Tag Archives: GMP

ORAL SOLID DOSE – Architectural Considerations

Hello good people of the world! Today we’re talking about architectural considerations in the design of oral solid dose (OSD) manufacturing facilities.

In addition to normal architectural standards, the following must be considered for OSD manufacturing facilities:

  • Manufacturing process flow
  • Personnel flow
  • Equipment flow (clean and dirty)
  • Waste flow

Risks to consider when mapping flows include:

  • Risk of contamination from outside contaminates
  • Risk of cross-contamination
  • Risk of mix-up

Risk mitigations should consider:

  • Process containment
  • Isolators
  • Environmental controls
  • Room size
  • Transition spaces and airlocks
  • Personnel controls such as gowning
  • Administrative controls such as frequency of operation

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ORAL SOLID DOSE – Unit Operations

Granulator at an OSD Plant in Vietnam

Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about unit operations typical in a oral solid dose manufacturing process.

Typical OSD processes may include some combination of weighing/dispensing, material transfer, blending, granulation, drying, milling/sieving, compression, encapsulation, and coating. Some considerations around each step may include:

  1. Weighing/Dispensing: includes sampling for quality purposes. Materials to be sampled typically include: APIs, excipients, primary and secondary packaging, cleaning agents. Sampling areas must be protected from contamination.
  2. Material Transfer: material flows should be documented and reviewed, with the intention of minimizing any contamination.
  3. Blending: materials are typically blended to ensure a uniform composition, prior to downstream process steps. Many methods exist, including: tumble blending, bin blending, and agitator mixers.
  4. Granulation: granulation is the process of combining particles into a granule. Many methods of granulation exist: wet massing/extrusion, high shear, spray, speronization, and hot melt extrusion, for example.
  5. Drying: the purpose of the drying step is to remove any excess moisture from the drug product. Drying methods include: tray , fluidized bed, and spray drying.
  6. Milling/Sieving: the purpose of this process step is to reduce granule size to conform to specification. Some methods include: impact/hammer mills, conical mills, and oscillating horizontal screens.
  7. Compression: compression is used to create tablets.
  8. Encapsulation: encapsulation is used to create capsules.
  9. Coating: coating is used to apply a coat to tablets

In the next post we’ll cover supporting equipment and quality systems. What process steps do you use in your OSD process? 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

Recovery Studies – What the Heck?!

Recovery

Hello, good people of the world! Recovery studies are studies to support surface swab processes. They typically involve “spiking” a “coupon” made from a particular material with a known amount of the contaminate you’re interested in, and then systematically quantifying the amount recovered via the swab process.

You’ll need to perform recovery studies for all product-contact materials you have in your manufacturing process. These typically include 316L stainless steel, PTFE, glass, etc.

Qualifying cGMP Warehouse Space

Warehouse

Hello, good people of the world! So you have a cGMP warehouse you need to qualify? Well, this post will provide plenty of information to get you started.

First, how do you know your warehouse is a “cGMP” warehouse. Well, it is if:

  • The warehouse will house any raw material, excipient, intermediate, or finished product
  • The warehouse will house equipment or process consumables, such as filters, bags, disposable tubing, etc.
  • Any cGMP operations will occur in the warehouse, such as sampling, dispensing, kitting, track and trace, etc.

Any examples of common or even possible non-cGMP warehouse space in the Biopharma industry? Please leave a comment below.

Continue reading Qualifying cGMP Warehouse Space