Good Practices for Quality Control Laboratories

QC | Slide 1 of 33 June 2006

Good Practices for Quality Control Laboratories

Part 1: Introduction, management and infrastructure

Supplementary Training Modules on Good Manufacturing Practice

WHO Technical Report Series, No. 902, 2002. Annex 3


Objectives

To discuss Good Practices for Quality Control laboratories including quality systems and infrastructure

To understand the role and importance of the Quality Control laboratory in:

– sampling and testing– materials, equipment and systems

To discuss approaches in inspecting a Quality Control laboratory

Part One.

Quality ControlQuality Control


Introduction

This Module consists of four parts:

Part 1: Management and organization

Part 2: Materials, equipment, instruments and devices

Part 3: Working procedures and documents, and safety in the laboratory

Part 4: Inspecting the laboratoryPart One.



Introduction (2)

Many of the recommendations relevant to quality control testing at the site of the pharmaceutical manufacturer

The QC laboratory provides a service and is like a manufacturing unit – its “products” include test results, advice and investigations

Needs– buildings, personnel, resources– equipment, raw materials– quality assurance programme

Part One.



In Part 1: Management and infrastructure:

Organization and management

Quality systems

Control of documentation and records

Data processing equipment

Personnel

Premises, equipment, instruments and other devicesPart One.



1. Organization and management:

Function in accordance with national legislation

Operate in accordance with the guideline–WHO Technical Report Series, No. 902, 2002, Annex 3

See also general texts on Good Manufacturing Practices and Good Practices in Quality control

–WHO Technical Report Series, No. 908, 2003, Annex 4

Part One 1.1– 1.2



1. Organization and management (2):

Personnel– Managerial and technical positions to ensure operation in

accordance with quality systems– No conflict of interest

Organizational chart and job descriptions

Supervision and training

Part One. 1.3



1. Organization and management (3):

Large laboratories may have subunits

A central registry responsible for:– receipt and distribution of samples– keeping records and documents of incoming samples– allocation of work and responsibilities– maintaining specifications "up to date" (specifications

"archive")


Part One. 1.4


2. Quality system:

Management to establish, implement and maintain quality system

– It should cover policies, systems, programmes, procedures and instructions

Communicated, available, understood and implemented

Documented in a quality manual– available to the laboratory personnel– maintained and updated by a responsible person


Part One. 2.1


The quality manual should contain at least:

Organizational chart; operational and functional activities

General and specific quality assurance procedures

Proficiency testing schemes

Use of reference materials

Feedback and corrective action (for testing discrepancies)


Part One. 2.1


The quality manual should contain at least (continued):

Procedure for dealing with complaints

A flow chart for samples

Details of audit and quality system review

Qualification of personnel

Training and maintaining competence of staff

A quality policy statement


Part One. 2.1


The quality policy statement should include at least:

A statement of the standard of service it will provide

The purpose of the quality system

Management's commitment to:– Good professional practice and quality of testing,

calibration, validation and verification, as a service to its clients

– Compliance with Good Practices

All personnel to familiarize themselves with the documentation concerning quality, implementation of the policies and procedures


Part One. 2.1


The quality system must be reviewed systematically and periodically

– e.g. internal and external audits with reports and details of any corrective action taken

Laboratory quality manager appointed with:– defined responsibilities and authority for ensuring that the

quality system is implemented and followed at all times– direct access to the highest level of management at which

decisions are taken on laboratory policies or resources


Part One. 2.2- 2.3


3. Control of documents

Documentation is essential

Procedures to control and review all documents

The laboratory must establish and maintain procedures for identification, collection, indexing, access, storage, maintenance and disposal of quality documentation and technical records


Part One. 3.1


4. Records

All original observations, calculations and derived data, calibration, validation and verification records, etc. and final results must be retained on record for an appropriate period of time, e.g.

– whole length of time the drug is on the market

Records to contain sufficient information to permit repetition of tests and include, e.g.:

– identity of the personnel involved in sampling, preparation and testing of the samples

– Instruments, equipment, etc.


Part One. 4.1 – 4.2


Records must be:

Legible and readily retrievable

Stored and retained in a manner that prevents modification, damage or deterioration and/or loss

Held secure and in confidence

Includes reports from internal audits and management reviews and records from possible corrective and preventive actions


Part One. 4.3


SOPs: written and authorized

For administrative and technical operations, such as:

Purchase and receipt of consignment of materials

– e.g. samples, reference material, reagents

Internal labelling, quarantine and storage of materials

Appropriate installation of each instrument and equipment

Sampling and inspection

Testing materials, describing the methods and equipment used


Part One. 4.4


Other SOPs:

Qualification, analytical apparatus

Calibration, maintenance, cleaning, sanitation

Safety measures

Personnel matters including

– qualification, training, clothing, and hygiene

Environmental monitoring

Preparation and control of reference materials


Part One. 4.4


5. Data processing equipment

Includes computers, automated tests or calibration equipment;used for collection, processing, recording, reporting, storage or retrieval of test and/or calibration data

Where used, requires systematic verifications of calculations and data transfers

For computer software developed by the user:– this documented in detail– validated or verified as being adequate for use


