Food packaging

• 17

  Guideline on the pharmaceutical quality of inhalation and
  nasal medicinal products

  18

  Table of contents

  19

  Executive summary ..................................................................................... 3

  20

  1.

• Lifecycle management ........................................................................................ 28

  49

  Definitions ................................................................................................. 29

  16

  50
  51

  Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
  EMA/CHMP/20607/2024

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  52

  Executive summary

  53

  This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

  54

  products (EMEA/CHMP/QWP/49313/2005 Corr).

• Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

  66

  safety testing (e.g., for excipients and leachables) is also considered.

• 69

  Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

  70

  analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

  71

  impactor analysis) is not included in this guideline.

• Scope

  74

  The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

  75

  new marketing authorisation applications, including abridged applications.

• Liquid inhalation anaesthetics and nasal ointments, creams and gels are

  88

  excluded, however the general principles described in this guideline should be considered.

• 118

  Different polymorphic forms including any amorphous content could affect the quality or performance

  119

  of the finished medicinal product.

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  132

  The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

  133

  components required for reasons of stability should be described.

• Pharmaceutical
  development study

  (a) Physical
  characterisation
  (b) Minimum fill
  justification
  (c) Extractable
  volume

  Pressurised

  Dry powder

  Preparations for

  Non-

  metered-

  inhalers (DPI)

  nebulisation

  pressurised

  dose

  metered-

  Device-

  Pre-

  Single-

  Multi-

  (pMDI)

  metered

  metered

  dose

  dose

  inhalers

  Yesa

  Yes

  Yes

  Yesa

  Yesa

  Yesa

  Yes

  Yes

  Yes

  Yes

  Yes

  Yes

  No

  No

  No

  Yes

  No

  No

  inhalers

  Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
  EMA/CHMP/20607/2024

  dose

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  Table 4.2.1.

• The last doses delivered by

  Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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  179

  the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

  180

  for delivered dose and fine particle dose.

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  263
  264

  4.2.2.8.

• Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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  345

  Instructions regarding cold temperature use should be provided in the product information.

• Finished medicinal
  product

  Pressurised

  Dry powder inhalers

  Preparations for

  metered-

  (DPI)

  nebulisation

  dose

  Nonpressurised
  metered-dose

  Device-

  Pre-

  Single-

  Multi-

  (pMDI)

  metered

  metered

  dose

  dose

  inhalers

  (a) Description

  Yes

  Yes

  Yes

  Yes

  Yes

  Yes

  (b) Assay

  Yes

  Yes

  Yes

  Yes

  Yes

  Yes

  (c) Moisture content

  Yes

  Yes

  Yes

  No

  No

  No

  Yes

  Yes

  Yes

  No

  No

  Yes

  Yes

  Yes

  Yes

  No

  No

  Yes

  specification test

  (d) Mean delivered
  dose
  (e) Uniformity of
  delivered dose

  inhalers

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  Table 4.2.2.

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  510

  4.2.5.4.

• The proposed specification limits should take into account the shelf-life performance of the
  Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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  552

  medicinal product.

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  586

  All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

  587

  outlined in the Medical Device Regulation (EU) 2017/745.

• Stability (CTD 3.2.P.8)

  598

  All inhalation medicinal products should be tested on stability against the stability indicating tests

  599

  included in the finished medicinal product specification.

• Quality data requirements as

  619

  described in this guideline should be met, supplemented by appropriate comparative quality and

  620

  clinical data with respect to the chosen reference medicinal product.

• 621

  For inhalation medicinal products comparative in vitro data between the abridged application medicinal

  622

  product and the reference medicinal product must be provided.

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  670

  Nature and contents of container: The type of the device and its components should be listed.

• Nasal medicinal products

  695

  Inhalation and nasal medicinal products have many similarities and therefore, most of the

  696

  requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

  697

  products.

• One difference between inhalation and nasal medicinal products is the desired

  698

  particle/droplet size of the finished medicinal product.

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  704

  5.2.

• Nasal liquids
  Pharmaceutical
  development
  study

  Pressurised

  Nasal

  metered-

  powders,

  dose nasal

  device-

  spray

  metered

  NonSingledose
  drops

  Multidose
  drops

  Single-

  pressurised

  dose

  multidose

  spray

  metereddose spray

  (a) Physical
  characterisation
  (b) Minimum fill
  justification
  (d) Extractables /
  leachables

  Yesa

  Yes

  Yesa

  Yesa

  Yesa

  Yesa

  Yes

  Yes

  Yes

  Yes

  Yes

  Yes

  Yes

  No

  Yes

  Yes

  Yes

  Yes

  Yes

  Yes

  No

  No

  Yes

  Yes

  Yes

  Yes

  No

  No

  No

  Yes

  Yes

  Yes

  No

  No

  Yes

  Yes

  (f) Particle /
  droplet size
  distribution
  (g) Uniformity of
  delivered dose
  through container
  life
  (j) Actuator /
  mouthpiece
  deposition

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  Table 5.2.1.

