OPPI Guidelines on Good Laboratory Practices(GLP)

7/25/2019 OPPI Guidelines on Good Laboratory Practices(GLP)

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Good Lab orat ory Pract ices (GLP) Guidelines

ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIARG NIS TION OF PH RM CEUTIC L PRODUCERS OF INDI



ACKNOWLEDGEMENTS

O PPI Technical C om m ittee 2004-05 led by M r. A jit Singh,

M anaging D irector, A ssociated C apsules Pvt. Ltd. contributed

tow ards O PPI G ood Laboratory Practices (G LP) G uidelines.

M em bers of Technical C om m ittee, M r. G .K. N air, Technical

A dvisor, A ssociated C apsules Pvt. Ltd. and D r. A .G .

Seshadrinathan, Vice President, Technical, Raptakos Brett & C o.spearheaded the preparation of the publication.



OPPI TECHNICAL COMMITTEE

CHAIRMAN

VICE-CHAIRMAN

MEMBERS:

A jit Singh A ssociated C apsules

R . R aghunandanan G laxoSm ithKline

G .K. N air A ssociated C apsules

D r. K.R .P. Shenoy A straZeneca

Satish L. Rajkondaw ar Sanofi Aventis G roup

Ram Parthasarathy B axter

D r. U .C . Shetty Johnson & Johnson

Pram od Pim plikar M erck

D r. B om i M . G agrat Pfizer

M s. Shw eta Purandare Procter & G am ble

D r. A .G . Seshadrinathan Raptakos B rett & C o.V.N . Phatak Solvay

D r. A m it B hadra W yeth





Sr. No. Page No.

1. O bjective 1

2. Scope 2

3. Personnel 2

4. Facilities 3

5. D ocum entation 5

6. C alibration 9

7. O ut of Specification (O O S) 10

8. Validation ot A nalytical M ethods 12

9. C hange C ontrol 14

10. Laboratory Reagents & Reference Standards 14

11. Safety 15

12. Training 17

13. Q uality Audit 19

14. M anagem ent Review 20

15. D efinitions 22

15.1 G LP

15.2 Test Facility

15.3 Test Facility M anager

15.4 Study Plan / Test M ethod

15.5 Raw D ata

15.6 Standard O perating Procedures (SO P)

15.7 Q uality A ssurance Program

16. B ibliography 24

CONTENTS





1

OPPI

GOOD LABORATORY PRACTICES (GLP)

G UIDELINES

C om pliance w ith G LP is a regulatory / legal requirem ent for the acceptance

of certain ‘studies’, undertaken by facilities, to be subm itted to Regulatory /

H ealth Authorities, for risk assessm ent in H ealth & Environm ental Safety.

For exam ple in U K the G ood L aboratory Practice M onitoring A uthority

(G LPM A ) enforces com pliance. The G LP Regulations require that any test

facility that conducts, intends to conduct a “regulatory study”m ust be a

m em ber, or prospective m em ber, of the U K G LP C om pliance program m e.

H ow ever there are test facilities, typically as part of a m anufacturing

organization, that conduct studies (Tests) w hich are not “regulatory

studies”. This docum ent is intended for such facilities. Besides this, in the

arena of Life Sciences, w hether in Research or D evelopm ent or

M anufacture, a good testing L aboratory is a m ust for building confidence

that the basis of G M P and product assessm ent is logically and scientifically

correct. H ow ever the various branches of Life Sciences need such specific

testing facilities from recom binant D N A testing to Pharm acovigilence that it

w ill not be possible to cover all such esoteric testing facilities. This docum ent

therefore provides the basic requirem ents in the running of a general testing

Laboratory in term s of good practices. The objective is to facilitate the

1. O BJ ECTIVE



2

proper application and interpretation of G LP principles in a generic

m anner.

This docum ent is designed to facilitate the proper application and

interpretation of the G LP principles for the O rganization and for the

M anagem ent of a Q uality C ontrol Laboratory and to provide guidance for

the appropriate application of G LP principles to testing. This guidance

docum ent is organized in such a w ay as to provide easy reference to the

G LP principles by follow ing the sequence of the different parts of these G LP

principles.

