Saturday, May 12, 2018
Friday, May 11, 2018
Best Practices for Shipping Single-Use Systems
A thorough understanding of the distribution cycle and potential transportation risks is required. In this article, Elisabeth Vachette, senior product manager, and Jean-Marc Cappia, vice-president of marketing, both at Sartorius Stedim Biotech FMT, Aubagne, France, share with Pharmaceutical Technology some of the key issues and challenges involved, and how to meet them effectively.
Regulatory issues
PharmTech:Which regulations and standards govern long-distance shipping of liquids in single-use systems?
Vachette:Currently, there is no dedicated regulatory guidance on the subject. FDA, the European Medicines Agency (EMA), and other regulatory bodies require that companies have qualified processes and can prove that the process will meet the quality standards of the final drug product.
[Neither FDA nor EMA] provide very specific requirements. They want end users to be in control of their processes. What they say is that the process of drug making should be qualified, whether that involves filtration, bag or virus inactivation, transportation, or storage space during manufacturing.
It is up to end users to establish documented evidence providing assurance that processes are under control and meeting specs and defined quality attributes (i.e., that the process is stable, robust, and free of any leakage or contamination).The Parenteral Drug Association’s (PDA) technical report TR66 recommends that shipping systems be qualified for intended use through “proper design and testing in consultation with a packaging engineer.”
Conditions for international shipment must be defined. They can be based on international standards such as the American Society for Testing and Materials’ (ASTM) D4169 or the International Safe Transit Association (ISTA) 3 series (Tables I and II). The level of severity for test conditions must be based on real-world shipping conditions. We recommend a holistic, four-step approach (Figure 1).
Technical challenges
PharmTech: What major technical challenges do pharma and biopharma companies face when shipping liquids in single-use systems over long distances by air or sea?
Cappia: The first and main challenge is preserving product integrity within the bag, and the robustness and integrity of the system. Any leaks or bacterial ingress must be prevented.
During shipping, bags can move, resulting in water hammer and stress. The challenge for the supplier is, first, to design systems that can pass these tests. Currently, single-use systems use better films and technologies than they did in the past, so the bags can more readily pass ASTM test requirements, which are very aggressive.
Once the integrity and robustness challenge is overcome, end users must monitor the shocks and temperature variations that the pharmaceutical product can experience when it is shipped to its destination.
Vachette: For liquid shipping, there is a need first to understand the distribution cycle, what is really happening, and what kind of shipping transportation means you are using. By knowing the distribution cycle, process validation will integrate severe conditions over the normal distribution cycle in order to provide correct and meaningful qualification. This approach allows end users to validate processes in worst-case conditions.
ASTM’s testing involves worst-case conditions, and also requires monitoring that enables the complete traceability of product, which might include tracking temperature.
The responsibility is to define the distribution cycle. End users select a supplier of transport services and a means of transporting the product (i.e., dedicated shipment, during which product is passed in a controlled way).
For exceptions, they will use a dedicated truck with cold-chain management. The approach that is used depends on the transportation supplier, although our company offers contract supply chain management and testing services for this type of process validation.
Outsourcing testing
PharmTech: Which aspects of testing and data collection can be outsourced for single-use shipping?
Cappia: We have qualified on ASTM standards and can supply technical data to provide a view of the regime and the constraints and stresses we have applied during testing, in terms of vibrations, shocks, and shakes.
In addition, when manufacturers are simulating shipping conditions, they can send us the bags to check for integrity. We can either make a pressure or ink tests on the bag, or perform bacterial ingress tests on the bags. We offer these services to support customer validation, since they must simulate shipping conditions and ensure that results are within the proper framework.
The industry’s understanding of shipping requirements varies
PharmTech: Are most biopharmaceutical companies already aware of what they need to do to validate single-use shipping for liquid products, or are they leaving any vital steps out of the plannint process?
Vachette: The level of understanding varies. Some companies, for example, the large biotech companies, are very well prepared and understand exactly what they need to include in their validation efforts. But that is not the case for all of the smaller and mid-sized manufacturers. As a vendor, we believe that we can play a role in educating manufacturers on what is required, and providing the testing services themselves if and when needed.
Article Details
Pharmaceutical Technology
Vol. 42, No. 5
May 2018
Pages: 55–57, 61
Citation
When referring to this article, please cite it as A. Shanley, “Best Practices for Shipping Single-Use Systems,” Pharmaceutical Technology 42 (5) 2018.
Two day Process Validation Guidance Requirements Workshop: FDA and EU Annex 15 – Qualifications and Validation (Boston, United States – July 7th-8th, 2018) – ResearchAndMarkets.com | Technology
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management.
The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.
Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.
This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.
What FDA segments are included and excluded within the “NEW” Process Validation.Where does the Process Validation commence.What are the Three Stages and Where DThey Apply within the NEW Process Validation.How Stage 1 integrates with Phase 1.The Validation approaches that are included within this Guidance document.The Statutory and Regulatory Requirements for Process Validation.An Introduction tPhase 1 Guidance for Industry and Its Application within the “NEW” Process Validation.The Phase 1 Investigational Drug Requirements — What is and What is NOT Required.General Considerations for Process Validation – Stage 2 Process Qualification.Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.General Considerations for Process Validation – Stage 3 Continued Process Verification.A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance.
