Category Archive: Compliance

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“Complete” Means “Complete”

By | January 17, 2020 | Compliance, FDA, Regulatory Affairs, Science & Technology | 2 |

“Complete” seems like a simple unambiguous word.  So why do so many firms struggle with complying with the following two predicate rules of cGMP compliance?

  • 21 CFR 211.188 Batch production and control records (here)

“Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.”

  • 21 CFR 211.194(a) Laboratory records (here)

“Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards,

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The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: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

Our Holiday Gift (or Torture) to Our Readers

By | December 19, 2019 | ANDAs, BLA, CBER, CDER, Compliance, FDA, FDA, IND, NDA, OGD, Regulatory Affairs, Science & Technology, Uncategorized | 3 |

Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer.  So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th.

To the tune of “Winter Wonderland,” this is “Winter Wonderland,

Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

Woodcock and Churchward Give Stimulating Presentations at Last Week’s ISPE Global Regulatory Summit

By | December 10, 2019 | Compliance, FDA, Quality, Regulatory Affairs, Science & Technology | 1 |

The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD.  The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”.  The conference opened with excellent keynote presentation from Janet Woodcock (Director of FDA’s Center for Drug Evaluation and Research) and David Churchward (Deputy Unit Manager,

The Case of NDMA – Is Metformin Next?

By | December 9, 2019 | ANDAs, Compliance, FDA, NDA, Regulatory Affairs, Science & Technology | Like |

N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine  (a heartburn medication) has caused nationwide recalls of the products.  Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences Authority (HSA) recently announced a recall of several lots of the product in Singapore.

Baseball Player Hitting Ball During Baseball Game In Outdoor Stadium

Training Fundamentals: Important to Baseball and the Analytical Laboratory

By | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology | 3 |

Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training.  At this time, team management is evaluating where the team succeeded and where improvement is needed.  It is interesting that the ICH Q10 Pharmaceutical Quality System guidance recommends pharmaceutical management take the same approach towards quality objectives. 

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,

CVM Issues Guidance on Enforcement Policy Regarding the Compounding of Vet Drugs Using Bulk Drug Substances

By | November 19, 2019 | Compliance, Compounding, CVM, Regulatory Affairs | Like |

In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals.

Unlike the statute and regulations for human drugs, there are no provisions for compounding animal drugs using bulk drug substances.  

Engineers examining a machine in a factory

It Is All About the “Risk”

By | November 7, 2019 | Compliance, FDA, Generics, Regulatory Affairs | 2 |

Is there a Pre-Approval Inspection (PAI)? When will it be?  Will our site be inspected?  The anxiety-tinged queries from production (and management) personnel start almost as soon as an application is submitted, and until now regulatory personnel had little answers to offer except vague reassurances like, “We have to wait and see” or “It’s up to OPQ”.  

Office of Compliance Reports Country Warning Letter Winner for 2019 Flip

By | November 5, 2019 | Compliance, FDA, Generics, Regulatory Affairs | 3 |

Donald Ashley, JD, Director of the Office of Compliance at CDER reported a rather surprising statistic relative to the country that received the most warning letters in FY 2019!  And the winner is – the United States!  Domestic firms received 54 warning letters, followed by India with 17 and China with 14.  Previous years had India or China with the dubious distinction of being issued the most warning letters.

Notice of Opportunity for Hearing Proposal to Withdraw Two ANDAs Implicates Cetero BE studies

By | October 28, 2019 | ANDAs, Compliance, FDA, Regulatory Affairs | Like |

In two separate Federal Register (FR) Notices on the FR prepublication page (here and here), the FDA proposed to withdraw approval of two ANDAs based on lack of confidence in the bioequivalence data contained in the applications.  The concern relates to a problem at a bioequivalence testing laboratory.  The Notices state:

“In May 2010 and December 2010,

Homeopathic Drugs Moving Closer to the Front Burner

By | October 25, 2019 | Compliance, FDA, Homeopathic Drugs, Regulatory Affairs | 1 |

The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products.  This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017.

Closeup of woman smoking electronic cigarette

E-Cigarettes – What Will Be Their Fate?

By | October 10, 2019 | Compliance, FDA, Regulatory Affairs | 1 |

In thinking about the current vaping issues, which have been associated with a significant number of deaths and hundreds, if not thousands, of lung-related injuries, I think the path to the future of these products needs to be critically evaluated by the FDA.  The introduction of e-cig came so fast that the FDA was not prepared to deal with the issue. 

Old Way x New Way Crossroad

Are All Methods Equivalent?

By | October 9, 2019 | BLA, Compliance, Generics, NDA, Regulatory Affairs, Science & Technology | 5 |

The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated.  Alternate methods can be easier to use and, in some instances, more accurate and reliable.  But how can you demonstrate that an alternate method is indeed equivalent to an existing method?

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