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Published Jun 22, 2022
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SOP s must be present for each instrument

They must be stored under recommended environmental conditions & calibrated regularly

Light & electrical systems must be as per regulations & not overloaded

Glassware must be calibrated & certified for use

Chemicals & reagents

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Storage of chemicals must be done as per the MSDS sheet

All chemicals must be appropriately labelled and stored with their MSDS sheet

Any transfer must occur with a proper audit trail

Any prepared solution must be labelled and dated with an expiry date

Mouth pipetting is unacceptable; use a rubber suction pump instead

Organisation & personnel

Every individual in the laboratory must have the necessary qualification and training to
participate

Sufficient number of personnel must be employed

Every individual must be given personal protective equipment (PPE)

A well-defined organogram of the laboratory must be drawn up and assigned based on

the roles required

Documentation

Every single procedure, event, and entry/ exit must be recorded

SOPs for usage, maintenance, and calibration must be provided for each equipment

All samples/ reagents must be labelled and stored as per guidelines

Examples: Sampling, Validation, Testing, Data recording, Operation, etc.

Quality Control

For samples: Documentation of receipt, usage and storage

Sampling procedure and testing methodologies used must be recorded

Safety

Personnel must be required to undertake required immunisations and protective measures

before beginning their experiments
 Facilities & accessories must be present for first aid, drug testing, accidents such as water
leakage or fires

Auditing Procedure

A dedicated committee must be instituted to maintain the quality standards of the

laboratory

It must be done in accordance with GLP requirements

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