WHO GUIDELINE TO THE INSPECTION OF HORMONE PRODUCT MANUFACTURING FACILITIES

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Not all hormone products are equally potent and risk assessment should be carried out to determine the potential hazards to operators and to the environment. The risk assessment should also determine which phases of the product production and control cycles, from API manufacture to finished product distribution, would fall under the requirements of this guideline.

Risk assessments applicable to the environment should include airborne contamination as well as
liquid effluent contamination.

Assuming that the risk assessment determines that the products or materials being handled pose a risk to the operators and/or the public and/or the environment, the guidelines to be followed for the facility design and operation should be as detailed in this document.

Permissible operator exposure levels (OEL) for the relative product should be taken into
account when conducting the risk assessment.

Results of the personal ambient sample (PAS) tests should be provided. These tests should be taken in the proximity of the operator’s head and indicate the 8-hour time weighted average level of contamination in the operator’s breathing zone.

A recognized risk assessment method should be used and documented.

The requirement for producing quality products, with respect to contamination and crosscontamination protection, cleanroom class of air, temperature and humidity should be as for
other pharmaceutical products. These requirements are covered in other WHO GMP guidelines.

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Continue at: https://www.who.int/medicines/services/expertcommittees/pharmprep/HormonePlantGuideline_QAS08_256_28022008.pdf

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