GOOD SANITATION AND HEALTH HABITS

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WEAR PROTECTIVE CLOTHING AS NECESSARY

•GOWN•GOGGLES•MASK•GLOVES•HEAD CAP

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ADEQUATE PERSONAL RECORDS•Name •Address•Qualification•Signature

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UNDERSTAND THE REQUIREMENTSAnd demands of your job. Determine how

you can do your job most efficiently.

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FOLLOWING SOP’S IS VITAL

…….AND SO ARE THE RECORDS WE KEEP!

•SOP’s•RECORDS

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REASONS FOR WRITING PROCEDURES

• AVOID/MINIMIZE MIX-UPS AND ERRORS

• ENSURE CONSISTENT QUALITY

• ENSURE COMPLIANCE WITH GMP REGULATION

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ACCURATE RECORD KEEPING IS VITAL …….

RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE THE JOB!!!

When did I do…. that?

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TRAINING MUST BE REINFORCED BY THE SUPERVISOR…..

BFAD INSPECTORS ASK TO SEE OUR TRAINING RECORDS….

FOLLOW S.O.P.‘s

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cGMP TRAINING MUST BE REINFORCED BY ON THE JOB SUPERVISION

AND WHERE REQUIRED, SUPPLEMENTED BY A REVIEW TRAINING COURSE.

FOLLOW SOP’S!!!

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DEVELOPING COMPETENCE

1. EDUCATION AND TRAINING

2. ON-THE-JOB EXPERIENCE

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COMPETENCE

IS DEMONSTRATED BY SUCCESSFUL

JOB PERFORMANCE

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DEFINITION OF COMPETENCE

WEBSTER1. Having ability or qualities2. Legally qualified or able

DR. LAWRENCE J. PETER(PETER PRINCIPLE)“COMPETENCE like truth, beauty and contact lenses, is in the eye of the beholder.”

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MEASURE OF COMPETENCE• NUMBER OF SUCCESSES?

• NUMBER OF FAILURES?

• PROMPTNESS OF ACTION?

• LEADTIME?

• QUALITY OF ACTION?

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1. DOCUMENTATION AFTER COMPLETION OF EACH STEP

2. VALIDATION OF SYSTEMS, EQUIPMENT AND PROCESSES

Proof of Successful Performance

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DEMONSTRATE COMPETENCE

ON THE JOB EXPERIENCE

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Y O U R J O B

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THREE P’s OF GMPPERFORMANCEPRIDEPROOF

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EQUIPMENTEquipment 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.

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EQUIPMENTREQUIREMENTS:

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.

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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.

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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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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.

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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.

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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.

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Equipment should be designed for the particular purpose for which it is intended.

This is an important

CGMP Regulatio

n!

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WHEN ?

WHAT ? WHO ?

EQUIPMENT LOG BOOK

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WE DON’T DO THINGS THIS WAY!

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DON’T DO THINGS THIS WAY!

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MAINTENANCE

- RETAIN EQUIPMENT IN ACCEPTABLE OPERATING CONDITION

- RESTORE EQUIPMENT TO AN ACCEPTABLE OPERATING CONDITION

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• IMPORTANCE OF MAINTENANCE

1.REDUCE DOWNTIME

2. INCREASE PLANT AVAILABILITY

3. INCREASE EFFICIENCY

4. REDUCTION OF MANPOWER LEVEL

5. REDUCTION OF PRODUCTION COST

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FOLLOW SOP’s …………………

……. WHEN CLEANING EQUIPMENT

GOOD JOB!

THANK YOU!

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BFAD CAN

HOLD US

RESPONSIBLE

FOR ANY

CGMP

VIOLATION.

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FACTORS TO CONSIDER IN DEVELOPING MAINTENANCE PROCEDURES

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.

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EQUIPMENT MAINTENANCE

MECHANICAL ANDPRECISION

EQUIPMENT MUSTBE CHECKED REGULARLY.

ALL AUTOMATIC ANDELECTRONIC EQUIPMENTLIKE COMPUTERS MUST

ALSO BE TESTEDAND INSPECTED.

