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Guidelines for ISM & HOMOEOPATHIC Drug Testing Laboratories


Definition Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.


Preface Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD Member countries have established criteria for the performance of these studies

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In 1979 and 1980, an international group of experts established under the Special Programme on the Control of Chemicals developed the “OECD Principles of Good Laboratory Practice” (GLP), utilizing common managerial and scientific practices and experience from various national and international sources. These Principles of GLP were adopted by the OECD Council in 1981, as an Annex to the Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30(Final)].

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In 1995 and 1996, a new group of experts was formed to revise and update the Principles. The current document is the result of the consensus reached by that group. It cancels and replaces the original Principles adopted in 1981. The purpose of these Principles of Good Laboratory Practice is to promote the development of quality test data.

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Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these Principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment

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Laboratory adopting GLP should have a written document because it is a well known fact that what is not recorded is not done . Laboratory adopting GLP should also have Quality objectives and a well defined organizational structure. Things done and observed in the laboratory must be recorded for future references.

Terms Concerning the Organization of a Test Facility:

Terms Concerning the Organization of a Test Facility Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. For multi-site studies, those which are conducted at more than one site, the test facility comprises the site at which the Study Director is located and all individual test sites, which individually or collectively can be considered to be test facilities.


ORGANISATION Laboratory is required to have the following type of organizational setup:- Technical evaluation and implementation wing : with an expert support of 3 personnel for different subjects viz. Chemistry, Botany and one from clinical side (Ayurveda/Unani/Siddha/Homoeopathy) Quality Assurance wing : with an expert support of 3 personnel for different subjects viz. Chemistry, Botany and one from clinical side (Ayurveda/Unani/Siddha/Homoeopathy) Experts of both wings will directly report to the Head of the laboratory.

Responsibilities of the Technical evaluation & implementation wing:

Responsibilities of the Technical evaluation & implementation wing In-charge may be an ‘Approved Person’ or a ‘Person’ appointed by the Govt. with sufficient educational background and experience to check, confirm and certify the testing work carried out by an analyst. In-charge shall be responsible for all technical evaluations as well as interpretation, analysis, documentation and reporting of the results.

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In-charge shall assure that-the protocol, including any change is approved and followed. In-charge will not approve the protocol but only makes sure that approval is obtained from management. All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. In-charge will assure that data is collected as specified by the protocol, SOP’s and accurate recording of unanticipated responses of the test

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In-charge shall also review data periodically and assure that the data are technically correct. Unforeseen circumstances that may affect the quality and integrity of the laboratory work be noted as and when they occur, immediately corrective action be taken and documented. Determination of the appropriateness of the test system is a scientific decision made by management at the time of protocol approval. In-charge need only to assure that protocol specifications are strictly followed.

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In-charge shall assure frequent interaction with experts of quality assurance unit. Deviations from GLP requirements noted by the quality assurance unit must be reported periodically to management and to in-charge of the laboratory. If those reports indicate that corrective action is still needed for any deviation from regulatory requirements, it is the responsibility of the in-charge to assure that corrective action occurs.

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Role of the in-charge is not simply to react on reports of regulatory deviations from the quality assurance unit, but also to play proactive role to assure that laboratory personnel are aware of GLP requirements and that deviations from those requirements do not occur. All raw data, documentation, protocols, specimens and final reports are transferred to the archive at the end of work.

Responsibilities of the QC unit:

Responsibilities of the QC unit QC unit will be responsible for reporting implementation of GLP to the top management. QC unit shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with the regulations. For any given study, QC unit shall be entirely separate from the independent of the personnel engaged in the laboratory work.

Activities of QC unit:

Activities of QC unit QC unit will maintain a copy of the master schedule sheet of all activities of a laboratory conducted by test article containing the test system, nature of study and the name of in-charge. QC unit will maintain copies of all protocols pertaining to all activities of the laboratory for which unit is responsible. Proper discharge of QC unit responsibilities requires a knowledge of protocol requirements. QC unit’s responsibility is to inspect the laboratory to assure that there are no deviations from protocol requirements.

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QC unit will inspect each activity of the laboratory at intervals to assure the integrity of the activity Maintain written and properly signed records of each periodic inspection showing the date of inspection, the activity inspected, person performing the inspection, findings and problems, action recommended and taken to resolve existing problems and any scheduled date for re-inspection.

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Any problems found during the course of an inspection which are likely to affect integrity of the activity shall be brought to the notice of the in-charge as well as management immediately. QC unit will submit written status report on each study, noting any problems and the corrective actions taken periodically to the in-charge as well as to the management. There should be no deviations from approved protocols or Standard Operating Procedures without proper authorization and documentation.


