BASIC GMPBASIC GMPTRAININGTRAINING

BCNBCN

Mrs. N. OsujiMrs. N. Osuji

The principle of cGMPThe principle of cGMP ‘‘current Good Manufacturing Practice’current Good Manufacturing Practice’ means …making products that are means …making products that are alwaysalways ‘‘fit for their intended use’fit for their intended use’ ** The The quality quality of healthcare products is absolutely of healthcare products is absolutely

crucialcrucial ** Following the procedures of cGMP at Following the procedures of cGMP at every every

stage of product manufacture will ensure the stage of product manufacture will ensure the correctcorrect quality for patients quality for patients

** The product must be in a properly The product must be in a properly sealed sealed and and

intact intact containercontainer **

The container must be right for The container must be right for that that product…product…and carry a label which displays all the and carry a label which displays all the correctcorrect information about the product.information about the product.

The product The product mustmust be of the required quality and be of the required quality and strength…strength…

FreeFree from contamination or deterioration… and above from contamination or deterioration… and above all … all … it must be the right productit must be the right product

** Testing a complete product batch is often impossible Testing a complete product batch is often impossible

withoutwithout destroying it destroying it ** It is essential that each sample tested mustIt is essential that each sample tested must accurately represent accurately represent the whole batchthe whole batch ** Quality Quality hashas to be built in to to be built in to everyevery process from start to process from start to

finishfinish

Manufacturing Process Manufacturing Process controlcontrol

Quality cannot be achieved without Quality cannot be achieved without rigorous control of both the rigorous control of both the processprocess and and the the peoplepeople who work with it who work with it

** It is vital that It is vital that everyoneeveryone obeys the rules obeys the rules

from their very from their very first first day at workday at work ** Following the S.O.P.’s – ‘Standard Following the S.O.P.’s – ‘Standard

Operating Procedures’ will ensure that Operating Procedures’ will ensure that everyone knows everyone knows whatwhat to do and to do and howhow to to do itdo it

EverythingEverything in the production process is subject in the production process is subject to a to a detaileddetailed specification specification

Each step of product manufacture is detailed in Each step of product manufacture is detailed in a a ‘Batch Manufacturing Record’‘Batch Manufacturing Record’

Operations in the packaging process are Operations in the packaging process are detailed in a ‘detailed in a ‘Packing Record’Packing Record’

** Operations not Operations not directlydirectly related to the related to the

production process are generally detailed in production process are generally detailed in the general ‘S.O.P.’sthe general ‘S.O.P.’s

Record keepingRecord keeping ‘‘Batch Manufacturing’ and ‘Packing Records’… prescribe what Batch Manufacturing’ and ‘Packing Records’… prescribe what mustmust

be done and record what be done and record what hashas been done been done ** Because quality is so important and mistakes so dangerous… it is Because quality is so important and mistakes so dangerous… it is

essential essential that records are completed properly …accurately…and at that records are completed properly …accurately…and at the the timetime of event… of event…never never laterlater

** All records All records must must be signed and datedbe signed and dated ** If there is something you do not agree with…If there is something you do not agree with… don’t sign the recorddon’t sign the record…mistakes costs lives…mistakes costs lives ** Any error on the record should be crossed through once…and Any error on the record should be crossed through once…and once once

only…neveronly…never obliterate the entry obliterate the entry ** If any doubt…ASKIf any doubt…ASK

The product and youThe product and you People are the People are the greatest greatest source of contamination in the source of contamination in the

healthcare industryhealthcare industry ** Normally harmless microorganisms Normally harmless microorganisms cancan have devastating have devastating

effects on a sick person if introduced via medicine, eye effects on a sick person if introduced via medicine, eye drops, medical devices or cosmetics, which they may take drops, medical devices or cosmetics, which they may take or use.or use.

** Products Products must must be protected from these organismsbe protected from these organisms and therefore…and therefore…youyou ** Personal cleanliness Personal cleanliness mustmust be an essential part of your be an essential part of your

everyday routine for working in a healthcare environment.everyday routine for working in a healthcare environment.

