Need to the guideline reference number
Please refer WHO Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products, Annex 8, TRS 1010, 2018
13.1 Operation and maintenance (O&M) manuals, procedures and records
should be available and kept up to date with details of any system
13.2 O&M manuals, schematic drawings, protocols and reports should be
maintained as reference documents for any future changes and upgrades
to the system.
13.3 The O&M manuals may typically contain the following information:
■ system description;
■ operating instructions;
■ commissioning data;
■ maintenance instructions;
■ list of equipment suppliers;
■ spare parts list;
■ equipment data/capacity schedules;
■ supplier’s literature;
■ control system description;
■ electrical drawings;
■ as-built drawings.
13.4 There should be a planned preventive maintenance programme for the
HVAC system. The details of this programme should be commensurate
with the criticality of the system and components.
13.5 Maintenance activities should not have any negative impact on product
quality and should normally be scheduled to take place at appropriate
times, for example, outside production hours.
In case of system stoppages, appropriate quality management
system procedures should be followed. Where necessary, the root cause
and impact should be assessed and appropriate corrective and preventive
action taken. Where necessary, qualification or requalification should
13.6 HEPA filters should be changed by a competent person and this should be
followed by installed filter leakage testing.
13.7 Records should be kept for a sufficient period of time.
HVAC systems should be checked routinely because mold in a ventilation system may be spread throughout the building. Drain or condensate pans should also be checked routinely because they can become reservoirs for mold and bacteria if not installed and maintained properly. These pans are designed to remove water produced by cooling hot air from the ventilation system. If the pans do not drain, or are not cleaned frequently, they may allow water to enter the HVAC system and contaminate the ventilation ducts in the building. The pans themselves may also grow mold and allow mold spores to be spread throughout the building. Filters for the HVAC system also should be kept dry and changed frequently.
Dear sir please help me to know about the guidelines for tablet manufacturing