LABORATORY SETUP Drug testing/ QC lab. should have sections of Pharmacognosy/ Botany Phytochemistry Microbiology Pharmacology Museum Herbarium Reference Library Herbal Garden

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Each wing should be sufficiently staffed. Each personnel will be responsible to conduct tests and analysis, irrespective of the status and shall maintain a daily work diary indicating the allotment of work and work done. Attendance of every staff member may be made compulsory. Technical staff should have at least post graduate qualification in the concerned discipline. There should be a moisture free and air conditioned storage facility.


PERSONNEL Each individual engaged for the supervision of a laboratory shall have required education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. Each Section/Department shall maintain a current summary of training and experience and job description for each individual engaged in supervising the laboratory. Each staff member is supposed to mark attendance irrespective of the status.

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Qualifications of the employee may be carefully considered by laboratory management. Laboratory management, therefore, has considerable latitude to define job qualifications. It is in the interest of any reputed laboratory to engage competent individuals and to provide adequate on-the-job training to qualify those individuals to perform their assigned duties.

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Documentation of employee qualifications may include, an educational and employment history for each employee, and a description of any acquired training provided to the employee. Documentation should be updated periodically to reflect changes in educational background and any additional training undergone by the employee.

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There shall be a sufficient number of personnel according to the protocol. A shortage of qualified personnel can lead to inadequate or incomplete monitoring of a study and to delayed preparation and analysis of study results. Scientific disciplines, education, training or expertise of the personnel participating in the analysis should vary according to the types of analysis being carried out by them.


OPERATIONAL REVIEW A review by the members of the review committee should be performed at regular intervals. Agenda of the review may cover- Quality control data, Pharmacopoeial data and their implementation. Development of protocols for testing and quality assurance of drugs, both for raw materials and finished products.


STANDARD OPERATING PROCEDURES Standard operating procedures are the written procedures for the different activities being conducted in a laboratory All the analytical processes to be validated & documented with detailed written procedure. When it is followed by a responsible and trained person will result in analyzing the drugs with accuracy, precision, consistency and without any deviation.

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These written down procedures are to be reviewed and approved finally by the quality assurance unit. Thereafter, these approved written down procedures shall be followed in the execution of the various analytical activities. These procedures are commonly known as “Standard Operating Procedures” or “SOPs”.

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SOPs define how to carry out protocols of specified activities . SOPs should be written in a chronological order indicating different steps leading to analysis of drugs. There should be a mandatory requirement to have SOP manuals and protocols usually reviewed, revised after every two years until and unless otherwise required .

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Major consideration in writing the SOP should be the degree of details incorporated therein. It is always advisable to allow acceptable approaches for any method. The range of topics for which SOPs are required will be governed by the variety of studies routinely conducted in the laboratory. For each procedure required by each type of study, the laboratory should prepare an SOP describing how that procedure should be performed.

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SOPs be established for the following :- Sample handling & maintenance of records Foreign matters and adulterants Methods of preparation of drugs Powder fineness and Sieve size Ash determination Extractable matter determination Receipt identification, storage, mixing & method sampling of the test

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Record keeping, reporting, storage and retrieval of data Element of technical audit in respect of equipments and machines and their maintenance and operation. Maintenance, calibration & testing of the equipment /instruments. Reagent and solutions, their preparation & standardization, storage and maintenance. Health and safety protection

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Raw Data Animal room maintenance Animal care Micro organisms and maintenance of microbial cultures Maintenance of sterility room Use and storage of reference standards Protocols

Sample handling & Maintenance of records:

Sample handling & Maintenance of records Plant based drugs, due to lack of their homogeneity require special handling procedures for sampling. At the time of inspection of a sample, following points may be considered Organoleptic characteristics (color, texture and odour) Presentation of the material (raw, cut, crushed, compressed) Presence of adulterants, foreign matter (sand, glass particles, dirt , metal), mould or signs of decay Presence of insects

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Samples are tested for the following characteristics Degree of fragmentation (sieve test) Identity and level of impurities and type of adulteration Moisture and ash content Presence of active ingredients, as far as possible. A portion of each sample should be retained which may also be used for re-test purposes, if necessary. Macroscopic, microscopic characters and TLC pattern of main ingredients be reproducible

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Procedures shall be established for a system for the handling of the samples to ensure that There is proper storage and labelling. Proper identification is maintained throughout the distribution process. Receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.