EveryoneEveryone involved involved mustmust work….dress….and…..behave work….dress….and…..behave correctlycorrectly

Every Every item must be appropriately item must be appropriately labeled at labeled at every every stage of productionstage of production

Accurate records Accurate records must must be kept at be kept at everyevery stage of stage of everevery activityy activity

The quality and safety of medicines The quality and safety of medicines can only be sustained by can only be sustained by responsible peopleresponsible people

Protective clothing and gloves Protective clothing and gloves mustmust be worn be worn according to the procedures you will be taughtaccording to the procedures you will be taught

** Never Never touch the product touch the product withoutwithout wearing wearing the appropriate protective garmentsthe appropriate protective garments ** AlwaysAlways report any illness… infection… or open report any illness… infection… or open

wound.wound. ** Never…Never…NEVERNEVER…eat…drink…chew…or smoke…eat…drink…chew…or smoke in production areasin production areas **

Always Always work carefully and tidily to avoid creatingwork carefully and tidily to avoid creating dust and spillages…dust and spillages…don’t rushdon’t rush

AlwaysAlways follow instructions precisely follow instructions precisely ** Cultivating the right attitude to working with cGMP, will Cultivating the right attitude to working with cGMP, will

ensure the ensure the highest highest quality of the product.quality of the product. ** Remember… the Remember… the basic basic rule of your training is… if you rule of your training is… if you

don't know or are not sure… don't know or are not sure… askask… … and keep on asking and keep on asking until each task is fully understooduntil each task is fully understood

** If there is no one to ask… If there is no one to ask… don’t do it!don’t do it!

QUESTION?QUESTION?

THANK YOUTHANK YOU

UNDERSTANDING UNDERSTANDING GMPGMP

IntroductionIntroduction Medicines have to be taken Medicines have to be taken entirely entirely on on

trusttrust Medicines, if Medicines, if wronglywrongly made or made or wronglywrongly

labeled may prove labeled may prove fatalfatal Only the Only the highesthighest quality standards quality standards mustmust

apply in medicine manufactureapply in medicine manufacture Quality is Quality is criticalcritical Quality is Quality is controlledcontrolled by by

Good Manufacturing Practice Good Manufacturing Practice GMPGMP

What is GMP?What is GMP?

The GMP definition of Quality;The GMP definition of Quality; ``that every product must be fit for its ``that every product must be fit for its

intended purpose”intended purpose” Doctors and patients Doctors and patients must be assuredmust be assured that that

medicines are; free from contamination…medicines are; free from contamination… Made to the correct formula…Made to the correct formula… Have not deteriorated…Have not deteriorated… And…are in the correct sealed containerAnd…are in the correct sealed container

GMP is the overriding principle which GMP is the overriding principle which governs the quality of every aspect of governs the quality of every aspect of making a medicine.making a medicine.

To illustrate GMP it is explained as a To illustrate GMP it is explained as a series of principles which includes;series of principles which includes;

EveryEvery action action mustmust be undertaken by be undertaken by following written instructionsfollowing written instructions

Raw materials Raw materials mustmust be stored and be stored and handled correctlyhandled correctly

Facilities and machinery Facilities and machinery mustmust be be correct for their purpose.correct for their purpose.

Quality control Quality control mustmust be undertaken at every be undertaken at every stage of the manufacturing process.stage of the manufacturing process.

AllAll work work mustmust be undertaken be undertaken correctly…..precisely….and….accuratelycorrectly…..precisely….and….accurately

Contamination of materials Contamination of materials mustmust be avoided be avoided atat all all times.times.

Correct labeling is carried out at Correct labeling is carried out at every every stage stage of production.of production.

Accurate records are kept at Accurate records are kept at everyevery stage of stage of productionproduction

EveryEvery product must be fit for its intended product must be fit for its intended use.use.

Documentation & Documentation & RecordsRecords Inaccurate records are Inaccurate records are

potentially potentially veryvery dangerous dangerous

Accurate records are the means Accurate records are the means by which by which corrective actioncorrective action may may be takenbe taken

Documentation and RecordsDocumentation and Records To be certain that nothing is left to chance, GMP To be certain that nothing is left to chance, GMP

depends on the principle that everything will be depends on the principle that everything will be completely documented.completely documented.

