GMP Obligations for Small and Medium Enterprises (SMEs): GMP Clearance processes – common mistakes made with applications

1. GMP Clearance – Common mistakes made
Stephen Farrell and Darika Sowana
Clearance Section, Manufacturing Quality Branch
Medical Devices and Product Quality Division, TGA
GMP Forum, 26 June 2018

2. Topics
• Australian regulatory guidelines
• Different regulatory frameworks
• Scope, Code tables and product lodgement systems
• Evidence
• E-form selections
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3. Australian regulatory guidelines
• All steps of manufacture are required to be GMP compliant unless
they are exempt.
• GMP clearance is not necessarily required unless the product is to
be registered or listed and the manufacturing step recorded on the
Australian Register of Therapeutic Goods (ARTG).
• The Australian Regulatory Guidelines (ARG) for different product
classes are located on the TGA website
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4. Australian regulatory guidelines
• These include:
− ARGCM (Complimentary Medicines)
− ARGOM (Over the counter Medicines)
− ARGPM ( Prescription Medicines)
− ARGB (Biologicals)
• They contain important information regarding product quality and
GMP requirements
• This may include whether or not GMP clearance is possible or even
required for your product registration or listing
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5. Australian regulatory guidelines
Common issues seen in GMP Clearance section:
• GMP clearances are submitted by applicants when they are not
permitted to use the MRA or CV pathways (For example, Biological
manufacturers or testing labs)
• GMP clearances submitted by applicants when they are not required
for registration or listing (For example, milling or micronisation of
Active Pharmaceutical Ingredient (API)
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6. Different Regulatory Frameworks
• Every international regulatory authority has their own unique
regulatory framework
• Differences between these frameworks become extremely important
when using the GMP clearance process
• This is because the standards used during an overseas regulators
inspection may not be equivalent to that which would be applied to
Australian manufacturers. For example:
− some complementary and listed medicines, including
sunscreens may not be regulated as medicines in other
countries
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7. Different Regulatory Frameworks
Common issues seen in GMP Clearance section:
• GMP clearances are submitted by applicants when the evidence
provided is not equivalent to the Australian manufacturing
principles
• An example of this is a manufacturing facility located in the USA
which was inspected by the USFDA to the dietary supplements
compliance program and not the drug compliance program.

8. • Selecting the appropriate scope for your GMP clearance application
is extremely important
• The TGA code tables are quite extensive and there are a range of
different options to select for both dosage forms and manufacturing
steps
• The code tables are used across the TGA for various purposes
Scope, code tables and product lodgement systems
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9. • The scope of your GMP clearance application should align with
the supporting evidence you intend to provide as much as possible
• Incorrect selections can result in significant delays to processing
times and even validation errors on product lodgement systems
• These systems are designed to limit the dosage forms and
manufacturing steps required for the specific product types
Scope, code tables and product lodgement systems
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10. Evidence
Common evidence issues seen in GMP Clearance section:
• All evidence has not been provided
• Does not meet the requirements outlined in the GMP clearance
guidance
• Evidence has expired or been superseded
• Does not cover the scope of the GMP clearance application
• Has not been translated by an independent and certified translator
• Is unclear and ambiguous
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11. E-Form Selections
• The re-designed e-forms introduced several questions which are
used to appropriately identify the type and quality of the application
upfront
• To work effectively it is solely dependent on user selections being
accurate
• Incorrect selections can result in significant delays to processing
times or incorrect fees being applied to your applications
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12. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Incorrect application type selected
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13. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Selecting new manufacturer when existing
manufacturer is available for selection
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14. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Selecting the correct dosage form and scope
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15. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Not selecting the regulatory submissions type linked to the GMP
clearance
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16. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Not selecting the correct option resulting in no fees being raised
• Uploading inspection cover letters instead of GMP certificates or
requesting TGA to liaise
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17. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Incorrectly selecting N/A for the applicable evidence for your
application type
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18. E-Form Selections
Common e-form issues seen in GMP Clearance section:
• Not entering Letter of Access in the delivery methods in mandatory
evidence resulting in no validation of existing clearance to occur
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19. Questions?
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