FOREIGN MATTER Drugs should be entirely free from visible sign of contamination by moulds or insects, and other animal contamination, including animal excreta. No abnormal odour, discolouration, slime or signs of deterioration should be detected. It is seldom possible to obtain marketed raw drugs that are entirely free from some form of innocuous foreign matter. However, no poisonous, dangerous or otherwise harmful foreign matter or residue should be allowed.

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Macroscopic examination can conveniently be employed for determining the presence of foreign matter. However, microscopy is indispensable for powdered drugs. Any soil, stones, sand, dust and other foreign inorganic matter must be removed before raw drugs are cut or ground for testing.

Sample size :

Sample size The following quantities constitute a sample, unless otherwise specified in the test procedure for the plant material concerned.

Recommended procedure for determining foreign matter:

Recommended procedure for determining foreign matter Weigh a sample of drug, taking the quantity indicated above unless otherwise specified in the text for the plant drug concerned. Spread it in a thin layer and sort the foreign matter into groups either by visual inspection, using a magnifying lens, or with the help of a suitable sieve, according to the requirement of plant drug concerned.

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Shift the remainder of the sample through a No.250 sieve; dust is regarded as mineral admixture. Weigh the portions of this sorted foreign matter to within 0.05 g. Calculate the content of each group in grams per 100g of air-dried sample.


POWDER FINENESS & SIEVE SIZE Coarseness or fineness of a powder of plant drug is classed according to the nominal aperture size expressed in µ size of the mesh of the sieve through which the powder will pass, and is indicated as follows :


ASH DETERMINATION Ash remaining following ignition of plant drugs is determined by three different methods which measure total ash, acid-insoluble ash and water-soluble ash. The method for total ash is designed to measure the total amount of material remaining after ignition . This includes both “Physiological ash” which is derived from the plant tissue itself, and “Non-physiological ash” which is the residue of the extraneous matter (e.g. sand and soil) adhering to the plant surface

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Acid –insoluble ash is the residue obtained after boiling the total ash with dilute hydrochloric acid, and igniting the remaining insoluble matter. This measures the amount of silica present, especially as sand and siliceous earth. Water-soluble ash is the difference in weight between the total ash and the residue after treatment of the total ash with water.


EXTRACTABLE MATTER DETERMINATION Amount of active constituents extracted with different solvents from a given amount of plant drug. Method I. HOT EXTRACTION Method II. COLD MACERATION

RECEIPT, IDENTIFICATION, STORAGE, MIXING & METHOD SAMPLING OF THE TEST Necessary to prevent contamination or mix-ups, so separate areas for 1. Receipt and storage of the samples 2. Mixing of the samples with a carrier 3. Storage of the sample-mixtures Identity, strength, purity & composition of the samples be determined for each batch & documented :

RECEIPT, IDENTIFICATION, STORAGE, MIXING & METHOD SAMPLING OF THE TEST Necessary to prevent contamination or mix-ups, so separate areas for 1. Receipt and storage of the samples 2. Mixing of the samples with a carrier 3. Storage of the sample-mixtures Identity, strength, purity & composition of the samples be determined for each batch & documented

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Plant based drug samples, must be stored under specified conditions in order to avoid contamination and deterioration Container be labelled by name, chemical abstract number or code number, batch number and expiration date, if any. Expiration date needs to be included on the label only if one has been established. Container and its closure must not interact physically or chemically with the material within in any way that would alter its quality.

Protection from light:

Protection from light Plant based drug samples requiring protection from light, should be placed inside a suitable light-resistant (opaque) container and/or stored in a dark place Temperature Drugs that need to be stored at temperatures other than room temperature should be labelled accordingly Humidity Low humidity may be maintained, if necessary, by the use of a desiccant in the container provided that direct contact with the product is avoided

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For each sample that is mixed with a carrier, appropriate analytical methods shall be conducted (a) to determine the uniformity of the mixture and to determine the concentration of the sample in the mixture (b) to determine the stability of the sample in the mixture Where any of the components of the sample-carrier mixture has an expiry date, that date shall be clearly shown on the container If more than one component has an expiry date, the earliest date shall be shown


RECORD KEEPING, REPORTING, STORAGE AND RETRIEVAL OF DATA All the new data, documentation, SOP, Protocols, final reports shall be retained. Shall be archives for orderly storage and expeditious retrieval of all raw data, documentation, protocols interim and final report. Proper conditions shall minimize deterioration of documents. Paper documents should not be kept for very long periods under high humidity.

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Persons responsible for archives shall be identified. Only authorized person should enter the archives. Preservation of raw data in the form of tape and discs is to be properly taken care of. In case of only optical disc, the life time of disc should be longer than the storage time. Raw data on thermal paper is likely to fade away with time, therefore, a photocopy of such documents should form a part of the archive. Time for which the records shall be retained, should be clearly prescribed in the documents.