The Test Facility m ust have adequate personnel w ith the requiredqualification, experience and training (and ‘Approval’from regulatory

authorities w herever needed) to carry out the assigned functions in a tim ely

m anner according to the principles of G LP.

A Job D escription of every category / level of personnel in the Test Facility

m ust be m aintained. This m ust cover every individual engaged in testing /

analyzing or supervising the analysis. The Job D escription m ust also specify

the lim its of authority at each level / category.

2. SCOPE

3. PERSONNEL



The training record for every individual cross-referenced w ith the Job

description and D epartm ental training including M aterial Safety D ata sheet

m ust be available.

The Test Facility M anager m ust have sufficient educational background,

experience, training and authority to ensure that the Principles of G LP are

com plied w ith, in the test facility.

The Test Facility M anager w ill ensure that the personnel clearly understand

the functions they are to perform and, w here necessary, provide training for

these functions. The Indian D rugs & C osm etics Act and Rules there under

requires that each area of operations in the Laboratory has an “approved”

person (com petent technical staff) to conduct the tests and /or sign off the

docum entation.

The test facility should ideally be situated w ith direct access to personnel

w orking in them , w ithout the need to enter through the m anufacturing area,

and should be separated from m anufacturing areas. This is particularly

im portant for laboratories involved in the control of biologicals,

m icrobiologicals and radioisotopes, w hich should also be separated from

each other. Steps should be taken in order to prevent the entry of

unauthorized personnel. The area m ust not be used as a right of w ay by

personnel w ho do not w ork in them . Laboratory personnel, how ever, m ust

4 . FACILITIES

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4

have access to production areas for sam pling and investigation as

appropriate.

Facilities should be designed to suit the operations to be carried out in them .

Lighting, tem perature, hum idity and ventilation should be appropriate and

such that they do not adversely affect the products being tested or the

accurate functioning of equipm ent. If sterility testing is conducted then the

area should m im ic the aseptic production conditions and gow ning and

entry procedures, w ith the final stage of the changing room being, in the at-

rest state, of the sam e air quality / air classification as that into w hich it

finally opens, viz. the aseptic testing area. Sterility test m ust be conducted

under G rade A conditions, typically in a Lam inar Flow M odule, placed in

class 100 conditions. Sufficient space should be available to avoid m ix-ups

and cross-contam ination. There should be adequate storage space for

sam ples and records.

All laboratory instrum ents and equipm ent should be qualified and

calibrated in accordance w ith the m anufacturer’s recom m endations and

pharm acopoeial requirem ents. All the test instrum ents and equipm ent m ust

have unique identification num bers,(for their use, cleaning, calibration,

service & m aintenance) that can be linked to analytical raw data,

calibration reports and logbooks.

Separate room s w hich are clim ate controlled, m ay be necessary to protect

sensitive instrum ents from electrical interference, hum idity, vibrations etc.



C ontrol sam ples or reference sam ples also w ill need a separate room w hich

is equipped w ith tem perature and hum idity control capable of achieving

the sam e storage conditions as stated on the labels of the m aterials being

tested. Proper consideration should be given to ventilation requirem ents of

the areas depending on the activities carried out therein e.g. extraction,

handling of fum ing chem icals, organic solvents, distillation involving

heating etc.

Personal protective equipm ent should be w orn by personnel in the

laboratory (see chapter on Safety). Ideally a distinctive overall or Lab-coat

is advisable for laboratory personnel.

If part or all of the testing is contracted out and a contract testing laboratory

is used, this should be audited and approved based on com pliance w ith

G LP. A technical agreem ent m ust be in place betw een the contract giver

and the contract acceptor w ith a system in place to provide updatedauthorized analytical m ethods and specifications for the analysis involved.

A change control system m ust also be in place w ith the contract testing

laboratory.