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DATE ACTIVITY DATE STARTED

DATE FINISHED

SIGNATURE

1-16-09 MFG. RHEA ALC. BATCH

1234

1-16-09 1-17-09

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

1-19-09 MFG. RHEA ALCOLOGNE

B#5

1-19-09 1-19-09

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 NEW MIXTURE

1-25-09 1-26-09

1-26-09 MFG. ALCOMFORAD

O B#1

1-26-09 1-27-09

SEQUENTIAL LOGNAME OF MACHINE: TAG NO:CAPACITY:

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TYPES OF MAINTENANCE

PREVENTIVE - ROUTINE

- PLANNED

CORRECTIVE - EMERGENCY

- PLANNED

MODIFICATION - PLANNED

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MAINTENANCE RECORD

1. PROCEDURES AND SCHEDULES

2. CALIBRATION LOGS

3. EQUIPMENT LOGS

4. DOCUMENTATION OF MAINTENANCE

CLEAN ENVIRONMENT + MAINTAINED EQUIPMENT = QUALITY PRODUCT

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MAINTENANCE RECORDNAME OF EQUIPMENT: TAG NO.DATE INSTALLED:SUPPLIER:

SERVICE JAN. FEB. MAR. APR.DONE

NOT DONE

REASON

A. MONTHLY MAINTENANCE

B. QUARTERLY MAINTENANCE

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

NOT DONE

REASON

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YEARLY MAINTENANCE RECORD

NAME OF EQUIPMENT: TAG NO.DATE INSTALLED:SUPPLIER:

SERVICES 2006 2007 2008 2009

DONE

NOT DONE

REASON

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REGULAR MAINTENANCE CHECKS…..

………..RECORDED ON PROPER FORMS!!

Mechanical

Equipment Precision MachinesAutomatic

& Electronic

Equipment & Computers

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WE TEST OUR PRODUCTS FOR:

A. PRESENCE OF COMPONENTS PRESUMED TO BE THERE

B. CONTAMINANTS PRESUMED MIGHT BE THERE

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WE DO NOT LOOK FOR CONTAMINANTS INTRODUCED BY:

1. INADEQUATE MANUFACTURING CONTROLS

2. INADEQUATE ENVIRONMENTAL CONTROLS

3. IMPROPER HANDLING

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DON’T TRUST YOUR MEMORY!!

RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE THE JOB!

Maintenance &

Cleaning Record

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COMPONENTS CONTROL• 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.

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COMPONENT

Includes packagingmaterials as wellas raw materials

Any material intended for use in the

manufacturing of our product

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COMPONENTS

CORRECT SPECIFICATION + CORRECT MATERIALS = CORRECT PRODUCT

We must control upon receipt and

in use.

Must come from

approved suppliers.

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ALL MATERIAL RECEIPT MUST BE

IN GOOD CONDITION

CLEAN AND IDENTIFIED

Intact, no damage

RAW MATL’S

RAW MATL’S

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All components must be sampled and tested by quality control……….

……to ensure that theyconform tostandards.

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…….

All newly receivedmaterials must be:

• Properly identifiedand recorded

• Examined to make surethat each container is

still tightly sealed

• Examined to make sure that each container

is not damaged

• Examined to make surethere is no visible sign of

contaminationor impurity

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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?

• ?????

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And must be protected from damage by outside elements such as wind, rain and insects.

It helps prevent mix-ups and

errors!!

All components must be stored in

a safe and orderly way . . .

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After testing and examination by quality control …….

It may then be approved and released for manufacturing use!

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COMPONENTS MUST BE PROTECTED FROM

HARMFUL

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BACTERIAImportant: report all accidents, cuts, sores, or illness!!

Bacteria = Contaminatio

n

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Reserve samples for every approved

component…..

• Clearly identified• Kept for at least

one year after theexpiration of the

Product

A rejected component must beproperly identified and keptseparate until it is disposedof.

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COMPONENTS MUST BE USED INPRODUCTION ON THE BASIS OF

“FIRST IN – FIRST OUT”

…….an exception may be made if it is temporary and appropriate.