TECHNICAL AUDIT PERFORMANCE & REPORTING Technical audit shall include inspection of each activity of the laboratory at intervals to assure the integrity of the activity Maintain written and properly signed records of each periodic inspection showing the date of inspection, the activity inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems and any scheduled date for re-inspection. Any problem found during the course of an inspection which are likely to affect integrity of the activity shall be brought to the notice of the in-charge as well as management immediately


EQUIPMENT Equipment should be of appropriate design and of adequate capacity to function according to the protocols. Examples of such equipment include balances; colorimeters; spectrophotometers; pH meters; refractometer , polarimeter ; analytical equipment (HPLC,GC, HPTLC,AAS etc.); computerized equipment for direct capture of data. Suitably located for operation, inspection , cleaning and maintenance.

Maintenance, calibration & testing of the equipments:

Maintenance, calibration & testing of the equipments Maintenance and their calibration, procedures should be designed in such a way that they perform consistently Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated and/or standardized. Establish schedules for such operations because the frequency for calibration and testing varies from instrument to instrument.

Maintenance, calibration:

Maintenance, calibration Ex: pH meter should be calibrated every time before each use Titrator should be calibrated every month or whenever cells are reinstalled. Performance test for chromatography equipment should be carried out twice a year. UV spectrophotometer and visible colorimeter - after every three months.

Maintenance, calibration:

Maintenance, calibration Laboratory’s program (schedules) for routine inspection, cleaning, maintenance, testing calibration and/or standardization of equipment must be in writing Description of calibration and standardization methods and parameters; and the job title of personnel responsible for the performance of each operation. Common trouble-shooting problems with appropriate remedial actions are frequently included in equipment manuals provided by the manufacturer which can be cited in the Standard operating procedures .

Maintenance, calibration:

Maintenance, calibration Copies of equipment SOP’s be easily and readily accessible by laboratory personnel. Record for reflecting the nature of defect , how and when the defect was discovered, remedial action taken in response of the defect. Equipment inspection, maintenance, and repair records can be recorded in a log book especially designed for that purpose.

Maintenance, calibration:

Maintenance, calibration For equipment that is moved from laboratory to laboratory, the log book should accompany the equipment when it is moved. Documentation of calibrating or standardizing operations, be efficiently recorded with the data acquisition activities Following check can also be maintained for particular equipments.

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BALANCES Name of the manufacturer, model no. etc Date of purchase Type Capacity Reproducibility Log of calibration and repair

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COLORIMETERS Name of the manufacturer, model no. etc Filters available Log of lamp replacement and repair pH meters Name of the manufacturer, model no. etc Reproducibility Log of electrode replacement showing date and reason for replacement

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SPECTROPHOTOMETERS Name of the manufacturer, model no. etc Type Spectral range Standards use for calibration-(a) Wave length (b) Absorbance Log of calibration for wavelength and absorbance showing (a) Date (b) Signature and (c) Deviation found Log of lamp replacement Repair log (a) Date (b) Signature


REAGENTS AND SOLUTIONS All reagents and solutions in the laboratory shall be properly labelled. Concentration and the expiry date of reagent and solution shall also be indicated clearly on the label. Special attention should be given to those reagents having a tendency to deteriorate on exposure to light and to those require refrigeration. Solutions having a tendency to deteriorate on exposure to light need to be protected from light.


HEALTH & SAFETY PROTECTION Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems. Personnel shall wear clothing appropriate for the duties they perform. Clothing shall be changed as often as necessary to prevent microbiological, radiological or chemical contamination in tests and control articles. Wearing of hats, gloves, masks and shoe covers (preferably of the disposable variety) is highly recommended.


HEALTH & SAFETY PROTECTION Safety glasses or protective goggles will be appropriate for some hazardous operations Any individual found at any time to have an illness that may adversely affect the quality and integrity of the laboratory work shall be excluded from direct contact with tests and control articles until the condition is corrected. All personnel shall be instructed to report to their immediate supervisor for any health or medical conditions that may reasonably be considered to have an adverse effect


HEALTH & SAFETY PROTECTION Disturbances from continuous noise either within or from outside, obnoxious odors, inadequate or poor illumination should be avoided with proper infra structural designing. Smoking should be prohibited within the laboratory premises. Environment in which these activities are performed should not invalidate the results or adversely affect the required accuracy of measurements. All chemicals and solvents should be handled in a hood. Provision of exhaust fan is must


RAW DATA Raw data refers to the laboratory work sheet, records, memoranda, notes thereof that may be the result from general observations and other activities. Include hand written notes, computer printouts , spectral charts or recorded data from automated equipments. Include results of environmental monitoring, instrument calibration record, integrator output from analytical equipment including worksheet used to read a note.


