Organization of QA -GMP Compliance

7/23/2019 Organization of QA -GMP Compliance

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Organization of QA

cGMP compliance

BIT 230

Chapters 1 an 2 !"#$soll%



TQM

Total Quality Management

Approach a company uses day to day

7 strategies Leadership

Information and analysis

Strategic planning Human resource development and

management



TQM

Strategies continued Process quality management

Quality and operational results ustomer focus and satisfaction

! "ften focus is on the customer # so last$ut not least% customer driven success



Q#alit& Ass#rance

A unit that is part of the &hole

'S () # 'nited States ode of

(ederal )egulations% de*nes thequality unit+s ,o$

Approve or re,ect all materials

associated production of any product# includes containers- components-la$els- other pac.aging materials



Q#alit&

/nsure purity% 0 1 goal

Also strength and quality

2e& $iotech lose site of quality #develop science *rst- then quality

Should $e done in parallel to have less

pro$lems later )ole of QA $etter esta$lished in large

pharma



Q#alit& Control !QC% 'ithin

QA

Q is a testing function

3e*ned as *tness for use

2eed to $e integrated throughout process (itness for use divided into several

components % ne4t slide5 these 6 ma,or

components su$divided into furthercategories % TH/S/ important regardlessof product





Manage from the top o'n

'pper management sets tone forcompany style and compliance

iopharm products comple4% thereforeneed 8quality of manufacture9

() de*nition of QA unit % 7 points



QA f#nction

!pertaining to a non(

clinical la)% 1: Maintain master schedule sheet

;: Maintain protocol records

<: Inspect each phase of study 6: Su$mit periodic &ritten status reports

=: /nsure S"Ps are follo&ed

>: )evie& *nal study report 7: Prepare a signed statement ?&ith

inspection dates- etc: for *nal study@:



QA *s+ QC

ill discuss more later- $ut ma,orpoint of confusion

Q function limited % testing methods 8ontrols the product9 in production

() does not clearly de*ne Q% more

of a QA de*nition



Pro#ct pro#ction

QA de*nes systems and methods to

ensure quality of a product% Q testsvarious aspects of a product as it is$eing developed



,hich f#nction- QA or QC.

S"P for measuring pH of a production run

measuring pH of a production run < B daily

*lling in $atch records developing $atch record

signing and dating $atch record

con*rming integrity of ra& material de*ning ra& material to $e used in

production



/o#tine f#nctions of QA

Testing

3ocumentation

La$eling

Cendor audits

Cendor approval



/o#tine QA f#nctions

cont

)a& material receipt

Product release

Product Speci*cations

Training

Calidation



Other QA #nctions

1: ompany a&areness long and short term goals

QA part of $usiness involvement team if QA operates as a separate group

company not as successful

upper management must commit to QA

sometimes overloo.ed in $iotech



Other QA #nctions cont

;: Product .no&ledge

&ithout it failure is li.ely

.no& the product- process used todevelop it- support systems- and productuse ?e:g: target population% ("SAMABe4ample % older population- people &ith

arthritis- people &ith diDculty sitting up@ AEAI2- product de*ned $y systems

esta$lished to assure its consistency




<: (acility .no&ledge function of equipment

function of local environment ofproduction facility

need personnel e4pertise in these areas% proper training- etc:

don+t &or. in a vacuum




6: 2et&or.ing through outsideorganiFations

regulatory agencies other companies &ith similar product

line

conferences understand industry and regulatory

standards




=: )is. analysisGdecision ma.ing analyFe situations

ma.e recommendations% if so- assure proper

modi*cation of S"P

ris.G$ene*t ratio to modi*cation of S"P

Page 8 % quality systems functions and percentage

at various companies httpGG&&&:mtm%la$oratories:comG,anusmtmportalGportalGtemplateGHomeGactionGne&s6:html