Work can only be relied on to be done properly Work can only be relied on to be done properly when each step is written down clearly with no when each step is written down clearly with no reliance on memory or word of mouth reliance on memory or word of mouth instructions. instructions.

This applies equally to the choice of materials to This applies equally to the choice of materials to be used and actions to be carried out.be used and actions to be carried out.

As well as recording what has been done.As well as recording what has been done.

There are four groups of documents. There are four groups of documents. The first is SPECIFICATIONS. The first is SPECIFICATIONS.

These specify the standards or These specify the standards or measurable performance of materials measurable performance of materials to be used. For example, there are to be used. For example, there are specifications for; specifications for;

Raw materials.....Raw materials..... Packaging materials such as Packaging materials such as

containers and labels....containers and labels.... MachinesMachines Environment …..etc.Environment …..etc.

And the product been made And the product been made

The second group of documents isThe second group of documents is MANUFACTURING and PACKAGING MANUFACTURING and PACKAGING INSTRUCTIONS. INSTRUCTIONS.

Here, the documents are specific to Here, the documents are specific to the particular product to be made and the particular product to be made and will detail:will detail:

Which materials are to be used...Which materials are to be used... The quantities of materials needed...The quantities of materials needed... Which items of machinery or equipment Which items of machinery or equipment

will be required and location……..will be required and location……..

The environmental conditions and The environmental conditions and Equipment settings…..Equipment settings…..

The Line Clearance checks to be The Line Clearance checks to be donedone

The procedures and Quality checks The procedures and Quality checks to be followed – either to to be followed – either to manufacture or to package the manufacture or to package the product.product.

Bulk and intermediate product Bulk and intermediate product storage conditions…storage conditions…

A batch manufacturing and a batch packaging A batch manufacturing and a batch packaging instruction is issued for every batch being made. instruction is issued for every batch being made.

No matter how many times this has been done No matter how many times this has been done before, it is before, it is essentialessential that the new documents are that the new documents are referred to each time. referred to each time.

In fact, to ensure that this is done, each In fact, to ensure that this is done, each document has to be signed in the appropriate document has to be signed in the appropriate place by each person involved.place by each person involved.

The supervisor must also countersign each The supervisor must also countersign each

significant entry significant entry

The third group of documents is often The third group of documents is often described as described as `̀Standard Operating Standard Operating ProceduresProcedures’, ’, (usually shortened to (usually shortened to S.O.P’s). S.O.P’s).

The name may vary from country to The name may vary from country to country but they are all concerned with country but they are all concerned with detailing the manufacturing and detailing the manufacturing and packaging activities that are not packaging activities that are not specific to any one product.specific to any one product.

S.O.P.’s are issued to cover the S.O.P.’s are issued to cover the methods to be used for methods to be used for Stores operations, such as the receipt and Stores operations, such as the receipt and

handling of raw materials, packaging items handling of raw materials, packaging items and products.....and products.....

Procedures to be followed when dispensing Procedures to be followed when dispensing materials...materials...

How to clean manufacturing or packaging How to clean manufacturing or packaging areas and equipmentareas and equipment

What sort of clothing and other items, such as What sort of clothing and other items, such as eye protection and gloves, should be used eye protection and gloves, should be used and how to use them ...and how to use them ...

How to operate the water system...How to operate the water system...How to set-up and operate each How to set-up and operate each

machine....machine....Even how to move materials from one Even how to move materials from one

place to another....place to another....And how to handle the problems And how to handle the problems

arising from mistakes which have been arising from mistakes which have been made, either immediately, or when made, either immediately, or when complaints have been received.....complaints have been received.....

...there should be a standard operating ...there should be a standard operating procedure for every eventualityprocedure for every eventuality

The final group of documents is The final group of documents is RECORDS.RECORDS.

These, obviously, record what These, obviously, record what has been done.has been done.

