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

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Related Topics:Pharmaceutical Manufacturing

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INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

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PUB: 05/10/2018 12:23 PM/DISC: 05/10/2018 12:23 PM

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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.

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Porvair offers validation services for pharmaceutical industry

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Yada/shutterstock.comPart one of this article introduced the concept of sampling distribution of acceptance value (AV) in uniformity of dosage units (UDU) (1). With different sample sizes such as n= 10 and 30, their AV distributions will be different, resulting in different critical AV values (i.e., the values at the locations covering 95% of the distributions that are equal to, for example, 12.5 and 9.1 for n = 10 and 30, respectively). Such critical values will be employed as AV working limits rather than using the single compendial limit of not more than (NMT) 15 (2). 

Part two of this article described how to establish the corresponding acceptance limits for AV data for process validation batches as well as the typical characteristics of AV distributions. 

Click here to view a PDF of this article.

Peer-Reviewed

Submitted: February 22, 2018
Accepted: March 27, 2018

About the Author

Pramote Cholayudth is validation consultant to Biolab Co., Ltd. in Thailand. He is the founder and manager of PM Consult, [email protected].

Article Details

Pharmaceutical Technology
Vol. 42, No. 5
May 2018
Pages: 34–44

Citation

When referring to this article, please cite it as P. Cholayudth, “Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3,” Pharmaceutical Technology 42 (5) 2018. 

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