RAW DATA A single line should strike through the data being changed, the correct information should be recorded along with the data of change and the reason for change The person making the change should be identified by his signatures or initials. In case of automated data collection system, the person responsible should be identified at the time of data output.


RAW DATA Any changes made should be in such a way that the original entry is saved and person responsible should be identified. Data integrity and security should be taken care of so that unauthorized users should not have any access to this data


ANIMAL ROOM MAINTENANCE Proper animal house separate from the test system and quarantine for animals should be provided. In the animal house, the facilities for collection and disposal of animal waste should be provided. The disposal should be such, so as to minimize the contamination of the environment


ANIMAL CARE SOP’s for feeding, handling and care of animals. New animals received from the outside source should be isolated and their health studies should be properly evaluated before they are made to join the existing animal’s population in the laboratory. Separate provision for keeping the diseased animals. Treatment should be carried out after proper diagnosis giving the description of treatment, date of treatment etc. with proper documented record.


ANIMAL CARE Separate housing for the different types of animals and the proper identification mark should be made on the cages with suitable labels. A proper exercise should be adopted for sanitation. Written schedule for cleaning the cages, racks & other equipments. Food and water used for animals should be free from contaminants and if required quality of the food should be checked time to time. Bedding material used in animal cages or racks should not interfere for carrying out the studies and should be changed as and when necessary to keep animals dry and clean. Temperature, humidity and light monitored and documented periodically.


MICRO ORGANISMS Plant based drugs normally carry a great number of bacteria and moulds, often originating in soil. Current practices of harvesting, handling and production may cause additional contamination and microbial growth. The determination of Escherichia coli and moulds may indicate quality of production and harvesting practices.

Test for specific micro organisms:

Test for specific micro organisms Pretreatment of the material Enterobacter and certain other Gram-negative bacteria Escherichia coli Salmonella spp.


MICROBIAL CULTURES SOP’s for storage of microbial cultures with proper labeling. Records of sub culturing of microbial culture should be properly maintained. In case the cultures have become non-viable or ineffective, proper procedure should be followed to destroy it by autoclaving. No unauthorised person should have access to the stock cultures. Air circulation in the sterile area should be such that it ensures the maintenance of aseptic conditions in the area. People working in the sterile area should be properly dressed and trained for the aseptic area.


MAINTENANCE OF STERLITY ROOM Area of the sterile room should be of class 100. There should be a laminar flow with a hepa filter of 0.2 micron. Persons should wash hands, preferably use the disposable hand gloves and change into clean footwear before entering into the sterile area. Required to wear either a clean cap or a suitable headcover so as to avoid any possibility of contamination by hair or perspiration. All persons shall be free from contagious or obnoxious disease.


REFERNCE STANDARDS One of the most important element is the quality and accuracy of the standards which are used. Standards can be classified in two categories i.e. primary standards and secondary standards. Security of standards should be properly maintained by keeping them in locked standard cabinet.


REFERNCE STANDARDS Secondary standards are those obtained from reliable source and whose purity and strength have been obtained through tests comparing with the primary standards. Advisable that the information related to source, date , receipt, lot no. etc. should be recorded. Record of each standard in respect of analytical data should be maintained and updated. Secondary standard should not be accepted unless it is evaluated and the written record is available for evaluation


PROTOCOLS All methods for conducting the studies or analysis Approved written protocols clearly defining the objectives of changes Retention of approved protocols and reasons thereof should be documented Signed by the in-charge with the date mentioned with the protocols. If there is any deviation from the protocols intended to be permanent, the amended protocol should be issued.


PROTOCOLS In a pharmaceutical analysis, the protocols from different Pharmacopoeias are used In case of Patents and Proprietary preparations protocols developed by the manufacturers form part of the routine analysis. Protocols should stand to the requirements of parameters in regard to the precision, accuracy, reproducibility, specificity, ruggedness etc.

Ten Commandments of GLP:

Ten Commandments of GLP Thou shalt write procedures ! Thou shalt follow thy written procedures ! Thou shalt correctly document thy work ! Thou shalt review and retain thy work ! Thou shalt validate thy work ! Thou shalt be neat and clean in thy work !

Ten Commandments of GLP:

Ten Commandments of GLP Thou shalt plan & build & procure proper systems facilities and instruments ! Thou shalt audit to control systems, facilities & instruments for assessing quality of products ! Thou shalt maintain & improve thy systems, facilities & instruments ! Thou shalt be competent !

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