Category Archive: Data Integrity

/ Data Integrity

The Role of Risk Assessment within Data Integrity

By | January 8, 2020 | Compliance, Data Integrity, FDA, Regulatory Affairs, Science & Technology | 2 |

The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement:

“Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks”

and then further it states:

“application of QRM with identification of all areas of risk to DI through data integrity risk assessment (DIRA) and implementation of appropriate controls to eliminate or reduce risks to an acceptable level throughout the life cycle of the data”;

Happy multi-generation family holding Thanksgiving turkey together at dining table.

Hope at This Time of Giving Thanks

By | November 26, 2019 | 505(b)(2), Abuse deterrent, Accelerated Approval, Advertising, Analytical Methods, ANDAs, Approvals, Bioanalytical, Bioequivalence, Biologics, Biosimilars, BLA, Brand Name Drugs, Bulk Drugs List, CBER, CDER, Chemistry, Clinical, CMC, Combination Products, Complex Generics, Compliance, Compounders, Compounding, Controlled correspondence, CVM, Data Integrity, DEA, Device, Dietary Supplements, Drug Pricing, Drug Shortages, eCTD, Emerging Technology, Enforcement, Exclusivity, FDA, FDA, First Generics, Foods, GDUFA Fees, Generics, Guidance, Homeopathic Drugs, ICH, Imports, International, Label Changes, Labeling, Laboratories, Manufacturing, Medical Devices, NDA, New Drugs, OGD, Opioids, OTC, Petitions, PMA, Post Approval, projectsnowflake, Receipts, Regulatory Affairs, Safety, Science & Technology, Shortages, Training, Uncategorized, User Fees, Validation | 3 |

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,

Frances Zipp Shares Market Insights at the CPhI China Exhibition in Shanghai

By | June 25, 2019 | Biosimilars, Compliance, Data Integrity, Generics, Regulatory Affairs | 2 |

On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio Arias,

Happy Holidays from Us to You!

By | December 20, 2018 | ANDAs, Approvals, Bioequivalence, Biologics, Chemistry, Combination Products, Complex Generics, Compliance, Compounding, Data Integrity, Dietary Supplements, eCTD, FDA, FDA, Generics, Guidance, Manufacturing, NDA, News, OTC, Regulatory Affairs, Science & Technology, Shortages, Training, Uncategorized, User Fees, Validation | Like |

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

Revision to Data Integrity Guidance Issues

By | December 12, 2018 | Compliance, Data Integrity, FDA, Generics, NDA, Regulatory Affairs, Science & Technology | 1 |

Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here).  The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.”

The guidance does have additional examples and clarifying language. 

Close-up of unrecognizable laboratory worker viewing statistical data while analyzing result of DNA test

The Importance of Trending During Laboratory Investigations

By | October 1, 2018 | Compliance, Data Integrity, FDA, Science & Technology | 2 |

It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action.  However, what can get overlooked during the investigation process is the importance of trending.  This is a key component of root cause confirmation, assessing the appropriateness and effectivity of corrective action and determining whether there are any underlying cause/s for noted repeat incidents.

Awareness And Precision Are Key To Manufacturing Data Integrity

By | September 7, 2018 | Compliance, Data Integrity, Manufacturing, Science & Technology | Like |

The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory.

The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the data compliance issues that have plagued the laboratories are relevant to areas such as manufacturing.