Compliance Archives - Lachman Consultant Services, Inc.

Supply Chain Resilience and the Value of Digitization and Data Themed at the 2023 ISPE Europe Annual Conference in Amsterdam

By Scott Deckebach May 15, 2023 Compliance Data Integrity Validation

Amsterdam’s iconic concentric circles of interlocking canals, its international appeal and its historical role in shaping our modern world provided the perfect backdrop for the 2023 ISPE Europe Annual Conference which, in Amsterdam fashion, served as a focus for some of the pharmaceutical industry’s most important and contemporary challenges –forces which will most certainly reshape […]

May

Digitization and Future Highlighted at the May PDA Robotics and Automation Conference in Amsterdam

By Scott Deckebach May 08, 2023 Compliance Data Integrity FDA Regulatory Affairs

The 2023 PDA Robotics and Automation Conference, which just concluded in Amsterdam, Netherlands, highlighted the significant new value and promise of advanced technologies, robotics, automation and digitization across the pharmaceutical value chain from clinical to manufacturing to distribution, and for all sectors including small and large molecule and medical device. Conference presentations and panels highlighted […]

May

Regulatory Due Diligence for Drugs – Hidden Surprises?

By Bob Kelly May 03, 2023 Compliance Due diligence FDA Regulatory Affairs

Many companies are always on the lookout for in‑licensing opportunities and/or product acquisitions to boost their product portfolio or to quickly fill voids in their development program. Given the cost outlay for such opportunities and their associated risks, it is imperative that due diligence of these new potential assets is performed by qualified individuals who […]

May

Are You Initiating Quality Investigations When Required?

By Paul Mason, PhD. May 03, 2023 Compliance FDA Investigations Quality

When a firm is evaluating the effectiveness of their investigation program (as part of assessing the effectiveness of the Quality Management System (QMS)) the focus tends to be towards evaluating the quality / robustness of the resulting investigations. However, one of the questions that should also be asked is are investigations being initiated when required? […]

May

Another Unapproved Drug a Slap in the Face

By Bob Pollock May 02, 2023 Compliance FDA Regulatory Affairs Unapproved New Drugs

FDA has warned consumers not to use two products containing ammonia chloride, “Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy.” The Agency says, “Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction” and it “has received reports of adverse events […]

Apr

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

By Bob Pollock Apr 05, 2023 ANDAs API BLA Compliance Drug Shortages FDA NDA

The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]

Apr

503B Outsourcing Facilities Batting 1 for 11 in This Round of Bulk Substances Reviewed

By Bob Pollock Apr 05, 2023 503B Compliance Compounding FDA Regulatory Affairs

The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]

Mar

FDA Issues Draft Guidance with Definitions of Terms in Drug Supply Chain Security Act (DSCSA)

By Bob Pollock Mar 16, 2023 Compliance DSCSA FDA Quality Regulatory Affairs

Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here). The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]

Mar

Are You a “Bee-Watcher-Watcher”?

By Mrinmoy Nag Mar 09, 2023 Compliance FDA Quality Regulatory Affairs

Have you ever wondered why, in many airports across different countries, there are multiple random security checks after the initial check at the entrance and before boarding the plane? Do all these intermediate checks make flying much safer? Are intermediate checks required because the initial check may not be trustworthy, or are they intended to […]

Mar

FDA Announces Dietary Supplement List

By Bob Pollock Mar 07, 2023 Compliance Dietary Supplements FDA Regulatory Affairs

In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them. This is a confusing area for the […]

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