Category Archives: Quality Systems

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!

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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?

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Corrective Action / Preventive Action (CAPA)

CAPA Process
Hello good people of the world! Today’s post is about Corrective Action / Preventive Action, typically referred to as CAPA. CAPA is an integral part of any Quality System, and certainly one of the first things an agency will look at in any audit.

There is a ton of good information out there already on CAPA, including FDA’s own guidance from 2014.

I’ve personally used a few software packages for CAPA management, including MasterControl and Oracle’s Agile, among others, but have not seen any standouts.

The key points of the CAPA program are:

  1. Issue identification, i.e. ensuring the issue is truly understood and well documented
  2. Root cause analysis, i.e. identifying the root cause of the issue
  3. effectiveness check, i.e. verifying actions have actually resolved the issue

What tips have you learned from your CAPA program? Comment below.

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WHO’s Draft Guidelines on Validation May 2016

Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.

This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016

Quality During Construction

Construction Quality Assurance

Hello good people of the world! This blog post covers Construction Quality Assurance, based on an article that appeared in the Nov/Dec 2012 edition of Pharmaceutical Engineering titled “Assured Construction Quality Saves Time and Money.” All credit goes to the authors: Jay Lad of Skanska Pharmaceutical Group and Bruce Beck of Eli Lilly. Continue reading Quality During Construction

Revision to EudraLex Volume 4 August 2014

EU

Hello good people of the world! Another short post today, this one on the revision to EudraLex Volume 4 (GMPs) dated 13 August 2014. The revision is here. A short revision, the changes include updates to Chapter 3 (Premises and Equipment) and Chapter 5 (Production) around prevention of cross-contamination and qualification of suppliers.

Of note is the increased guidance around the use of quality risk management principles.

The revision will come into affect in March 2015.

What do you think of these changes? How will you adjust your quality program, if at all?

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Quality Metrics

Metrics
Metrics

Hello, good people of the world! If you know me, then you know I’m into “metrics” – ways to evaluate the health of a system or process quantitatively. We know finding and correctly interpreting the “right” metrics is not trivial, and looking at the “wrong” metrics can do more harm then good.

ISPE has recently released a whitepaper suggesting quality metrics for the FDA to use in their inspection process. I’ve uploaded a copy Continue reading Quality Metrics