The availability of a com plete set of SO Ps necessary to govern all the

pertinent activities and procedures in the test facility is an absolute

prerequisite. They define how to carry out protocol specific activities. They

5. DO CUMENTATION

5



6

should be w ritten in a chronological order listing different steps in the

accom plishm ent of an activity. There m ust be a clear m ention of

responsibilities. SO Ps m ust be subjected to periodic review s for updating, if

required, w hile it m ust rem ain user friendly. M ajor consideration should be

given to the degree of details incorporated in them . Som e of the key SO Ps

w hich need to be addressed include:

a. Sam ples handling and accountability.

b. Receipt, identification, storage, m ethod of sam pling of test and

control articles.

c. Record keeping, reporting, storage and retrieval of data.

d. O perating of technical audit personnel in conducting and

reporting audits, inspections, reports, review s.

e. Routine inspection of cleaning, m aintenance, testing,calibration of equipm ent.

f. H andling of O ut O f Specification (O O S) results.

g. C alibration m anagem ent.

h. Validation of analytical m ethods.

i. C hange control procedure.

j. H ealth and safety protection.



k. Anim al room preparation and anim al care.

l. Storage, m aintenance and traceability of m icrobial cultures.

m . Storage, use of reference standards and Reagents.

n. Laboratory w aste handling.

There m ust be a SO P in place in the laboratory for glassw are cleaning & it

should be based on glassw are w ashing efficiency both related to chem ical

labs & m icro labs. Sensitive item s like cells for photom etry readings m ust

have cleaning procedures that dem onstrate adequate cleaning.

All docum ents used should be review ed, approved, authorized prior to use.

In case of exclusive use of the electronic m edia, the softw are and processes

used should be validated and suitable m easures put in place to ensure

passw ord controls.

D ocum ents should be periodically review ed and w here necessary, revised

to ensure continuing suitability. Invalid or superseded docum ents m ust be

prom ptly rem oved or otherw ise assured against unintended use. C hanges

to docum ents should be review ed and approved by the sam e function that

perform ed the original review .

Procedures should be established to describe how changes in docum ents in

com puterized system s can be m ade and controlled. Additionally, clear-cut

procedures m ust be evolved for storage, distribution, retrieval and

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8

destruction of docum ents.

Provision m ust be m ade to retain raw data, SO Ps, docum ents, final reports

for a predeterm ined period. There should be archives for orderly storage

and expeditious retrieval. C onditions of storage should m inim ize

deterioration. Persons responsible for archiving m ust be identified and only

authorized persons m ust enter the archives.

Raw data should be recorded on duly controlled raw data sheets or pre-

paginated authorized logbooks. It should be verified independently by

another com petent person. The raw data including the autom ated

instrum ent printouts should be im m ediately signed and dated by the

analyst perform ing the test. The data stored on tem porary storage m edia

(e.g. therm al paper) should be transferred to a robust storage m edia (e.g.

photocopy or scan of the print out) and duly authorized establishing

traceability to the original raw data. D ata should be recorded, w hereverpossible, so as to facilitate trending.

Tests perform ed m ust be recorded and the records should include at least

the follow ing data:

i. N am e of the m aterial and w here applicable dosage form .

ii. Batch no. and w here appropriate the m anufacturer and/or the

supplier.

iii. Reference to the relevant specifications and test procedures.



iv. Test results, including observations and calculations, and

reference to any C ertificates of A nalysis.

v. D ate of testing.

vi. Initials of the person/s that perform ed the test.

vii. Initials of the person /s w ho verified the testing and the

calculations w here appropriate.

viii. A clear statem ent of the status decision (release or reject etc.)

and the dated signature of the designated Facility M anager or

Responsible Person.

All test and m easuring equipm ent are likely to influence the test results

directly or indirectly and m ust be subject to calibration.

The frequency of calibration depends on the instrum ent, the

recom m endation from m anufacturers, laboratory experience and extent of

use. Procedures em ployed for calibration m ust be clearly w ritten dow n and

test report m ust conclude w ith a statem ent of ‘status’. In case of non-

conform ity, the report m ust indicate corrective and preventive action.

All the test instrum ents and equipm ent m ust have a unique identification

num ber that should be linked to analytical raw data, calibration reports and

6. CALIBRATION

9



10

logbooks for their use.

C alibration certificate / calibration record / calibration report should carry a

unique identification num ber, the nam e and address of the agency, if

outside expert is involved, in addition to the identification and description

of test procedure including traceability to prim ary standards if used. The

certificate should also indicate the calibration results and the due date for

next calibration. The equipm ent should have a tag displaying the status of

calibration.

