ORGANISATION jcgpoihgpi

8/3/2019 ORGANISATION jcgpoihgpi

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Structure

Functions

Quality manual

sitemasterfile



y Qc

y Inspection&testing quality assuarance

y Systems&procedures(review&audit)



y Independent policy type role

y Monitoring entire production process

y Monitoring purchase,distribution&use of products



y Ev aluates data onprocess,materials,suppliers

y Recommends the changes to impro v e efficiency &consistency



y Discussion on organisational reporting lines

y Shouldnot report to the person directly accountablefor production



y Enlightened company-e v eryone is aware of importanceof quality & commited to its achie v ements

y Someothercompanies-reports to scientific or technical

unit.(more le v el of independence)



y Entire plant operates as quality aware team

y Ev ery indi v idual performs their job to achie v e quality standards



y If qc reports directly to plant manager

y If clear functional reporting relationship to scientificprofessional in the organisation



y More & more achie v ements of quality standards

If e v eryone in v ol v ed in understanding cause of problem,implications of decisions&takingappropriate actions



y QC Rejects if allstandards are not reached

y Ev ery indi v idual in a teamha v e to accept thatrejection

y Final decision resides withQC

y Plant manager cannoto v erride



y More effecti v eapproach has been todesign quality into

products during theDEVELOPMENT PHASE

y To build in additional

assurance during thePR ODUCTION

y Quality of components & products was inspected

y QC testing done

y Ev aluation of small sample

y Abo v e approach isineffecti v e & inefficient

y Seperates accountability for production & quality



y Responsibility &authority to reject allcontainers,closures,pack

agingmateris,labellingdrugproducts,

y Authority to re v iewproduction records sothat it must be sure that

no errors ha v e occured



y Adequate facilities fortesting & appro v al of

componentsy Appro v es or rejects all

procedures affectingidentity,quality,strengt

h,purity of drugproduct

y All written proceduresrelated to responsibilities& procedures shall befollowed

y All quality impacting

procedures & systems areto be appro v ed by QC



y Appro v e/rejection responsibility also applies tooperations contracted out to other companies

y This wont require additional or duplicate testing

y If contractor has adequate procedeures & iscompliance with cGMP, test data is compared with std



y Audit & testing in parallel for a period of time

y Periodic re-e v aluation



y Quality must be a prime cosideration in research &de v elopment of medicene to assure safety & efficacy.



y Pro v en chemical structure

y Minimum of impurities

y Compatible with excipients

y Stable to en v ironmentalstress



y Formulation

Research&de v elopment

Production

Significant change



y Stability of final packs must be confirmed

y All experience gained during de v elopmentmust be embodied in documents.Specifications will be written for all thestarting & packaging materials, Final packsmust comply with any rele v ant officialmonographs & must be acceptable to

intended suppliers



y Marketed goods when stored under appro v edconditions,they remains fit throughout its establishedshelflife

y

Manufacturing & marketing organisations should ha v eboth systems & staff to deal with these aspects of post-marketing quality assurance.



y Understanding of company philosophy on quality.

y Direct in v ol v ement of employees inthe impro v ement of processes.

y De v eloping goodrelationship,communication,understa

nding between managers & staff.y Considerable benefit to the company.



y Established managenent techniques

y For assessment of the costs

y

In v ol v ed in assurance of quality



y pre v ention: costs incurred in pre v enting failure.

y Appraisal:costs incurred in assessing materials &product confirmity.

y Internal failure:costs arising from rejectedmaterials,lost orders,inefficient utilisation of process equipment.

y External failures:costs arising from customercomplaints,lack of customer ser v ice.



