Good Laboratory Practices.pptx

5/26/2018 Good Laboratory Practices.pptx

1/21

Good Practices in QC

Prepared by:

Sajan Maharjan

M. Pharm (1stYear)

Kathmandu University

(Working in SR Drug Laboratories)

1


2/21

Quality control

laboratories

Sampling Testing Documentation

API

Excipients

Packaging

materials

Stability

Testing

Test

Reports

Preparation of

specificationsPreparation of

SOPs

Pharmaceutical

Products

2


3/21

Good Practices in QC

Management

and

Infrastructure

Materials,

equipments,

instruments

and other

devices

Working

Procedures

SafetyInternal

Audits

3


4/21

Organization and

Management

Control of document

Records

Personnel

Premises

Management

and

Infrastructure

4


5/21

Organization and Management

Managerial and technical personnel with the authority and resources needed to carry out

duties and to identify the occurrence of departures from the quality management and initiateactions to prevent or minimize such departures.

A Laboratory should have

Arrangements to ensure that its management and personnel are not subject to political,

financial and other pressures or conflicts of interest that may adversely affect the quality of

their work.

A policy and procedure to ensure confidentiality of

transfer of results or reports

to protect data in archives (paper and electronic)

Specify the responsibility, authority and interrelationships of all personnel

Provide adequate supervision of staff, including trainees, by persons familiar with the test,calibration, validation and verification methods and procedures.

Ensure adequate information flow between staff at all levels.

Maintain an up-to-date collection of all specifications and related documents (paper or

electronic) used in the laboratory.

5


6/21

Control of document

Each document, whether a technical or a quality document, should have a unique identifier,

version number and date of implementation.

Appropriate, authorized SOPs should be available at the relevant locations, e.g. near

instruments.

All the documents should be kept up to date and reviewed as required.

Any invalid document should be removed and replaced with the authorized, revised

document with immediate effect.

All relevant staff should be trained for the new and revised SOPs.

It is more relevant to prepare the revised documents by the initiator, or a person who

performs the same function, reviewed and approved at the same level as the original

document and subsequently released by the quality manager.

6


7/21

Records

The laboratory should establish and maintain procedures for the identification, collection,indexing, retrieval, storage, maintenance and disposal of technical/scientific records

(including analytical test reports, certificates of analysis and analytical worksheets).

All original observations, including calculations and derived data, calibration, validation and

verification records and final results, should be retained on record for an appropriate period of

time

All quality and technical/scientific records should be legible, readily retrievable, stored and

retained within facilities that provide a suitable environment that will prevent modification,

damage or deterioration and/or loss.

Quality management records should include reports from internal and external audits and

management reviews, as well as records of all complaints and their investigations, including

records of possible corrective and preventive actions.

7

If you have not documented it, you have not done it


8/21

Personnel

Head of

laboratory

Technical

management

Analysts

Technical

staff

-Check certificates of analysis (COA) and analytical testing reports

-Ensure all key members of the laboratory staff have the requisite

competence for the required functions

-Ensure adequacy of existing staffs

-Ensure training procedures are reviewed periodically-Ensure the technical management is adequately supervised

-Ensure procedures for performing calibration, verification and

qualification of instruments

-regular in-service training programs to update and extend the skills

of both professionals and technicians-monitoring of environmental and storage conditions

graduates in pharmacy, analytical chemistry, microbiology or other

relevant subjects

diplomas in their subjects awarded by technical or vocational schools

8


9/21

Premises

Suitable size, construction and location

Rest and refreshment rooms should be separate from laboratory areas.

Changing areas and toilets should be easily accessible and appropriate for the number

of users

Equipped with adequate instruments and equipment, including work benches, work

stations and fume hoods

Adequate safety equipment located appropriately

Microbiological testing, if performed, should be contained in an appropriately

designed and constructed laboratory unit

The environmental conditions, including lighting, energy sources, temperature,

humidity and air pressure, are to be appropriate to the functions and operations to be

performed.

The storage facilities should be well organized

9


10/21

Premises

For

equipments

Sensitive

(UV, IR,

HPLC,

Balance)

Heat

generating

(Furnance,Oven)

Others

Reagents

Non

ToxicToxic

Danger

Precaution

Storage of

documents

-Easy Retrieval

-Safe

Proper

indexing for

easy retrieval

All specified storage conditions should be controlled, monitored and records maintained (if

necessary). Access should be restricted to designated personnel only.

Referencestandard

-Separate refrigerator

-Dessicator

-Bottles with proper

enclosure

-Properly placed with

indexing

Data entry and

documentation

equipped with

computers

10


11/21

Materials,

Equipment,

Instrumentsand

other devices

Reagents Reference

Substances

Calibration, verification

of performance

and

qualification of

equipment, instruments

and other devices

Traceability

11


12/21

Reagents

Bulk Reagents

(Purchased from supplier)

Prepared Reagents

(Prepared in Lab)

-Should be of appropriate quality.

-Should be purchased from reputed and

approved suppliers

-Responsibility should be specified

-use procedures in accordance with published

pharmacopoeia or other standards where

available.

Content

Manufacturer

Date received and date of

opening of the container

Concentration (if

applicable)

Storage conditions

Expiry date or retest date

Check label for:

Reagent Solution Volumetric Solution

Name

Date of preparation and

initials of technician or

analyst prepared by Expiry date or retest date

Concentration (if

applicable)

Name

Molarity (concentration)

Date of preparation and

initials of technician/analyst Date of standardization and

initials of technician/analyst

Standardization factor

Stock reagents should be maintained in a store under the appropriate storage conditions

Availability of clean bottles, spoons, funnels and labels, as required, for dispensing

reagents from larger to smaller containers. A person in charge should look after the storage facilities and their inventory.