Good!!! Makes

Sense!

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RAW MATERIALS

include both active and

inactive

are the ingredients that go into our products

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EXCIPIENTS OR INACTIVE INGREDIENTS

• Protects the product

• Covers up unpleasant odor

• Makes product look good

Has no effect on the user

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ACTIVE INGREDIENT

With direct effect on the user

Makes the product effective

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CERTIFICATE OF ANALYSIS• Maybe accepted ifanalytical competence hasbeen established

• Typical analysisnot accepted

• Full analysis isa must

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

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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

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PACKAGING MATERIALSIncludes such

Items as:

CapsBottlesLabelsInsertsBoxesBagsWrappersDroppersShippersSealPlugs

All the materials

used in the packaging of

a product

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STORAGESIMILAR 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

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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

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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

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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

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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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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.

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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.

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SHALL INCLUDE:1. NAME AND STRENGTH OF THE PRODUCT2. 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 CODES4. 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

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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

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4. INSTRUCTION FOR IN-PROCESS CONTROLS5. STATE STORAGE CONDITION, INCLUDING THE

CONTAINER TO BE USED, LABELLING, ETC.6. PROVISION FOR SIGNATURES AND CHECKS

FOR EACH STEP OF PROCESSING7. SPECIAL PRECAUTIONS8. 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.

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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

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5 .A STATEMENT WHERE TO INDICATE LOT NUMBER AND EXPIRY DATE

6. SPECIAL PRECAUTIONS7. DESCRIPTION OF THE PACKAGING

OPERATION AND EQUIPMENT TO BE USED8. DETAILS OF IN-PROCESS CONTROLS AND

SAMPLING AND ACCEPTANCE LIMITS9. DESCRIPTION OF THE PRODUCT CONTAINER

AND CLOSURE10. YIELD AND PERCENTAGE OF THEORETICAL

YIELD

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DISPENSINGREQUIREMENTS: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.

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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.

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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.

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

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D. DISPENSING ATTIRE• LONG GOWN• MASK• CAP• GLOVES

E. OTHERS1. 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.

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POWDER LEFT ON THE SCOOP WHEN WEIGHING DIFFERENT COMPONENTS CAN CONTAMINATE THE

PRODUCT AND CAUSE A VERY SERIOUS DRUG INTERACTION.

?

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QUALITY MATERIALS+

QUALITY PROCESSING=

QUALITY PRODUCTS

Processing system …..we produce

well designed and qualitycorrectly operated….. products

every time

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DOCUMENTS REQUIRED FOR PRODUCTION

1. MANUFACTURING MONOGRAPH

“RECIPE”

2. BATCH RECORD

“WHAT”

3. CONTROL MONOGRAPH

“TESTS”

4. “SOP’s”

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BATCH PRODUCTION RECORDS MUST BE CAREFULLY FOLLOWED AND

MONITORED…..

……..THROUGHOUT THE PRODUCTION PROCESS

QUALITY CONTROL MANUFACTURING

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Manufacturing Monograph

Control

Monograph

Batch Record

SOP’s

… They tell us what and how to produce our

products

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No one changes the SOP’s…Manufacturing and Control

Monographs

...until it has been approved by the heads of Manufacturing and Quality

Control

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Each step is spelled out in detail

Sample Batch Record

STEP

----------------------------------------------

RESPONSIBLE FOR STEP

Mary Jones

DATE

Sept. 15, 2008

Person Responsible

for step

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

4. Control 5. Reviewer 6. Record

FUNCTIONS OF WRITTEN PROCEDURE

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MANUFACTURING AND PACKAGING

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

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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 productthroughout manufacturing

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THIS LOT NUMBERIS THE KEY TO THE

RECORDED HISTORY OF THE:

MANUFACTURING

PROCESSING

PACKAGING

HOLDING AND

DISTRIBUTION OF THE PRODUCT

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LOT NUMBER is the specific identification assigned to each individual lot ……..