The important thing about The important thing about records is that they must be records is that they must be kept for kept for every single activityevery single activity and they must be made at the and they must be made at the time the activity is carried outtime the activity is carried out. .

Not only must the detail be recorded Not only must the detail be recorded from :from : The cleaning and preparation of The cleaning and preparation of

equipment ...equipment ... The issuing and receipt of materials...The issuing and receipt of materials... The handling of containers in The handling of containers in

quarantine...quarantine... To the completed labeling of a batch...To the completed labeling of a batch... But this must be entered clearly and But this must be entered clearly and

precisely, complete with the time and precisely, complete with the time and date when it was done. date when it was done.

If an entry was made incorrectly then If an entry was made incorrectly then it must be shown as such and there it must be shown as such and there should be no attempt to obliterate it.should be no attempt to obliterate it.

It must be correctly dated and signed. It must be correctly dated and signed. Inaccurate records are potentially Inaccurate records are potentially very dangerous.very dangerous.

Records are kept for very good Records are kept for very good reasons, not the least being, that if reasons, not the least being, that if any problems about a particular any problems about a particular matter or batch should arise in the matter or batch should arise in the future, the records can be referred to future, the records can be referred to and corrective action taken and corrective action taken

Quality Assurance & Quality Quality Assurance & Quality ControlControl

Quality Assurance defines the activities Quality Assurance defines the activities undertaken to undertaken to ensureensure that a product is fit that a product is fit for its intended use.for its intended use.

The role of Quality Control is to verify The role of Quality Control is to verify everyevery activity and check the activity and check the qualityquality of of the end productthe end product

Quality Control is also necessary for Quality Control is also necessary for ensuringensuring that the environment is that the environment is monitored and the process is validated monitored and the process is validated for its intended purposefor its intended purpose

Stores And MaterialsStores And Materials Materials from Regular suppliers Materials from Regular suppliers cannot cannot

be assumed be assumed to be correctto be correct Raw materials must Raw materials must alwaysalways be placed in be placed in

quarantine to await quality control quarantine to await quality control samplingsampling

Correct product and material labeling is Correct product and material labeling is crucialcrucial

Materials should Materials should alwaysalways be moved with be moved with great care and stored in a secure and great care and stored in a secure and non-damaging waynon-damaging way

Detailed instructions Detailed instructions mustmust be be followed followed preciselyprecisely for the mixing of for the mixing of materials used in the preparation of materials used in the preparation of medicinesmedicines

Thorough cleaning and sanitization Thorough cleaning and sanitization of all containers, equipment and the of all containers, equipment and the environment is environment is essentialessential

Materials Materials mustmust meet the standards meet the standards detailed in the specificationsdetailed in the specifications

The Environment & The Environment & MachineryMachinery

Manufacturing conditions Manufacturing conditions mustmust be to a be to a standard which does standard which does not not impair the impair the productproduct

Control of environment quality is Control of environment quality is vitalvital for parenteral product manufacturefor parenteral product manufacture

Medicines must contain Medicines must contain onlyonly the the formulated ingredientsformulated ingredients

Improper cleaning of containers Improper cleaning of containers maymay cause contamination from chemical cause contamination from chemical residuesresidues

Sterile products Sterile products must be absolutely free must be absolutely free of of allall microorganisms both living and microorganisms both living and deaddead

Personnel Personnel must pay particular attention must pay particular attention to personal hygiene and correct to personal hygiene and correct behavior at behavior at allall times times

Control of contamination is the Control of contamination is the major major objectiveobjective in the cleaning and in the cleaning and disinfection of buildings and equipmentdisinfection of buildings and equipment

Maintenance of the environment and Maintenance of the environment and production equipment is production equipment is criticalcritical to the to the principles of GMPprinciples of GMP

People & TrainingPeople & Training GMP GMP depends depends on people doing the on people doing the rightright

thing….in the thing….in the rightright way….at the way….at the rightright time time Training Training ensuresensures that that everyevery individual knows individual knows

how to undertake their specific taskshow to undertake their specific tasks Particular attention Particular attention mustmust be paid to what be paid to what

people wear….to protect themselves people wear….to protect themselves andand the the productproduct