W hen an instrum ent for calibration has been adjusted or replaced, the

calibration results before and after repair, if available, should be reported.

Reference m aterials used m ust be characterized, certified, purchased from

reputable sources and traceable to national and international m easures.

W hen an instrum ent is found “O ut of C alibration” it should be

conspicuously labeled as such so that its use for testing is prevented. The testresults betw een non-com pliant calibration results and last successful

calibration should be review ed to confirm the correctness of the test results

reported and appropriate action should be taken based on the outcom e of

the investigation. In case of frequent failures, the frequency of calibration

and preventive m aintenance should be review ed and revised if necessary.

O ut O f Specification (O O S) results are those results, generated during

7. O UT OF S PECIFICATION (OO S )



testing, that do not com ply w ith the relevant specifications or standards or

w ith the defined acceptance criteria. If at any tim e during the process of

study or testing, a result is obtained that is out of specification or is

considered “atypical”(for exam ple during stability testing), a defined

procedure m ust be follow ed to investigate the result and determ ine the

course of action.

The objective of the procedure is to ascertain if the O O S or atypical result is

valid (i.e. that the result is an accurate representation of the m easured

attribute of the sam ple taking into consideration the precision of the

analytical m ethod) and, if the result is valid, to determ ine its probable cause

and im pact. O O S or atypical results can arise from causes that can be

divided into 3 m ain categories:

• Laboratory Error

• O perator error –N on-Process Related

• Process related –M anufacturing Process Error

The first stage of the procedure is a laboratory investigation to determ ine if

the O O S is clearly assignable to laboratory error. If so then the result m ay be

discarded and the test repeated. If the O O S is not clearly due to laboratory

error then the investigation is expanded outside the laboratory testing and

can include re-sam pling. The aim s of the expanded investigation are to

identify the probable cause of the O O S or atypical result and to determ ine

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the significance of the result w hen m aking decisions about the m aterial or

product under test.

U nder certain circum stances there m ay be justification for not follow ing the

above procedure w hen O O S or atypical result is obtained. Exam ples of

such situations include, but are not lim ited to:

• Pharm acopoeial specifications w hich give specific guidance in

tests like C ontent U niform ity, D issolution, Sterility Testing etc.

• Stability Testing, w here prediction from trend analysis indicate

that the result is valid

• O O S supported by results for other tests like low assay w ith

high result for im purity content.

• Investigation of O O S for a starting m aterial, raw m aterial or

interm ediate m ay, w here justified, be restricted to aconsideration of the suitability of the m aterial for onw ard

processing.

In circum stances w here the procedure is not follow ed, the justification for

this approach m ust be docum ented and approved by the Facility M anager.

All analytical m ethods, particularly non-standard and in-house test

8 . VALIDATION OF ANALYTICAL METHO DS



m ethods m ust be validated by a laid dow n procedure. All analytical

equipm ent m ust be appropriately qualified before m ethod validation. The

degree of validation should reflect the purpose of analysis and the type of

product being tested. For exam ple there should be an increasing degree

betw een tests for packaging m aterials, raw m aterials, interm ediates and

finished products or clinical trial m aterials. The validation m ethodology

m ust be clearly docum ented and should include:

• Selectivity and specificity

• Range

• Linearity and range

• Robustness

• Bias

• Precision

• Lim it of detection

• Lim it of quantification

A record m ust be m aintained of any m odification of the validated m ethod

and should include reason for m odification and appropriate data to verify

that results are as accurate and reliable as the established m ethod.

Suitability of all m ethods should be verified under actual conditions of use

and docum ented. In addition, it w ould also be useful to perform inter-

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laboratory com parison of results periodically.

A ll changes in equipm ent, test environm ent, test m ethod, services, system s

or location that m ay affect reproducibility, accuracy or standards m ust be

form ally requested, docum ented and accepted. The likely im pact of the

change should be evaluated and the change control procedure should

ensure that sufficient supporting data are generated to dem onstrate that

change does not affect the end result or the in-house or registered

specifications.

There m ust be w ritten procedures in place for the handling of reagents and

preparation of standard solutions.