We call it the “lot number”

We call it the “batch

number”

We call it the “control number” We call it…

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LOT

some companies split their batches into several lots!!

It can be a part of a

batch

Can mean an entire

batch

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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 cycleof manufacture

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The lot number remains with the batch from start to finish

Must appear on the .. label shelf carton shipping carton

From start to finish

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To minimize possibility of bringing in

Wear protective clothing

such gloves, gown, cap,

mask…

… foreign materials in

the production

area.

For our safety health.

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It is important to carefully measure correct portions when you are dispensing

ingredients.

This cannot change

from batch to batch!

STRENGTH OF A

PRODUCT

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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 marked with the product name and lot number.

All major equipment must have ID numberrecorded in the Batch Record.

PRODUCT NAME

AND LOT

NUMBER

BATCH PRODUCTION

RECORD

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TWO SIGNATURES ARE REQUIRED FOR SIGNIFICANT STEPS…

RESPONSIBLE FOR PERFORMING THE WORK

RESPONSIBLE FORCHECKING THE WORK

BATCH RECORDS MUST BE FILLED IN AND SIGNED IMMEDIATELY AFTER A STEP IS DONE.

BATCH PRODUCTION RECORD

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During manufacturing,in-process testing is doneby Quality Control to makesure that the product meetsthe specifications in thebatch Production Records.

….and SOP’s have been

followed and recorded

where required.

Quality Control

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At any point, adjustments to

bring the batch up to specifications may be made according to the SOP’s.

…And we have to approve it.

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I’M NOT MEAN…IM JUSTTOUGH!

Samples to be tested

QUALITY

CONTROL

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PREPARATION FOR PACKAGING & LABELLING

Packing lines and Packaging lines mustmachines must be be identified withcleaned and inspected proper identifying

Lot Number.

Every thing is ready to roll when Quality Control and Production give the approval

Ok GO!!

Ok GO!!

GO!! GO!!

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LINE CLEARANCE

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

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The packaging department follows thepackaging directionsfor eachindividual lot.

This includesaffixing the lotnumber andexpiration date.

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

It’s All here!!

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

PACKAGING DEPT.

Packaging Order

- IDENTITY

- QUALITY

- QUALITYCONTROLRELEASE

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Empty containers must not be used to store things that don’t belong in them…these must be cleaned immediately and covered during storage!

WHAT’S THIS!!!

ERRRrrrr…

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PRODUCT CONTAINERS MUST BE MADE OF SUBSTANCES……………………..

………….THAT WILL NOT REACT WITH OR ABSORB ANY COMPONENTS THEY CONTACT.

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ALL CONTAINERS MUST PROVIDE PROTECTION FROM EXTERNAL CONTAMINATION

It’s no use!!!

Everything is tightly

sealed!!

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CONTAINERS ARE CONTAMINATED BY IMPROPER CLEANING

WE MUST HAVE SOP ON CLEANING CONTAINERS

CONTAMINATE!!

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ALL CONTAINERS MUST BE STORED SAFELY ……………….

…………….TO PREVENT DAMAGE AND CONTAMINATION

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IF CONTAINERS ARE NOT STURDY, AND IF THE COVERS OR LIDS DO NOT CLOSE TIGHTLY….

IT COULD CAUSEDETERIORATION

WHICH COULDREDUCE THE STRENGTH

OF THEPRODUCT!!!

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After packaging and labeling are completed…

Name of Product Control Number

Quantity

Hold for

Release

CARTONS ARE TIGHTLY SEALED

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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.

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We must make sure…packages in batch are correctly labeled and packaged

It’s gotta’ Be Correct!

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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.

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• 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.

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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 kept…

……for at least one year after the expiry date or according to policy

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Any complaints of a product is automatically Investigated.

The entire Batch Production Record and Batch Control Record must be reviewed.

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• 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.

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Nature of Complaint

Name and Address Productof person complaining Name

Result of investigationand follow-up its strength

Lot NumberIf no investigation…reason why and the nameof the person making thedecision Reply

Record of complaint

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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.

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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.

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• 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.