sta)lishing QA

3e*ne the function of QA ?chic.en andegg pro$lem@

Should start $efore production ofmaterial to $e used in Phase 1 clinicaltrials

Start &hen $iotech company is small hat quality systems are needed

)is.s of leaving out some QA functionsJ



e' compan& QA

hat type of product

omple4ity of end material

Production method (inancial considerations

Stage of development

is product in%licensedJ is there some parameters for product

development already determinedJ



actors to achie*e Q#alit&

Page 9-10 ?points 1%1;@

Key points

Quality indicators discussed not hidden%pro$lem in other sectors of company- not ,ust quality ?e:g: Cio44- &as everythingtransparentJ@

resource allocation good e4change of dialogue

accept responsi$ility ?e:g:- Tylenol case@



QA f#nctions

Assay development and validation

equipment validation

process validation

vendor quali*cations

ra& material and product specs

documentation

Q testing



People4 people4 people

In%house e4pertise ?product quality@

need for e4ternal e4pertise ?advisory-

etc:@ add sta as need arises

proper training

other company personnel should $e partof day%to%day QA decisions and processes

avoid attitude that QA is not needed



QA organization

Figure 1.3, Page 11

ompares organiFation at variousstages of a company

Large pharma has a separate QAdepartment &ith signi*cant sta



5a&(to(a& goals

Setting standards

sets standards for goals for $oth QA groupand entire company

&ritten

especially important for process deviations

$ased on e4pectations and outcomes for

product Ho& is the e4perience gained &ith a

productJ



5a&(to(a& cont

Implement training

can+t really do it here in class% need to $e onthe ,o$5 $ut learn the $asics here ?e:g:-micro$iological procedures % sterile technique@

ongoing training needed

ma.e time for training ?can easily $e castaside@

ma.e training a goal ?o$,ective@ of theemployee+s yearly plan% re&ard $uilt in



5a&(to(a& cont

(eed$ac. constructive

realistic communication .ey

support time commitments and

constraints hat is your time $ac. up planJ



Coming into cGMP

compliance

Chapter 2



"o' oes a compan& loo6

pre(GMP.

Small company% fe& to a fe& doFenemployees

mostly research scientists very fe& others as administrative-

production- testing and support

operating style develops quic.ly8corporate culture9

pro$lems &ith this during mergers



Pre GMP compan&

reative and fast

long hours for employees

good interaction react quic.ly to issues % not much red tape

less documentation % many things decidedver$ally &ith no paper trail% can lead topro$lems as the company gro&s

costly



GMP compliant compan&

Large pharmaceutical companies

many employees in production- testing-

support and administrative equal or outnum$er ) 3 scientists

follo& accepted- validated- approved

methods slo&er to change

large volume of documentation



Mo*ing from Pre( to GMP

ompany has identi*ed product toproduce5 plan needed to develop productunder EMP

e part of company master plan

site a$le to produce EMP product or must*nd alternate manufacturing facility

)egulatory aairs personnel % al&ays ,o$sin this areaN



Mo*ing to GMP

(inaliFe plan

3etermine $udget ?may $e &hen a

company goes pu$lic@ STA)T the pro,ect

I+ll say it again documentationN

Ho& is the documentation usedJ



GMP re7#ire oc#ments

Process varia$les

analytical methods used to determine

quality of intermediate and *nalproducts

functioning of support systems

facility is functional and suita$le clean and functional equipment

reproduci$ility



Remember Flu

Vaccineproblem this

past Fall??



Clinical pro#ction

2eed EMP here- too

included to document

ra& materials

la$eling

$atch records

equipmentG$uilding preventative maintenance

Oields

Figure 2.1, page 19



GMP training

"n%the%,o$ training necessary

8validation9 of personnel

trainer content e4pert5 e4perience asinstructor

upper management ac.no&ledges the

need for on%going training often e4ternal trainers $rought in

?certi*ed@



GMP training

Audits % internal and follo& same EMPguidelines as e4ternal audit

&ritten and &ell organiFed follo& approved procedures

auditors trained and from outside immediate&or. area

/4ternal audits include revie& of internalaudits- although not (3A+s current policy



5oc#ments for a#iting

Master schedule

generated up to ; years in advance

may $e included in S"P internal audits not surprise

$ut- not a time to do everything at lastminute5 must perform duties regularly

hold post%audit meeting

have corrective action and $ac.%up plans



There’s never timeto do it right, but

always time to do

it over!

Organization of QA -GMP Compliance

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