No product No product should be touchedshould be touched without without wearing gloves and protective clothingwearing gloves and protective clothing

Eating…drinking…smoking…the chewing of Eating…drinking…smoking…the chewing of gum….and the taking of medicines is gum….and the taking of medicines is prohibitedprohibited in production areas in production areas

Labelling Labelling Every product Every product must be must be clearlyclearly and and accuratelyaccurately

labelledlabelled Identity labels Identity labels indicate the product and what it indicate the product and what it

contains. They contains. They must must show the batch show the batch number….the material code number….and …the number….the material code number….and …the datedate

Status labels Status labels indicate the state of progress of the indicate the state of progress of the product. They product. They must must show the batch number…the show the batch number…the material code number…and …the datematerial code number…and …the date

BothBoth identity labels and status labels are used on identity labels and status labels are used on the same product itemsthe same product items

Labels must Labels must alwaysalways be placed on the body of the be placed on the body of the container….container….nevernever on the lid on the lid

ConclusionConclusion The concept of GMP is to The concept of GMP is to ensureensure that the that the

risks of making mistakes is reduced to a risks of making mistakes is reduced to a minimumminimum

AllAll activities activities mustmust follow written or follow written or documented proceduresdocumented procedures

Raw materials Raw materials mustmust be stored and be stored and handled correctly and handled correctly and onlyonly the correct the correct materials mixedmaterials mixed

Correct cleaning procedures for the Correct cleaning procedures for the environment facilities and equipment environment facilities and equipment must must be followedbe followed

PERSONAL PERSONAL HYGIENEHYGIENE

IntroductionIntroduction GMP requires that GMP requires that everyone everyone is trained in personal is trained in personal

hygienehygiene ** Remember that medicine must Remember that medicine must alwaysalways be made be made

correctlycorrectly ** People are one of the People are one of the greatgreat contaminators contaminators ** Skin flakes Skin flakes causecause contamination contamination ** Bacteria and microorganisms live on Bacteria and microorganisms live on deaddead skin flakes skin flakes ** Germs live Germs live on on us and us and inin us and can cause infection in us and can cause infection in

patientspatients Each person is responsible for Each person is responsible for his or her ownhis or her own hygiene hygiene

and cleanlinessand cleanliness

The HeadThe Head Hair Hair mustmust be kept clean be kept clean ** The head The head mustmust be properly covered be properly covered ** Beards and mustaches Beards and mustaches must must be correctly be correctly

coveredcovered ** The nose and mouth are both The nose and mouth are both danger danger areasareas ** Don’t Don’t shout …try shout …try notnot to sneeze or cough to sneeze or cough

Good oral hygiene is very importantGood oral hygiene is very important ** AlwaysAlways wear correctly fitting masks wear correctly fitting masks ** Don’tDon’t rub your eyes, ears or nose rub your eyes, ears or nose ** Be Be awareaware of dangerous mannerisms of dangerous mannerisms

Cosmetics & Make upCosmetics & Make up

Make up is a Make up is a seriousserious contaminatorcontaminator

The BodyThe Body

Wash Wash regularlyregularly**Showers are Showers are better better than than bathsbaths

The HandsThe Hands Hands are Hands are majormajor contaminators contaminators ** They They transporttransport contaminations and they contaminations and they

also also harbor harbor contaminationcontamination ** Hands must be kept Hands must be kept totallytotally clean clean ** Pay Pay particular particular attention to cuticles and attention to cuticles and

nailsnails

JewelrJewelry AND y AND HealthHealth

Jewelry should Jewelry should not not be wornbe worn AllAll personnel should be medically personnel should be medically fitfit ** Smoking …eating…chewing and Smoking …eating…chewing and

drinking drinking are are prohibited prohibited in production areasin production areas

SUMMARYSUMMARY

ThinkThink clean… clean…Dress Dress clean…clean…Work Work clean… and…clean… and…KeepKeep clean at all clean at all timestimes

QUESTION?QUESTION?

THANK YOUTHANK YOU