A prim ary standard is one that has been show n by an extensive set of

analytical tests to be authentic m aterial of established quality. This standard

m ay be obtained from a recognized source (like U SP, B P etc) or m ay be

prepared by independent synthesis or by further purification of existing

production m aterial. An “in-house prim ary standard”is an appropriately

characterized m aterial prepared by the m anufacturer from a representative

lot for the purposes of physicochem ical testing of subsequent lots and

against w hich in-house reference m aterial is calibrated. A “secondary

9. CHANGE CO NTROL

10 . LABO RATOR Y REAGENTS & REFERENC E STANDARDS



standard”is a substance of established quality, as show n by com parison to

a prim ary reference standard, used as reference standard for routine

laboratory analysis.

Reagents should be dated as soon as received and a “use by”date assigned

based on experience or alternatively a short date (1 year) first assigned

w hich can then be extended based on retesting. Laboratory reagents

intended for prolonged use should be m arked w ith the preparation date and

the signature of the person w ho prepared them . The expiry date of unstable

reagents and culture m edia should be indicated on the label, together w ith

specific storage conditions. In addition, for volum etric solutions, the last date

of standardization and the last current factor should be indicated.

Reagents and chem icals should be stored by their hazard class and not by

alphabetical order. For exam ple storage should be by segregating into

groups of ‘oxidizers’, ‘reactives’, corrosives etc. W ithin the particular groupalphabetical storage m ay then be done.

People w ho w ork in scientific laboratories are exposed to m any kinds of

hazards. This can be said of m ost w orkplaces; in som e, the hazards are w ell

recognized (those of ordinary fire, for exam ple) and the precautions to be

taken are obvious. Laboratories, how ever, involve a greater variety of

possible hazards than do m ost w orkplaces, and som e of those hazards call

11 . SAFETY

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for precautions not ordinarily encountered elsew here. It is how ever not

possible to enum erate each and every safety precaution that should be

follow ed; this chapter consequently sets forth som e of the m ajor rules for

safety and recom m ends the reader to the B ibliography at the end for w ider

reading and understanding of specific hazards and safety practices to deal

w ith these.

The design and construction is the first instance of building safety features in

the laboratory. Laboratory m ust be equipped w ith adequate fire

extinguishers, personal protective equipm ent (PPE), safety show ers, eye

w ash fountains and first aid kits. The design should facilitate the change of

street clothes and footw ear to specific PPE needed by the laboratory

personnel.

N o em ployee should w ork alone in a laboratory or chem ical storage area

w hen perform ing a task that is considered usually hazardous by thelaboratory supervisor or safety officer. C lothing w orn in the laboratory

should offer protection from splashes and spills, should be easily rem ovable

in case of accident, and ideally should be fire resistant. N o food, beverage or

cosm etic products should be allow ed in the laboratory or chem ical storage

area at any tim e.

Laboratories using com pressed gas cylinders should ensure that they are

secured at all tim es either to a w all or placed in a holding cage to prevent

tipping. Since the gases are contained in heavy, highly pressurized m etal



containers, the large am ount of potential energy resulting from

com pression of the gas m akes the cylinder a potential rocket or

fragm entation bom b. In sum m ary, careful procedures are necessary for

handling the various com pressed gases, the cylinders containing the

com pressed gases, regulators or valves used to control gas glow, and the

piping used to confine gases during flow. Ideally the cylinders should be

located outside the lab, w ith clearly labeled piping identifying the gas, pipedinto instrum ents or parts of the lab.

Storage of flam m able solvents should be m inim ized as far as possible and

cabinets used for storage of flam m able liquids m ust be properly used and

m aintained and only m aterials that are com patible m ust be stored

together.(refer to ‘O SH A’in Bibliography). Reagents, solutions, glassw are

or other apparatus should not be stored in fum e / extraction hoods as this

not only reduces the available space but m ore im portantly m ay interfere

w ith the proper airflow pattern and reduce the effectiveness of the hood as a

safety device.