12


13/21

Reference Substances

Registration andlabelling

Retesting (monitoring)

An identification number should be assigned

to all reference substances, except for

pharmacopoeial reference substances

A new identification number should be

assigned to each new batch The identification number should be quoted

on the analytical worksheet every time the

reference substance is used

The register for all reference substances

should be maintained and contain the

following information:1. identification code

2. the location of storage in the laboratory

3. expiry date or retest date

4. certificate of a pharmacopoeial reference

substance

5. For reference substances prepared in the

lab, the file should include the results of alltests

All reference substances should be retested

at regular intervals to ensure that

deterioration has not occurred

The interval for retesting depends on anumber of factors, including stability of the

substance, storage conditions employed,

type of container and extent of use (how

often the container is opened and closed)

The results of these tests should be recorded

and signed by the responsible analyst

A person should be nominated to be

responsible for reference substances

13


14/21

Calibration, verification of performance and qualification of equipment, instruments

and other devices

All equipment, instruments and other devices requiring calibration should be labelled or coded

to indicate the status of calibration and the date when recalibration is due. As applicable, the performance of equipment should be verified at appropriate intervals

according to a plan established by the laboratory.

Measuring equipment should be regularly calibrated according to a plan established by the

laboratory.

Specific procedures should be established for each type of measuring equipment. For eg:

pH meters are verified with standard certified buffer solutions before use balances are to be checked daily using suitable test weights, and requalification should be

performed annually using certified reference weights.

Up-to-date SOPs on the use, maintenance, verification, qualification and calibration of

equipment, instruments and devices should be readily available.

Records should be kept of each of equipment, instrument or other device used to perform

testing (separate log books), verification and/or calibration. Equipment, instruments and other devices shown to be defective or outside specified limits,

should be taken out of service and clearly labelled or marked.

When the equipment, instruments and other devices have undergone major repair, the

laboratory should re-qualify the equipment to ensure its suitability for use.

14


15/21

Traceability

The result of an analysis should be traceable, when appropriate, ultimately to a primaryreference substance.

All calibrations or qualification of instruments should be traceable to certified reference

materials and to SI units (metrological traceability).

15


16/21

Working

Procedures

Incoming Samples

Analytical worksheet

Validation of analytical procedures

Testing

Evaluation of test results

Certificate of analysis

- Done as per validation protocol

- Revalidation will be required in case of a major

change to the analytical procedure, or in the

composition of the product tested.

In accordance with the work plan of the laboratory

Follow the specifications

Should meet specification used

Whenever doubtful (atypical) results are obtained they

should be investigated

16


17/21

Incoming Samples

Sampling

Registration

Visual

inspection

Storage

Forward to

testing

-Sampling plan and an internal procedure for sampling

-Samples should be representative of the batches

-avoid contamination and other adverse effects on quality, or mix-up

-proper labelling must be done on the sampled container-data related to sampling should be recorded

-assign a registration number for each received sample

-Separate registration numbers should be assigned to raw materials,

different dosage forms, or different batches of the same medicine

The sample received should be visually inspected by laboratory staff toensure that the labelling conforms with the information contained in the

test request ( intimation)

The sample prior to testing and the retained samples (control samples)

should be stored safely.

-Sample sent for testing is determined by the person responsible.

-The examination of a sample should not be started until all relevant

documents has been received.

-A request for analysis may be accepted verbally only in emergencies.

17


18/21

Analytical worksheet

The analytical worksheet is an internal document to be used by the analyst for recording

information about the sample, the test procedure, calculations and the results of testing.

A separate analytical worksheet should usually be used for each sample.

The analytical worksheet should provide the following information:a) the date on which the analysis was started and completed

b) description of the sample received

c) description of test methods by which the sample was tested, including the limits

d) the identification number of any reference substance used

e) the identification of reagents and solvents employed

f) the results obtainedg) the interpretation of the results and the final conclusions (whether or not the sample was

found to comply with the specifications)

h) any further comments

i) the name and signature of the analyst

All values obtained from each test should immediately be entered on the analytical

worksheet and all data obtained from recording instruments should be attached or betraceable to an electronic record file or document where the data are available.

When a mistake is made in an analytical worksheet, information should be deleted by

putting a single line through it and the new information added alongside. All such

alterations should be signed by the person making the correction.

The analytical worksheet should be kept safely together with any attachments, including

calculations and recordings of instrumental analysis. 18


19/21

Safety

General Rules

smoking, eating and drinking in the laboratory should be Prohibited

staff should be familiar with the use of fire-fighting equipment

staff should wear laboratory coats or other protective clothing, including eye protection

highly toxic and/or genotoxic samples should be handled in a specially designed facility to avoid the

risk of contamination

all containers of chemicals should be fully labelled and include prominentwarnings (e.g. poison,

flammable, radioactive)

adequate insulation and spark-proofing should be provided for electrical wiring and equipment,

including refrigerators staff should be aware of the need to avoid working alone in the laboratory

first-aid materials should be provided and staff instructed in first-aid techniques, emergency care and

the use of antidotes.

Staff training

For correct performance of techniques

Appropriate use of personal protection items

How to proceed in an emergency

Ensure there is safety manual in each area of lab containing risk agents with handling

precautions and emergency procedures.19


20/21

Internal Audits

To carry out systemic and independent examination, to determine whether the activities and

their results comply with the established documentation.

Internal Audits are generally performed by staff who do not have direct responsibility forthe area audited or by the QA department.

Review of documents

Drawing up an audit plan

Opening meeting between auditor and the area to be audited

Performance of the audit: interviews, check list, observation

Closing meeting

Audit Report

Follow-up audit

Steps

20


21/21

hank You21

Documents

Good Laboratory Practices.pptx