y Identification & analysis of the cost in v ol v ed in thefollowing can re v eal significant benefits of soundquality systems.Those are:

y Designy De v elopment

y Manufacture

y T

estingy Distribution



PARAVTHY SURAN

DEPARTMENT OF ANALYSIS



y The management of a company formulated apolicy to all employees and expanded in the formof a QU A LITY MA NU A L

y Publication and re v ision of this manual will ser v e

as a periodic restatement of the quality objecti v esof the company

y A manual that is v ague will fall into disuse becauseit is unhelpful

y

Re v

ision:4-6 months is the earliest time and 1 year would be the longest period between re v isions



y Quality policy

y General responsibilities

y Testing and release of components and finished

productsy Periodic inspection of stock

y V endor selection and de v elopment

y Stability studies program

y Manufacturing operations and controlsy Audits



y It is a document prepared by the manufacturer

y It contains specific and factual information aboutthe production and control of manufacturing

operationsy The main purpose of the site master file is to

compile and consolidate in one large document

y It contains key management contact information

and emergency contact information andemergency contact numbers for speedy responseto unexpected problems



y Information on the manufacturer, sites, manufacturingoperations

y Name and exact address of the site.

y No: of employees in each site, working time

y Quality assurance system

y Audit programmes(self or external inspections)

y Assessment of materials

y Procedures for release of finished products for sale

y T ypes of products manufactured, specific toxic or hazardous

y Mention if human and v eterinary products are both prepared onthe site



y Qualifications, experience and responsibilities

y How training records are maintained, identified by whom

y Sterile areas, v entilation system, water system

y Planned and pre v enti v e maintenance program

y Plan or description of manufacturing area for each production

y Nature of construction and finishes of all areas

y General description of equipments

y if any additional de v ices, materials used, ease of cleaning



y Describe the companysgeneral policy, protocolsfor qualifications, regular v alidation

y Equipment calibrationpolicy and recordkeeping

y

Cleaning procedures formanufacturing areas andequipment



y It in v ol v es the data of all acti v ities relating to theproduction

y Product/process specifications, raw

materials,packaging,analytical methodsy Standards operating procedures, training procedures, v alidation documents



Production operations ineach products

y Arrangements for raw

materials, packingmaterials, finishedproducts ,releases and

storagey Quality control in v ol v es

y Analyticaltesting,packaging,components , biological andmicrobiological testing



There shall be an adequate number of

perform and supervise the manufacture,

packing, or holding of each drug product.

Each person responsible for supervising the

function in such a manner as to provide

assurance that the drug product has the safety,

identity, strength, quality, and purity.



Personal engaged in the manufacture, processing,packing or holding of a drug product shall wear cleancloth.

Personnel shall practice good sanitation and healthhabits

Only personnel authorized by super v isory personnelshall enter those areas of the buildings and facilities

designated as limited access areas.



A Sufficient amount of clean uniform is provided

Washing and sanitation procedures should be checked

to confirm their effectiveness.

Employees in special clean areas should wear onlylint-free garments to prevent shedding.

Work clothing should not be worn outside of the

appropriate plant area and changing rooms should be

available.



To a v oid any sort of contamination, pharmaceuticalproducts ha v e to be produced with clean materials ,machine and human beings

Requirement of health, personal cleaning ,hygieneoperations, protecti v e clothing applicable to allproduction people , maintaing staff and all other v isitors ha v e to be strictly adhered

.



Pre employment medical examination inclusi v e of eyetesting must be insisted

Y early health checks should be carried out

Staff should report infectious disease, burns, open wounds and rashes.

Super v isory staff should look for signs and symptomsof unhealthy condition



Strict attention to personal hygiene is essential to stopthe spread of bacteria.

Food and drinks must not be consumed in the

manufacturing , packing, storage and laboratory areas. Smoking must not be permitted in any processing ,

storage or laboratory areas.

Food, drink and smoking material should not be

stored in manufacturing areas.



Purpose of protecti v e clothing is not only protection of the indi v idual but also protection of the product.

While handling dangerous or v olatile materials

personnel should be protected by head co v

ering, mask,safety goggles etc

Aseptic area garments should be stored and handledafter cleaning and sterilizing to minimize the

microbial contamination and accumulation of particulate matter.



This manual co v ers company policies on employees.

Records of all training acti v ities must be maintained.

Training is di v ided into 3 parts

GMP/GLP related training Job specific training

Beha v ioral and managerial training



Records to be maintained for training

Attendance records of training.

Training e v aluation records

Training manual should be updated from time to time. Documentation and records is to be retained for a

definite time period.



Special instruction must also be gi v en to staff working with highly potent , toxic or sensitizing materials.