Test Facility m anagem ent m ust provide training for all personnel w hose

duties involve the conducting of tests and analysis. Training should also be

provided to other personnel w hose activities could affect the quality of

testing. B esides the basic training on the theory and practice of G LP, new ly

12 . TRAINING

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recruited personnel should receive training appropriate to the duties

assigned to them . This should provide personnel w ith good m otivation to

perform the relevant tasks in a m anner aim ing tow ards full com pliance of

G LP.

Follow ing the identification of training needs, general training sessions or

sm all w orkshops for personnel should be laid dow n for successful

im plem entation of G LP. These should be follow ed by ‘hands on’exercises

leading to practical application of G LP principles. Training program s m ust

lead to change in “cherished habits”of personnel. The im portance of

docum entation used for legible, indelible recording of all events, data and

other occurrences together w ith their dating and initialing, correctly

introducing changes into records m ust be highlighted. Training program

should be designed so as to m aintain continuity. A constant coaching m ay

be needed to enable the im m ediate detection, adm onition and correction

of slips, errors, om ission and neglect.

A form al training program , in the form of an SO P, m ust be in place w hich

includes a procedure for assessing the com petence/skills of the personnel

undergoing training. Records m ust be m aintained of persons w ho are

adjudged com petent and authorized, including dates of authorization to

perform specific tasks such as sam pling, testing, calibration, operating

typical equipm ent, issuing of test reports, etc.

In addition, the records of their educational and professional qualification,



training undergone, skills and experience shall also be m aintained (See

chapter on Personnel).

The test Facility should have a docum ented Q uality A ssurance (Q A)

Program to assure that tests / studies perform ed are in com pliance w ith

these principles of G ood Laboratory Practice. The Q A program or Self

Audit should be carried out by an individual or by individuals w ho are

designated by and directly responsible to the Facility M anager and w ho are

thoroughly fam iliar w ith the test procedures. These individuals m ust not be

involved in the conduct of the study / test being assured.

The responsibilities of these Q A / Audit personnel include, but are not

lim ited to, the follow ing functions:

a. M aintain a copy of all approved test m ethods / study plans and

SO Ps in use in the test facility.

b. Verify that the test m ethods / study plans contain the

inform ation required for com pliance w ith these principles of

G ood Laboratory Practice.

c. C onduct audits / inspections to assure that tests are conducted

in accordance w ith these principles of G ood Laboratory

Practice. Inspections can be of three types as specified by the

13 . Q UALITY AUDIT

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20

Q A SO P :

i. Study / Test-based inspection

ii. Facility-based inspection

iii. Process-based inspection

d. D ocum ent and retain records of all inspections.

e. Inspect the final reports to confirm that the m ethods,

procedures and observations are accurately and com pletely

described and that the reported results accurately and

com pletely reflect the raw data of the studies / tests.

f. Prom ptly report inspection results in w riting to the Facility

M anager and ensure that corrective action is put in place if

necessary.

M anagem ent of a test facility has the ultim ate responsibility for ensuring that

the facility as a w hole operates in com pliance w ith the G LP principles. This

w ill involve the im plem entation of Q uality A ssurance or Q uality A udit

program w hich is independent of the actual conduct of test / study and is

designed to assure the test facility m anagem ent of com pliance w ith these

principles of G LP.

14 . MANAGEMENT REVIEW



The individual or individuals responsible for conducting the program m ust

not be involved in the test or in any study program being assured. The

im plem entation of such an audit program is discussed under the chapter

“Q uality A udit”. Records of these inspections along w ith corrective actions

taken should be archived. Archival facilities should enable secure storage

and retrieval of all docum ents like Test m ethods, raw data, final reports etc.

N orm ally an inspector from a R egulatory A gency w ill not request to see an

actual report of an audit as such requests could inhibit auditors w hen

preparing inspection reports. It is sufficient to show that a program of self

audit exists through docum ented evidence and to show that a procedure for

corrective action is also in place.

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15 . DEFINITIONS

15 .1 GLP :

G ood Laboratory Practice is concerned w ith the organizational processes

and the conditions under w hich laboratory tests are planned, perform ed,

m onitored, recorded, archived and reported. Adherence by test facilities to

the principles of G LP ensures proper planning of tests and the provision of

adequate m eans to carry them out. It facilitates the proper conduct of tests,prom otes their full and accurate reporting and provides m eans w hereby the

validity and integrity of the tests and analytical data can be verified. It also

facilitates an audit trail of the products m anufactured.

