Manufacturing

Lachman Consultant Services, Inc. / Blog / Manufacturing
01
Sep

Lachman and Law Firm Arnold & Porter to Host Webinar on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

By    Sep 01, 2022    Biologics Compliance FDA Manufacturing

Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]

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10
Aug

Data Integrity Series: Episode 2

By    Aug 10, 2022    Compliance Data Integrity Emerging trends Laboratories Manufacturing Medical Devices Pharma 4.0

Traditionally, data integrity programs have focused on electronic systems, but to keep pace with the industry, your company must evolve. Achieving digital maturity requires companies to develop a multi-dimensional program of governance for their data. Learn what a well-conceived program that achieves lasting data integrity consists of. “The primary purpose of this message is solely […]

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03
Jun

Data Integrity Series: Episode 1

By    Jun 03, 2022    Compliance Data Integrity Emerging trends Laboratories Manufacturing Medical Devices Pharma 4.0

FDA warning letters have doubled since 2015 and more than 50% of observations involve data integrity. Fines up to $1 million per incident are possible. Get prepared and avoid the fines. “The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no liability for the accuracy and completeness […]

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08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

By    Dec 08, 2020    Compliance Coronavirus Data Integrity Drugs Emerging Technology Facilities FDA FDA Generics Inspections Laboratories Manufacturing Medical Devices Regulatory Affairs Science & Technology

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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30
Sep

Ensuring Manufacturing Continuity for Essential Medicines

By    Sep 30, 2020    Clinical Clinical Studies Clinical Trials Contract Manufacturers Coronavirus COVID-19 Manufacturing Quality Quality

John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster. Here is a brief excerpt from the article: “As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is […]

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08
May
Document Issued for Manufacturing Facility Information Image

Even In the Face of COVID 19, the Beat Still Goes On

By    May 08, 2020    Compliance Contract Manufacturers COVID-19 Drugs Enforcement FDA Manufacturing Quality

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

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21
Feb
Colored skittles with different sizes

Less is More!

By    Feb 21, 2020    Biologics Biosimilars BLA CBER CDER Chemistry Compliance FDA Manufacturing New Drugs Regulatory Affairs

Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA).  Specifically, the […]

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20
Feb
Linked together in logistics

Regulatory Affairs and the CMO Factor

By    Feb 20, 2020    ANDAs Bioequivalence Brand Name Drugs CDER CMC Compliance Contract Manufacturers eCTD FDA FDA Generics Manufacturing NDA Quality Regulatory Affairs

The use of contract manufacturers for the production of approved drug products has become more and more commonplace, particularly with the steady increase through the years of virtual pharmaceutical companies, a business model where the majority of the drug development and production work is outsourced to third parties as needed.  While the use of a […]

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18
Feb
Businessman examines a tablet with a magnifying glass. Concept of internet security

Out-of-Specification Investigations – Lessons Learned, or Not?

By    Feb 18, 2020    Analytical Methods Bioanalytical Bioequivalence CBER CDER Chemistry CMC Compliance Data Integrity Laboratories Manufacturing Quality

The FDA Guidance for Industry, Investigating Out‑of-Specification (OOS) Test Results for Pharmaceutical Production, was published in October 2006 (here).  The pharmaceutical industry has had about 14 years to learn how to comply to this guidance.  A quick survey of recent Form 483s and Warning Letters would indicate that there is still much to be learned […]

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13
Feb
Fingerprint

What Is It? – Identity Testing Re-visited

By    Feb 13, 2020    Analytical Methods ANDAs BLA Chemistry CMC Compliance Excipients FDA Generics Inactive ingredients IND Manufacturing NDA New Drugs OGD Quality Regulatory Affairs Safety

In earlier blogs, we have written about specific technical items related to identity testing.  However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

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