It should monitor and e v aluate the effecti v eness of

training and competency of all personnel Qc department should monitor or audit to ensure that

appropriate training has gi v en



Planning Site Layouts When planning construction site

layouts the following must be taken

into account:ySite Acti v ities

y T

heE

fficiency yFacilities and Accommodation



ySite ActivitiesThe time needed for carrying out the

principal acti v ities can be estimated:

y labor requirements, example speed of

transporting the mix to the appropriatepositions.



yThe Efficiency To achie v e maximum efficiency the site layout mustaim at maintaining the desired output of the planned

acti v ities. This will depend largely upon the followingfactors: A v oidance, as far as practicable of double handlingmaterials. Walking distance are kept to a minimum to reduce

the non producti v e time spent in co v ering the distancebetween working, rest and storage areas.



y a v oidance of loss by the elements; pro v ide adequate protection for unfixedmaterial on site, there by pre v enting timeloss and cost of replacing damagematerials, Proper store keeping arrangements toensure that the materials are of the correcttype, in the correct quantity and area v ailable when required.



y Minimizing on-site traffic congestion; plan deli v ery arri v als,

pro v

ide adequate parking facilities forstaff cars and mobile machinery whennot in use, pro v ide sufficient turning circle roomfor the type of deli v ery v ehicles likely toenter site.



yFacilities and Accommodation Within the site layout, the main

contractor is obliged to pro v

ide a safe,healthy place of work and safe systemof work, plant and equipment whichare not a risk to health as well asen v ironment:



y A safe and health y place of work,ySafe access and egress from place of work,ySafe and efficient system of work,ySafe items of plant and equipment,ySuitable and adequate training,

supervision and instruction in theuse of equipment,



y Suitable and appropriate Personal ProtectiveEquipment (PPE),

y Material and substances which are safe to use

y

Apart from legislative necessities, the main areaof concern will be sizing, equipping and assigneda location to the various units of accommodationssuch as:



yMess Hut or quarters

yToilets and washing area

y

First aid and medical roomsyOffices Contractors super v isory staff,

Clerk of works, Reception of material

or security yLock up store for materials and tools



yPlant and machinery area such as towercrane, concrete deli v eries, sand andcement storage, and site mixer

yFencing or hoarding to mark boundary

yGreat ser v ices and welfare

ySite Identification for workers and v isitors



QUALITY ASSURANCE

MERIN K OOMMEN

PHARMACEUTICAL ANALYSIS



yTraffic control

yHousekeeping

y

Surface disinfectiony Air control



y A carefully designed arrangement to control andminimize traffic ,particularly in and out of theaseptic area ,is essential.

y

Access by personnel to the aseptic corridor andaseptic compounding and filling rooms is only through air lock

y Pass-through openings and double-ended

sterilizers are pro v ided to permit controlledpassage of supplies from nonaseptic to asepticareas.



y Personnel should be permitted to enter asepticareas only after following rigidly prescribed

procedures for remo v ing street clothing, washingtheir hands and donning gowns,hats,shoes,facemasks and glo v es.

y Once they ha v e entered the aseptic area, they should not be permitted to mo v e in and out of thearea with out regowning.



y All equipment and surrounding working areashould be cleaned thoroughly at the end of the working day.

y No contaminating residues from the concludedprocess may remain

y T

he ceiling, walls and other structural surfacesmust be cleaned frequently in a laminar airflowfacility.



y After thorough cleaning ,all surfaces should bedisinfected, atleast in the aseptic areas.An effecti v edisinfectant should be sprayed or wiped.

y

ULTRA- VIOLET L AMPS(ultra- v iolet rays) may beparticularly useful to irradiate the inside,exposedsurfaces of processing tanks,the surfaces of con v eyor belts and similar confined surfaces that

are otherwise difficult to render aseptic



y In any area occupied by personnel,the air must beexchanged at frequent inter v als

y Fresh outside or recycled air must first be filteredto remo v e gross particulate matter

y A spun glass,cloth,or polyethylene filter is used forthis preliminary cleaning operation.



y To remo v e finer debris down to the submicronrange ,including microorganisms, a high efficiency particulate air filter(HEPA) filter is used

y It is defined as at least 99.97% efficient inremo v ing particles of 0.3 micronmeter size andlarger and composed of glass fibres and filters



y The clean, aseptic air is distributed in such amanner that it flows into the maximum security rooms at the greatest v olume flow rate,there by

producing a positi v

e pressure at these areas

y This pre v ents unclean air from rushing into theaseptic area through cracks,temporarily opened

doors, or other openings.