Laura Wood, Senior Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Pharmaceutical Manufacturing
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
Copyright Business Wire 2018.
PUB: 05/10/2018 12:23 PM/DISC: 05/10/2018 12:23 PM
Copyright Business Wire 2018.
Thursday, May 10, 2018
Two day Process Validation Guidance Requirements Workshop: FDA and EU Annex 15 – Qualifications and Validation (Boston, United States – July 7th-8th, 2018) – ResearchAndMarkets.com | Business
DUBLIN–(BUSINESS WIRE)–May 10, 2018–The “Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop ” conference has been added to ResearchAndMarkets.com’s offering.
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management.
The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.
Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.
This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.
Learning Objectives:
What FDA segments are included and excluded within the “NEW” Process Validation.Where does the Process Validation commence.What are the Three Stages and Where DThey Apply within the NEW Process Validation.How Stage 1 integrates with Phase 1.The Validation approaches that are included within this Guidance document.The Statutory and Regulatory Requirements for Process Validation.An Introduction tPhase 1 Guidance for Industry and Its Application within the “NEW” Process Validation.The Phase 1 Investigational Drug Requirements — What is and What is NOT Required.General Considerations for Process Validation – Stage 2 Process Qualification.Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.General Considerations for Process Validation – Stage 3 Continued Process Verification.A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance.
For more information about this conference visit https://www.researchandmarkets.com/research/22rbv4/two—day—process?w=4
View source version on businesswire.com:https://ift.tt/2rzGPAN
CONTACT: ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Pharmaceutical Manufacturing
KEYWORD:
INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
Copyright Business Wire 2018.
PUB: 05/10/2018 12:23 PM/DISC: 05/10/2018 12:23 PM
https://ift.tt/2I7uTBF
Copyright Business Wire 2018.
MetroWest Business Digest for May 10, 2018 – News – MetroWest Daily News, Framingham, MA
Information Security Summit slated for May 24
MassBay Community College and Towerwall will hold the sixth annual Information Security Summit from 7:30 a.m. to 1:30 p.m. May 24 at the MassBay Wellesley Hills campus, 50 Oakland St. Attendees will learn from industry experts as they share their experience and knowledge regarding guiding principles of information security, user awareness, training/social engineering, cloud and security, threats and ransomware, risk management and compliance, enabling the summit participants to connect through the leaders driving innovation in the security sector. This year’s keynote address will be given by Bob Bragdon, senior vice president and publisher of CSO, the leading information resource for security, risk and privacy executives. Bragdon leads all operations for the full CSO product line, including http://CSOonline.com, the CSO portfolio of national and regional events and the Security Smart Newsletter. During his keynote, he will be discussing “Building a secure business: from culture to cloud”. Preregistration is required and a $45 registration fee does apply. To register: https://bit.ly/2FWjoqK. For information: http://massbay.edu/iss.
Great Elm Capital Corp.announce stockholder approval
Great Elm Capital Corp., of Waltham, an externally managed, business development company focused on investing in debt instruments of leveraged middle market issuers, recently announced that a majority of the stockholders of the company approved the application of the modified minimum asset coverage requirements set forth in Section 61(a)(2) of the Investment Company Act of 1940, as amended, in accordance with the Small Business Credit Availability Act (“SBCAA”) that was signed into law on March 23. As a result of such approval, and subject to satisfying certain ongoing disclosure requirements under the SBCAA, effective May 4, the asset coverage ratio test applicable to the Company has been decreased from 200 percent to 150 percent, permitting the company to incur additional leverage.
Technical Communications Corporation announces results
Technical Communications Corporation, of Concord, announced its results for the three and six month periods ended March 31. For the three months ended March 31, the company reported a net loss of $313,000, or $0.17 per share, on revenue of $930,000, compared to net income of $128,000, or $0.07 per share, on revenue of $1,385,000 for the quarter ended April 1, 2017. For the six months ended March 31, the company reported a net loss of $365,000, or $0.20 per share, on revenue of $2,046,000, compared to a net loss of $567,000, or $0.31 per share, on revenue of $2,017,000 for the six months ended April 1, 2017.
Proteon Therapeutics announces contract extension
Proteon Therapeutics, of Waltham, a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, recently announced a long-term contract extension with Lonza Pharma & Biotech for the commercial supply of investigational vonapanitase’s active pharmaceutical ingredient. Lonza has manufactured API for Proteon at its microbial manufacturing facility in Visp since 2009. Initially, a small-scale process was transferred into Lonza’s development labs for process optimization and consistency studies. The process was then scaled up to 1,000L scale cGMP manufacture to support Proteon’s early clinical studies and potential commercial requirements. As Proteon worked to complete enrollment in its ongoing phase three clinical trial, PATENCY-2, Lonza supported Proteon with three process validation batches at 1,000L commercial scale, each of which met the intended release criteria. If PATENCY-2 is successful, Proteon expects to include results from these validation runs in a potential Biologics License Application filing in the second half of 2019, which Lonza will support.