Glp qc labs

QC | Slide 1 of 21 June 2006

Good Practices for Quality Control Laboratories

Part 2: Materials and set-up of equipment, instruments and other devices

Supplementary Training Modules on Good Manufacturing Practice

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


Specifications archive Current versions of all specifications – as described in

pharmacopoeial compendia or in manufacturers' registration documents

The specifications archive must contain: List of all pharmacopoeias in the laboratory

– all updates and corrections must be noted– adequate numbers of supplements and addenda

File of non-pharmacopoeial quality specifications

– numbered and dated, latest version

– information relevant to the status of the quality specifications

– corrections or changes appropriately handled, including producing a revised document as soon as possible

Part Two. 9.1 – 9.2

Quality ControlQuality Control


Specifications archive (2)

Use of the master copy– photocopies accounted for and controlled for use

Confidentiality of specifications

Responsibility defined for:

Updating all pharmacopoeias – including supplements, addenda, and corrective measures used in the laboratory

Maintaining a specifications filePart Two. 9.3 – 9.5



Reagents

Reagents, chemicals, including solvents and materials used in tests and assays – of appropriate quality and supplied with COA

List of prequalified suppliers

Clear responsibility in job descriptions for the preparation of reagents in the laboratory

SOPs according to pharmacopoeia or other standards

Records for the preparation, and standardization of volumetric solutions


Part Two. 10.1 – 10.3


Reagent labels must clearly specify:– the contents, the manufacturer, the date received, and as

appropriate, the concentration, standardization factor, shelf-life and storage conditions (purchased)

– date of preparation, name and initials of person (if prepared in the laboratory)

Volumetric solutions:– the name of the manufacturer of the original reagent (where

diluted), the date of preparation, the date of standardization and factor, and identify the responsible technician

Reagents must not be moved unnecessarily from unit to unit

Whenever possible, transportation in original containers

Subdivided in scrupulously clean, fully labelled containersPart Two. 10.4-10.5



Inspect reagent containers when delivered (e.g. seals intact)

Inspection recorded on the label giving the date, name and initials

If tampered with, rejected, unless identity and purity can be confirmed

Distilled water and deionized water

Water should be considered as a reagent

Precautions to avoid contamination during:– supply, storage and distribution

To comply with pharmacopoeia and other official requirements for quality Part Two. 10.6 - 10.11



Storage

Appropriate storage conditions

Storage area with clean bottles, vials, spoons, funnels, and labels required for dispensing reagents from larger to smaller containers

Store keeper responsibilities:

Store and inventory, expiry dates

Areas for flammable substances, for fuming and concentrated acids, etc.

Self-igniting materials, such as metallic sodium, stored separately

Part Two. 10.12 – 10.14



Reference materials

Used for testing and/or calibration, validation or verification of a sample or equipment, instruments or other devices

Responsibility must be assigned to a specific person

Registration and labelling with an identification number assigned– a new identification number to each new batch– number marked on each vial– quoted on the analytical worksheet at every use

Part Two. 11.1. – 11.5



Central register for reference materials containing information:

identification number of the materialprecise description of the materialsourcedate of receiptbatch designation or other identification code intended use of the material (e.g. as an infrared reference

material, as an impurity reference material for thin-layer chromatography, etc.)

location of storage in the laboratory, and any special storage conditions

further indications (e.g. results of inspections)Part Two. 11.7



Information file for reference materials containing information:

In addition to the central register – a file containing information on the properties of each reference material

Working standards – include the results of all tests and verifications

Inspection

Inspected at regular intervals, no deterioration, appropriate storage conditions

Inspections must be recorded in the central register and/or the information file

See also "The general guideline on the establishment, maintenance and distribution of reference materials" Part Two. 11.10 – 11.14



Calibration, validation and verification of equipment, instruments and other devices

Regular calibration, validation and verification of all equipment, instruments and other devices used to measure the physical properties of substances must be performed

Specific procedures for each type of equipment, instrument and other devices must be established, having regard to the extent of which they are used, verified and calibrated at regular intervals according to SOP

Part Two. 12.1 - 12.2



Examples:

pH meters are verified with a certified solution at least once a day

Infrared spectrophotometers require verification at least once a day and calibration at regular intervals

Discuss other examples . . .



Authorized personnel to operate equipment

Instructions on the use, maintenance, verification and calibration of equipment, instruments and devices (e.g. a copy placed beside each apparatus together with a schedule of the dates)

The results of verification must be recorded

Each item of equipment, instrument – uniquely identified

Records must be maintained

Part Two. 12.3 – 12.5



The records must include at least the following:

name of equipment, instrument and other devices

manufacturer's name, type identification, serial number or other unique identification

verification/calibration to comply with the specifications

current location, where appropriate

the manufacturer's instructions, if available, or reference to their location

Part Two. 12.5



The records must include at least the following (2):

dates, results and copies of reports, verifications and certificates of all calibrations, adjustments, acceptance criteria, and due date of next verification/calibration

maintenance carried out to date and the maintenance plan

history of any damage, malfunction, modification or repair. It is also recommended to keep records and additional observations of the time, the equipment, instruments or devices were used

Part Two. 12.5



Prevent contamination or deterioration – perform systematic verifications

Maintenance procedures and records

Defective instruments – taken out of service, and clearly labelled or marked

Status of calibration and the date when recalibration is due, indicated

Instruments to be satisfactory before being returned to service

Part Two. 12.6 – 12.10



Analytical equipment, instruments and other devices can be either

– grouped together

– dispersed between the various units

– protected from extreme states of humidity or temperature in a specially designed area and

– adequately protected to be resistant to corrosion and against mould and fungal growth

See also Procedures for verifying and calibrating instruments in The International Pharmacopoeia, and Validation of analytical procedures used in the examination of pharmaceutical materials gives chemical and physicochemical attributes

Part Two. 12.11 – 12.12



Traceability

Analytical specificities of each measurement procedure and reference material that is used to ascertain traceability, must be known

Traceability chain, including measurement procedures and reference materials at all levels, must be prepared

Laboratory investigations – applies to measurement procedures as well as to reference materials used

Part Two. 13.1 – 13.3



There are quantitative and qualitative measurement procedures

“Semi-quantitative” measurement procedures– less accurate and less precise than quantitative

measurement (“Limit tests”)

Qualitative measurement procedures are descriptive

Part Two. 13.4, 13.6 -13.7



Reference materials have assigned values of a quantity. Hierarchy for reference materials:Primary chemical substance

– has appropriate qualities within a specified context, and whose value is accepted without requiring comparison to another chemical substance

Secondary chemical reference substance– characteristics are assigned and/or calibrated by comparison

with a primary chemical reference substance. The extent of characterization and testing of a secondary chemical reference substance may be less than for a primary chemical reference substance. This definition may apply inter alia to some substances termed “working standards

Part Two. 13.8 (a-b)



International Biological Standards– a category of biological reference material having World

Health Organization (WHO) status

A working standard (working calibrator) has an assigned value of a quantity

A manufacturer’s product calibrator is used for the calibration of a routine measurement procedure of an end user

A control material is used to test for the precision and accuracy of results. A control material should have a matrix similar to the samples to be measured. Assigned values with an uncertainty of measurement appropriate to the intended use should be given

Part Two. 13.8 (c-f)


Glp qc labs

Health & Medicine

Transcript of Glp qc labs