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  728

  5.2.2.2.

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  769

  5.2.5.

• Quality data requirements as described in

  799

  this guideline should be met, supplemented by appropriate comparative quality and clinical data with

  800

  respect to the chosen reference medicinal product.

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  849

  5.5.

• 866

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  867

  Definitions
  Activation:

  The act of setting in motion the delivery device.

• Delivery device:

  The sum of component(s) of the container closure system responsible for
  delivering the active substance to the respiratory tract (inhalation medicinal
  product) or the nasal and/or pharyngeal region (nasal medicinal product).

• Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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  Label claim:

  The amount of active substance (usually on a per actuation basis) declared
  on the label of the medicinal product.

• Nasal medicinal

  A finished medicinal product (including the delivery device, where

  product:

  applicable) whose intended site of deposition is the nasal and/or pharyngeal
  region.

• 868
  Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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• The U.S. Environmental Protection Agency now believes there is no safe level for two common PFAS – PFOA and PFOS – in drinking water, and it acknowledges that very low concentrations of other PFAS present human health risks.
• The agency issued the first legally enforceable national drinking water standards for five common types of PFAS chemicals, as well as PFAS mixtures, on April 10, 2024.

What exactly are PFAS?

• This is a large group of human-made chemicals – currently estimated to be nearly 15,000 individual chemical compounds – that are used widely in consumer products and industry.
• They can make products resistant to water, grease and stains and protect against fire.

• The short answer is that PFAS are harmful to human health and the environment.
• Some of the very same chemical properties that make PFAS attractive in products also mean these chemicals will persist in the environment for generations.
• The U.S. Geological Survey estimates common types of PFAS are now in at least 45% of the country’s tap water.

What are the health risks from PFAS exposure?

• Research consistently demonstrates that PFAS are associated with a variety of adverse health effects.
• A review by a panel of experts looking at research on PFAS toxicity concluded with a high degree of certainty that PFAS contribute to thyroid disease, elevated cholesterol, liver damage, and kidney and testicular cancer.

• Additionally, current research suggests that babies exposed prenatally are at higher risk of experiencing obesity, early-onset puberty and reduced fertility later in life.
• Collectively, this is a formidable list of diseases and disorders.

Who’s regulating PFAS?

• DuPont called it Teflon, which eventually became a household name for its use on nonstick pans.
• Decades later, in 1998, Scotchgard maker 3M notified the Environmental Protection Agency that a PFAS chemical was showing up in human blood samples.
• At the time, 3M said low levels of the manufactured chemical had been detected in people’s blood as early as the 1970s.
• The Agency for Toxic Substances and Disease Registry has a toxicological profile for PFAS.

How can you reduce your PFAS exposure?

• The best ways to protect yourself and your family from risks associated with PFAS are to educate yourself about potential sources of exposure.
• Products labeled as water- or stain-resistant have a good chance of containing PFAS.
• Strategies for monitoring and reporting PFAS contamination vary by location and PFAS source, so the absence of readily available information does not necessarily mean the region is free of PFAS problems.

Kathryn Crawford receives funding from National Institutes of Health and US Geological Survey.

• SAYREVILLE, N.J., April 09, 2024 (GLOBE NEWSWIRE) -- Sabert Corporation, a leading global manufacturer of innovative food packaging solutions, today announced the launch of its new line of Pulp Protein and Produce Trays.
• The Pulp 2S Produce Tray caters to the growing consumer trend of hybrid cooking, blending meal planning, meal kits and ready-to-eat items.
• Engineered with Sabert's Pulp Plus™ molded fiber blend, the Pulp Produce Tray is refrigerator safe for up to seven days.
• For more information about Sabert's Pulp Produce and Protein Trays, please visit www.sabert.com .

• Celanese Corporation (NYSE: CE), a global specialty materials and chemical company, today announced several strategic milestones at its Clear Lake, Texas, and Nanjing, China, plants to enhance the competitive cost position, sustainable footprint and operational flexibility of the Acetyl Chain (AC) business and allow it to meet future demand growth.
• The low-carbon methanol can provide customers with low-carbon ECO-CC AC and Engineered Materials downstream products for a wide range of consumer applications.
• The startup of a new vinyl acetate ethylene (VAE) unit in Nanjing and completion of global, low-capital downstream redispersible polymer powders (RDP) debottlenecking projects.
• The Celanese subsidiary, Celanese (Nanjing) Chemical Co. Ltd., has extended its CO Phase II contract with Nanjing Chengzhi Clean Energy Co., Ltd. for the supply of carbon monoxide to its facility in Nanjing.