Tag Archives: Quality

ORAL SOLID DOSE – Supporting Equipment and Systems

Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about supporting equipment and systems. The main equipment in unit operations get the spotlight when it comes to manufacturing Oral Solid Dosage forms, but they cannot work without supporting equipment and systems.

Supporting Equipment:
Typical supporting equipment in a OSD manufacturing process includes:

  1. Air Systems: all modern manufacturing processes use air systems for process, instruments, and environment. HVAC helps control environmental conditions, including particulate (viable and nonviable) counts, temperature, and humidity. Compressed air systems may be used in the process to cool or cover product, such as with nitrogen, or operate unit operation steps, such as in fluid bed drying. Automated systems will use compressed air to pneumatically control valves and other components.
  2. Dust Collection: compared to biotech and other pharmacuetical processes, OSD processes have the added complication of dust collection. OSD material movement and processes can create a lot of dust, which can be a risk from a product quality point-of-view, but also a safety point-of-view, since dust can lead to fires and even explosions. Dust collection equipment must be employed to minimize and control dust.
  3. Vacuum Systems: vacuum systems may be used for cleaning, dust collection, and also in process steps such as vacuum drying.

Supporting Systems:
Typical supporting systems include:

  1. Change Control: it is expected that engineering changes are controlled with quality oversight through a formal process.
  2. Preventive Maintenance: it is expected that regular preventive maintenance be performed and documented formally.
  3. Calibration: it is expected that “critical” instruments are calibrated at regular intervals traceable to an international standard. Calibration procedures and results must be formally documented. The method to determine and results of the determination of critical instruments must be documented.

What supporting equipment and/or systems do you use in your OSD manufacturing process? Comment below!

Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!

Oral Solid Dose – Quality Risk Management Considerations

Hello good people of the world! Today’s post is the second in the series covering the commissioning, qualification, and validation of facilities, systems, and equipment involved in the manufacture of oral solid dose (OSD) products. This post covers quality risk management.

Quality Risk Management is performed per the principles outlined in ICH Q9. The management process may then be divided up into six (6) steps:

  1. Determine risk areas. These are typically safety, product quality, schedule, cost, etc.
  2. Identify the risks for each area defined in step 1. For example, microbiological contamination may be a risk to product quality, APIs may be a risk to personnel safety.
  3. Identify the failure modes which contribute to the risks identified in step 2. For example, pests contribute to microbiological contamination risk, and HVAC failure could be a vector by which personnel are exposed to an API.
  4. Analyze failure modes and identify mitigations. In our examples procedures around pest control and qualification of HVAC systems could be mitigation to the failure modes identified.
  5. Implement monitoring and CAPA (corrective and preventative action) processes.
  6. Apply a continuous improvement plan to periodically review risks, risk assessments, and mitigation.

There are many tools which may be used to document the process, such as: FMEA, HAZOP, PHA, etc.

How do you execute your quality risk management process?

Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!