InstantGMP Compliance Series - Improving Batch Production RecordsInstantGMP™
Batch record violations were frequently cited during FDA inspections of dietary supplement manufacturers. This presentation provides some guidance on what is needed for batch records to be in compliance with GMPs.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...MilliporeSigma
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest procss technologies wthin innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring systems
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
InstantGMP Compliance Series - Improving Batch Production RecordsInstantGMP™
Batch record violations were frequently cited during FDA inspections of dietary supplement manufacturers. This presentation provides some guidance on what is needed for batch records to be in compliance with GMPs.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...MilliporeSigma
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest procss technologies wthin innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring systems
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
Bilcare Global Clinical Supplies is a leading global provider of Clinical Trial Materials (CTM) services to the pharmaceutical and biotechnology industries.
Bilcare GCS is a business unit of Bilcare Ltd. - an innovation-led solutions provider that partners with the global pharmaceutical and healthcare industry to improve patient healthcare outcomes.
LGM Pharma | Drug Research & Development APIsLGM Pharma
LGM Pharma is a leading innovative U.S. supplier and distributor of active pharmaceutical ingredients (APIs) to pharmaceutical, manufacturing, biotech, and pharma R&D markets.
Proven Process Medical Devices, Design, Development, Testing, and ManufactureMichael Kanis
Medical Device, Diagnostics, Therapeutics, Surgical tools, FDA, QSR, Therapeutics, Implantables, Drug Delivery Pumps, RF Ablation Devices, Project Management, Class 7 clean room, High risk Class II and III devices.
2. Vision
“By 2012, Biotec will be the market leader in cold chain pharmaceutical services,
headquartered in the UK with a global presence. We will achieve this through a
highly skilled, motivated team using best practice and technological advances.”
Mission
We ensure that patients’ and clients’ needs are at the forefront of our business
whether the medicines are for clinical trials or everyday use.
3. Background Core Services
Founded 1997 QP & GMP Consultancy
Privately owned Clinical Supply
Purpose built facility Unlicensed medicines
Queen’s Award for Enterprise 2009 Marketed Product
Cold chain specialists Logistics
Fully licensed & inspected by MHRA Stand-alone storage
4. Biotec’s wide product experience includes:
• Biopharmaceuticals • Small molecules
Monoclonal antibodies Oral
Vaccines Injectables
Therapeutic proteins Topicals
Inhalation products
• Advance Therapy Medicinal products
Stem cells •Controlled drugs
Gene therapies (schedules 3 and 4)
Tissue Engineered product
• Devices
For patient use
For surgical use
5. QP & GMP Consultancy
• 6 QPs with wide experience • Assistance with:
of all core areas EU regulatory requirements
• Manufacturing process Label text compliance
review and development Blinding issues
• Facility development
• Batch certification
• IMPD review
• QP audits and familiarisation visits
for IMP and Marketed Product
importation
6. Protocol interpretation
for kit design and
supply strategy
Clinical Supply: Returns and destruction
IVR and IWR
controlled studies
Global distribution Product
specification file
Expiry date (PSF) set up
extension
Randomisation
schedules and
Patient Pack decode options
assembly
Primary packing Sourcing of comparators
and ancillary products
Label and leaflet
design, translation and
printing using Prisym
software
7. Unlicensed medicines
• Management of unlicensed medicines • Compassionate Use:
(treatment of patients under Continuation of treatment following
the responsibility of the physician) participation in a clinical trial
• Named Patient • Biotec can assist with:
UK “Specials” legislation, commonly Import authorisation
known as “Named Patient” Labelling and assembly
France – ATU QA release
US – expanded access Global distribution
8. Marketed Pharmaceuticals
• Biotec can assist with: • Biotec specialises in small batches
Artwork generation for niche markets
Multi language label and leaflet design,
• Low temperature
translation and printing
and difficult-to-handle products
Label and assembly
QP certification
Management of invoicing on behalf
of licence holder
9. Biotec can provide the following Logistics
services (Import and Export services)
• Fully qualified shipping systems • A range of temperature monitors to suit
for transport of product at: the specified temperatures
15 to 25ºC
• GMP storage and re-packaging
2 to 8ºC for trans-shipments
-15 to -25ºC
• Product – specific qualification of shippers
-60 to -80ºC
& transport systems to meet individual needs
-140ºC
• A range of specialist courier options
• Preparation of shipping documentation
• Depots for storage and distribution
Customs invoices
where appropriate
Shipping declarations
10. Biotec offers:
• Temperature controlled storage at • Cold rooms and freezers have
Controlled ambient (+15 to +25ºC) back-up condensers
Refrigerated (+2 to +8ºC)
• Customised non-standard storage
Frozen (-15 to -25ºC)
solutions on request
Ultra-low temp (-80ºC)
Vapour (-140ºC) or Liquid Nitrogen (-196ºC) • Available capacity
• All areas fully validated, temperature
mapped, monitored and linked
to emergency back-up