y An efficient air control system achie v es a Class 100clean room.

y A Class 100 clean room is defined as a room in which the particle count in the air is not more than100 per cubic foot of 0.5micrometer and larger insize

y The airflow must be uniform in v elocity and

direction throughout any gi v en cross-section of the area, being exhausted from th opposite side.



y The air v elocity employed should be 100±20 ft/min

y Achie v ing Class 100 cleanliness requires effecti v emaintenance and monitoring

y

Class 100 worksite is employed for operations such ashandling precleaned containers, procecess filtrationand aseptic gowning of personnel



y THE THEOR Y A ND PRACTICE OF INDUSTR I A L PHARMAC Y by L ACHMA NN,LIEBERMA NN,KA NI



The area that contains not more than 10,000 particles

per cubic feet.

The sterile area can be divided in to following

categories.1.clean up area

2.preparation area or compounding area

3.aseptic area

4.quarantine area

5.finishing and packaging area



Clean area

the room should under go a minimum of 10 ± 15 air

changes per hour.

Preparation or compounding area

it is not essential that the area should be aseptic but

controlling measures are provided to control the dust

generated from weighing and compounding



Aseptic areathe aim to have aseptic area is to prevent micro organisms duringthe preparation and testing of pharmaceutical product.

Quarantine area

different batches can be stored physically segregated from either in process batches or approved batches in a locked store to whichaccess is restricted to a responsible person.



Labeling and packing area

batch numbering and over printing of labels should take

place.



Site

it is ad v isable to site the asepsis laboratory as far aspossible from the rooms to which non pharmaceuticalstaff has access.

The area should be away from stairs lift shafts andcorridors.



size

It is best to have a small room so that cleaning and

maintenance will be quite easy.

windowsLarge windows of clear glass are most acceptable, but

they must not open and ventilation must be provided by an

air filtration system.



Doors

If possible the sterile area should be entered through an air lock with double doors about 1m apart.

This prevent a sudden inrush of air when door is opened.

Surface materials The floors , walls and bench tops of sterile area must be

easily cleaned, smooth, imper v ious and resistant tochemicals.



dry cleaning v accum cleaners are v ery satisfactory if the bag hasa paper insert to pre v ent tiny particles frompassing through the fabric.

wet cleaningmopping with hot water containing detergent isused.

disinfection

the class of germicide recommended for floors andsurfaces are synthetic phenols, quaternary ammonium compounds and iodophores.



clothing

To obtain maximum protection the body must be covered

completely , since micro organism may shed from the skin,hair, respiratory tract and normal clothing.

Dress code inside an aseptic area includes

Gowns and trousers

Hair dresses Masks

Gloves

Foot wares

spectacles



Sources of contamination AtmosphereDustDropletsBreathHandsClothingHair Working surfaceequipment



y Manufacturing facilities include maximum degree of

cleanliness in aseptic filling rooms.

y Constuction using best materials and design

y

The ceilings, walls and floors should be constructed of materials which are easy to clean and non porous so as to

prevent accumulation of dust and moisture.



y Environmental control

good environmental control is required prior and during

processing.

y

Traffic control persons should be permitted to enter aseptic areas only

after following prescribed procedures.



y Disinfection

all the surface should be disinfected in aseptic area and

effective disinfectant should be sprayed or wiped on all

surfaces.

y Irradiation

UV rays are anti bacterial in action, hence they produce a

disinfectant action on directly irradiative surface.



y Air control

clear and aseptic air is passed and maintained under positive pressure.

air of uniform velocity is produced by laminar air flow

benches.y Personnel requirements

they should be of good health.

they must have some knowledge about basic principles of

aseptic process.



y Movements with in the room should be minimum.

y Every individual shall use sterile uniform after every

break point.



Cooper and Gunns dispensing for pharmaceuticalstudents 494-516

A text book of hospital pharmacy by S.H Merchantand J.S Qadrys page no. 180-190

ORGANISATION jcgpoihgpi

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