Premises – Good Practices for Pharmaceutical Quality Control Laboratories

The laboratory Premises are to be of a suitable size, construction and location. These Premises are to be designed to suit the functions and operations to be conducted in them. 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.

The laboratory Premises should have adequate safety equipment located appropriately and measures should be in place to ensure good housekeeping. Each laboratory should be equipped with adequate instruments and equipment, including work benches, work stations and fume hoods.

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 laboratory should ensure that the environmental conditions are monitored, controlled and documented and do not invalidate the results or adversely affect the quality of the measurements.

Special precautions should be taken and, if necessary, there should be a separate and dedicated unit or equipment (e.g. isolator, laminar fl ow work bench) to handle, weigh and manipulate highly toxic substances, including genotoxic substances. Procedures should be in place to avoid exposure and contamination.

Archive Premises should be provided to ensure the secure storage and retrieval of all documents. The design and condition of the archives should be such as to protect the contents from deterioration. Access to the archives should be restricted to designated personnel.

Procedures should be in place for the safe removal of types of waste including toxic waste (chemical and biological), reagents, samples, solvents and air filters.

Microbiological testing, if performed, should be contained in an appropriately designed and constructed laboratory unit. For further guidance see the draft working document WHO guideline on good practices for pharmaceutical microbiology laboratories (reference QAS/09.297).

If in vivo biological testing (e.g. rabbit pyrogen test) is included in the scope of the laboratory activities then the animal houses should be isolated from the other laboratory areas with a separate entrance and air-conditioning system. The relevant guidance and regulations are to be applied (18).

Laboratory storage Premises

The storage Premises should be well organized for the correct storage of samples, reagents and equipment.

Separate storage Premises should be maintained for the secure storage of samples, retained samples (see Part three, section 20), reagents and laboratory accessories (see Part two, sections 10.13– 10.14), reference substances and reference materials (see Part two, section 11). Storage facilities should be equipped to store material, if necessary, under refrigeration (2–8°C) and frozen (-20°C) and securely locked. All specified storage conditions should be controlled, monitored and records maintained. Access should be restricted to designated personnel.

Appropriate safety procedures should be drawn up and rigorously implemented wherever toxic or flammable reagents are stored or used. The laboratory should provide separate rooms or areas for storing flammable substances, fuming and concentrated acids and bases, volatile amines and other reagents, such as hydrochloric acid, nitric acid, ammonia and bromine. Self-igniting materials, such as metallic sodium and potassium, should also be stored separately. Small stocks of acids, bases and solvents may be kept in the laboratory store but the main stocks of these items should preferably be retained in a store separate from the laboratory building.

Reagents subject to poison regulations or to the controls applied to narcotic and psychotropic substances should be clearly marked as required by national legislation. They should be kept separately from other reagents in locked cabinets. A designated responsible member of staff should maintain a register of these substances. The head of each unit should accept personal responsibility for the safekeeping of any of these reagents kept in the workplace.

Gases also should be stored in a dedicated store, if possible isolated from the main building. Wherever possible gas bottles in the laboratory are to be avoided and distribution from an external gas

store is preferred. If gas bottles are present in the laboratory they should be safely secured.    Note:Consideration should be given to the installation of gas generators

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