15 .2 Test Facil i ty :

M eans the O perational U nit, including the prem ises, equipm ent,

instrum ents and persons, w hich are necessary for conducting the studies.

15 .3 Test Facili ty Mana ger:

M eans the person w ho has the authority and form al responsibility for the

organization and functioning of the Test Facility according to these

principles of G ood Laboratory Practice.

15.4 Study Plan / Test method

M eans a docum ent w hich defines the objectives and experim ental designfor the conduct of the test / study including specified instrum ents to be used



and the acceptance criteria of the data.

1 5 .5 R aw da t a

M eans all original test records and docum entation, or verified copies

thereof, w hich are the result of original observations and activities in a study

/ test. Raw data also could include hand w ritten notes, com puter printouts,

recorded data from autom ated instrum ents, or any other data storagem edium that has been validated as capable of providing secure storage of

inform ation. These should be linked to final outcom e such that traceability

is possible.

15.6 Standa rd Operat ing Procedures (SOP) :

M eans docum ented procedures w hich describe how to perform all the

pertinent activities and procedures in the test facility. The com pilation of

topics for SO Ps w ill involve the logical dissection of w hole processes, suchas conduct of studies / tests, into their single activities, as w ell as an effort to

list equipm ent, apparatus or instrum ent w hich w ould be used in the G LP

relevant areas. The SO P should also include the necessary precautions to

be taken w hile perform ing a particular test.

15.7 Qual i ty Assurance Program

M eans a defined system , including personnel, w hich is designed to assure

test facility m anagem ent of com pliance w ith these principles of G ood

Laboratory Practices.

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BIBLIOGRAPHY

1. O EC D (O rganization for Econom ic C o-operation and D evelopm ent,

Paris 1998) Principles of G ood Laboratory Practice

2. O E C D Q A and G LP, 1999

3. O EC D in Vitro G LP, 2004

4. G uide to U K G LP Regulations, Feb 2000 (by G LPM A)

5. IC H Q 7A G M P section 11 Laboratory Controls

6. O SH A (O ccupational Safety and H ealth A dm inistration U SA ;

w w w.osha.gov)

7. ISO / IEC 17025; 1999

8. G LP W hy & H ow by D r Jurg Seiler. Publ. Springer-Verlag.

9. M C A “O range G uide”(Rules and G uidance for Pharm aceutical

M anufacturers and D istributors 2002)



25

About O PPI

O PPI is an organisation of pharm aceutical m anufacturers established in 1965.

Its m em bership consists of Research based International and large Indian

pharm aceutical com panies.

O PPI m em bers account for a substantial share of the industry's total

investm ent, export and R& D . The m arket share of its M em ber-Firm s in total

Pharm aceuticals M arket in India is over 60% .

O PPI is not only an industry association but also a scientific and professional

body. It organises national and international sem inars and w orkshops relating

to key issues of the pharm aceutical industry and healthcare. It supports

scientific research by professional and academ ic institutes. It also brings out

technical publications, like Q uality A ssurance G uide and Environm ent, H ealth

& Safety G uide, Pharm aceutical C om pendium , Research report on

outsourcing opportunities, M odel G uidelines etc.

O PPI m em bers adhere to the C ode of Pharm aceutical M arketing Practices of

International Federation of Pharm aceutical M anufacturers A ssociations

(IFPM A ). O PPI has developed operational guidelines for its m em bers for

interpretation and im plem entation of this Code of Ethical M arketing Practices.

O PPI is also a m em ber of the W orldSelf-M edication Industry (W SM I), France

and has developed code of ethics for advertisem ent of drugs.

O PPI identifies itself w ith the country's national health objectives and

encourages its m em bers to m ake substantial contributions to social concerns. It

also co-ordinates its M em bers' efforts in national calam ities like epidem ics,

floods, earthquakes and cyclone.

O PPI also assists other scientific and educational program m es besides having

its ow n on-going program m es of health education and supports the country's

national objectives of health im provem ent.

Documents

OPPI Guidelines on Good Laboratory Practices(GLP)