Part One. 5.1


5. Data processing equipment

Located in suitable environmental supporting operating conditions

Maintenance of computers and automated equipmentProcedures established and implemented for protecting data

integrity– Include, e.g. integrity and confidentiality of data entry or

collection, data storage, transmission and processingProcedures in place to describe how:

– Changes are made, documented and controlled for information maintained

– To protect and keep back-up data at all times

– To prevent unauthorized access or amendments to the data


Part One. 5.1


6. Personnel

Sufficient number, with necessary education, training, technical knowledge and experience

No conflict of interest or other pressure

Competence ensured for activities, performing tests and/or calibrations, validations or verifications, evaluation of results and signing test reports and calibration certificates

Staff undergoing training – supervised, with formal assessment after training

Personnel must be qualified on the basis of appropriate education, training, experience and/or demonstrated skills


Part One. 6.1 – 6.3


6. Personnel (2)

Permanently employed, or under contract

Contracted personnel to be supervised and sufficiently competent, motivated – work complying good practice of the laboratory

Current job descriptions for managerial, technical and key support personnel

Records of competence, educational and professional qualifications, training, skills and experience

– Readily available, and include date of confirmation of competence, plus criteria for confirmation and name of the confirming authority


Part One. 6.4 – 6.5


Managerial and technical personnel:

Head of laboratory (supervisor)

Head of central registry

Analysts

Technical staff

Head of central store

Quality Manager


Part One. 6.6


Head of laboratory (supervisor) should have extensive experience in drug analysis and laboratory management. Functions include:

All key staff have the requisite competence

Standard samples are analysed

Periodic review of adequacy of existing staffing, management, and training procedures

"Self-checking" procedures for instrument operators are devised

Regular in-service training programmes are arranged

Safe-keeping of any narcotics as where relevant


Part One. 6.6.1


Head of central registry functions include:

Receiving and keeping records of all incoming samples and accompanying documents

Supervising their consignment to the specific units

Monitoring the progress of analyses and dispatch of completed reports (see also Part One,1.4)

May collate and evaluate the test results for each analysis


Part One. 6.6.2


Analysts and technical staff:

Graduates or diplomas in pharmacy, analytical chemistry, microbiology, or other relevant subjects

Knowledge, skills and ability to adequately perform the tasks

Store keeper:

Keeping the central store – competent and trained to handle reagents and materials with the necessary care and safety.

Quality manager (see Part One, 2.3)


Part One. 6.6.3 – 6.7.2


Other staff members can be:

Heads of various subunits

Reference material coordinator (see Part Two,11.3.2)

Ratio of personnel:– In general technicians to analysts in a routine testing

environment has been shown to be 3:1 in a chemical or physicochemical unit

– and 5:2 in a biological or microbiological laboratory


Part One. 6.7 – 6.8


7. Premises

Suitable size, construction and location – safety requirements considered in the design

Adequate degree of separation of the activities

Sufficient number of rooms or areas to assure the isolation of test systems

Suitable testing and safety equipment– e.g. voltage stabilizers should be installed where needed

Storage rooms or areas for supplies and materials with protection against infestation, contamination, and/or deterioration


Part One. 7.1 – 7.5


7. Premises (2)

Separate areas for receipt, storage and sample preparation to prevent contamination or mix-ups

Ensure maintaining identity, concentration, purity, and stability

Safe storage of hazardous substances

Fire regulations

Flammable reagents, fuming and concentrated acids, bases, volatile amines – safe storage separately


Part One. 7.6 – 7.7


Central store

Separate for secure storage of samples, retained samples, reagents, laboratory accessories, reference materials

Appropriate storage conditions, e.g. refrigeration where necessary

Restricted access to designated personnel

Organized to accommodate incoming and outgoing samples, reagents, equipment, instruments and other devices


Part One. 7.7.1.1 – 7.7.1.4


Central store (2)

Safety instructions if toxic or flammable reagents are stored or used

Poison, narcotic and psychotropic substances– marked as "Poison", kept separately, in locked cabinets– register maintained

Archive facilities– documents, samples and specimens– conditions to protect from deterioration, and access restricted

Handling and disposal of wastes– facilities for collection, storage and disposal– decontamination, where applicable, and transportation


Part One. 7.7.1.4 – 7.10


Central store (3)

Laboratory environment suitable and not influence the tests– Protected from excessive conditions, e.g. heat, cold, dust,

moisture, steam, noise, vibration and electromagnetic disturbance or interference

– Monitoring devices for environmental conditions

Good housekeeping


Part One. 7.10


8. Equipment, instruments and other devices

Designed, constructed, adapted, located, calibrated, qualified, verified and maintained

Purchased from approved suppliers – can give technical support, maintenance

Documentation in the language employed in the laboratory Appropriate test equipment, instruments or other devices in the

laboratory Suitable for correct performance of tests and/or calibrations,

validations and verifications Meet laboratory's requirements, and comply with the relevant

standard specifications, as well as be verified and/or calibrated (see Part One, 5)


Part One. 8.1 – 8.3

Documents

Good Practices for Quality Control Laboratories